Results from a pivotal phase 3 clinical trial show dupilumab to be effective in treating a prurigo nodularis.
The trial, known as the PRIME2 trial, examined the efficacy of dupilumab (n=78) to placebo (n=78) in patients with prurigo nodularis, a rare skin disorder. The results, yet to be published in a peer reviewed journal, were presented in a news release by the developers of dupilumab, Regeneron and Sanofi, and showed the orphan drug to be highly effective at improving itching, skin complexion, pain, anxiety, depression, and quality of life.
The study met its primary endpoint (itching at week 12) and all key secondary endpoints. More specifically, the study observed that 37% of patients receiving dupilumab had a clinically meaningful reduction in itching from baseline (compared to 22% in the placebo group) by week 12 and by week 24, 58% of patients receiving dupilumab had a reduction in itching from baseline (compared to 20% in the placebo group). Furthermore, 45% of patients receiving dupilumab achieved clear or almost clear skin compared to 16% in the placebo group. Statistically significant improvements in pain, anxiety, depression, and quality of life were also observed in the patients receiving dupilumab.
Prurigo nodularis is an inflammatory skin disease characterized by extreme itching and symmetrical rashes, most commonly on the arms, legs, the upper back and/or the abdomen. The exact cause of PN is unknown, but altered function of the immune system may be involved. Dupilumab is a monoclonal antibody directed towards the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. At present, there is no FDA approved treatment for prurigo nodularis and treatment is often a combination of behavioral (e.g., long sleeves, bandages, shortened fingernails) and medical therapies (e.g., antihistamines, topical corticosteroids).
To stay informed about this and other skin disorders, go to checkrare.com/diseases/skin-conditions/
