Sanofi and Regeneron’s Dupixent Scores Confirmatory Win in Prurigo Nodularis
Dupixent gets positive results for treating Prurigo Nodularis.
Paris-based Sanofi and New York-based Regeneron announced Wednesday that their biologic Dupixent® (dupilumab) has confirmed significant improvements in patients with prurigo nodularis (PN) in a second positive Phase III trial.
Dupixent is a human monoclonal antibody that inhibits the signaling interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. These pathways are the central drivers of the type 2 inflammation that cause the hallmark symptoms of PN: unbearably itchy, burning and stinging skin, and dozens of thick skin lesions covering the body.
In October 2021, the companies announced that Dupixent was the first and only biologic to significantly reduce itch and skin lesions in patients with Prurigo Nodularis in the first successful Phase III trial, which met all primary and key secondary endpoints. In the second trial, compared to placebo, more than three times as many patients taking Dupixent experienced clinical reduction in itch from baseline, and more patients on Dupixent also attained clear or almost clear skin and had lower rates of skin infections after a 24-week treatment period.
“These results strengthen our understanding of the underlying biology of prurigo nodularis and are encouraging as we seek to help patients severely impacted by symptoms like unbearable itch, skin lesions, stinging and burning,” said Naimish Patel, M.D., head of global development, immunology and inflammation at Sanofi. “We are committed to researching the science behind type 2 inflammation to advance and shift perceptions in a number of inflammatory skin diseases that are not well understood.”
Is There Any Treatment for Prurigo Nodularis?
PN, an underdiagnosed and misunderstood disease, currently has no approved systemic treatment. Although potent topical steroids are currently prescribed to patients with uncontrollable itch, pain and burning, there are safety risks if they are used long-term and, in some cases, the steroids are unable to control the disease. In addition to physiological consequences, people with Prurigo Nodularis can experience a decrease in quality of life as the disease impacts mental health, daily life activities and social interactions. Treatment with Dupixent in Phase III trials also showed significant improvements in measures of overall health-related quality of life, including a reduction in symptoms of anxiety and depression.
Treatment with Dupixent was a component of the PRIME trial, part of the LIBERTY-PN PRIME clinical program. The randomized, Phase III, double-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of the biologic in adults with PN that had not been controlled with topical steroid therapies or whose treatment with such therapies was not suitable. The treatment period lasted for 24 weeks and patients either received Dupixent or placebo every two weeks with or without topical treatments. Data from both Phase III trials show that the biologic is safe and well-tolerated, with the most commonly observed adverse events being nasopharyngitis and headache.
Sanofi and Regeneron intend to begin international regulatory filing during the first half of 2022 for the treatment of Prurigo Nodularis using Dupixent. The pair also plan to present detailed results from the trial at an upcoming medical congress.
Currently, the biologic is approved for use in specific patients including those with moderate-to-severe atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). The companies are also studying this therapy in several other diseases driven by type 2 inflammation such as pediatric atopic dermatitis and eosinophilic esophagitis. PN is the third dermatological disease in which Dupixent has shown significant reduction in skin symptoms, which demonstrates the importance of targeting IL-4 and IL-13 in diseases with type 2 inflammation.