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Clinical Trial Results:
A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants with Severe Asthma including Several Under-Studied Populations in the United States

Summary
EudraCT number	2026-000081-25
Trial protocol	Outside EU/EEA
Global end of trial date	01 Oct 2025

Results information
Results version number	v1(current)
This version publication date	12 Apr 2026
First version publication date	12 Apr 2026
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

D5180C00032

ISRCTN number

US NCT number

NCT05329194

WHO universal trial number (UTN)

Sponsor organisation name

AstraZeneca

Sponsor organisation address

AstraZeneca AB, Södertälje, Sweden, 151 85

Public contact

Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com

Scientific contact

Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

27 Jan 2026

Is this the analysis of the primary completion data?

Yes

Primary completion date

01 Oct 2025

Global end of trial reached?

Yes

Global end of trial date

01 Oct 2025

Was the trial ended prematurely?

Main objective of the trial

To describe asthma exacerbations in the 12-month periods before (baseline period) and after initiation of tezepelumab (study period).

Protection of trial subjects

This study was performed in accordance with the relevant International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines - which are based on the ethical principles originating from the Declaration of Helsinki and applicable laws and regulations.

Background therapy

Evidence for comparator

Actual start date of recruitment

29 Apr 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 286

Worldwide total number of subjects

286

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

190

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted from 29 April 2022 (first subject first visit) to 01 October 2025 (last subject last visit) at 32 study sites in the United States of America (USA).

Screening details

Subjects who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of activities.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Tezepelumab

Arm description

Subjects received 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.

Arm type

Experimental

Investigational medicinal product name

Tezepelumab

Investigational medicinal product code

Other name

AMG 157 or MEDI9929

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Tezepelumab was administered as a subcutaneous injection every 4 weeks from Week 0 until Week 48.

Number of subjects in period 1	Tezepelumab
Started	286
Completed	255
Not completed	31
Consent withdrawn by subject	16
Death	2
Other	5
Lost to follow-up	6
Development of study-specific withdrawal criteria	2

Baseline characteristics

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Reporting group title

Tezepelumab

Reporting group description

Subjects received 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.

Reporting group values	Tezepelumab	Total
Number of subjects	286	286
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	19	19
Adults (18-64 years)	190	190
From 65-84 years	77	77
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	52.9 ( 16.2 )	-
Gender categorical
Units: Subjects
Female	186	186
Male	100	100
Race (NIH/OMB)
For single subjects of a particular race, the data has been reported as 'Other' to maintain subject's confidentiality.
Units: Subjects
White	204	204
Black or African American	63	63
Asian	8	8
Native Hawaiian or Other Pacific Islander	0	0
American Indian or Alaska Native	4	4
Multiple	0	0
Not reported	2	2
Other	5	5
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	27	27
Not Hispanic or Latino	259	259

End points

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Reporting group title

Tezepelumab

Reporting group description

Subjects received 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.

Primary: Annualized asthma exacerbation rate (AAER)

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End point title

Annualized asthma exacerbation rate (AAER) ^[1]

End point description

Asthma exacerbations were defined by worsening of asthma symptoms that leads to temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days, or an emergency department (ED) or urgent care visit due to asthma that required systemic corticosteroid (SCS), and/or inpatient hospitalization (≥24 hours) due to asthma. The AAER was based on exacerbations reported by the investigator over 52 weeks. The exacerbation rate was compared between the 12-month period before [baseline period (BP)] and the 12-month period after initiation of tezepelumab [up to study Week 52 (Visit 15) - study period (SP)]. Full analysis set (FAS) included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Primary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analysis was exploratory for this study and hence it has not been presented in the results form.

End point values	Tezepelumab
Number of subjects analysed	286
Units: Adjusted rate (exacerbations per year)
number (confidence interval 95%)
Baseline Period	2.8783 (2.69 to 3.08)
Study Period	0.8665 (0.71 to 1.05)

No statistical analyses for this end point

Secondary: Cumulative asthma exacerbation days

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End point title

Cumulative asthma exacerbation days

End point description

The cumulative asthma exacerbation days over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) was assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Days
number (not applicable)
Baseline Period	8855
Study Period	2326

No statistical analyses for this end point

Secondary: Number of subjects with asthma exacerbations

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End point title

Number of subjects with asthma exacerbations

End point description

The number of subjects with at least one asthma exacerbation in the 12-month period before (baseline period) and after initiation of tezepelumab (study period) (up to study Week 52 - study period) were assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Baseline Period	285
Study Period	120

No statistical analyses for this end point

Secondary: Number of subjects who completed the 52 -week study period with any reduction in total number of asthma exacerbations

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End point title

Number of subjects who completed the 52 -week study period with any reduction in total number of asthma exacerbations

End point description

The number of subjects who completed the 52 -week study period following tezepelumab initiation with at least 50% reduction, and 100% reduction in total number of asthma exacerbations were assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
At least 50% reduction	209
100% reduction	148

No statistical analyses for this end point

Secondary: Rate of asthma exacerbations associated with hospitalizations

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End point title

Rate of asthma exacerbations associated with hospitalizations

End point description

The rate of asthma exacerbations associated with hospitalization over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) were assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Adjusted rate (exacerbations per year)
number (confidence interval 95%)
Study Period	0.0364 (0.02 to 0.08)
Baseline Period	0.1714 (0.12 to 0.24)

No statistical analyses for this end point

Secondary: Time to first asthma exacerbation

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End point title

Time to first asthma exacerbation

End point description

The time to first exacerbation after initiation of tezepelumab was assessed. Data for median time to event have been presented for this endpoint. The median is the descriptive statistics median calculated using a subset of subjects with an event. For this endpoint, ‘median’ was selected as the measure type, for which a precision/dispersion value is not applicable. However, due to a limitation in the EudraCT tool, a precision/dispersion type must be selected. To resolve the validation error, ‘standard deviation’ was chosen and an arbitrary value of ‘9999’ was entered to indicate that no precision/dispersion data are available. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study. Visit8 = 6 months; Visit15 = 12 months

End point type

Secondary

End point timeframe

Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Days
median (standard deviation)
Visit8	61 ( 9999 )
Visit15	102 ( 9999 )

No statistical analyses for this end point

Secondary: Rate of asthma exacerbations associated with hospitalizations or ED/UC visits

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End point title

Rate of asthma exacerbations associated with hospitalizations or ED/UC visits

End point description

The rate of asthma exacerbations associated with hospitalizations or ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) was assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Adjusted rate (exacerbations per year)
number (confidence interval 95%)
Study Period	0.1647 (0.11 to 0.24)
Baseline Period	0.6807 (0.55 to 0.84)

No statistical analyses for this end point

Secondary: Rate of asthma exacerbations associated with emergency department /urgent care (ED/UC) visits

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End point title

Rate of asthma exacerbations associated with emergency department /urgent care (ED/UC) visits

End point description

The rate of asthma exacerbations associated with ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) were assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Adjusted rate (exacerbations per year)
number (confidence interval 95%)
Study Period	0.1568 (0.11 to 0.23)
Baseline Period	0.6771 (0.55 to 0.84)

No statistical analyses for this end point

Secondary: Number of subjects with asthma exacerbations associated with hospitalizations or ED/UC visits

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End point title

Number of subjects with asthma exacerbations associated with hospitalizations or ED/UC visits

End point description

The number of subjects with asthma exacerbations associated with hospitalizations or ED/UC visits in in the 12-month periods before (baseline period) and after initiation of tezepelumab (study period) (up to study Week 52) were assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Baseline Period	102
Study Period	34

No statistical analyses for this end point

Secondary: Cumulative asthma exacerbation days associated with hospitalizations or ED/UC visits

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End point title

Cumulative asthma exacerbation days associated with hospitalizations or ED/UC visits

End point description

The cumulative asthma exacerbation days associated with hospitalizations or ED/UC over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) were assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study. Total days of exacerbations resulting in hospitalizations or ED/UC visits have been presented.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Days
number (not applicable)
Baseline Period	2518
Study Period	517

