Dupilumab a Potential Treatment for Prurigo Nodularis

Dupilumab significantly reduces itch levels and skin lesions in patients with prurigo nodularis (PN), according to research presented at the 2022 Annual Meeting of the European Academy of Dermatology and Venerology (EADV) Congress, held from September 7 to 10, 2022 in Milano, Italy.

Investigators conducted a randomized, double-blind, placebo-controlled, phase 3 trial in adults with PN whose symptoms were inadequately controlled with topical treatment. Eligible patients had 20 or more nodules at the time of enrollment. Patients were randomly assigned 1:1 to receive either dupilumab or placebo every 2 weeks for 24 weeks. Dupilumab was administered subcutaneously in 300 mg doses, with a loading dose of 600 mg. The primary endpoint, measured at week 24, was the percentage of patients achieving a 4-point or greater reduction from baseline in weekly average Worst-Itch Numeric Rating Scale (WI-NRS) score. The secondary outcome was the percentage of patients who achieved an Investigator’s Global Assessment PN-Stage (IGN-PN-S) score of 0 or 1, indicating clear or almost clear skin, at week 24.

A total of 151 patients were randomly assigned: 75 to the dupilumab arm and 76 to the placebo arm. At baseline, the mean WI-NRS score was 8.5±1.0 out of 10, indicating severe itch. The majority (71.3%) of patients had from 20 to 100 nodules at enrollment; 28.7% had more than 100 nodules. At week 24, 60.0% of patients in the dupilumab arm achieved a 4-point or greater reduction in WI-NRS, compared with just 18.4% of patients in the placebo arm (P <.0001). The percentage of patients achieving IGA-PN-S of 0 or 1 at Week 24 was also greater in the dupilumab vs placebo arm (48.0% vs 18.4%; P =.0004). Treatment-emergent adverse events were reported by 70.7% of the dupilumab group and 62.7% of the placebo group. The most common adverse events were headache and nasopharyngitis, which occurred with similar frequencies across study arms.

Results from this study suggest to investigators the efficacy of dupilumab in the treatment of PN. “Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch response and skin lesions vs placebo in adult patients with PN,” they concluded. No new safety signals were observed.

Disclosure: This research was supported by Sanofi and Regeneron Pharmaceuticals, Inc. Please see the original reference for a full list of authors’ disclosures.