Study: Dupilumab Associated With Positive Outcomes in Patients With Prurigo Nodularis

Dupilumab (Dupixent, Regeneron) significantly reduced itch and skin lesions compared to placebo in adults with uncontrolled prurigo nodularis, according to the results of a phase 3 trial. The investigators said that prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions, has one of the highest quality of life impacts of any inflammatory skin disease with intense, chronic itch.

"Prurigo nodularis is an underdiagnosed disease with immense physical and emotional burden for the 74,000 people in the US who are unable to control their disease with topical steroids and otherwise do not have an approved treatment option," said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, in a press release. "These patients are left to cope with severe itching and painful nodules that, in turn, significantly impair one's quality of life with many resorting to immunosuppressants and some to antidepressants. These results show—for the first time in a Phase 3 prurigo nodularis trial—that a systemic medicine was able to address the most debilitating symptoms such as itch without broadly suppressing the immune system, building on the promise of Dupixent in a broad range of serious dermatologic, respiratory and gastrointestinal diseases."

The study found that 37% of patients receiving dupilumab experienced a clinically meaningful reduction in itch from baseline at week 12, compared to 22% of placebo patients. At week 24, the number of participants receiving dupilumab who experienced itch reduction climbed to 58%, versus 20% of patients receiving placebo. Further, 45% of patients receiving dupilumab achieved clear or almost clear skin, compared to 16% of those receiving placebo.

"We are encouraged that patients in this trial experienced a significant reduction in itch and skin lesions, especially given that prior to enrollment nearly all patients had severe itch and nearly 40% had 100 or more nodules covering their body," said John Reed, MD, PhD, global head of research and development at Sanofi, in the release. "These data are an important step forward in furthering our knowledge of the role that targeting IL-4 and IL-13 can play in the treatment of skin diseases that cause extreme itch. We are committed to continuing to leverage the robust Dupixent clinical program to transform the understanding of the science behind a number of type 2 inflammatory diseases and look forward to presenting the full results at a future medical congress."

Currently, there are no approved systemic treatments for prurigo nodularis, with high-potency topical steroids commonly being used to treat the condition. According to the investigators, these steroids are associated with safety risks if used long-term. The potential for treatment using dupilumab in prurigo nodularis is currently under clinical development, and the safety and efficacy have yet to be fully evaluated by a regulatory authority.

REFERENCE

Dupixent® (dupilumab) is the first biologic to significantly reduce itch and skin lesions in phase 3 trial for prurigo nodularis, demonstrating the role of type 2 inflammation in this disease [news release]. Regeneron; October 22, 2021. Accessed October 22, 2021. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-first-biologic-significantly-reduce-itch-and