Trial Outcomes & Findings for An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor (NCT NCT01557348)
NCT ID: NCT01557348
Last Updated: 2017-01-24
Results Overview
The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour \[mm/hr\]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.
Recruitment status
COMPLETED
Target enrollment
1239 participants
Primary outcome timeframe
Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6
Results posted on
2017-01-24
Participant Flow
This observational study was conducted in 11 countries from 02 June 2009 to 19 March 2012.
Of 1239 enrolled participants, 9 had no information on second biologic treatment/reasons for discontinuing prior tumor necrosis factor inhibitor (TNFi), 1111 had one previous TNFi,119 had more than one previous TNFi. Of 1111 participants, 728 were considered for primary effectiveness analysis (405 in Rituximab arm and 323 in Alternative TNFi arm).
Participant milestones
| Measure |
Rituximab
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Alternative TNFi
Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
604
|
507
|
|
Overall Study
Safety Population
|
604
|
507
|
|
Overall Study
COMPLETED
|
524
|
417
|
|
Overall Study
NOT COMPLETED
|
80
|
90
|
Reasons for withdrawal
| Measure |
Rituximab
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Alternative TNFi
Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
16
|
|
Overall Study
Infusion reaction event
|
5
|
5
|
|
Overall Study
Death
|
7
|
4
|
|
Overall Study
Insufficient Therapeutic Response
|
13
|
28
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
26
|
22
|
|
Overall Study
Administrative
|
18
|
11
|
Baseline Characteristics
An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor
Baseline characteristics by cohort
| Measure |
Rituximab
n=405 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Alternative TNFi
n=323 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Total
n=728 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 12.61 • n=99 Participants
|
54.7 years
STANDARD_DEVIATION 13.26 • n=107 Participants
|
55.7 years
STANDARD_DEVIATION 12.93 • n=206 Participants
|
|
Gender
Female
|
310 Participants
n=99 Participants
|
259 Participants
n=107 Participants
|
569 Participants
n=206 Participants
|
|
Gender
Male
|
95 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.
The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour \[mm/hr\]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.
Outcome measures
| Measure |
Alternative TNFi
n=323 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=405 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6
|
-1.1 scores on a scale
Standard Error 0.23
|
-1.5 scores on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.
The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour \[mm/hr\]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.
Outcome measures
| Measure |
Alternative TNFi
n=266 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=332 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12
|
-1.2 scores on a scale
Standard Error 0.29
|
-1.5 scores on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'.
The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). A total of 28 joints were assessed for tenderness. Decrease in score indicated an improvement in disease activity.
Outcome measures
| Measure |
Alternative TNFi
n=255 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=338 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in TJC at Months 6 and 12
Month 6 (n= 338, 255)
|
-4.5 tender joints
Standard Error 1.24
|
-5.7 tender joints
Standard Error 1.20
|
|
Least Squares Mean Change From Baseline in TJC at Months 6 and 12
Month 12 (n= 281, 216)
|
-3.7 tender joints
Standard Error 1.36
|
-4.7 tender joints
Standard Error 1.29
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'.
The SJC is the most specific clinical method to quantify abnormalities in participants with RA. A total of 28 joints were assessed for swelling. Decrease in the score indicated improvement in disease activity.
Outcome measures
| Measure |
Alternative TNFi
n=256 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=339 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in SJC at Months 6 and 12
Month 6 (n= 339, 256)
|
-2.8 swollen joints
Standard Error 0.97
|
-3.3 swollen joints
Standard Error 0.93
|
|
Least Squares Mean Change From Baseline in SJC at Months 6 and 12
Month 12 (n= 283, 215)
|
-2.4 swollen joints
Standard Error 1.04
|
-2.7 swollen joints
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'.
C-reactive protein (CRP) is an inflammation marker. Normal range is from 0-10 milligram/Liter. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity.
Outcome measures
| Measure |
Alternative TNFi
n=227 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=278 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12
Month 6 (n= 278, 227)
|
-29.9 milligram/Liter
Standard Error 8.43
|
-29.1 milligram/Liter
Standard Error 7.95
|
|
Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12
Month 12 (n=251, 199)
|
-15.3 milligram/Liter
Standard Error 8.91
|
-11.6 milligram/Liter
Standard Error 8.47
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'.
The ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells sediment in a period of one hour. Normal range is 0-30 mm/hr. A reduction in the level of ESR is considered as an improvement in disease activity.