No statistical analyses for this end point

Secondary: Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

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End point title

Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

End point description

Lung function (FEV1) was measured pre-bronchodilator (pre-BD) by spirometry test. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration. Here, 'n' in each row represents number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	285
Units: Litre (L)
arithmetic mean (standard deviation)
Baseline n=285	2.160 ( 0.735 )
Visit 8 n=264	2.257 ( 0.776 )
Visit 15 n=223	2.281 ( 0.743 )

No statistical analyses for this end point

Secondary: Change from baseline in pre-bronchodilator FEV1

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End point title

Change from baseline in pre-bronchodilator FEV1

End point description

Change from baseline in pre-bronchodilator FEV1 was assessed after initiation of tezepelumab. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration. Here, 'n' in each row represents number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	263
Units: Litre (L)
arithmetic mean (standard deviation)
Change from baseline: Visit 8 n=263	0.113 ( 0.361 )
Change from baseline: Visit 15 n=222	0.111 ( 0.403 )

No statistical analyses for this end point

Secondary: Number of pre-BD FEV1 responders

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End point title

Number of pre-BD FEV1 responders

End point description

Number of pre-BD FEV1 responders was defined as subjects who achieved either at least 5% or 100 mL improvement from baseline. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Visit8 n=286	128
Visit15 n=286	107

No statistical analyses for this end point

Secondary: Asthma Control Questionnaire (ACQ-6)

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End point title

Asthma Control Questionnaire (ACQ-6)

End point description

The ACQ-6 is a shortened version of the ACQ that assesses the adequacy of asthma control and change in asthma control which occurs spontaneously or as a result of treatment. ACQ assesses symptoms and rescue bronchodilator use. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean (average) ACQ-6 score is the mean of the responses. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	280
Units: Average Score
arithmetic mean (standard deviation)
Baseline n=280	2.3863 ( 1.1588 )
Visit8 n=262	1.2971 ( 1.0078 )
Visit15 n=222	1.1291 ( 1.0164 )

No statistical analyses for this end point

Secondary: Asthma Impairment and Risk Questionnaire (AIRQ)

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End point title

Asthma Impairment and Risk Questionnaire (AIRQ)

End point description

The Asthma Impairment and Risk Questionnaire (AIRQ) is a PRO tool intended to identify subjects 12 years and older whose health may be at risk because of uncontrolled asthma. It has 10 questions that ask about respiratory symptoms, activity limitation, sleep, rescue medication use, social activities, exercise, difficulty controlling asthma, and exacerbations. All items have a yes/no response option and the tool is scored by summing the total number of ‘yes’ responses. This sum score is used to assess level of asthma control where: 0-1 is well controlled, 2-4 is not well controlled, and 5-10 is very poorly controlled. Thus, a higher score indicates worse control status. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	280
Units: Sum Score
arithmetic mean (standard deviation)
Baseline n=280	5.1 ( 2.5 )
Visit8 n=262	2.3 ( 2.4 )
Visit15 n=222	2.2 ( 2.5 )

No statistical analyses for this end point

Secondary: St. George’s Respiratory Questionnaire (SGRQ)

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End point title

St. George’s Respiratory Questionnaire (SGRQ)

End point description

SGRQ is a 50-item PRO instrument used to measure health status of subjects with airway obstruction diseases. Questionnaire has 2 parts: part 1 consists of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consists of 42 items related to daily activity and psychosocial impacts of individual’s respiratory condition. SGRQ yields a total score and 3 components scores (symptoms, activity, and impacts). Total score indicates impact of disease on overall health status, and it is expressed as percentage of overall impairment, in which 100 represents worst possible health status and 0 indicates best possible health status. Likewise, domain scores range from 0 to 100, with higher scores indicative of greater impairment. Here, 'n' in each row represents number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in study.

End point type

Secondary

End point timeframe

Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	280
Units: Total Score
arithmetic mean (standard deviation)
Baseline n=280	52.4219 ( 19.9071 )
Visit8 n=262	31.7205 ( 21.3066 )
Visit15 n=222	29.9202 ( 22.6859 )

No statistical analyses for this end point

Secondary: Change from baseline in ACQ-6 score

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End point title

Change from baseline in ACQ-6 score

End point description

Change from baseline in ACQ-6 score was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	256
Units: Average Score
arithmetic mean (standard deviation)
Visit8 n=256	-1.0944 ( 1.1486 )
Visit15 n=219	-1.2352 ( 1.2540 )

No statistical analyses for this end point

Secondary: Change from baseline in AIRQ score

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End point title

Change from baseline in AIRQ score

End point description

Change from baseline in AIRQ score was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	256
Units: Sum Score
arithmetic mean (standard deviation)
Visit8 n=256	-2.9 ( 2.7 )
Visit15 n=219	-2.9 ( 2.8 )

No statistical analyses for this end point

Secondary: Change from baseline in SGRQ score

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End point title

Change from baseline in SGRQ score

End point description

Change from baseline in SGRQ score was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	256
Units: Total Score
arithmetic mean (standard deviation)
Visit8 n=256	-20.9296 ( 19.9668 )
Visit15 n=219	-22.2776 ( 22.1774 )

No statistical analyses for this end point

Secondary: Number of ACQ-6 responders

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End point title

Number of ACQ-6 responders

End point description

Number of ACQ-6 responders were assessed. Individual changes from baseline of ≥ 0.5 were considered to be clinically meaningful (minimum clinically important difference [MCID]). ACQ-6 responders in this study were defined as subjects who achieved ≥ 1 MCID. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Visit8 n=286	180
Visit15 n=286	162

No statistical analyses for this end point

Secondary: Number of AIRQ responders

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End point title

Number of AIRQ responders

End point description

Number of AIRQ responders were assessed. Individual changes from baseline of ≥ 2 were considered to be clinically meaningful (MCID). AIRQ responders in this study were defined as subjects who achieved ≥ 1 MCID. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Visit8 n=286	168
Visit15 n=286	139

No statistical analyses for this end point

Secondary: Number of SGRQ responders

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End point title

Number of SGRQ responders

End point description

Number of SGRQ responders were assessed. Individual changes from baseline of ≥ 4 were considered to be clinically meaningful (MCID). SGRQ (total and component score) responders in this study were defined as subjects who achieved ≥ 1 MCID. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Visit8 n=286	207
Visit15 n=286	175

No statistical analyses for this end point

Secondary: Cumulative annualized SCS dose

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End point title

Cumulative annualized SCS dose

End point description

Cumulative annualized SCS dose in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) were assessed. Cumulative annualized SCS dose for each subject was calculated as followed: Cumulative annualized SCS dose = [sum of (cumulative SCS dose)/length of the planned treatment period]*365.25 Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	279
Units: Milligram (mg)
arithmetic mean (standard deviation)
Baseline Period n=279	3671.704 ( 24494.741 )
Study Period n=129	1283.780 ( 3983.790 )

No statistical analyses for this end point

Secondary: Number of subjects who require any systemic corticosteroid (SCS) use

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End point title

Number of subjects who require any systemic corticosteroid (SCS) use

End point description

Number of subjects who require any SCS use in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52 -study period) were assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Baseline Period	279
Study Period	129

No statistical analyses for this end point

Secondary: Number of subjects who require longer-term (>30 consecutive days) SCS use

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End point title

Number of subjects who require longer-term (>30 consecutive days) SCS use

End point description

Number of subjects who require longer-term (>30 consecutive days) SCS use in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) were assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Baseline Period	22
Study Period	11

No statistical analyses for this end point

Secondary: Number and type of asthma-related healthcare resource utilization (HRU)

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End point title

Number and type of asthma-related healthcare resource utilization (HRU)

End point description

Number of subjects with specific type of asthma-related HRU in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) were assessed. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study. HRE = Health related event, BP = Baseline Period, SP = Study Period, HIC = Hospitalization intensive care, HGC = Hospitalization general care, HCC = Hospitalization coronary care, ED = Emergency department, HC = Health care, APFT = Advanced pulmonary function test, CT = Computed tomography, HA = Hospital admission, MT = Medical testing

