Dupilumab significantly improves skin lesions and itching among treated patients with prurigo nodularis

These data demonstrate dupilumab has the potential to address and manage these debilitating symptoms in another chronic skin disease with underlying type 2 inflammation."

The late-breaking data presented at the EADV 2022 Congress are from the randomized, placebo-controlled Phase 3 PRIME trial, which met its primary and key secondary endpoints. At 24 weeks, among patients treated with Dupixent in the trial:

• More than three times as many (60%) experienced a clinically meaningful reduction in itch from baseline, the primary endpoint, compared to placebo patients (18%; p<0.0001).
• Nearly three times as many (48%) achieved clear or almost clear skin, a key secondary endpoint, compared to placebo patients (18%; p=0.0004).

The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatological indication. For the 24-week treatment period, overall rates of adverse events (AEs) were 71% for Dupixent and 63% for placebo.

AEs most commonly observed with Dupixent (≥5%) included nasopharyngitis (5% Dupixent, 4% placebo) and headache (5% Dupixent, 5% placebo). The rate of treatment discontinuation due to AEs prior to week 24 was 0% for Dupixent compared to 4% for placebo. A numerically lower rate of skin infections was observed with Dupixent (4% Dupixent, 9% placebo).

Results from this and an earlier Phase 3 trial, PRIME2, will form the basis of regulatory submissions around the world for Dupixent in prurigo nodularis this year. Regulatory submissions are already under review by the European Commission and the U.S. Food and Drug Administration, with the FDA granting Priority Review in May 2022 and a target action date of September 30, 2022.

The potential uses of Dupilumab in prurigo nodularis, chronic spontaneous urticaria and bullous pemphigoid are currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

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Late-breaking session at the European Academy of Dermatology and Venereology (EADV) 2022 Congress.