Scientific Breakthrough in COPD Treatment: Dupilumab Shows Significant Benefits

A new phase 3 study reveals that dupilumab significantly reduces the frequency of severe exacerbations and improves lung function in patients with type 2 COPD. These findings could revolutionize treatment and offer new hope to millions of patients.

Chronic obstructive pulmonary disease (COPD) is a serious condition often associated with high morbidity and mortality. In some COPD patients, type 2 inflammation, characterized by elevated blood eosinophil levels, plays a crucial role. Dupilumab, a monoclonal antibody that blocks the interleukin-4 and interleukin-13 pathways, has previously shown positive results in treating COPD. The current study (NOTUS) evaluates the efficacy and safety of dupilumab in a large international patient population.

In the phase 3, double-blind, randomized study, 935 patients with COPD and elevated blood eosinophil counts (≥300 cells/μl) received either an injection of dupilumab (300 mg) or placebo every two weeks. The primary endpoint was the annualized rate of moderate or severe exacerbations, an acute worsening of the symptoms. Secondary endpoints included changes in forced expiratory volume in one second (FEV1) and quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ).

Rate of exacerbations significantly reduced

The study results showed that the annualized rate of moderate or severe exacerbations was 0.86 with dupilumab and 1.30 with placebo, representing a 34% reduction (P<0.001). Patients receiving dupilumab showed a mean improvement in FEV1 of 139 mL at 12 weeks compared to 57 mL in the placebo group. This improvement was maintained through week 52 (P=0.02). There were no significant differences in quality of life, as measured by the SGRQ, between the two groups at 52 weeks.

 The incidence of adverse events was similar in both groups, with the most common events being COVID-19, nasopharyngitis, and headache. Serious adverse events occurred in 13% of the dupilumab group and 15.9% of the placebo group.

Better control of disease symptoms

In conclusion, dupilumab reduced the rate of exacerbations and improved lung function in patients with COPD and type 2 inflammation. These results underscore the importance of type 2 inflammation in COPD and demonstrate the efficacy of dupilumab as a treatment option for this patient population. The study was sponsored by Sanofi and Regeneron Pharmaceuticals. These findings could significantly change the treatment approach for COPD patients with type 2 inflammation, offering new hope for more effective control of disease symptoms and progression.

Original publication: Christenson SA, Papi A, Singh D, Laws E, Patel N, Yancopoulos GD, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB; NOTUS Study Investigators. Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation. N Engl J Med. 2024 Jun 27;390(24):2274-2283. doi: 10.1056/NEJMoa2401304. Epub 2024 May 20. PMID: 38767614.