Dupilumab First and Only Treatment Approved for Adults with Prurigo Nodularis

The US Food and Drug Administration recently announced approval of dupilumab as the first and only treatment indicated for adults with prurigo nodularis (PN).

Dupilumab is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways; however, it is not an immunosuppressant. It has already been indicated for atopic dermatitis, asthma, nasal polyposis, and eosinophilic esophagitis.

The approval was granted following 2 Phase 3 trials (PRIME and PRIME2) where dupilumab was evaluated for efficacy and safety in adults with PN. Both studies showed a significant reduction in itch and presented clear skin. For itch reduction, about 3 times the patients taking dupilumab (60% and 58%) experienced a reduction in itch from baseline at 24 weeks compared with 18% and 20% of the patients receiving a placebo. Additionally, about twice as many patients taking dupilumab (48% and 45%) achieved clear or almost clear skin at 24 weeks compared with 18% and 16% of those in the placebo group. Overall, about 3 times as many patients taking dupilumab (39% and 32%) experienced both a significant reduction in itch and clear or almost clear skin at 24 weeks compared with the placebo group (9% and 9%).

Dupilumab can cause serious side effects such as severe allergic reactions, eye/vision problems, inflammation in blood vessels, and joint aches and pains.

Reference
Dupixent (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis. News Release. Regeneron. September 28, 2022. Accessed September 29, 2022. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-fda-first-and-only-treatment