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
BP, Any HREs	211
SP, Any HREs	166
BP, Asthma HREs	211
SP, Asthma HREs	166
BP, Ambulance transport	6
SP, Ambulance transport	4
BP, HIC	11
SP, HIC	2
BP, HCC	2
SP, HCC	3
BP, HGC	24
SP, HGC	22
BP, Urgent care visit	63
SP, Urgent care visit	46
BP, Emergency room visit	59
SP, Emergency room visit	54
BP HA or ED >24 hours	35
SP, HA or ED >24 hours	28
BP, Visit to specialist	188
SP, Visit to specialist	138
BP, Visit to primary HC physician	98
SP, Visit to primary HC physician	71
BP, Other HC visit	22
SP, Other HC visit	38
BP, Home visit physician	0
SP, Home visit physician	0
BP, Home visit nurse	2
SP, Home visit nurse	2
BP, Home visit other HC	0
SP, Home visit other HC	3
BP, Telephone call Physician	34
SP, Telephone call Physician	41
BP, Telephone call Nurse	26
SP, Telephone call Nurse	25
BP, Telephone call Specialist	66
SP, Telephone call Specialist	64
BP, Telephone call Other physician/HC	11
SP, Telephone call Other physician/HC	26
BP, MT Spirometry	124
SP, MT Spirometry	75
BP, MT APFT	35
SP, MT APFT	12
BP, MT Plain chest X-ray	80
SP, MT Plain chest X-ray	57
BP, MT CT	48
SP, MT CT	39
BP, MT Oxygen initiated	20
SP, MT Oxygen initiated	10

No statistical analyses for this end point

Secondary: AAER for asthma exacerbations (subgroups of subjects)

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End point title

AAER for asthma exacerbations (subgroups of subjects)

End point description

AAER based on asthma exacerbations in the 12-month period before [baseline period (BP)] and after initiation of tezepelumab [up to study Week 52- study period (SP)] was assessed in following subgroups of subjects: Blood eosinophil count (BEC) ≥300 cells/microliter; BEC <300 cells/microliter; With clinically-relevant allergy to perennial aeroallergen; Without clinically-relevant allergy to a perennial aeroallergen; Subjects who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate chronic obstructive pulmonary disease (COPD); Significant smoking history (≥10 pack-years of smoking). Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study. FEIA = Fluorescent Enzyme Immunoassay PFN = Perennial FEIA negative PFP = Perennial FEIA positive

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	167
Units: Adjusted rate (exacerbations per year)
number (confidence interval 95%)
Baseline BEC: <300 SP n=163	0.9751 (0.76 to 1.25)
Baseline BEC: <300 BP n=163	2.8092 (2.61 to 3.02)
Baseline BEC: ≥300 SP n=121	0.7142 (0.53 to 0.96)
Baseline BEC: ≥300 BP n=121	2.9865 (2.63 to 3.40)
All PFN SP n=119	1.0585 (0.80 to 1.40)
All PFN BP n=119	2.8411 (2.57 to 3.14)
Any PFP SP n=167	0.7352 (0.57 to 0.95)
Any PFP BP n=167	2.8939 (2.64 to 3.17)
Baseline BEC <300 & with all PFN SP n=74	1.2936 (0.92 to 1.81)
Baseline BEC <300 & with all PFN BP n=74	2.8269 (2.51 to 3.18)
Baseline BEC <300 & with any PFP SP n=89	0.7345 (0.51 to 1.06)
Baseline BEC <300 & with any PFP BP n=89	2.8020 (2.55 to 3.08)
Baseline BEC ≥300 & with all PFN SP n=45	0.7032 (0.45 to 1.10)
Baseline BEC ≥300 & with all PFN BP n=45	2.8677 (2.41 to 3.41)
Baseline BEC ≥300 & with any PFP SP n=76	0.7175 (0.49 to 1.06)
Baseline BEC ≥300 & with any PFP BP n=76	3.0649 (2.56 to 3.67)
Black or African American SP n=63	0.9007 (0.61 to 1.34)
Black or African American BP n=63	3.2865 (2.81 to 3.85)
Adolescents SP n=19	0.6684 (0.34 to 1.30)
Adolescents BP n=19	2.3218 (1.97 to 2.74)
Mild to moderate COPD SP n=57	0.9377 (0.60 to 1.46)
Mild to moderate COPD BP n=57	2.7046 (2.42 to 3.03)
Baseline smoking status SP n=83	1.0363 (0.74 to 1.46)
Baseline smoking status BP n=83	2.8811 (2.63 to 3.16)

No statistical analyses for this end point

Secondary: Duration of asthma-related hospitalizations

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End point title

Duration of asthma-related hospitalizations

End point description

Duration of asthma-related hospitalization in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52-study period) was assessed. Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study. Hosp. = Hospitalization

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	31
Units: Crude rate (days per year)
number (not applicable)
Study Period, Hosp. n=25	5.7382
Baseline Period, Hosp. n=31	4.3374
Study Period, HIC n=2	3.4928
Baseline Period, HIC n=11	4.9259
Study Period, HGC n=22	6.0572
Baseline Period, HGC n=24	3.2612

No statistical analyses for this end point

Secondary: Number of subjects with asthma exacerbations (subgroups of subjects)

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End point title

Number of subjects with asthma exacerbations (subgroups of subjects)

End point description

The number of subjects with at least one asthma exacerbations in the 12-month period before [baseline period (BP)] and after initiation of tezepelumab [up to study Week 52- study period (SP)] were assessed in the following subgroups of subjects: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Subjects who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking). Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	89
Units: Subjects
Allergic & BEC ≥300 BP n=76	75
Allergic & BEC ≥300 SP n=76	30
Non-allergic & BEC ≥300 BP n=45	45
Non-allergic & BEC ≥300 SP n=45	19
Allergic & BEC <300 BP n=89	89
Allergic & BEC <300 SP n=89	32
Non-allergic & BEC <300 BP n=74	74
Non-allergic & BEC <300 SP n=74	37
Black/African American BP n=63	63
Black/African American SP n=63	27
Adolescents BP n=19	19
Adolescents SP n=19	7
Mild to moderate COPD BP n=57	57
Mild to moderate COPD SP n=57	26
Smokers BP n=83	83
Smokers SP n=83	38

No statistical analyses for this end point

Secondary: Number of subjects who completed the 52-week study with any reduction in total number of asthma exacerbations (subgroups of subjects)

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End point title

Number of subjects who completed the 52-week study with any reduction in total number of asthma exacerbations (subgroups of subjects)

End point description

The number of subjects who completed the 52-week study period following tezepelumab initiation with at least 50% reduction, and 100% reduction in total number of asthma exacerbations were assessed in the following subgroups of subjects: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Subjects who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking). FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study. red = Reduction

End point type

Secondary

End point timeframe

From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Allergic and BEC ≥300 ≥50% red	60
Allergic and BEC ≥300 100% red	40
Non-allergic and BEC ≥300 ≥50% red	36
Non-allergic and BEC ≥300 100% red	26
Allergic and BEC <300 ≥50% red	68
Allergic and BEC <300 100% red	50
Non-allergic and BEC <300 ≥50% red	44
Non-allergic and BEC <300 100% red	32
Black/African American ≥50% red	44
Black/African American 100% red	31
Adolescents ≥50% red	14
Adolescents 100% red	10
Mild to moderate COPD ≥50% red	41
Mild to moderate COPD 100% red	28
Smokers ≥50% red	56
Smokers 100% red	39

No statistical analyses for this end point

Secondary: Cumulative asthma exacerbation days (subgroups of subjects)

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End point title

Cumulative asthma exacerbation days (subgroups of subjects)

End point description

The cumulative asthma exacerbation days over 52 weeks before [baseline period (BP)] and after initiation of tezepelumab [study period (SP)] were assessed in the following subgroups of subjects: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Subjects who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking). Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	89
Units: Days
number (not applicable)
Allergic and BEC ≥300 BP n=76	2539
Allergic and BEC ≥300 SP n=76	478
Non-allergic and BEC ≥300 BP n=45	1230
Non-allergic and BEC ≥300 SP n=45	291
Allergic and BEC <300 BP n=89	2735
Allergic and BEC <300 SP n=89	727
Non-allergic and BEC <300 BP n=74	2322
Non-allergic and BEC <300 SP n=74	806
Black/African American BP n=63	1865
Black/African American SP n=63	441
Adolescents BP n=19	425
Adolescents SP n=19	73
Mild to moderate COPD BP n=57	1679
Mild to moderate COPD SP n=57	554
Smokers BP n=83	2384
Smokers SP n=83	837

