The following article is a part of conference coverage from the American Academy of Allergy, Asthma & Immunology Annual Meeting, being held in Phoenix, Arizona, from February 25 to 28, 2022. The team at Pulmonology Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from the AAAAI 2022 Virtual Annual Meeting.
In adults and adolescents with severe, uncontrolled asthma, use of tezepelumab is associated with a swift and sustained reduction in symptomatic days. This was among the findings of research presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting held in Phoenix, AZ, February 25 to 28, 2022.
In the current study, researchers conducted a pre-specified exploratory analysis of the phase 3 NAVIGATOR study (ClinicalTrials.gov Identifier: NCT03347279) in order to evaluate the effect of tezepelumab, a human monoclonal antibody targeting thymic stromal lymphopoietin, on asthma symptomatic days. NAVIGATOR, which explored the safety and efficacy of tezepelumab in patients with severe, uncontrolled asthma, was a multicenter, double-blind, randomized, placebo-controlled study of 1059 adult and adolescent patients 12 to 80 years of age. Of those patients, 528 received subcutaneous 210 mg tezepelumab and 531 received subcutaneous placebo every 4 weeks for 52 weeks.
Patients in the trial used an Asthma Symptom Diary (ASD) to self-record 5 morning and 5 evening asthma symptoms, rating each symptom with a severity score from 0 (none) to 4 (very severe). The mean score of these 10 items then became the daily ASD score. The change in percentage of asthma symptomatic days (defined as a mean ASD ≥1) per week from baseline to week 52 was evaluated.
Through the 52-week study, the median number of asthma symptomatic days per patient was 42 with tezepelumab and 61 with placebo. The mean change in the percentage of asthma symptomatic days per week with tezepelumab and placebo, respectively, from baseline, was -17.9% and -9.7% for week 2 (difference, -8.2% [95% CI, -12.1 to -4.3]). Subsequently, differences between tezepelumab and placebo were -7.2% at week 26 (95% CI, -12.4, to -2.1) and -7.9% at week 52 (95% CI, -13.4 to -2.5).
Researchers concluded, “Tezepelumab treatment resulted in an early and sustained reduction in the weekly percentage of asthma symptomatic days vs placebo in patients with severe, uncontrolled asthma.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
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Carr W, Jain N, Ambrose C, et al. Tezepelumab treatment reduced asthma symptomatic days in adults and adolescents with severe, uncontrolled asthma in the Phase 3 NAVIGATOR Study. American Academy of Allergy, Asthma & Immunology (AAAAI) 2022 Annual Meeting; February 25–28, 2022; Phoenix, AZ. Abstract 046.