Outcome measures
| Measure |
Alternative TNFi
n=250 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=343 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in ESR at Months 6 and 12
Month 6 (n= 343, 250)
|
-7.0 mm/hr
Standard Error 4.22
|
-13.2 mm/hr
Standard Error 3.91
|
|
Least Squares Mean Change From Baseline in ESR at Months 6 and 12
Month 12 (n=297, 215)
|
-8.6 mm/hr
Standard Error 4.90
|
-11.6 mm/hr
Standard Error 4.58
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'.
Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.
Outcome measures
| Measure |
Alternative TNFi
n=169 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=203 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12
Month 6 (n= 203, 169)
|
-14.8 mm
Standard Error 6.65
|
-21.0 mm
Standard Error 6.13
|
|
Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12
Month 12 (n= 169, 144)
|
-14.3 mm
Standard Error 7.30
|
-21.8 mm
Standard Error 6.69
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'.
Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.
Outcome measures
| Measure |
Alternative TNFi
n=219 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=288 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12
Month 12 (n= 242, 189)
|
-17.1 mm
Standard Error 6.24
|
-19.7 mm
Standard Error 5.85
|
|
Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12
Month 6 (n= 288, 219)
|
-10.2 mm
Standard Error 5.77
|
-17.0 mm
Standard Error 5.48
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'.
Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain". Higher scores indicate worsening of disease.
Outcome measures
| Measure |
Alternative TNFi
n=197 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=236 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12
Month 6 (n= 236, 197)
|
-10.8 mm
Standard Error 7.02
|
-15.7 mm
Standard Error 6.48
|
|
Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12
Month 12 (n=194, 171)
|
-10.0 mm
Standard Error 7.10
|
-19.0 mm
Standard Error 6.58
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'.
Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty.
Outcome measures
| Measure |
Alternative TNFi
n=131 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=164 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12
Month 6 (n= 164, 131)
|
-0.5 scores on a scale
Standard Error 0.19
|
-0.6 scores on a scale
Standard Error 0.18
|
|
Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12
Month 12 (n=142, 112)
|
-0.2 scores on a scale
Standard Error 0.22
|
-0.3 scores on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as 'n'.
Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Participants with available data at the time of assessment were included in the analysis.
Outcome measures
| Measure |
Alternative TNFi
n=180 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=233 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12
Month 6 (n= 233, 180)
|
-4.3 minutes
Standard Error 27.37
|
-19.0 minutes
Standard Error 25.38
|
|
Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12
Month 12 (n=206, 156)
|
-1.4 minutes
Standard Error 28.19
|
-16.7 minutes
Standard Error 25.81
|
SECONDARY outcome
Timeframe: Month 6 and Month 12Population: Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (i.e,Treatment Group) and reason for changing biologic therapy was known.
Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported.
Outcome measures
| Measure |
Alternative TNFi
n=507 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=604 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy
|
NA Percentage of participants
The data recorded on the eCRF was insufficient to determine this outcome measure.
|
NA Percentage of participants
The data recorded on the eCRF was insufficient to determine this outcome measure.
The data recorded on the eCRF was insufficient for us to be able to determine this measure.
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (ie,Treatment Group) and reason for changing biologic therapy was known.
Outcome measures
| Measure |
Alternative TNFi
n=507 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=604 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice
|
NA Number of participants
Data was not actually collected as per the eCRF
|
NA Number of participants
Data was not actually collected as per the eCRF
|
SECONDARY outcome
Timeframe: Up to 12 MonthsPopulation: Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.
An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Outcome measures
| Measure |
Alternative TNFi
n=507 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=604 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death
Any AE
|
241 participants
|
291 participants
|
|
Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death
AE leading to withdrawal
|
39 participants
|
17 participants
|
|
Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death
Death
|
4 participants
|
7 participants
|
|
Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death
Any SAE
|
56 participants
|
82 participants
|
SECONDARY outcome
Timeframe: Day 1 (Study entry visit)Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.
The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance.
Outcome measures
| Measure |
Alternative TNFi
n=323 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=405 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Number of Participants With Reasons for Discontinuation of the First TNFi Therapy
Inefficacy
|
236 participants
|
311 participants
|
|
Number of Participants With Reasons for Discontinuation of the First TNFi Therapy
Intolerance
|
79 participants
|
89 participants
|
|
Number of Participants With Reasons for Discontinuation of the First TNFi Therapy
Other reasons
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Day 1 (Study entry visit)Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as 'n'.
The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported.
Outcome measures
| Measure |
Alternative TNFi
n=323 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=405 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Number of Participants With Previous TNFi Therapy
Etanercept (Enbrel)
|
162 participants
|
176 participants
|
|
Number of Participants With Previous TNFi Therapy
Infliximab (Remicade)
|
42 participants
|
95 participants
|
|
Number of Participants With Previous TNFi Therapy
Adalimumab (Humira)
|
116 participants
|
131 participants
|
|
Number of Participants With Previous TNFi Therapy
Certolizumab pegol (Cimzia)
|
0 participants
|
3 participants
|
|
Number of Participants With Previous TNFi Therapy
Golimumab (Simponi)
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 (Study entry visit)Population: The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as 'n'.
