Dupilumab Reduces COPD Exacerbations, Shows Promise for Personalized Treatment: Study Finds

The findings, published in The Lancet Respiratory Medicine, suggest that dupilumab, when used alongside standard triple therapy, significantly reduces the rate of moderate or severe exacerbations, offering a targeted approach for managing COPD in patients with specific clinical profiles.

COPD is a progressive lung disease often characterized by recurrent exacerbations that lead to worsening lung function and reduced quality of life. While standard treatments help manage symptoms, there remains a need for therapies tailored to specific disease subtypes, such as those with underlying type 2 inflammation. Dupilumab is a fully human monoclonal antibody that targets the shared receptor for IL-4 and IL-13, two key drivers of type 2 inflammation. Given their role in COPD with type 2 inflammation, Prof Surya P Bhatt, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama, Birmingham, AL, USA, and colleagues aimed to evaluate the effectiveness and safety of dupilumab in treating these patients.

For this purpose, the researchers conducted a pooled analysis of data from the phase 3 BOREAS and NOTUS trials, which included patients from 38 countries. Participants were 40–85 years old, had COPD diagnosed for at least a year, a smoking history of at least 10 pack-years, and experienced frequent exacerbations despite triple therapy. Patients were randomly assigned to receive either subcutaneous dupilumab 300 mg or a placebo every two weeks for 52 weeks. The study aimed to assess the effectiveness of dupilumab in reducing moderate or severe exacerbations while maintaining standard inhaled therapy.

Key Findings:

• One-thousand-eight hundred and seventy-four patients were enrolled in the BOREAS and NOTUS trials between May 9, 2019, and May 23, 2023. Of these, 938 (50.1%) received dupilumab, while 936 (49.9%) were given a placebo.
• The average age was 65.1 years, with 33.2% female and 66.8% male participants. Most patients (86.9%) were White, 38.4% were from Eastern Europe, and 70.2% were former smokers.
• Over 52 weeks, 559 moderate or severe exacerbations occurred in 36.0% of the dupilumab group, compared to 774 exacerbations in 42.1% of the placebo group.
• Dupilumab reduced the annualized rate of moderate or severe exacerbations (0.794 vs. 1.156 in the placebo group, incidence rate ratio: 0.687).
• The time to the first severe exacerbation was longer with dupilumab compared to placebo (0.611).
• However, there was no significant reduction in the annualized rate of severe exacerbations (0.084 vs. 0.124).
• The rates of treatment-related adverse events, serious adverse events, discontinuations, and deaths were similar in both groups.

The study showed that dupilumab, when added to standard triple therapy, significantly lowered the annualized rate of moderate or severe exacerbations compared to placebo.

"These findings highlight its potential as a targeted treatment option for COPD patients with specific clinical profiles," the authors concluded.

Reference:

Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB. Dupilumab for chronic obstructive pulmonary disease with type 2 inflammation: a pooled analysis of two phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2025 Mar;13(3):234-243. doi: 10.1016/S2213-2600(24)00409-0. Epub 2025 Jan 31. PMID: 39900091.