FRANCE – Regeneron Pharmaceuticals and French major, Sanofi, have announced positive pivotal Phase 3 results from a trial evaluating Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease characterized by severe itching and skin lesions.
The trial of the blockbuster met its primary and all key secondary endpoints, demonstrating that Dupixent significantly reduced itch and skin lesions in this investigational setting when compared to placebo.
Uncontrolled prurigo nodularis has the highest impact on quality of life of any inflammatory skin disease with intense, chronic itch.
Prurigo nodularis is characterized by intense, persistent itch and thick skin lesions (called nodules) that can cover the majority of the body.
It is frequently described as painful, with skin burning, stinging, and tingling. The incapacitating signs and symptoms of prurigo nodularis can have a negative impact on health-related quality of life, including mental health, daily activities, and social interactions.
There are no systemic treatments approved for prurigo nodularis. High-potency topical steroids are commonly used, but they are associated with safety risks if used for an extended period of time.
“Prurigo nodularis is an underdiagnosed disease with immense physical and emotional burden for the 74,000 people in the U.S. who are unable to control their disease with topical steroids and otherwise do not have an approved treatment option,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron.
Commenting about the Phase III milestone of the research, John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi said: “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.”
These data demonstrate the role of type 2 inflammation in this disease ad marks a significant step forward in furthering 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.” Dr. Reed added.
The trial’s safety results were generally consistent with Dupixent’s known safety profile in its approved indications.
Treatment-emergent adverse events occurred in roughly equal proportions in the Dupixent and placebo groups (57 percent [44/77] Dupixent, 51 percent [42/82] placebo).
Last year, Dupixent generated US$4.1 billion in sales thanks to approvals for eczema (2017), asthma (2018), atopic dermatitis in children (2019), and rhinosinusitis (2019).
The drug is being researched for use in ten other indications caused by type 2 inflammation, including chronic pulmonary disease, eosinophilic esophagitis, and chronic spontaneous urticaria. Nine of these ten programs are in their third phase.
Dupixent’s potential use in prurigo nodularis is currently in clinical development, and the safety and efficacy have not been thoroughly evaluated by any regulatory authority.
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