On Saturday, October 1, during a late-breaking session at the European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, Sanofi and Regeneron announced positive data from two Phase 3 clinical trials that support Dupixent (dupilumab) as effective in the treatment of moderate-to-severe atopic dermatitis (AD). The studies were published in The New England Journal of Medicine, and their findings were shared with an eager audience.
The data come from LIBERTY AD SOLO 1 and SOLO 2, two identical, placebo-controlled Phase 3 studies that measured the extent and severity of AD in affected patients. Patients enrolled were at least 18 years of age and had moderate-to-severe AD with a score of at least 3 (moderate) or 4 (severe) based on the Investigator’s Global Assessment (IGA), for which topical treatments were inadequate. Patients were given either Dupixent 300 mg or placebo via subcutaneous injection for 16 weeks; those who received the drug took it either weekly, or every other week in with matching placebo during the off weeks.
The SOLO 1 and SOLO 2 clinical trials indicated 2 primary endpoints:
Results were encouraging. At 16 weeks for SOLO 1 and SOLO 2, 37% and 36%, respectively, of patients who received Dupixent 300 mg weekly, and 38% and 36% of those who received it every 2 weeks, achieved clearing or near-clearing of skin according to the IGA scale. (Compared to 10% and 8% with placebo.) In addition, 52% and 48% of patients on the weekly dose, and 51% and 44% of those on the bi-weekly dose, showed a 75% or greater reduction in their EASI-75 score. (Compared to 15% and 12% with placebo.)
The studies also revealed positive results for secondary endpoints, including patient-reported reductions in the severity of itching, and significant reductions in scores on both the Hospital Anxiety and Depression Scale, and the Dermatology Life Quality Index.
Adverse events were also reported and were comparable between Dupixent groups and placebo groups, indicating no significant risks associated with the drug. The most common adverse events found in the Dupixent groups were injection site reactions and conjunctivitis.
The FDA gave Dupixent priority review with a target action of March 29, 2017. If approved, Dupixent will be commercially available by Regeneron and Sanofi Genzyme, the specialty care unit of Sanofi. According to an industry press release, the company is confident that “these results support the growing body of evidence for Dupixent as a potential new treatment option for patients with moderate-to-severe atopic dermatitis who are struggling to control their disease.”