Itepekimab lowers exacerbation rate in former smokers with COPD

Key takeaways:

• Included former smokers experienced at least two COPD exacerbations in the year prior to screening.
• Those receiving itepekimab vs. placebo had better exacerbation outcomes.

Receiving itepekimab led to a 51% lower adjusted annualized exacerbation rate in former smokers with moderate/severe COPD and exacerbation history, according to a poster presented at the European Respiratory Society International Congress.

“Itepekimab is investigational and not yet approved, but these data demonstrate the potential of this treatment in former smokers regardless of exacerbation history,” Klaus F. Rabe, MD, PhD, professor of pulmonary medicine at the University of Kiel and director of the department of pneumonology at LungenClinic Grosshansdorf in Germany, told Healio. “Exacerbations contribute to progressive lung function and worsen quality of life, so the potential to reduce these events is essential for any investigational COPD treatment.”

In a post hoc analysis of a double-blind, placebo-controlled, proof-of-concept phase 2a study of itepekimab (Sanofi, Regeneron) in COPD, Rabe and colleagues assessed 157 former smokers with moderate/severe COPD on a stable double- or triple-inhaled regimen who experienced at least two exacerbations in the year prior to screening to determine the impact of add-on 24- to 52-week itepekimab on time to first moderate/severe exacerbation and adjusted annualized exacerbation rate vs. placebo.

Of the total cohort, 81 patients received 300 mg of itepekimab every 2 weeks, and 76 patients received placebo every 2 weeks.

In the itepekimab group, 55 patients (mean age, 66.5 years; 45.5% women) had two exacerbations in the year before screening and 26 (mean age, 66.4 years; 30.8% women) had three or more exacerbations in the year before screening.

In the placebo group, 52 patients (mean age, 66.4 years; 57.7% women) had two exacerbations in the year prior to screening and 24 (mean age, 65.2 years; 54.2% women) had three or more exacerbations in the year prior to screening.

Among those with two exacerbations in the year before screening, researchers observed a longer time to first moderate/severe exacerbation in the itepekimab vs. placebo group (HR = 0.48; 95% CI, 0.26-0.91). Similarly, patients with at least three exacerbations in the year prior to screening receiving itepekimab had a longer time to first exacerbation compared with those receiving placebo (median, 237 days vs. 154 days; HR = 0.47; 95% CI, 0.21-1.04).

When evaluating adjusted annualized moderate/severe exacerbation rates in the two exacerbations subgroups, the itepekimab group had a 51% lower rate vs. the placebo group (0.54 vs. 1.09; P < .05). Researchers also found this outcome in the three or more exacerbations subgroup, with a 51% lower rate among those receiving itepekimab vs. placebo (1.26 vs. 2.59; P < .05).

“These results are in line with what we would expect from this itepekimab study for improving outcomes regardless of baseline characteristics in former smokers with COPD,” Rabe told Healio. “The data demonstrate that exacerbation history does not impact clinical outcomes in this population, with itepekimab reducing exacerbations by 51% compared to placebo regardless of whether patients had two or [three or more] exacerbations in the year before screening.

“Itepekimab is currently in two phase 3 trials, which have completed enrollment, and results are expected in the second half of next year,” Rabe added.