Dupixent Demonstrates Sustained Efficacy Over Three Years in Slowing Lung Function Decline in Moderate-to-Severe Asthma Patients

Today, Regeneron and Sanofi announced that Dupixent (dupilumab), the blockbuster IL-4/IL-13 inhibitor jointly developed by the two companies, demonstrated sustained efficacy and safety for up to three years in an open-label Phase 3 extension trial involving patients with moderate-to-severe asthma, while also slowing the decline in lung function.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials demonstrate that IL-4 and IL-13 are key drivers of type 2 inflammation, which plays a central role in asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and atopic dermatitis. Across all approved indications worldwide, more than 170,000 patients have been treated with Dupixent.

This long-term clinical extension trial included more than 2,200 patients who had previously participated in Dupixent asthma trials, including three pivotal trials lasting 24 to 52 weeks. Patients entered the extension trial after completing the initial trials and received additional treatment for up to 2 years, providing a total of up to 3 years of treatment data. The results showed:

Pulmonary Function: Compared with the baseline levels of forced expiratory volume in one second (FEV1) in the initial clinical trial, patients’ pulmonary function showed sustained improvement of 13–22% after 96 weeks of treatment.

Asthma Exacerbations: The rate of severe asthma exacerbations in treated patients averaged 0.31–0.35 per year. In the year prior to initiating the Dupixent trial, their rate of severe asthma exacerbations was 2.09–2.17 per year.

“These data suggest that Dupixent may slow the progressive decline in lung function experienced by many patients with moderate-to-severe asthma,” said Dr. Michael Wechsler, lead investigator of the clinical trial and Director of the National Jewish Cohen Family Asthma Institute in Denver, Colorado. “Moreover, patients treated with Dupixent achieved asthma control, leading to a reduced rate of severe asthma exacerbations that could result in hospitalization. These findings further underscore Dupixent’s role as a continuous long-term treatment option to improve patients’ respiratory capacity and enhance asthma control.”

References:

[1] Dupixent^® (dupilumab) Long-term Data Show Sustained Improvement in Lung Function and Reduction in Severe Exacerbations in Adults and Adolescents with Moderate-to-severe Asthma. Retrieved September 8, 2020, from https://www.prnewswire.com/news-releases/dupixent-dupilumab-long-term-data-show-sustained-improvement-in-lung-function-and-reduction-in-severe-exacerbations-in-adults-and-adolescents-with-moderate-to-severe-asthma-301125211.html

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