| Primary | Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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. |
| | | Title | Denominators | Categories |
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| Week 28 | | | | Week 52 | | |
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| Primary | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Annual Asthma Exacerbation Rate (AAER) Over Week 28 and Over Week 52 | 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). | 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. | Posted | | Number | | exacerbations/year | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Rate of Asthma Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks | 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). | 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. | Posted | | Number | | exacerbations/year | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Rate of Asthma Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks | 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). | 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. | Posted | | Number | | exacerbations/year | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Proportion of the Participants Who Did Not Experience an Exacerbation Over 28 Weeks and Over 52 Weeks | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage | | Week 28 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Tezepelumab | 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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| Secondary | Proportion of the Participants With ≥50% Reduction From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52 | 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). | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52 | 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). | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab (Week 28) | Participants with OCS-dependent asthma with high-dose ICS plus LABA with or without additional asthma controller and with at least 1 asthma exacerbation in the prior year who received at least one dose of tezepelumab |
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| Secondary | Absolute Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52 | 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). | 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. | Posted | | Mean | Standard Deviation | mg | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Percent Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52 | 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). | 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. | Posted | | Mean | Standard Deviation | Percentage change | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Change From Baseline in Post-bronchodilator FEV1 at Week 28 and Week 52 | 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 | 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. | Posted | | Mean | Standard Deviation | liter (L) | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Change From Baseline in ACQ-6 at Week 28 and Week 52 | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Change From Baseline in Standardised AQLQ(s)+12 Total Score at Week 28 and Week 52 | 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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| Secondary | Change From Baseline in SGRQ Total Score at Week 28 and Week 52 | 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. | 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. | Posted | | Mean | Standard Deviation | score | | Week 28 and Week 52 | | | | ID | Title | Description |
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| OG000 | Tezepelumab | 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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