Dupilumab Treats Asthma Exacerbation, Lung Function in Phase 3 Trial

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About one million US adults and adolescents live with uncontrolled, persistent asthma — despite there already being an intensive regimen of standard therapies. Dupilumab may be a missing piece to comprehensive treatment.

Atopic disease treatment Dupilumab, a monoclonal antibody, showed strength in treating uncontrolled, persistent asthma in a phase 3 trial.

According to data shared by Sanofi and Regeneron Pharmaceuticals from the LIBERTY ASTHMA QUEST study of dupilumab, the treatment reduced severe asthma attacks (exacerbations) and improved lung function when combined with standard therapies.

The pivotal trial enrolled 1,902 patients (1,795 adults, 107 adolescents) from 413 study sites worldwide. The 4 study groups included patients treated with 200 mg every other week with a loading dose of 400 mg, 300 mg every other week with a loading dose of 600 mg, and 2 separate placebo groups. Patients were randomized in a 2:1 fashion to active drug, versus placebo.

About 46% of a patient group prescribed 300 mg doses of dupilumab reported reduced exacerbations, and 60% of patients with 150 eosinophilic cells/microliter or greater similarly reported a reduction, both at 52 weeks. Even more so, 67% of patients with 300 eosinophilic cells/microliter or greater reported reduced exacerbations.

At the 12-week mark of the study, the 300 mg dupilumab dose group reported a mean improvement in lung function, versus placebo, as per forced expiratory volume over one second (FEV1). A 200 mg dose group similarly scored well on both exacerbation reduction and FEV1 to the 300 mg group.

Adverse events connected to treatment such as deaths, infections, conjunctivitis, herpes and discontinuations were comparable to placebo-treated groups. However, 17% of dupilumab patients reported injection site reactions, versus just 8% of placebo patients.

Under the market name Dupixent, dupilumab was approved by the FDA for treating moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies, in March of this year.

About one million US adults and adolescents live with uncontrolled, persistent asthma — despite there already being an "intensive regimen of standard therapies," George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, said. Dupilumab may be a missing piece to comprehensive treatment.

"Dupilumab has now demonstrated positive late-stage results in two serious allergic diseases — asthma and atopic dermatitis — with robust efficacy and an extensive safety database," Yancopoulos said. "These results continue to support our hypothesis that the IL4/IL13 pathway is a critical driver of allergic disease, and we remain committed to further investigating the IL-4/IL-13 pathway in other allergic diseases."

Elias Zerhouni, MD, President of Global R&D for Sanofi, said therapies like dupilumab, which focus on specific molecular pathways associated with multiple chronic allergic diseases, are "important targets for further investigation."

"The positive data from this large second pivotal trial in uncontrolled persistent asthma, following the positive results of dupilumab in atopic dermatitis, further support this view in our opinion," Zerhouni said. "We will work diligently with health authorities to bring this new application of dupilumab to the patients who most need it."

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