The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin. Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported.
Outcome measures
| Measure |
Alternative TNFi
n=323 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=405 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Aurothioglucose
|
1 participants
|
0 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Chloroquine
|
11 participants
|
27 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Sulfasalazine
|
86 participants
|
107 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Tiopronin
|
1 participants
|
0 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Aurotioprol
|
4 participants
|
4 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Azathioprine
|
9 participants
|
20 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Ciclosporin
|
27 participants
|
25 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Gold
|
20 participants
|
27 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Hydroxychloroquine
|
99 participants
|
96 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Infliximab
|
0 participants
|
1 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Leflunomide
|
126 participants
|
144 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Methotrexate
|
180 participants
|
199 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Methotrexate sodium
|
1 participants
|
3 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Minocycline
|
3 participants
|
0 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Penicillamine
|
5 participants
|
7 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Sodium aurothiomalate
|
4 participants
|
17 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Sodium aurotiosulfate
|
1 participants
|
0 participants
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Auranofin
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.
The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi. The participant characteristics included participant's option for treatment and option for follow-up. The other reasons included RA disease (rheumatoid factor \[RF\] and cyclic citrullinated peptide \[CCP\] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk). Participants were included in more than one of these factors.
Outcome measures
| Measure |
Alternative TNFi
n=507 Participants
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Rituximab
n=604 Participants
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
RA Disease (RF and CCP Status)
|
216 participants
|
344 participants
|
|
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Primary failure
|
135 participants
|
256 participants
|
|
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Route of administration
|
289 participants
|
123 participants
|
|
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Frequency of administration
|
174 participants
|
303 participants
|
|
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Low infectious risk
|
62 participants
|
172 participants
|
|
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Participant's option for treatment
|
278 participants
|
272 participants
|
|
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Rapidity of action
|
203 participants
|
82 participants
|
|
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
No lymphoma risk
|
17 participants
|
120 participants
|
|
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Participant's option for follow-up
|
89 participants
|
91 participants
|
Adverse Events
Rituximab
Serious events: 82 serious events
Other events: 79 other events
Deaths: 0 deaths
Alternative TNFi
Serious events: 56 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab
n=604 participants at risk
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Alternative TNFi
n=507 participants at risk
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.3%
8/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
1.6%
8/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
3/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.99%
5/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.59%
3/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.39%
2/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Pneumonia
|
0.66%
4/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Urinary tract infection
|
0.66%
4/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.50%
3/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Abscess limb
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Sepsis
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Arthritis bacterial
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Cellulitis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Device related infection
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Gastroenteritis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Genital infection female
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Lung infection
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Meningitis aseptic
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Pelvic abscess
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Skin infection
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Subcutaneous abscess
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Tooth abscess
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Angina unstable
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Cardiac arrest
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Coronary artery disease
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Myopericarditis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Pericarditis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.39%
2/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Ascites
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Gastritis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.39%
2/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer recurrent
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
General disorders
Chest pain
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
General disorders
Device dislocation
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.39%
2/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
General disorders
General physical health deterioration
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
General disorders
Pain
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Nervous system disorders
Sciatica
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Nervous system disorders
Headache
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Nervous system disorders
Quadriparesis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Nervous system disorders
Spinal cord compression
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Nervous system disorders
Syncope
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Surgical and medical procedures
Hospitalisation
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Surgical and medical procedures
Joint fluid drainage
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Surgical and medical procedures
Urethral meatotomy
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.33%
2/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Psychiatric disorders
Depression
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.39%
2/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.20%
1/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.17%
1/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
0.00%
0/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
Other adverse events
| Measure |
Rituximab
n=604 participants at risk
Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
Alternative TNFi
n=507 participants at risk
Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.83%
5/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
2.4%
12/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
12/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
2.6%
13/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.3%
14/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
2.0%
10/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Infections and infestations
Urinary tract infection
|
4.1%
25/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
3.2%
16/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Nervous system disorders
Headache
|
2.5%
15/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
3.0%
15/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
10/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
2.8%
14/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
8/604 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
3.0%
15/507 • Up to 12 months
All serious adverse events (SAEs) and non-serious adverse events (AEs) were reported for the safety population which included all participants who received a second biologic therapy at baseline and had one and only one previous biologic therapy.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER