Background
Chronic Obstructive Pulmonary Disease (COPD) is a significant global health issue, characterized by chronic respiratory symptoms and progressive airflow obstruction. Despite advancements in treatment, there remains a substantial unmet need for therapies that can further reduce the risk of exacerbations and improve patient quality of life. Interleukin (IL)-33 has been implicated in the pathogenesis of COPD, making it a potential target for novel treatments.
Study Design
AERIFY-1 and AERIFY-2 are global, multicentre, randomized, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of itepekimab in former smokers with moderate-to-severe COPD. The primary objective is to assess the annualized rate of moderate or severe acute exacerbations of COPD (AECOPD). Secondary objectives include evaluating lung function, severe exacerbations, and health-related quality of life.
Key Findings from Phase 2
In a phase 2 study, itepekimab showed a significant reduction in exacerbation rates and improved lung function in former smokers with COPD, with an acceptable safety profile. This subgroup analysis informed the focus on former smokers in the phase 3 trials.
Study Population
The trials will enroll patients aged 40-85 years with a smoking history of ≥10 pack-years and a diagnosis of moderate-to-severe COPD. Participants must have experienced ≥2 moderate or ≥1 severe exacerbations in the previous year despite standard-of-care therapy.
Endpoints
The primary endpoint is the annualized rate of moderate or severe AECOPD. Secondary endpoints include changes in lung function, time to first exacerbation, and patient-reported outcomes such as symptom control and quality of life.
Conclusion
The AERIFY-1 and AERIFY-2 trials represent a critical step forward in the search for effective treatments for COPD, particularly for former smokers who continue to experience significant morbidity despite smoking cessation. By targeting IL-33, itepekimab offers a novel approach to managing COPD, with the potential to significantly impact the course of the disease.