No statistical analyses for this end point

Secondary: Rate of asthma exacerbations associated with hospitalizations (subgroups of subjects)

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End point title

Rate of asthma exacerbations associated with hospitalizations (subgroups of subjects)

End point description

Rate of asthma exacerbations associated with hospitalization over 52 weeks before [baseline period (BP)] and after initiation of tezepelumab [study period (SP)] was assessed in the following subgroups of subjects: BEC ≥300 cells/µL; BEC <300 cells/µL; With a clinically-relevant allergy to perennial aeroallergen; Without a clinically-relevant allergy to perennial aeroallergen; Subjects who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking). Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	167
Units: Crude rate (exacerbations per year)
number (not applicable)
Baseline BEC: <300 SP n=163	0.0663
Baseline BEC: <300 BP n=163	0.1925
Baseline BEC: ≥300 SP n=121	0.0000
Baseline BEC: ≥300 BP n=121	0.1420
All PFN SP n=119	0.0626
All PFN BP n=119	0.1269
Any PFP SP n=167	0.0188
Any PFP BP n=167	0.2006
Baseline BEC <300 & with all PFN SP n=74	0.1032
Baseline BEC <300 & with all PFN BP n=74	0.1361
Baseline BEC <300 & with any PFP SP n=89	0.0361
Baseline BEC <300 & with any PFP BP n=89	0.2399
Baseline BEC ≥300 & with all PFN SP n=45	0.0000
Baseline BEC ≥300 & with all PFN BP n=45	0.1118
Baseline BEC ≥300 & with any PFP SP n=76	0.0000
Baseline BEC ≥300 & with any PFP BP n=76	0.1600
Black or African American SP n=63	0.0343
Black or African American BP n=63	0.4083
Adolescents SP n=19	0.0000
Adolescents BP n=19	0.2685
mild to moderate COPD SP n=57	0.0555
mild to moderate COPD BP n=57	0.1958
Baseline smokers SP n=83	0.0387
Baseline smokers BP n=83	0.2195

No statistical analyses for this end point

Secondary: Rate of asthma exacerbations associated with emergency department/urgent care (ED/UC) visits (subgroups of subjects)

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End point title

Rate of asthma exacerbations associated with emergency department/urgent care (ED/UC) visits (subgroups of subjects)

End point description

Rate of asthma exacerbations associated with ED/UC visits over 52 weeks before [baseline period (BP)] and after initiation of tezepelumab [study period (SP)] was assessed in following subgroups of subjects: BEC ≥300 cells/µL; BEC <300 cells/µL; With a clinically-relevant allergy to perennial aeroallergen; Without a clinically-relevant allergy to perennial aeroallergen; Subjects who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking). Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	167
Units: Crude rate (exacerbations per year)
number (not applicable)
Baseline BEC: <300 SP n=163	0.2205
Baseline BEC: <300 BP n=163	0.6567
Baseline BEC: ≥300 SP n=121	0.0679
Baseline BEC: ≥300 BP n=121	0.6340
All PFN SP n=119	0.1800
All PFN BP n=119	0.5706
Any PFP SP n=167	0.1390
Any PFP BP n=167	0.7007
Baseline BEC <300 & with all PFN SP n=74	0.2224
Baseline BEC <300 & with all PFN BP n=74	0.5997
Baseline BEC <300 & with any PFP SP n=89	0.2189
Baseline BEC <300 & with any PFP BP n=89	0.7046
Baseline BEC ≥300 & with all PFN SP n=45	0.1144
Baseline BEC ≥300 & with all PFN BP n=45	0.5230
Baseline BEC ≥300 & with any PFP SP n=76	0.0405
Baseline BEC ≥300 & with any PFP BP n=76	0.7012
Black or African American SP n=63	0.2595
Black or African American BP n=63	1.0795
Adolescents SP n=19	0.0000
Adolescents BP n=19	0.4866
Mild to moderate COPD SP n=57	0.2049
Mild to moderate COPD BP n=57	0.5630
Baseline smokers SP n=83	0.1688
Baseline smokers BP n=83	0.6520

No statistical analyses for this end point

Secondary: Rate of asthma exacerbations associated with hospitalizations or ED/UC visits (subgroups of subjects)

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End point title

Rate of asthma exacerbations associated with hospitalizations or ED/UC visits (subgroups of subjects)

End point description

Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over 52 weeks before [baseline period (BP)] and after initiation of tezepelumab [study period (SP)] was assessed in following subgroups of subjects: BEC ≥300 cells/µL; BEC <300 cells/µL; With clinically-relevant allergy to perennial aeroallergen; Without clinically-relevant allergy to perennial aeroallergen; Subjects who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking). Here, 'n' in each row represents the number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	167
Units: Crude rate (exacerbations per year)
number (not applicable)
Baseline BEC: <300 SP n=163	0.2339
Baseline BEC: <300 BP n=163	0.6632
Baseline BEC: ≥300 SP n=121	0.0679
Baseline BEC: ≥300 BP n=121	0.6340
All PFN SP n=119	0.1981
All PFN BP n=119	0.5794
Any PFP SP n=167	0.1390
Any PFP BP n=167	0.7007
Baseline BEC <300 & with all PFN SP n=74	0.2524
Baseline BEC <300 & with all PFN BP n=74	0.6140
Baseline BEC <300 & with any PFP SP n=89	0.2189
Baseline BEC <300 & with any PFP BP n=89	0.7046
Baseline BEC ≥300 & with all PFN SP n=45	0.1144
Baseline BEC ≥300 & with all PFN BP n=45	0.5230
Baseline BEC ≥300 & with any PFP SP n=76	0.0405
Baseline BEC ≥300 & with any PFP BP n=76	0.7012
Black or African American SP n=63	0.2595
Black or African American BP n=63	1.0795
Adolescents SP n=19	0.0000
Adolescents BP n=19	0.4866
Mild to moderate COPD SP n=57	0.2236
Mild to moderate COPD BP n=57	0.5630
Baseline smokers SP n=83	0.1819
Baseline smokers BP n=83	0.6520

No statistical analyses for this end point

Secondary: Number and type of asthma-related HRU (subgroups of subjects)

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End point title

Number and type of asthma-related HRU (subgroups of subjects)

End point description

Number of subjects with specific type of asthma related HRU in the 12-month period before [baseline period (BP)] and after initiation of tezepelumab [up to study Week 52- study period (SP)] were assessed in the following subgroups of subjects: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Subjects who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking). FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study. ER = Emergency Room; Phys = Physician; Prim = Primary; TC = Telephone call

