New phase 2 data are encouraging for patients with this difficult-to-treat condition.

The oral JAK1 inhibitor povorcitinib was shown to improve itch in prurigo nodularis, and also met its primary endpoints, according to new phase 2 data presented at the American Academy of Dermatology 2024 Annual Meeting in San Diego.

Researchers for the study enrolled 146 participants and randomized them to receive povorcitinib at 15 mg, 45 mg, and 75 mg, or to placebo. The treatment period ran 16 weeks, with a 24-week extension period. The primary study endpoint was the proportion of patients achieving ≥4-point improvement in Itch Numerical Rating Scale (NRS4) score at week 16. Secondary outcomes were also evaluated and included the proportion of patients achieving Investigator’s Global Assessment Treatment Success (IGA-TS) at week 16, defined as an IGA score of 0 or 1 with a ≥ 2-grade improvement from baseline.

The phase 2 results showed that more patients receiving povorcitinib saw significant ≥ 4-point improvements than did those receiving placebo, and at all dosing levels (36.1% [P<0.01]; 44.4% [P<0.001]; 54.1% [P<0.0001] for the 15 mg, 45 mg and 75 mg dosing groups, respectively, all of which beat placebo). Secondary endpoints were also met, with 13.9%, 30.6%, and 48.6% of patients receiving the 15 mg, 45 mg and 75 mg dosings, respectively, achieved IGA-TS improvement from baseline versus those receiving placebo. 

“The Phase 2 data reinforced povorcitinib’s potential role in treating patients with prurigo nodularis (PN), an often difficult-to-treat disease characterized by uncontrollable itching and scratching, as well as nodules on the patient’s skin,” Martin Metz, MD, a professor of dermatology and allergy at Charite Universitätsmedizin in Berlin,  and lead investigator on the study, told Practical Dermatology. “The study met is primary and secondary endpoints at 16 weeks, with improvements in itching and skin clearance seen across all on-treatment dosing groups, compared to placebo. These findings are encouraging for patients, caregivers and treating physicians, and I look forward to future research in this space.”

Source: Metz M. Efficacy and Safety of Oral Povorcitinib in Patients With Prurigo Nodularis: Results From a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study. Session S050. Presented at: American Academy of Dermatology 2024 Annual Meeting; March 8-12, 2024; San Diego.

Disclosures

 Dr. Metz reports the following relationships: Alk-Abelló – Speaker/Faculty Education(Honoraria); Almirall – Speaker(Honoraria), Speaker/Faculty Education(Honoraria); Amgen – Advisory Board(Honoraria); argenx – Advisory Board(Honoraria), Consultant (1099 relationship)(Honoraria); AstraZeneca – Advisory Board(Honoraria); Celldex – Advisory Board(Honoraria); Celltrion – Speaker(Honoraria); Escient Pharmaceuticals, Inc – Consultant (1099 relationship)(Honoraria); Galderma – Advisory Board(Honoraria), Speaker(Honoraria); GlaxoSmithKline Immunology – Advisory Board(Honoraria); Incyte Corporation – Advisory Board(Honoraria); Jasper Therapeutics – Advisory Board(Honoraria); Novartis – Advisory Board(Honoraria), Speaker(Honoraria); Pfizer Inc. – Speaker(Honoraria); Regeneron Pharmaceuticals, Inc. – Advisory Board(Honoraria); Sanofi – Advisory Board(Honoraria), Speaker(Honoraria); Teva Pharmaceuticals USA – Consultant (1099 relationship)(Honoraria); Vifor Pharma – Speaker(Honoraria)