Trial Outcomes & Findings for Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma (NCT NCT05274815)
NCT ID: NCT05274815
Last Updated: 2025-12-11
Results Overview
The proportion (expressed as a percentage) of participants who discontinued OCS without loss of asthma control is presented. Loss of asthma control was defined as asthma worsening or exacerbation. Asthma worsening was defined by an increase of Asthma Control Questionnaire 6 (ACQ-6) score ≥0.5 from baseline. Asthma exacerbation was defined by worsening of asthma symptoms that led to temporary bolus/burst of systemic corticosteroids (SCS; or a temporary increase in stable OCS background dose) for at least 3 consecutive days (a single depo-injectable dose of corticosteroids being considered equivalent to a 3-day bolus/burst of SCS), and/or an emergency room (ER) or urgent care visit requiring SCS, and/or inpatient hospitalisation, both due to asthma.
COMPLETED
PHASE3
305 participants
Week 28 and Week 52
2025-12-11
Participant Flow
A total of 305 participants were enrolled from 68 study sites across 11 countries, including sites in Argentina, Belgium, Bulgaria, France, Germany, Latvia, Mexico, Poland, Spain, UK, and USA.
Of the 305 participants that initiated treatment with tezepelumab, 7 were excluded from the efficacy and safety summary due to potential data fraud. Therefore, only 298 participants were included in the summaries.
Participant milestones
| Measure |
Tezepelumab
Tezepelumab 210 mg was administered subcutaneously (SC) every 4 weeks (Q4W) for a total of 13 doses
Induction phase (Week 0 to 4): At the screening visit, participants continued or were switched to prednisone or prednisolone. Participants started to receive tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline oral corticosteroid (OCS) dose during this phase.
OCS reduction and maintenance phase (Week 4 to Week 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W.
|
|---|---|
|
Overall Study
STARTED
|
298
|
|
Overall Study
COMPLETED
|
273
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Tezepelumab
Tezepelumab 210 mg was administered subcutaneously (SC) every 4 weeks (Q4W) for a total of 13 doses
Induction phase (Week 0 to 4): At the screening visit, participants continued or were switched to prednisone or prednisolone. Participants started to receive tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline oral corticosteroid (OCS) dose during this phase.
OCS reduction and maintenance phase (Week 4 to Week 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawn from study due to investigator's decision
|
1
|
|
Overall Study
Withdrawn from study due to participant's decision to withdraw
|
1
|
|
Overall Study
Withdrawn from study due to severe non-compliance with the protocol
|
1
|
|
Overall Study
Withdrawn from study due to subject decision
|
1
|
|
Overall Study
Withdrawn due to participant's decision not to continue for personal and family reasons
|
1
|
|
Overall Study
Withdrawn from study due to the participant stopped visit; agreed to a telephone contact at Week 52
|
1
|
|
Overall Study
Withdrawn from study due to randomization into closed cohort by mistake
|
1
|
|
Overall Study
Withdrawal by Subject
|
11
|
Baseline Characteristics
Full Analysis Set
Baseline characteristics by cohort
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Age, Continuous
|
54.4 Years
STANDARD_DEVIATION 12.0 • n=9 Participants • Full Analysis Set
|
|
Age, Customized
>=18 to <65 years
|
231 Participants
n=9 Participants • Full Analysis Set
|
|
Age, Customized
>=65 years
|
67 Participants
n=9 Participants • Full Analysis Set
|
|
Sex: Female, Male
Female
|
206 Participants
n=9 Participants • Full Analysis Set
|
|
Sex: Female, Male
Male
|
92 Participants
n=9 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
123 Participants
n=9 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
157 Participants
n=9 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Missing
|
18 Participants
n=9 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=9 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=9 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
White
|
258 Participants
n=9 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=9 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Not reported
|
18 Participants
n=9 Participants • Full Analysis Set
|
|
Region of Enrollment
Argentina
|
80 Participants
n=9 Participants
|
|
Region of Enrollment
Belgium
|
13 Participants
n=9 Participants
|
|
Region of Enrollment
Bulgaria
|
36 Participants
n=9 Participants
|
|
Region of Enrollment
France
|
18 Participants
n=9 Participants
|
|
Region of Enrollment
Germany
|
22 Participants
n=9 Participants
|
|
Region of Enrollment
Latvia
|
16 Participants
n=9 Participants
|
|
Region of Enrollment
Mexico
|
41 Participants
n=9 Participants
|
|
Region of Enrollment
Poland
|
40 Participants
n=9 Participants
|
|
Region of Enrollment
Spain
|
8 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=9 Participants
|
|
Region of Enrollment
United Kingdom
|
12 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The proportion (expressed as a percentage) of participants who discontinued OCS without loss of asthma control is presented. Loss of asthma control was defined as asthma worsening or exacerbation. Asthma worsening was defined by an increase of Asthma Control Questionnaire 6 (ACQ-6) score ≥0.5 from baseline. Asthma exacerbation was defined by worsening of asthma symptoms that led to temporary bolus/burst of systemic corticosteroids (SCS; or a temporary increase in stable OCS background dose) for at least 3 consecutive days (a single depo-injectable dose of corticosteroids being considered equivalent to a 3-day bolus/burst of SCS), and/or an emergency room (ER) or urgent care visit requiring SCS, and/or inpatient hospitalisation, both due to asthma.
