Extension Trial Shows Positive Results for Dupixent

Results from a yearlong extension of the pivotal trial of Dupixent (duplimab) as a treatment for moderate-to-asthma in children showed positive results, according to results presented this week at the 2022 European Respiratory Society International Congress held in Barcelona, Spain.

The 365 children who participated in the extension of the VOYAGE trial had low rates of severe asthma attacks compared with the baseline of the VOYAGE trial (0.118-0.124 events per year versus 2.16-2.56), according to a press release from Regeneron, which developed and markets Dupixent in a partnership with Sanofi. The children in the extension trial also had improved lung function compared with baseline levels in the VOYAGE trial.

The press release said safety results were consistent with what is already understood about Dupixent’s safety profile. During the year the trial was underway, adverse event rate was 61% to 68%, and the most common adverse events were nasopharyngitis (9% to 10%), pharyngitis(6% to 10%), upper respiratory tract infections (4% to 8%), flu (5% to 6%), eosinophilia (3% to 6%), allergic rhinitis (3% to 7%), diarrhea (4% to 6%) and injection site reactions (3% to 7%).

The extension trial was an open-label, multicenter study. The participants were ages 6 to 11 when they were enrolled in the VOYAGE trial, so some may have been older than 11 when they were in the extension trial.

Dupixent is a monoclonal antibody that inhibits the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. The Regeneron press release say that Dupixent has shown significant clinical benefit and a decrease in type 2 inflammation that establishes that IL-4 and IL-13 are “key and central drivers of type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.” Those diseases include approved indications for use of Dupixent: asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis.