Positive pivotal Phase III PRIME2 trial reports on Dupixent in adults with uncontrolled prurigo nodularis

The trial met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases with intense, chronic itch.

"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. "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 III 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."

People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. It is often described as painful with burning, stinging and tingling of the skin. The debilitating signs and symptoms of prurigo nodularis can negatively impact health-related quality of life, including mental health, activities of daily living and social interactions. There are no approved systemic treatments for prurigo nodularis. High-potency topical steroids are commonly used, which are associated with safety risks if used long-term.

In the Phase III PRIME2 trial, topline results comparing Dupixent (n=78) to placebo (n=82) showed : i. 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared to 22% of placebo patients (p=0.0216) at week 12, the primary endpoint. ii. At week 24, nearly three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline: 58% of Dupixent patients compared to 20% of placebo patients (p<0.0001). iii. at week 24, nearly three times as many dupixent patients achieved clear or almost clear skin. 45% of dupixent patients compared to 16% of placebo patients (p><0.0001). iv. dupixent patients experienced significantly greater improvements in measures of health-related quality of life, skin pain and symptoms of anxiety and depression.></0.0001).></0.0001).>

The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. The occurrences of treatment-emergent adverse events were generally similar between Dupixent and placebo groups (57% [44/77] Dupixent, 51% [42/82] placebo). Rates of conjunctivitis (6% [5/77] Dupixent, 0% [0/82] placebo) and herpes viral infections (6% [5/77] Dupixent, 0% [0/82] placebo) were similar to what was previously observed in atopic dermatitis trials, and there was a numerically lower rate of skin infections observed with Dupixent (5% [4/77] Dupixent, 9% [7/82] placebo). Additionally, 3% (2/77) of Dupixent patients and 30% (25/82) of placebo patients discontinued prior to week 24.

An additional trial in the LIBERTY-PN PRIME clinical program, PRIME, is fully enrolled. PRIME has a similar trial design and is expected to read out in in the first half of 2022. Regeneron and Sanofi plan to begin regulatory submissions in 2022.The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.