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
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|---|---|
|
Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52
Week 28
|
32.2 Percentage of participants
Interval 26.9 to 37.8
|
|
Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52
Week 52
|
50.3 Percentage of participants
Interval 44.5 to 56.2
|
PRIMARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The proportion (expressed as a percentage) of the participants who reduced daily prescribed maintenance OCS dose to ≤5 mg/day without loss of asthma control at Week 28 and Week 52 is presented.
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Proportion of the Participants Who Reduced Daily Prescribed Maintenance OCS Dose to ≤5 mg/Day Without Loss of Asthma Control at Week 28 and Week 52
Week 28
|
88.9 Percentage of participants
Interval 84.8 to 92.3
|
|
Proportion of the Participants Who Reduced Daily Prescribed Maintenance OCS Dose to ≤5 mg/Day Without Loss of Asthma Control at Week 28 and Week 52
Week 52
|
89.9 Percentage of participants
Interval 85.9 to 93.1
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The AAER over Week 28 and over Week 52 is presented. The AAER was calculated as the total number of asthma exacerbations over the period (Week 28/52) divided by the total time at risk for the period (Week 28 or Week 52).
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
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|---|---|
|
Annual Asthma Exacerbation Rate (AAER) Over Week 28 and Over Week 52
Week 28
|
0.66 exacerbations/year
|
|
Annual Asthma Exacerbation Rate (AAER) Over Week 28 and Over Week 52
Week 52
|
0.57 exacerbations/year
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The AAER for exacerbations associated with hospitalisation or ER visit over 28 weeks and over 52 weeks is presented. The AAER was calculated as the total number of asthma exacerbations over the period (Week 28/52) divided by the total time at risk for the period (Week 28 or Week 52).
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Rate of Asthma Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks
Week 28
|
0.13 exacerbations/year
|
|
Rate of Asthma Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks
Week 52
|
0.11 exacerbations/year
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The AAER for exacerbations associated with hospitalisation over 28 weeks and over 52 weeks are presented. The AAER was calculated as the total number of asthma exacerbations over the period (Week 28/52) divided by the total time at risk for the period (Week 28 or Week 52).
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Rate of Asthma Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks
Week 52
|
0.05 exacerbations/year
|
|
Rate of Asthma Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks
Week 28
|
0.06 exacerbations/year
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The proportion (expressed as a percentage) of participants who completed 28 or 52 weeks of treatment and did not experience an exacerbation over 28 weeks and over 52 weeks is presented.
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Proportion of the Participants Who Did Not Experience an Exacerbation Over 28 Weeks and Over 52 Weeks
Week 28
|
76.0 Percentage of participants
Interval 70.68 to 80.85
|
|
Proportion of the Participants Who Did Not Experience an Exacerbation Over 28 Weeks and Over 52 Weeks
Week 52
|
66.9 Percentage of participants
Interval 61.01 to 72.44
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The proportion (expressed as a percentage) of participants who completed 28 or 52 weeks of treatment and did not experience an exacerbation associated with hospitalisation or ER visit over 28 weeks and over 52 weeks is presented.
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks
Week 28
|
95.5 Percentage of participants
Interval 92.4 to 97.57
|
|
Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks
Week 52
|
92.7 Percentage of participants
Interval 88.99 to 95.5
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The proportion (expressed as a percentage) of participants who completed 28 or 52 weeks of treatment and did not experience an exacerbation associated with hospitalisation over 28 weeks and over 52 weeks is presented.