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
BP, Baseline BEC<300, Any HRE	121
SP, Baseline BEC<300, Any HRE	99
BP, Baseline BEC<300, Asthma HRE	121
SP, Baseline BEC<300, Asthma HRE	99
BP, Baseline BEC<300, Ambulance transport	2
SP, Baseline BEC<300, Ambulance transport	4
BP, Baseline BEC<300, HIC	7
SP, Baseline BEC<300, HIC	1
BP, Baseline BEC<300, HCC	1
SP, Baseline BEC<300, HCC	1
BP, Baseline BEC<300, HGC	14
SP, Baseline BEC<300, HGC	19
BP, Baseline BEC<300, UC visit	30
SP, Baseline BEC<300, UC visit	29
BP, Baseline BEC<300, ER visit	33
SP, Baseline BEC<300, ER visit	39
BP, Baseline BEC<300, HA or ED>24hours	22
SP, Baseline BEC<300, HA or ED>24hours	23
BP, Baseline BEC<300, Visit to specialist	109
SP, Baseline BEC<300, Visit to specialist	81
BP, Baseline BEC<300, Visit to prim HC physician	54
SP, Baseline BEC<300, Visit to prim HC physician	42
BP, Baseline BEC<300, Other HC visit	13
SP, Baseline BEC<300, Other HC visit	27
BP, Baseline BEC<300, Home visit physician	0
SP, Baseline BEC<300, Home visit physician	0
BP, Baseline BEC<300, Home visit nurse	0
SP, Baseline BEC<300, Home visit nurse	1
BP, Baseline BEC<300, Home visit other HC	0
SP, Baseline BEC<300, Home visit other HC	2
BP, Baseline BEC<300, TC physician	20
SP, Baseline BEC<300, TC physician	26
BP, Baseline BEC<300, TC nurse	14
SP, Baseline BEC<300, TC nurse	15
BP, Baseline BEC<300, TC specialist	35
SP, Baseline BEC<300, TC specialist	37
BP, Baseline BEC<300, TC other physician/HC	6
SP, Baseline BEC<300, TC, other physician/HC	16
BP, Baseline BEC<300, MT spirometry	66
SP, Baseline BEC<300, MT spirometry	43
BP, Baseline BEC<300, MT APFT	17
SP, Baseline BEC<300, MT APFT	9
BP, Baseline BEC<300, MT Plain chest X-ray	48
SP, Baseline BEC<300, MT Plain chest X-ray	42
BP, Baseline BEC<300, MT CT	29
SP, Baseline BEC<300, MT CT	32
BP, Baseline BEC<300, MT Oxygen initiated	14
SP, Baseline BEC<300, MT Oxygen initiated	7
BP, Baseline BEC≥300, Any HRE	89
SP, Baseline BEC≥300, Any HRE	65
BP, Baseline BEC≥300, Asthma HRE	89
SP, Baseline BEC≥300, Asthma HRE	65
BP, Baseline BEC≥300, Ambulance transport	4
SP, Baseline BEC≥300, Ambulance transport	0
BP, Baseline BEC≥300, HIC	4
SP, Baseline BEC≥300, HIC	1
BP, Baseline BEC≥300, HCC	1
SP, Baseline BEC≥300, HCC	2
BP, Baseline BEC≥300, HGC	10
SP, Baseline BEC≥300, HGC	3
BP, Baseline BEC≥300, UC visit	32
SP, Baseline BEC≥300, UC visit	16
BP, Baseline BEC≥300, ER visit	26
SP, Baseline BEC≥300, ER visit	15
BP, Baseline BEC≥300, HA or ED>24hours	13
SP, Baseline BEC≥300, HA or ED>24hours	5
BP, Baseline BEC≥300, Visit to specialist	78
SP, Baseline BEC≥300, Visit to specialist	55
BP, Baseline BEC≥300, Visit to prim HC physician	44
SP, Baseline BEC≥300, Visit to prim HC physician	28
BP, Baseline BEC≥300, Other HC visit	9
SP, Baseline BEC≥300, Other HC visit	11
BP, Baseline BEC≥300, Home visit physician	0
SP, Baseline BEC≥300, Home visit physician	0
BP, Baseline BEC≥300, Home visit nurse	2
SP, Baseline BEC≥300, Home visit nurse	1
BP, Baseline BEC≥300, Home visit other HC	0
SP, Baseline BEC≥300, Home visit other HC	1
BP, Baseline BEC≥300, TC physician	14
SP, Baseline BEC≥300, TC physician	14
BP, Baseline BEC≥300, TC nurse	12
SP, Baseline BEC≥300, TC nurse	10
BP, Baseline BEC≥300, TC specialist	31
SP, Baseline BEC≥300, TC specialist	25
BP, Baseline BEC≥300, TC other physician/HC	5
SP, Baseline BEC≥300, TC other physician/HC	10
BP, Baseline BEC≥300, MT spirometry	58
SP, Baseline BEC≥300, MT spirometry	31
BP, Baseline BEC≥300, MT APFT	18
SP, Baseline BEC≥300, MT APFT	3
BP, Baseline BEC≥300, MT Plain chest X-ray	31
SP, Baseline BEC≥300, MT Plain chest X-ray	14
BP, Baseline BEC≥300, MT CT	18
SP, Baseline BEC≥300, MT CT	7
BP, Baseline BEC≥300, MT Oxygen initiated	6
SP, Baseline BEC≥300, MT Oxygen initiated	3
BP, All PFN, Any HRE	88
SP, All PFN, Any HRE	73
BP, All PFN, Asthma HRE	88
SP, All PFN, Asthma HRE	73
BP, All PFN, Ambulance transport	1
SP, All PFN, Ambulance transport	1
BP, All PFN, HIC	2
SP, All PFN, HIC	0
BP, All PFN, HCC	0
SP, All PFN, HCC	0
BP, All PFN, HGC	8
SP, All PFN, HGC	11
BP, All PFN, UC visit	25
SP, All PFN, UC visit	25
BP, All PFN, ER visit	20
SP, All PFN, ER visit	24
BP, All PFN, HA or ED>24hours	11
SP, All PFN, HA or ED>24hours	13
BP, All PFN, Visit to specialist	77
SP, All PFN, Visit to specialist	57
BP, All PFN, Visit to prim HC physician	35
SP, All PFN, Visit to prim HC physician	36
BP, All PFN, Other HC visit	8
SP, All PFN, Other HC visit	16
BP, All PFN, Home visit physician	0
SP, All PFN, Home visit physician	0
BP, All PFN, Home visit nurse	0
SP, All PFN, Home visit nurse	2
BP, All PFN, Home visit other HC	0
SP, All PFN, Home visit other HC	2
BP, All PFN, TC physician	15
SP, All PFN, TC physician	20
BP, All PFN, TC nurse	10
SP, All PFN, TC nurse	14
BP, All PFN, TC specialist	26
SP, All PFN, TC specialist	25
BP, All PFN, TC Other physician/HC	3
SP, All PFN, Other physician/HC	14
BP, All PFN, MT spirometry	41
SP, All PFN, MT spirometry	27
BP, All PFN, MT APFT	13
SP, All PFN, MT APFT	7
BP, All PFN, MT Plain chest X-ray	28
SP, All PFN, MT Plain chest X-ray	28
BP, All PFN, MT CT	26
SP, All PFN, MT CT	24
BP, All PFN, MT Oxygen initiated	4
SP, All PFN, MT Oxygen initiated	2
BP, Any PFP, Any HRE	123
SP, Any PFP, Any HRE	93
BP, Any PFP, Asthma HRE	123
SP, Any PFP, Asthma HRE	93
BP, Any PFP, Ambulance transport	5
SP, Any PFP, Ambulance transport	3
BP, Any PFP, HIC	9
SP, Any PFP, HIC	2
BP, Any PFP, HCC	2
SP, Any PFP, HCC	3
BP, Any PFP, HGC	16
SP, Any PFP, HGC	11
BP, Any PFP, UC visit	38
SP, Any PFP, UC visit	21
BP, Any PFP, ER visit	39
SP, Any PFP, ER visit	30
BP, Any PFP, HA or ED>24hours	24
SP, Any PFP, HA or ED>24hours	15
BP, Any PFP, Visit to specialist	111
SP, Any PFP, Visit to specialist	81
BP, Any PFP, Visit to prim HC physician	63
SP, Any PFP, Visit to prim HC physician	35
BP, Any PFP, Other HC visit	14
SP, Any PFP, Other HC visit	22
BP, Any PFP, Home visit physician	0
SP, Any PFP, Home visit physician	0
BP, Any PFP, Home visit nurse	2
SP, Any PFP, Home visit nurse	0
BP, Any PFP, Home visit other HC	0
SP, Any PFP, Home visit other HC	1
BP, Any PFP, TC physician	19
SP, Any PFP, TC physician	21
BP, Any PFP, TC nurse	16
SP, Any PFP, TC nurse	11
BP, Any PFP, TC specialist	40
SP, Any PFP, TC specialist	39
BP, Any PFP, Other physician/HC	8
SP, Any PFP, Other physician/HC	12
BP, Any PFP, MT spirometry	83
SP, Any PFP, MT spirometry	48
BP, Any PFP, MT APFT	22
SP, Any PFP, MT APFT	5
BP, Any PFP, MT Plain chest X-ray	52
SP, Any PFP, MT Plain chest X-ray	29
BP, Any PFP, MT CT	22
SP, Any PFP, MT CT	15
BP, Any PFP, MT Oxygen initiated	16
SP, Any PFP, MT Oxygen initiated	8
BP, Black/African American, Any HRE	47
SP, Black/African American, Any HRE	40
BP, Black/African American, Asthma HRE	47
SP, Black/African American, Asthma HRE	40
BP, Black/African American, Ambulance transport	4
SP, Black/African American, Ambulance transport	3
BP, Black/African American, HIC	4
SP, Black/African American, HIC	0
BP, Black/African American, HCC	1
SP, Black/African American, HCC	2
BP, Black/African American, HGC	16
SP, Black/African American, HGC	8
BP, Black/African American, UC visit	15
