February 26, 2021
New Medication Reduces Asthma Exacerbations and Improves Lung Function in Patients with Severe, Uncontrolled Asthma
Results from the phase 3 NAVIGATOR study was presented during the 2021 AAAAI Virtual Annual Meeting.
MILWAUKEE, WI – Tezepelumab, a human monoclonal antibody, was found to be effective for patients with severe uncontrolled asthma in a phase 3 trial funded by AstraZeneca and Amgen, Inc. Data from the abstract was presented during the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.
NAVIGATOR, a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluated both the efficacy and safety of tezepelumab for patients with severe, uncontrolled asthma. Patients were randomized to receive tezepelumab or placebo subcutaneously every four weeks over the course of 52 weeks.
A total of 1,059 patients received tezepelumab or the placebo in the trial, with 528 receiving tezepelumab and 531 receiving the placebo. Researchers studied the annualized asthma exacerbation rate (AAER) as the primary efficacy indicator.
Compared to the placebo group, tezepelumab achieved a statistically significant and clinically meaningful 56% reduction in AAER in the overall population. It reduced the AAER by 70% in patients whose baseline blood eosinophil counts were higher than 300. For patients with blood eosinophil counts of less than 300 and less than 150 cells/µL, AAER was reduced by 41% and 39%, respectively.
“What’s really exciting about these results is that tezepelumab is reducing asthma exacerbations irrespective of baseline blood eosinophil count,” said Jonathan Corren, MD, an author of the study. “Importantly, the safety findings were similar in both treatments, meaning this treatment is effective and appears to be safe.”
Secondary outcomes assessed included changes in the forced expiratory volume in one second, results of the Asthma Control Questionnaire-6 and the scores for the Asthma Quality of Life Questionnaire. Asthma Symptom Diary scores were also reviewed, as well as the AAER associated with hospitalization or emergency department visit. Patients taking tezepelumab saw significant improvements in lung function and all of these questionnaire and diary scores. Additionally, tezepelumab reduced the rate of exacerbations leading to hospitalization or visits to the emergency department by 79% during the study.
The safety of tezepelumab was also analyzed. Overall, 77.1% of patients in the tezepelumab group reported an adverse event, compared to 79.5% of patients in the placebo group. Of those, 8.7% of patients in the tezepelumab group reported a serious adverse event, while 13.2% of the placebo group did. The most common adverse events included nasopharyngitis, upper respiratory tract infection, and headache. No anaphylactic reactions or cases of Guillain–Barré syndrome were reported related to the treatment.
“The results of the NAVIGATOR study are very important for the many patients with severe asthma who continue to be poorly controlled despite receiving standard of care inhaled medicines and currently approved biologics,” said first author Andrew Menzies-Gow, MD, Director of the Lung Division, Royal Brompton Hospital, Professor of Practice (Respiratory Medicine), Imperial College London. “By targeting upstream inflammation mediated by TSLP, tezepelumab has the potential to transform treatment for a broad population of patients with severe asthma irrespective of their type of inflammation, including those with and without an eosinophilic phenotype.”
Visit aaaai.org to learn more about asthma and visit annualmeeting.aaaai.org to learn more about the 2021 AAAAI Virtual Annual Meeting.
The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has over 7,000 members in the United States, Canada and 72 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.