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks
Week 28
|
97.9 Percentage
Interval 95.52 to 99.23
|
|
Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks
Week 52
|
96.0 Percentage
Interval 92.96 to 97.99
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The proportion (expressed as a percentage) of participants with ≥50% reduction from baseline in daily maintenance OCS dose at Week 28 and Week 52 is presented. The baseline OCS dose is the prescribed OCS dose prior to first dose of investigational product (IP). The final daily OCS dose was defined as the last dose reported by participants with asthma stability verified (no change in OCS dose for at least 2 consecutive weeks).
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Proportion of the Participants With ≥50% Reduction From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
Week 28
|
76.8 Percentage of participants
Interval 71.6 to 81.5
|
|
Proportion of the Participants With ≥50% Reduction From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
Week 52
|
81.9 Percentage of participants
Interval 77.0 to 86.1
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: Full Analysis Set: included all enrolled participants who received at least one dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.
The categorised percent reduction from baseline in the daily maintenance OCS dose (categories: ≥90% to ≤100% reduction, ≥75% to \<90% reduction, ≥50% to \<75% reduction, \>0% to \<50% reduction, no change or any increase) at Week 28 and Week 52 is presented. The baseline OCS dose is the prescribed OCS dose prior to first dose of IP. The final daily OCS dose was defined as the last dose reported by participants with asthma stability verified (no change in OCS dose for at least 2 consecutive weeks).
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 52: No change or any increase
|
14.1 Percentage of participants
Interval 10.4 to 18.6
|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 28: ≥90% to ≤100% reduction
|
35.2 Percentage of participants
Interval 29.8 to 41.0
|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 28: ≥75% to <90% reduction
|
14.1 Percentage of participants
Interval 10.4 to 18.6
|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 28: ≥50% to <75% reduction
|
27.5 Percentage of participants
Interval 22.5 to 33.0
|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 28: >0% to <50% reduction
|
8.1 Percentage of participants
Interval 5.2 to 11.7
|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 28: No change or any increase
|
15.1 Percentage of participants
Interval 11.2 to 19.7
|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 52: ≥90% to ≤100% reduction
|
52.0 Percentage of participants
Interval 46.2 to 57.8
|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 52: ≥75% to <90% reduction
|
9.1 Percentage of participants
Interval 6.1 to 12.9
|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 52: ≥50% to <75% reduction
|
20.8 Percentage of participants
Interval 16.3 to 25.9
|
|
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Week 52: >0% to <50% reduction
|
4.0 Percentage of participants
Interval 2.1 to 6.9
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: The analysis was done on the Full Analysis Set, including only subjects with an OCS dose at baseline and at least one non-missing post baseline value.
The absolute change from baseline in daily maintenance OCS dose at Week 28 and Week 52 is presented. The baseline OCS dose is the prescribed OCS dose prior to first dose of IP. The final daily OCS dose was defined as the last dose reported by participants with asthma stability verified (no change in OCS dose for at least 2 consecutive weeks).
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Absolute Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
Week 28
|
-6.951 mg
Standard Deviation 5.596
|
|
Absolute Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
Week 52
|
-7.704 mg
Standard Deviation 6.294
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: The analysis was done on the Full Analysis Set, including only subjects with an OCS dose at baseline and at least one non-missing post baseline value.
The percent change from baseline in daily maintenance OCS dose at Week 28 and Week 52 is presented. The baseline OCS dose is the prescribed OCS dose prior to first dose of IP. The final daily OCS dose was defined as the last dose reported by participants with asthma stability verified (no change in OCS dose for at least 2 consecutive weeks).
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Percent Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
Week 28
|
-61.919 Percentage change
Standard Deviation 41.773
|
|
Percent Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
Week 52
|
-69.844 Percentage change
Standard Deviation 43.666
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: The analysis was done on the FAS, including only subjects with post-BD FEV1 at baseline and at least one non-missing post baseline value.
The change from baseline in post-bronchodilator FEV1 at Week 28 and Week 52 is presented. Baseline was defined as the last measurement at or prior first dose of IP. FEV1 = forced expiratory volume in 1 second
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Change From Baseline in Post-bronchodilator FEV1 at Week 28 and Week 52
Week 28
|
0.0885 liter (L)
Standard Deviation 0.3405
|
|
Change From Baseline in Post-bronchodilator FEV1 at Week 28 and Week 52
Week 52
|
0.0737 liter (L)
Standard Deviation 0.3559
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: The analysis is done on the FAS, including only subjects with ACQ-6 score at baseline and at least one non-missing post baseline value.