SP, Black/African American, UC visit	11
BP, Black/African American, ER visit	28
SP, Black/African American, ER visit	16
BP, Black/African American, HA or ED>24hours	18
SP, Black/African American, HA or ED>24hours	10
BP, Black/African American, Visit to specialist	42
SP, Black/African American, Visit to specialist	34
BP, Black/African American, Visit to prim HC phys	25
SP, Black/African American, Visit to prim HC phys	17
BP, Black/African American, Other HC visit	8
SP, Black/African American, Other HC visit	9
BP, Black/African American, Home visit physician	0
SP, Black/African American, Home visit physician	0
BP, Black/African American, Home visit nurse	2
SP, Black/African American, Home visit nurse	0
BP, Black/African American, Home visit other HC	0
SP, Black/African American, Home visit other HC	1
BP, Black/African American, TC physician	10
SP, Black/African American, TC physician	13
BP, Black/African American, TC nurse	9
SP, Black/African American, TC nurse	4
BP, Black/African American, TC specialist	17
SP, Black/African American, TC specialist	12
BP, Black/African American, TC other physician/HC	5
SP, Black/African American, TC other physician/HC	7
BP, Black/African American, MT spirometry	34
SP, Black/African American, MT spiromtery	24
BP, Black/African American, MT APFT	12
SP, Black/African American, MT APFT	2
BP, Black/African American, MT Plain chest X-ray	28
SP, Black/African American, MT Plain chest X-ray	16
BP, Black/African American, MT CT	9
SP, Black/African American, MT CT	7
BP, Black/African American, MT Oxygen initiated	9
SP, Black/African American, MT Oxygen initiated	3
BP, Adolescents, Any HRE	12
SP, Adolescents, Any HRE	7
BP, Adolescents, Asthma HRE	12
SP, Adolescents, Asthma HRE	7
BP, Adolescents, Ambulance transport	0
SP, Adolescents, Ambulance transport	0
BP, Adolescents, HIC	2
SP, Adolescents, HIC	1
BP, Adolescents, HCC	0
SP, Adolescents, HCC	0
BP, Adolescents, HGC	1
SP, Adolescents, HGC	1
BP, Adolescents, UC visit	3
SP, Adolescents, UC visit	1
BP, Adolescents, ER visit	4
SP, Adolescents, ER visit	1
BP, Adolescents, HA or ED>24hours	3
SP, Adolescents, HA or ED>24hours	1
BP, Adolescents, Visit to specialist	9
SP, Adolescents, Visit to specialist	6
BP, Adolescents, Visit to prim HC physician	7
SP, Adolescents, Visit to prim HC physician	1
BP, Adolescents, Other HC visit	0
SP, Adolescents, Other HC visit	0
BP, Adolescents, Home visit physician	0
SP, Adolescents, Home visit physician	0
BP, Adolescents, Home visit nurse	0
SP, Adolescents, Home visit nurse	0
BP, Adolescents, Home visit other HC	0
SP, Adolescents, Home visit other HC	0
BP, Adolescents, TC pnhysician	0
SP, Adolescents, TC physician	2
BP, Adolescents, TC nurse	1
SP, Adolescents, TC nurse	0
BP, Adolescents, TC specialist	1
SP, Adolescents, TC specialist	4
BP, Adolescents, TC other physician/HC	0
SP, Adolescents, TC other physician/HC	0
BP, Adolescents, MT spirometry	10
SP, Adolescents, MT spirometry	2
BP, Adolescents, MT APFT	3
SP, Adolescents, MT APFT	1
BP, Adolescents, MT Plain chest X-ray	2
SP, Adolescents, MT Plain chest X-ray	1
BP, Adolescents, MT CT	0
SP, Adolescents, MT CT	0
BP, Adolescents, MT Oxygen initiated	2
SP, Adolescents, MT Oxygen initiated	1
BP, mild to moderate COPD, Any HRE	42
SP, mild to moderate COPD, Any HRE	35
BP, mild to moderate COPD, Asthma HRE	42
SP, mild to moderate COPD, Asthma HRE	35
BP, mild to moderate COPD, Ambulance transport	1
SP, mild to moderate COPD, Ambulance transport	2
BP, mild to moderate COPD, HIC	2
SP, mild to moderate COPD, HIC	0
BP, mild to moderate COPD, HCC	2
SP, mild to moderate COPD, HCC	2
BP, mild to moderate COPD, HGC	6
SP, mild to moderate COPD, HGC	8
BP, mild to moderate COPD, UC visit	15
SP, mild to moderate COPD, UC visit	11
BP, mild to moderate COPD, ER visit	12
SP, mild to moderate COPD, ER visit	15
BP, mild to moderate COPD, HA or ED>24hours	6
SP, mild to moderate COPD, HA or ED>24hours	10
BP, mild to moderate COPD, Visit to specialist	36
SP, mild to moderate COPD, Visit to specialist	31
BP, mild to moderate COPD, Visit to prim HC phys	17
SP, mild to moderate COPD, Visit to prim HC phys	18
BP, mild to moderate COPD, Other HC visit	9
SP, mild to moderate COPD, Other HC visit	12
BP, mild to moderate COPD, Home visit physician	0
SP, mild to moderate COPD, Home visit physician	0
BP, mild to moderate COPD, Home visit nurse	0
SP, mild to moderate COPD, Home visit nurse	1
BP, mild to moderate COPD, Home visit other HC	0
SP, mild to moderate COPD, Home visit other HC	2
BP, mild to moderate COPD, TC physician	8
SP, mild to moderate COPD, TC physician	10
BP, mild to moderate COPD, TC nurse	2
SP, mild to moderate COPD, TC nurse	6
BP, mild to moderate COPD, TC specialist	8
SP, mild to moderate COPD, TC specialist	12
BP, mild to moderate COPD, TC other physician/HC	2
SP, mild to moderate COPD, TC other physician/HC	9
BP, mild to moderate COPD, MT spirometry	21
SP, mild to moderate COPD, MT spirometry	17
BP, mild to moderate COPD, MT APFT	7
SP, mild to moderate COPD, MT APFT	2
BP, mild to moderate COPD, MT Plain chest X-ray	17
SP, mild to moderate COPD, MT Plain chest X-ray	22
BP, mild to moderate COPD, MT CT	13
SP, mild to moderate COPD, MT CT	13
BP, mild to moderate COPD, MT Oxygen initiated	7
SP, mild to moderate COPD, MT Oxygen initiated	5
BP, Baseline Smokers, Any HRE	58
SP, Baseline Smokers, Any HRE	51
BP, Baseline Smokers, Asthma HRE	58
SP, Baseline Smokers, Asthma HRE	51
BP, Baseline Smokers, Ambulance transport	0
SP, Baseline Smokers, Ambulance transport	2
BP, Baseline Smokers, HIC	5
SP, Baseline Smokers, HIC	0
BP, Baseline Smokers, HCC	2
SP, Baseline Smokers, HCC	2
BP, Baseline Smokers, HGC	7
SP, Baseline Smokers, HGC	7
BP, Baseline Smokers, UC visit	24
SP, Baseline Smokers, UC visit	17
BP, Baseline Smokers, ER visit	16
SP, Baseline Smokers, ER visit	21
BP, Baseline Smokers, HA or ED>24hours	9
SP, Baseline Smokers, HA or ED>24 hours	10
BP, Baseline Smokers, Visit to specialist	49
SP, Baseline Smokers, Visit to specialist	44
BP, Baseline Smokers, Visit to prim HC physician	24
SP, Baseline Smokers, Visit to prim HC physician	24
BP, Baseline Smokers, Other HC visit	7
SP, Baseline Smokers, Other HC visit	14
BP, Baseline Smokers, Home visit physician	0
SP, Baseline Smokers, Home visit physician	0
BP, Baseline Smokers, Home visit nurse	0
SP, Baseline Smokers, Home visit nurse	1
BP, Baseline Smokers, Home visit other HC	0
SP, Baseline Smokers, Home visit other HC	2
BP, Baseline Smokers, TC physician	13
SP, Baseline Smokers, TC physician	17
BP, Baseline Smokers, TC nurse	9
SP, Baseline Smokers, TC nurse	9
BP, Baseline Smokers, TC specialist	19
SP, Baseline Smokers, TC specialist	21
BP, Baseline Smokers, TC Other physician/HC	2
SP, Baseline Smokers, TC Other physician/HC	9
BP, Baseline Smokers, MT spirometry	26
SP, Baseline Smokers, MT spirometry	24
BP, Baseline Smokers, MT APFT	6
SP, Baseline Smokers, MT APFT	2
BP, Baseline Smokers, MT Plain chest X-ray	25
SP, Baseline Smokers, MT Plain chest X-ray	27
BP, Baseline Smokers, MT CT	18
SP, Baseline Smokers, MT CT	19
BP, Baseline Smokers, MT Oxygen initiated	6
SP, Baseline Smokers, MT Oxygen initiated	4

