Trial Outcomes & Findings for Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis (NCT NCT03478787)
NCT ID: NCT03478787
Last Updated: 2021-07-13
Results Overview
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
327 participants
Primary outcome timeframe
Week 16
Results posted on
2021-07-13
Participant Flow
A total of 327 participants were randomized from 53 sites across 9 countries including Canada, France, Germany, Italy, The Netherlands, Poland, Spain, the United Kingdom, and the United States.
Eligible participants were randomized to receive risankizumab or secukinumab in a 1:1 ratio. The randomization was stratified by weight (≤ 100 kg vs. \> 100 kg) and prior systemic biologic for psoriasis (0 vs. ≥ 1).
Participant milestones
| Measure |
Secukinumab
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
|
Risankizumab
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
164
|
|
Overall Study
COMPLETED
|
134
|
151
|
|
Overall Study
NOT COMPLETED
|
29
|
13
|
Reasons for withdrawal
| Measure |
Secukinumab
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
|
Risankizumab
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
7
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
Other, Not Specified
|
3
|
0
|
Baseline Characteristics
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Secukinumab
n=163 Participants
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
|
Risankizumab
n=164 Participants
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 40 years
|
60 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Age, Customized
40 to < 65 years
|
81 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Age, Customized
>/= 65 years
|
22 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
129 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
256 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
144 Participants
n=99 Participants
|
151 Participants
n=107 Participants
|
295 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Intent to Treat (ITT) analysis set: all participants who were randomized at Baseline. Non-responder imputation (NRI) was used for missing data.
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Secukinumab
n=163 Participants
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
|
Risankizumab
n=164 Participants
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
|
|---|---|---|
|
Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
|
65.6 percentage of participants
|
73.8 percentage of participants
|
PRIMARY outcome
Timeframe: Week 52Population: ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.
Outcome measures
| Measure |
Secukinumab
n=163 Participants
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
|
Risankizumab
n=164 Participants
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
|
|---|---|---|
|
Percentage of Participants With a PASI 90 at Week 52
|
57.1 percentage of participants
|
86.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.
Outcome measures
| Measure |
Secukinumab
n=163 Participants
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
|
Risankizumab
n=164 Participants
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
|
|---|---|---|
|
Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52
|
39.9 percentage of participants
|
65.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all 3; Almost clear (1) = mean \> 0, \< 1.5; Mild (2) = mean ≥ 1.5, \< 2.5; Moderate (3) = mean ≥ 2.5, \< 3.5; and Severe (4) = mean ≥ 3.5.
Outcome measures
| Measure |
Secukinumab
n=163 Participants
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
|
Risankizumab
n=164 Participants
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
|
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
|
58.3 percentage of participants
|
87.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.
Outcome measures
| Measure |
Secukinumab
n=163 Participants
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
|
Risankizumab
n=164 Participants
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
|
|---|---|---|
|
Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
|
69.9 percentage of participants
|
89.6 percentage of participants
|
Adverse Events
Secukinumab
Serious events: 6 serious events
Other events: 71 other events
Deaths: 0 deaths
Risankizumab
Serious events: 9 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab
n=163 participants at risk
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48 and received at least one dose of study drug.
|
Risankizumab
n=164 participants at risk
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France) and received at least one dose of study drug .
|
|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Cardiac disorders
ARRHYTHMIA SUPRAVENTRICULAR
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Endocrine disorders
BASEDOW'S DISEASE
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.61%
1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.00%
0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
0.61%
1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.00%
0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.61%
1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.00%
0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.61%
1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.00%
0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
1.2%
2/164 • Number of events 2 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.61%
1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.00%
0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HISTIOCYTIC NECROTISING LYMPHADENITIS
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Nervous system disorders
TOXIC ENCEPHALOPATHY
|
0.61%
1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.00%
0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.61%
1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.61%
1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.00%
0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.61%
1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.00%
0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.61%
1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
0.00%
0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
Other adverse events
| Measure |
Secukinumab
n=163 participants at risk
Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48 and received at least one dose of study drug.
|
Risankizumab
n=164 participants at risk
Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France) and received at least one dose of study drug .
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
5.5%
9/163 • Number of events 12 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
5.5%
9/164 • Number of events 11 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Infections and infestations
BRONCHITIS
|
6.7%
11/163 • Number of events 11 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
1.8%
3/164 • Number of events 3 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.6%
27/163 • Number of events 38 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
21.3%
35/164 • Number of events 48 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
8.6%
14/163 • Number of events 20 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
12.8%
21/164 • Number of events 25 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.1%
10/163 • Number of events 13 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
5.5%
9/164 • Number of events 12 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Nervous system disorders
HEADACHE
|
9.2%
15/163 • Number of events 27 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
5.5%
9/164 • Number of events 20 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
|
Vascular disorders
HYPERTENSION
|
3.1%
5/163 • Number of events 5 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
5.5%
9/164 • Number of events 10 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER