To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.
This is a multicenter, single-arm, open-label, Post-authorization, Phase 4 study to assess the effectiveness of tezepelumab in the United States (US) among a real-world population of adults and adolescent participants with asthma requiring medium-dose to high-dose inhaled corticosteroids (ICS), with additional controller(s) for at least 12 months with documented history of at least 2 asthma exacerbations during the year prior to enrolment. The total duration of the study for each participant will be approximately 56 weeks. Approximately 400 participants will be enrolled. Participants will receive tezepelumab via subcutaneous injection at the study site, over a 48-week treatment period. The study also includes a post-dosing follow-up period from Weeks 48 to 52.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Participants will be receiving subcutaneous injection of tezepelumab.
Annualized Asthma Exacerbation Rate (AAER)
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 \[up to study Week 52 (Visit 15) = study period (SP)\].
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants With Asthma Exacerbations
The number of participants 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.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants Who Completed the 52 -Week Study Period With Any Reduction in Total Number of Asthma Exacerbations
The number of participants 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.
Time frame: From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52)
Cumulative Asthma Exacerbation Days
The cumulative asthma exacerbation days over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) was assessed.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Time to First Asthma Exacerbation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Mobile, Alabama, United States
Research Site
Gilbert, Arizona, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Rancho Mirage, California, United States
Research Site
Westminster, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Chicago, Illinois, United States
...and 27 more locations
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 Participants with an event.
Time frame: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Rate of Asthma Exacerbations Associated With Hospitalizations
The rate of asthma exacerbations associated with hospitalization over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) was assessed.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Emergency Department /Urgent Care (ED/UC) Visits
The rate of asthma exacerbations associated with ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) was assessed.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Hospitalizations or ED/UC Visits
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.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants With Asthma Exacerbations Associated With Hospitalizations or ED/UC Visits
The number of participants 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 = study period) were assessed.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Cumulative Asthma Exacerbation Days Associated With Hospitalizations or ED/UC Visits
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. Total days of exacerbations resulting in hospitalizations or ED/UC visits have been presented.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1)
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.
Time frame: Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Change From Baseline in Pre-bronchodilator FEV1
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.
Time frame: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Number of Pre-BD FEV1 Responders
Number of pre-BD FEV1 responders was defined as participants who achieved either at least 5% or 100 mL improvement from baseline.
Time frame: Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Asthma Control Questionnaire (ACQ-6)
The Asthma Control Questionnaire-6 (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), with higher scores indicating worse asthma control. The mean (average) ACQ-6 score is the mean of the responses.
Time frame: Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Asthma Impairment and Risk Questionnaire (AIRQ)
The Asthma Impairment and Risk Questionnaire (AIRQ) is a Patient Reported Outcome (PRO) tool intended to identify participants 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, ranging from 0 to 10, with higher scores indicating worse asthma control, where: 0-1 is well controlled, 2-4 is not well controlled, and 5-10 is very poorly controlled.
Time frame: Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
St. George's Respiratory Questionnaire (SGRQ)
St. George's Respiratory Questionnaire (SGRQ) is a 50-item Patient Reported Outcome (PRO) instrument used to measure health status of participants 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.
Time frame: Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Change From Baseline in ACQ-6 Score
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score was assessed. 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), with higher scores indicating worse asthma control.
Time frame: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Change From Baseline in AIRQ Score
Change from baseline in Asthma Impairment and Risk Questionnaire (AIRQ) score was assessed. AIRQ is a Patient Reported Outcome (PRO) tool intended to identify participants 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, ranging from 0 to 10, with higher scores indicating worse asthma control, where: 0-1 is well controlled, 2-4 is not well controlled, and 5-10 is very poorly controlled.
Time frame: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Change From Baseline in SGRQ Score
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) score was assessed. SGRQ is a 50-item Patient Reported Outcome (PRO) instrument used to measure health status of participants 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.
Time frame: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Number of ACQ-6 Responders
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 participants who achieved ≥ 1 MCID.
Time frame: Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of AIRQ Responders
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 participants who achieved ≥ 1 MCID.
Time frame: Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of SGRQ Responders
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 participants who achieved ≥ 1 MCID.
Time frame: Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of Participants Who Require Any Systemic Corticosteroid (SCS) Use
Number of participants 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.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Cumulative Annualized SCS Dose
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 participant was calculated as followed: Cumulative annualized SCS dose = \[sum of (cumulative SCS dose)/length of the planned treatment period\]\*365.25
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants Who Require Longer-term (>30 Consecutive Days) SCS Use
Number of participants 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.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number and Type of Asthma-related Healthcare Resource Utilization (HRU)
Number of participants 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.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Duration of Asthma-related Hospitalizations
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.
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
AAER for Asthma Exacerbations (Subgroups of Participants)
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 participants: 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; Participants 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).
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants With Asthma Exacerbations (Subgroups of Participants)
The number of participants 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 participants: 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; Participants 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).
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants Who Completed the 52-week Study With Any Reduction in Total Number of Asthma Exacerbations (Subgroups of Participants)
The number of participants 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 participants: 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; Participants 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).
Time frame: From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52)
Cumulative Asthma Exacerbation Days (Subgroups of Participants)
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 participants: 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; Participants 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).
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Hospitalizations (Subgroups of Participants)
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 participants: BEC ≥300 cells/µL; BEC \<300 cells/µL; With a clinically-relevant allergy to perennial aeroallergen; Without a clinically-relevant allergy to perennial aeroallergen; Participants 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).
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Emergency Department/Urgent Care (ED/UC) Visits (Subgroups of Participants)
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 participants: BEC ≥300 cells/µL; BEC \<300 cells/µL; With a clinically-relevant allergy to perennial aeroallergen; Without a clinically-relevant allergy to perennial aeroallergen; Participants 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).
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Hospitalizations or ED/UC Visits (Subgroups of Participants)
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 participants: BEC ≥300 cells/µL; BEC \<300 cells/µL; With clinically-relevant allergy to perennial aeroallergen; Without clinically-relevant allergy to perennial aeroallergen; Participants 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).
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number and Type of Asthma-related HRU (Subgroups of Participants)
Number of participants 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 participants: 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; Participants 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). FEIA = Fluorescent enzyme immunoassay
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Duration of Asthma-related Hospitalizations (Subgroups of Participants)
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 participants: BEC≥300 cells/µL; BEC\<300 cells/µL; With clinically-relevant allergy to perennial aeroallergen; Without clinically-relevant allergy to perennial aeroallergen; Participants 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).
Time frame: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)