No statistical analyses for this end point

Secondary: Duration of asthma-related hospitalizations (subgroups of subjects)

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End point title

Duration of asthma-related hospitalizations (subgroups of subjects)

End point description

Duration of asthma-related hospitalization in 12-month period before [baseline period (BP)] and after initiation of tezepelumab [up to study Week 52- study period (SP)] was assessed in following subgroups of subjects: BEC≥300 cells/µL; BEC<300 cells/µL; With clinically-relevant allergy to perennial aeroallergen; Without clinically-relevant allergy to perennial aeroallergen; Subjects who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking). Here, 'n' in each row represents number of subjects analyzed for each timepoint. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study. Here, 0.9999 indicates that data could not be calculated due to less than 10 subjects in that subgroup or when the subgroup had less than 3 subjects who experienced exacerbation in each population.

End point type

Secondary

End point timeframe

Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

End point values	Tezepelumab
Number of subjects analysed	23
Units: Crude Rate (days per year)
number (not applicable)
SP, Baseline BEC: <300, Hosp. n=20	6.5463
BP, Baseline BEC: <300, Hosp. n=18	4.9057
SP, Baseline BEC: <300, HIC	0.9999
BP, Baseline BEC: <300, HIC	0.9999
SP, Baseline BEC: <300, HGC n=19	6.6300
BP, Baseline BEC: <300, HGC n=14	3.2970
SP, Baseline BEC ≥300, Hosp. n=5	2.7070
BP, Baseline BEC ≥300, Hosp. n=13	3.5506
SP, Baseline BEC ≥300, HIC	0.9999
BP, Baseline BEC ≥300, HIC	0.9999
SP, Baseline BEC ≥300, HGC n=3	2.6136
BP, Baseline BEC ≥300, HGC n=10	3.2110
SP, All PFN, Hosp. n=11	5.6316
BP, All PFN, Hosp. n=8	2.7594
SP, All PFN, HIC	0.9999
BP, All PFN, HIC	0.9999
SP, All PFN, HGC n=11	5.6316
BP, All PFN, HGC n=8	2.1323
SP, Any PFP, Hosp. n=14	5.8273
BP, Any PFP, Hosp. n=23	4.8863
SP, Any PFP, HIC n=2	3.4928
BP, Any PFP, HIC n=9	5.4631
SP, Any PFP, HGC n=11	6.5206
BP, Any PFP, HGC n=16	3.8256
SP, Baseline BEC <300 & with all PFN, Hosp. n=10	5.9877
BP, Baseline BEC <300 & with all PFN, Hosp. n=5	3.2110
SP, Baseline BEC <300 & with all PFN, HIC	0.9999
BP, Baseline BEC <300 & with all PFN, HIC	0.9999
SP, Baseline BEC <300 & with all PFN, HGC n=10	5.9877
BP, Baseline BEC <300 & with all PFN, HGC n=5	2.4082
SP, Baseline BEC ≥300 & with all PFN, Hosp.	0.9999
BP, Baseline BEC ≥300 & with all PFN, Hosp.	0.9999
SP, Baseline BEC ≥300 & with all PFN, HIC	0.9999
BP, Baseline BEC ≥300 & with all PFN, HIC	0.9999
SP, Baseline BEC ≥300 & with all PFN, HGC	0.9999
BP, Baseline BEC ≥300 & with all PFN, HGC	0.9999
SP, Baseline BEC ≥300 & with any PFP, Hosp. n=4	2.8760
BP, Baseline BEC ≥300 & with any PFP, Hosp. n=10	4.0137
SP, Baseline BEC ≥300 & with any PFP, HIC	0.9999
BP, Baseline BEC ≥300 & with any PFP, HIC	0.9999
SP, Baseline BEC ≥300 & with any PFP, HGC	0.9999
BP, Baseline BEC ≥300 & with any PFP, HGC	0.9999
SP, Black/African American, Hosp. n=9	5.5664
BP, Black/African American, Hosp. n=17	3.6006
SP, Black/African American, HIC	0.9999
BP, Black/African American, HIC	0.9999
SP, Black/African American, HGC n=8	5.9368
BP, Black/African American, HGC n=16	2.8849
SP, Adolescents, Hosp.	0.9999
BP, Adolescents, Hosp.	0.9999
SP, Adolescents, HIC	0.9999
BP, Adolescents, HIC	0.9999
SP, Adolescents, HGC	0.9999
BP, Adolescents, HGC	0.9999
SP, mild to moderate COPD, Hosp. n=9	6.6060
BP, mild to moderate COPD, Hosp. n=7	6.7373
SP, mild to moderate COPD, HIC	0.9999
BP, mild to moderate COPD, HIC	0.9999
SP, mild to moderate COPD, HGC n=8	7.3133
BP, mild to moderate COPD, HGC n=6	4.1810
SP, Baseline smokers, Hosp. n=8	9.2988
BP, Baseline smokers, Hosp. n=10	3.4117
SP, Baseline smokers, HIC	0.9999
BP, Baseline smokers, HIC	0.9999
SP, Baseline smokers, HGC n=7	10.5870
BP, Baseline smokers, HGC n=7	1.5768
SP, Baseline BEC <300 & with any PFP, Hosp. n=10	7.1639
BP, Baseline BEC <300 & with any PFP, Hosp. n=13	5.5575
SP, Baseline BEC <300 & with any PFP, HIC	0.9999
BP, Baseline BEC <300 & with any PFP, HIC	0.9999
SP, Baseline BEC <300 & with any PFP, HGC n=9	7.4268
BP, Baseline BEC <300 & with any PFP, HGC n=9	3.7908

No statistical analyses for this end point

Other pre-specified: Number of subjects with serious adverse events (SAEs), adverse events that lead to tezepelumab treatment discontinuation (DAEs), and adverse events of special interest (AESIs)

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End point title

Number of subjects with serious adverse events (SAEs), adverse events that lead to tezepelumab treatment discontinuation (DAEs), and adverse events of special interest (AESIs)

End point description

The safety and tolerability of tezepelumab were assessed. Data for adverse events on-treatment period have been presented. FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study. Study intervention = SI

End point type

Other pre-specified

End point timeframe

Up to Week 52

End point values	Tezepelumab
Number of subjects analysed	286
Units: Subjects
Any SAE	28
Any SAE with outcome of death	1
Any AE leading to SI discontinuation	6

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to Week 52

Adverse event reporting additional description

FAS included all enrolled subjects who received at least 1 dose of tezepelumab, irrespective of their protocol adherence and continued participation in the study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

28.1

Reporting group title

Tezepelumab

Reporting group description

Subjects received 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.

