Nemolizumab Shows Lasting Benefits in Prurigo Nodularis

TOPLINE:

Nemolizumab was well tolerated and provided lasting relief from itching and disease severity while improving quality of life in patients with prurigo nodularis (PN) over 68 weeks. Patients also decreased their use of topical corticosteroids.

METHODOLOGY:

• A Japanese phase 2/3 randomized, double-blind, placebo-controlled study enrolled 226 Asian patients aged ≥ 13 years with PN who had an inadequate response to treatment with higher-potency topical corticosteroids and oral antihistamines.
• Participants were randomly assigned (1:1:1) to receive nemolizumab 30 mg, 60 mg, or placebo with concomitant medium-potency topical corticosteroids every 4 weeks for 16 weeks, followed by nemolizumab for 52 weeks when placebo-treated patients were reallocated to either 30-mg or 60-mg groups.
• Outcomes included Peak Pruritus Numerical Rating Scale (PP-NRS), 5-level itch scale, Investigator’s Global Assessment (IGA), number of PN nodules, Insomnia Severity Index (ISI), Dermatology Life Quality Index (DLQI), topical corticosteroid use, and treatment-emergent adverse events.
• At baseline, all patients had a PP-NRS score ≥ 7 and a 5-level itch scale score ≥ 3.

TAKEAWAY:

• By week 68, PP-NRS scores decreased by 78.6% in the 30-mg dose group and 76.5% in the 60-mg group from baseline. Patients who switched from placebo showed reductions of 78.4% and 70.7% in PP-NRS scores, respectively.
• By week 68, 45.9%-61.8% across all nemolizumab treatment groups had a PP-NRS score < 3, and 40.5%-59.2% had a 5-level itch scale score ≤ 1.
• By week 68, 70.1% of patients in the 30-mg group and 69.7% in the 60-mg group achieved an IGA score ≤ 1, and 35.1% and 40.8%, respectively, achieved complete resolution, with an IGA score of 0. The number of nodules decreased by 86.1%-95.9% from baseline, and improvements were maintained after treatment cessation.
• Across groups, 55.6%-63.3% of patients reported significant improvement in sleep (based on ISI scores), and 73.5%-91.4% had improved quality of life (based on DLQI scores). Nemolizumab-treated patients reduced their use of topical corticosteroids by at least 50%, and 9.1%-16.2% discontinued use altogether. More than 90% of patients experienced mild or moderate treatment-emergent adverse events, primarily skin-related conditions such as eczema and erythema.

IN PRACTICE:

“The long-term efficacy and safety data from this phase II/III study in patients with PN and moderate to severe pruritus confirm that nemolizumab elicits continuous and durable improvements in pruritus, PN severity, and quality of life, while also allowing reductions in the use of topical corticosteroids,” the authors concluded.

SOURCE:

The study was led by Hiroo Yokozeki, Department of Dermatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University in Tokyo, Japan. It was published online on March 21 in the British Journal of Dermatology.

LIMITATIONS:

The findings may not be generalizable to other countries and racial groups. In addition, there was no control group during the long-term extension phase, and the follow-up period after treatment cessation may not have been long enough to fully assess relapse risk.

DISCLOSURES:

The study was funded by Maruho Co., Osaka, Japan. Yokozeki reported receiving grants, honoraria, and advisory fees from Maruho and other companies. Other authors also reported financial relationships and employment with Maruho.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.