The Asthma Control Questionnaire 6 (ACQ-6) is a 6-item questionnaire which includes the following questions: 1) Awakening at night by symptoms, 2) Limitations of normal daily activities, 3) Waking in the morning with symptoms, 4) Dyspnoea, 5) Wheeze, and 6) Daily rescue medication. Questions were scored from 0 (totally controlled) to 6 (severely uncontrolled) and the ACQ-6 score was computed as the unweighted mean of the responses to the 6 questions. Higher scores indicate poorer outcomes. The change from baseline in ACQ-6 at Week 28 and Week 52 is presented.
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
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|---|---|
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Change From Baseline in ACQ-6 at Week 28 and Week 52
Week 28
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-1.12 Score on a scale
Standard Deviation 1.00
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Change From Baseline in ACQ-6 at Week 28 and Week 52
Week 52
|
-1.20 Score on a scale
Standard Deviation 1.09
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SECONDARY outcome
Timeframe: Week 28 and Week 52Population: The analysis is done on the FAS, including only subjects with AQLQ(S)+12 total score at baseline and at least one non-missing post baseline value.
The Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ\[S\]+12) is a questionnaire that measures the health-related quality of life experienced by asthma participants. Questions were scored from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Higher scores indicate better outcomes. The change from baseline in standardised AQLQ(S)+12 total score at Week 28 and Week 52 is presented.
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
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|---|---|
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Change From Baseline in Standardised AQLQ(s)+12 Total Score at Week 28 and Week 52
Week 28
|
1.1455 Score on a scale
Standard Deviation 1.0419
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Change From Baseline in Standardised AQLQ(s)+12 Total Score at Week 28 and Week 52
Week 52
|
1.1932 Score on a scale
Standard Deviation 1.1551
|
SECONDARY outcome
Timeframe: Week 28 and Week 52Population: The analysis is done on the FAS, including only subjects with SGRQ total score at baseline and at least one non-missing post baseline value.
The St. George's Respiratory Questionnaire (SGRQ) is a 50-item instrument developed to measure the health status of participants with airway obstruction diseases. The total score indicates the impact of disease on overall health status. The total score ranges for the SGRQ are 0-100, with higher scores indicating worse health status. The change from baseline in SGRQ total score at Week 28 and Week 52 is presented.
Outcome measures
| Measure |
Tezepelumab
n=298 Participants
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
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Change From Baseline in SGRQ Total Score at Week 28 and Week 52
Week 52
|
-16.6593 score
Standard Deviation 18.7749
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Change From Baseline in SGRQ Total Score at Week 28 and Week 52
Week 28
|
-16.2919 score
Standard Deviation 18.1489
|
Adverse Events
Tezepelumab
Serious adverse events
| Measure |
Tezepelumab
n=298 participants at risk
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
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Endocrine disorders
Adrenocortical insufficiency acute
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Gastrointestinal disorders
Dysphagia
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Gastrointestinal disorders
Gastritis
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Gastrointestinal disorders
Vomiting
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Hepatobiliary disorders
Bile duct stone
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0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
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Immune system disorders
Anaphylactic reaction
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Infections and infestations
Bronchitis bacterial
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Cardiac disorders
Angina pectoris
|
0.67%
2/298 • Number of events 2 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Infections and infestations
Covid-19
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Infections and infestations
Pneumonia
|
1.0%
3/298 • Number of events 3 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.4%
13/298 • Number of events 15 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Cardiac disorders
Atrial fibrillation
|
0.67%
2/298 • Number of events 3 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Cardiac disorders
Cardiac failure acute
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Cardiac disorders
Tachycardia foetal
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
Other adverse events
| Measure |
Tezepelumab
n=298 participants at risk
Tezepelumab 210 mg was administered SC Q4W for a total of 13 doses.
Induction phase (Week 0 to 4): Participants received tezepelumab treatment at Visit 2/Week 0 (baseline) and had to remain stable on their baseline OCS dose during this phase.
OCS reduction and maintenance phase (Week 4 to 52): Initial OCS tapering was guided by an algorithm based on baseline OCS dose until the lowest stable OCS dose (OCS discontinued or no further OCS reduction possible) was reached or until Week 48; dosages were reduced in 2.5- to 5-mg increments weekly, every 2 weeks, or Q4W OCS dose.
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Psychiatric disorders
Insomnia
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Cardiac disorders
Atrial fibrillation
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.34%
1/298 • Number of events 1 • From the date of first dose of IP until study completion or withdrawal date, up to 64 weeks
Only events that fall into the following categories were collected in this study: serious AEs, AEs leading to discontinuation of IP, and AEs of special interest. Participants with multiple occurrences in the same category were counted once per category regardless of the number of occurrences.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER