Positive Phase 3 results with Sanofi/Regeneron's IL4/IL-13-targeting antibody dupilumab (Dupixent) in adolescents with moderate-to-severe atopic dermatitis will form the basis of a regulatory submission in this new patient population, according to announcements of Sanofi.
According to data presented at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, the inhibitor of type 2 inflammations showed significant improvement on multiple measures of disease severity in adolescents with atopic dermatitis who didn't respond sufficiently to topical treatments. Because there are no systemic biologic medications approved for topical treatment refractive adolescent patients (12-17 years) with moderate-to-severe atopic dermatitis, the US Food & Drug Administration granted breakthrough status for the antibody in this patient group in 2016. In adult patients with moderate-to-severe atopic dermatitis, dupilumab has been approved in the US, the EU, Canada and Japan.
"The results show the potential for Dupixent in adolescents to not only help clear the skin and reduce itching, but also improve certain aspects of quality of life in adolescents who may be dealing with these unbearable symptoms," said Amy S. Paller, principal investigator of the trial.
41.5% of patients who received Dupixent every two weeks and 38% of patients who received Dupixent every four weeks achieved 75% or greater skin improvement (EASI-75) compared to 8% with placebo. 24% of patients who received weight-based dosing of Dupixent every two weeks (200 mg or 300 mg) and 18% of patients who received a fixed dose of Dupixent every four weeks (300 mg) achieved the primary endpoint – clear or almost-clear skin (IGA; score of 0 or 1) - compared with 2% with placebo. Along these co-primary endpoints several secondary endpoints were reached in the study population. The overall rate of adverse events was 72% for Dupixent every two weeks, 64% for Dupixent every four weeks and 69% for placebo.
Atopic dermatitis is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Itch is one of the most burdensome symptoms for patients and can be debilitating. Dupilumab works by inhibiting interleukin-4 and interleukin-13 (IL-4 and IL-13), which contribute to type 2 inflammation, a systemic, allergic response known to play a role in moderate-to-severe atopic dermatitis as well as a range of other allergic or atopic diseases, in which Sanofi/Regeneron assess safety and efficacy of the antibody. They include asthma (Phase 3), pediatric (6-11 years) atopic dermatitis (Phase 3), nasal polyps (Phase 3), eosinophilic esophagitis (Phase 3) and grass allergy (Phase 2). Future trials are planned for chronic obstructive pulmonary disease and food allergy (including peanut). Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.