Serious adverse events	Tezepelumab
Total subjects affected by serious adverse events
subjects affected / exposed	31 / 286 (10.84%)
number of deaths (all causes)	1
number of deaths resulting from adverse events	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Squamous cell carcinoma
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Lung neoplasm malignant
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vascular disorders
Arterial occlusive disease
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
Death
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Non-cardiac chest pain
subjects affected / exposed	2 / 286 (0.70%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Acute respiratory failure
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Asthma
subjects affected / exposed	6 / 286 (2.10%)
occurrences causally related to treatment / all	0 / 9
deaths causally related to treatment / all	0 / 0
Pneumothorax
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Psychiatric disorders
Hallucination, auditory
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Cardiac disorders
Myocardial infarction
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Paraesthesia
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Seizure
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Transient ischaemic attack
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Small intestinal obstruction
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Abdominal hernia
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Arthritis
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Atypical pneumonia
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
COVID-19 pneumonia
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
COVID-19
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumonia bacterial
subjects affected / exposed	3 / 286 (1.05%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Sepsis
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Tooth infection
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Urosepsis
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumonia
subjects affected / exposed	4 / 286 (1.40%)
occurrences causally related to treatment / all	0 / 4
deaths causally related to treatment / all	0 / 0
Pneumonia viral
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metabolism and nutrition disorders
Lactic acidosis
subjects affected / exposed	1 / 286 (0.35%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Tezepelumab
Total subjects affected by non serious adverse events
subjects affected / exposed	4 / 286 (1.40%)
Injury, poisoning and procedural complications
Ligament sprain
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Procedural pain
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Nervous system disorders
Neuralgia
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Syncope
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Gastrointestinal disorders
Nausea
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Rash erythematous
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Musculoskeletal and connective tissue disorders
Spinal stenosis
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Intervertebral disc degeneration
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Muscle spasms
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Muscle twitching
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Osteoarthritis
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1
Scoliosis
subjects affected / exposed	1 / 286 (0.35%)
occurrences all number	1

More information

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Were there any global substantial amendments to the protocol? Yes

24 Jan 2022

Amendment 1, Version 2.0 - PGI-C was removed from Visit 2. - Text was added regarding approval of tezepelumab in the US. - Citation for TEZSPIRE USPI was added. - “Uncontrolled asthma” was changed to “severe asthma”, where needed. - Text was added regarding adequate enrollment of patients with comorbid nasal polyps. - “Male or female” subject was added.

12 Jan 2023

Amendment 2, Version 3.0 - The endpoints (annualized rate of ED/UC visits and hospitalizations) related to the secondary objective on asthma-related HRU were removed. - New secondary objective ‘To describe the time to first exacerbation after initiation of tezepelumab’ was added. - Clinical remission assessment was removed from the Schedule of Activities. - Weight and height were added to the Schedule of Activities. - Inclusion criterion related to the requirement to complete the full course of COVID-19 vaccination at least 28 days prior to the administration of tezepelumab were removed. - ICF signing requirements for re-screened subjects were updated. - The reporting of device malfunctions in paper form (AstraZeneca Product Complaint Intake form) instead of eCRF was modified. - Text on medical device deficiencies including reporting requirements was added. - A new section was added to explain that ‘X-ray, CT scan, and/or FeNO’ assessments performed as per routine clinical practice would be collected retrospectively. - ‘Serious cardiac events’ as one of the AESIs for tezepelumab was added. AESI definition and reporting requirements were updated. - Analysis of SAEs, DAEs and AESIs to include summarization of these events during the on-treatment and on study periods and by causality/relatedness and maximum intensity was updated. - Interim analysis text was updated to remove specific timings, to explain the rationale for interim analysis, to explain that the results of the interim analysis would not result in study design changes. - Table was updated to add additional maintenance therapy options and update total daily doses.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants with Severe Asthma including Several Under-Studied Populations in the United States

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Annualized asthma exacerbation rate (AAER)

Primary: Annualized asthma exacerbation rate (AAER)

Secondary: Cumulative asthma exacerbation days

Secondary: Cumulative asthma exacerbation days

Secondary: Number of subjects with asthma exacerbations

Secondary: Number of subjects with asthma exacerbations

Secondary: Number of subjects who completed the 52 -week study period with any reduction in total number of asthma exacerbations

Secondary: Number of subjects who completed the 52 -week study period with any reduction in total number of asthma exacerbations

Secondary: Rate of asthma exacerbations associated with hospitalizations

Secondary: Rate of asthma exacerbations associated with hospitalizations

Secondary: Time to first asthma exacerbation

Secondary: Time to first asthma exacerbation

Secondary: Rate of asthma exacerbations associated with hospitalizations or ED/UC visits

Secondary: Rate of asthma exacerbations associated with hospitalizations or ED/UC visits

Secondary: Rate of asthma exacerbations associated with emergency department /urgent care (ED/UC) visits

Secondary: Rate of asthma exacerbations associated with emergency department /urgent care (ED/UC) visits

Secondary: Number of subjects with asthma exacerbations associated with hospitalizations or ED/UC visits

Secondary: Number of subjects with asthma exacerbations associated with hospitalizations or ED/UC visits

Secondary: Cumulative asthma exacerbation days associated with hospitalizations or ED/UC visits

Secondary: Cumulative asthma exacerbation days associated with hospitalizations or ED/UC visits

Secondary: Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

Secondary: Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

Secondary: Change from baseline in pre-bronchodilator FEV1

Secondary: Change from baseline in pre-bronchodilator FEV1

Secondary: Number of pre-BD FEV1 responders

Secondary: Number of pre-BD FEV1 responders

Secondary: Asthma Control Questionnaire (ACQ-6)

Secondary: Asthma Control Questionnaire (ACQ-6)

Secondary: Asthma Impairment and Risk Questionnaire (AIRQ)

Secondary: Asthma Impairment and Risk Questionnaire (AIRQ)

Secondary: St. George’s Respiratory Questionnaire (SGRQ)

Secondary: St. George’s Respiratory Questionnaire (SGRQ)

Secondary: Change from baseline in ACQ-6 score

Secondary: Change from baseline in ACQ-6 score

Secondary: Change from baseline in AIRQ score

Secondary: Change from baseline in AIRQ score

Secondary: Change from baseline in SGRQ score

Secondary: Change from baseline in SGRQ score

Secondary: Number of ACQ-6 responders

Secondary: Number of ACQ-6 responders

Secondary: Number of AIRQ responders

Secondary: Number of AIRQ responders

Secondary: Number of SGRQ responders

Secondary: Number of SGRQ responders

Secondary: Cumulative annualized SCS dose

Secondary: Cumulative annualized SCS dose

Secondary: Number of subjects who require any systemic corticosteroid (SCS) use

Secondary: Number of subjects who require any systemic corticosteroid (SCS) use

Secondary: Number of subjects who require longer-term (>30 consecutive days) SCS use

Secondary: Number of subjects who require longer-term (>30 consecutive days) SCS use

Secondary: Number and type of asthma-related healthcare resource utilization (HRU)

Secondary: Number and type of asthma-related healthcare resource utilization (HRU)

Secondary: AAER for asthma exacerbations (subgroups of subjects)

Secondary: AAER for asthma exacerbations (subgroups of subjects)

Secondary: Duration of asthma-related hospitalizations

Secondary: Duration of asthma-related hospitalizations

Secondary: Number of subjects with asthma exacerbations (subgroups of subjects)

Secondary: Number of subjects with asthma exacerbations (subgroups of subjects)

Secondary: Number of subjects who completed the 52-week study with any reduction in total number of asthma exacerbations (subgroups of subjects)

Secondary: Number of subjects who completed the 52-week study with any reduction in total number of asthma exacerbations (subgroups of subjects)

Secondary: Cumulative asthma exacerbation days (subgroups of subjects)

Secondary: Cumulative asthma exacerbation days (subgroups of subjects)

Secondary: Rate of asthma exacerbations associated with hospitalizations (subgroups of subjects)

Secondary: Rate of asthma exacerbations associated with hospitalizations (subgroups of subjects)

Secondary: Rate of asthma exacerbations associated with emergency department/urgent care (ED/UC) visits (subgroups of subjects)

Secondary: Rate of asthma exacerbations associated with emergency department/urgent care (ED/UC) visits (subgroups of subjects)

Secondary: Rate of asthma exacerbations associated with hospitalizations or ED/UC visits (subgroups of subjects)

Secondary: Rate of asthma exacerbations associated with hospitalizations or ED/UC visits (subgroups of subjects)

Secondary: Number and type of asthma-related HRU (subgroups of subjects)

Secondary: Number and type of asthma-related HRU (subgroups of subjects)

Clinical Trial Results:
A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants with Severe Asthma including Several Under-Studied Populations in the United States