The U.S. Food and Drug Administration (FDA) has approved dupilumab to treat adults with prurigo nodularis.

Prurigo nodularis is an inflammatory skin disorder characterized by extreme itching and symmetrical rashes. Most areas commonly affected are the arms, legs, the upper back and/or the abdomen.

Dupilumab is a monoclonal antibody directed towards the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. Until today, there was no FDA approved treatment for prurigo nodularis and treatment would be limited to a combination of behavioral (e.g., long sleeves, bandages, shortened fingernails) and non-specific medical therapies (e.g., antihistamines, topical corticosteroids).

The FDA approval was largely based on two phase 3 clinical trials (PRIME and PRIME2) that showed the drug to be significantly effective in reducing itching due to the rare disease. Furthermore, twice as many patients taking dupilumab compared to those receiving placebo  (48% and 45% vs  18% and 16%).

Most common adverse events include nasopharyngitis (5%) conjunctivitis (4%), herpes infection (3%), dizziness (3%), muscle pain (3%), and diarrhea (3%).

To stay informed about this and other skin disorders, go to checkrare.com/diseases/skin-conditions/