Dupilumab long-term data show sustained improvement in moderate to severe asthma

Long-term treatment with dupilumab shows sustained improvement in lung function and reduction in severe exacerbations in patients with moderate to severe asthma, according to new results from a phase 3, open-label extension trial.

Michael E. Wechsler, MD, MMSc, professor of medicine, director of the National Jewish Health Cohen Family Asthma Institute and pulmonologist in the division of pulmonary, critical care and sleep medicine, reported new results from the LIBERTY ASTHMA TRAVERSE study. The open-label extension study enrolled 2,282 patients with moderate to severe or oral corticosteroid-dependent severe asthma who completed a previous dupilumab (Dupixent, Sanofi/Regeneron) asthma study (phase 2b, phase 3 QUEST, phase 3 VENTURE or phase 2a EXPEDITION). Patients were assigned add-on dupilumab 300 mg every 2 weeks. Ninety-six percent of patients had a study duration of 48 weeks and 54% had a study duration of 96 weeks.

Researchers assessed treatment-emergent adverse events, annualized rate of severe asthma exacerbations and change from parent study baseline in FEV₁ and biomarkers up to week 96 of open-label extension.

In total, 2,039 patients completed the open-label extension study. The safety profile of dupilumab was consistent with previously published short-duration parent studies, with no new safety signals observed, according to Wechsler.

Treatment-emergent adverse events ranged from 76% to 88%. The most common adverse events in any treatment group were nasopharyngitis and injection-site erythema. Nine percent to 13% of patients experienced serious adverse events.

Researchers observed low annualized severe asthma exacerbation rates in patients assigned dupilumab that were similar to rates observed in the parent studies, ranging from 0.31 to 0.35 events per year in the non-oral corticosteroid-dependent population and from 0.29 to 0.33 events per year in the subgroup of non-oral corticosteroid-dependent patients with a type 2 phenotype.

At 96 weeks, patients continued to experience improvement in lung function, with an absolute mean FEV₁ ranging from 2.02 L to 2.12 L, which was a 13% to 22% mean percent change from results from the parent studies.

Additionally, improvements in lung function and asthma exacerbations were greater in patients with elevated baseline blood eosinophils or fractional exhaled nitric oxide. In these long-term results, patients showed reductions in blood eosinophils of 23% to 35% and in blood immunoglobulin E for patients from the pivotal phase 2 trial of 82% compared with baseline in the parent studies, according to a company press release.

“In conclusion, long-term treatment with dupilumab is generally well tolerated,” Wechsler said. “Patients exposed to dupilumab for up to 96 weeks demonstrated maintenance in the clinical efficacy that was observed in the parent studies, including a persistently low exacerbation rate and sustained improvements in lung function.”