Phase 3 Data Show Benefit of Dupixent to Reduce Itch in Prurigo Nodularis

FDA Approves New Dupixent Prefilled Pen Designed to Support More Convenient SelfAdministration image

The second phase 3 trial in adults PN shows reduction in itch and increased skin clearance compared to placebo.

Dupixent® (dupilumab) from Sanofi and Regeneron significantly reduced itch and skin lesions compared to placebo at 24 weeks in a phase 3 trial in adults with uncontrolled prurigo nodularis. The new data confirm positive results previously reported from the phase 3 PRIME2 trial and will be submitted to regulatory authorities around the world starting in the first half of this year. The impact of prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases, due to extreme itch. 

“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,” says Naimish Patel, MD, 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. The decision to accelerate directly into a Phase 3 clinical trial for prurigo nodularis was driven by our conviction that type 2 inflammation is a key driver of this highly pruritic disease and underscores our commitment to quickly bring novel treatments to patients who are in urgent need of new options.”  

In the Phase 3 PRIME trial, topline results at week 24 showed that, compared to placebo, more than three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline, the primary endpoint (60% of Dupixent patients compared to 18% of placebo patients).

Nearly three times as many Dupixent patients achieved clear or almost clear skin, a secondary endpoint.

Dupixent patients experienced significantly greater improvements in measures of overall health-related quality of life, skin pain, and symptoms of anxiety and depression.

Safety results in the trial were consistent with what was observed in PRIME2 and were also generally consistent with the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, overall rates of treatment-emergent adverse events were 71% for Dupixent and 63% for placebo. Adverse events most commonly observed with Dupixent included nasopharyngitis (5% Dupixent, 4% placebo) and headache (5% Dupixent, 5% placebo). Additionally, 0% of Dupixent patients and 4% of placebo patients discontinued treatment due to adverse events prior to week 24. 

Consistent with published literature for the atopic dermatitis trials, numerically lower rates of skin infections were seen with Dupixent in this trial (4% Dupixent, 9% placebo).

Detailed results from this trial will be presented at an upcoming medical congress. 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.

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