Dupilumab improves lung function, reduces exacerbations in COPD with type 2 inflammation

Key takeaways:

• Adults with moderate or severe COPD receiving dupilumab every 2 weeks had a 34% lower rate of exacerbations vs. placebo at week 52.
• Two phase 3 trials now support the use of dupilumab in this patient population.

Adults with moderate to severe COPD and type 2 inflammation receiving dupilumab vs. placebo had fewer exacerbations and improved lung function at 52 weeks, according to topline results from the phase 3 NOTUS trial.

These results add to previous evidence from the BOREAS trial, which supports dupilumab (Dupixent; Regeneron, Sanofi) use in this patient population, according to the press release from Sanofi.

“This is the first and only time an investigational biologic in COPD has shown a significant and clinically meaningful reduction in exacerbations in two phase 3 trials and we are pleased that we can potentially deliver Dupixent faster to patients in need where no new advancements have been identified in over a decade,” Naimish Patel, MD, head of global development in immunology and inflammation at Sanofi, said in the release.

In the phase 3 NOTUS trial, researchers assessed 935 current/former smokers with moderate to severe COPD and type 2 inflammation treated with maximal standard of care inhaled therapy to see how added dupilumab (n = 470) performs against added placebo (n = 465) when evaluating exacerbations after 52 weeks of treatment, which was given every 2 weeks.

Researchers also assessed lung function at week 12 and week 52 of treatment vs. baseline as a secondary endpoint.

At the 52-week mark, the dupilumab group had a 34% decrease in moderate or severe acute COPD exacerbations vs. the placebo group (P = .0002), according to the release.

Compared with patients receiving placebo, patients receiving dupilumab also demonstrated better lung function from baseline to week 12 (pre-bronchodilator FEV₁, 139 mL vs. 57 mL; P = .0001), which continued to be the case at week 52 (115 mL vs. 54 mL; P = .0182).

In terms of safety, both groups had a similar rate of adverse events (dupilumab, 67% vs. placebo, 66%), and researchers reported that “results were generally consistent with the known safety profile” of the treatment.

More patients receiving dupilumab vs. placebo experienced COVID-19 (9.4% vs. 8.2%), nasopharyngitis (6.2% vs. 5.2%) and headache (7.5% vs. 6.5%), whereas more patients receiving placebo experienced COPD (7.8% vs. 4.9%), according to the release.

Notably, slightly more patients in the dupilumab group died because of an adverse event than in the placebo group (2.6% vs. 1.5%).

Between the NOTUS trial and the BOREAS trial, researchers found comparable efficacy and safety results.

“These data validate our belief that Dupixent has the potential to transform the treatment of moderate to severe COPD and given the significant unmet needs for patients with uncontrolled COPD, we are not stopping with Dupixent,” Patel said in the release. “Our second program in COPD, itepekimab, continues with data expected in 2025. If positive, Dupixent and itepekimab could emerge as treatments for approximately 80% of those suffering from moderate to severe COPD with recurrent exacerbations.”

The press release noted that full findings from this trial will be presented at a future scientific forum.