Long-term (68 weeks) administration of nemolizumab and topical corticosteroids for prurigo nodularis in patients aged ≥13 years: efficacy and safety data from a phase II/III study.

Abstract

Background: The biological therapy nemolizumab has been shown to improve the signs and symptoms of prurigo nodularis (PN) to a significantly greater extent than placebo over 16 weeks of treatment. We now report efficacy and safety data over 68 weeks.

Objectives: To evaluate the long-term impact of nemolizumab on pruritus, disease severity, quality of life, and topical corticosteroid usage in patients with PN in Japan, and to confirm the safety profile.

Methods: Asian patients aged ≥13 years 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. For the subsequent 52 weeks, nemolizumab treatment was continued, while placebo-treated patients were reallocated to either the 30-mg or 60-mg nemolizumab groups. Efficacy outcome measures included the Peak Pruritus Numerical Rating Scale (PP-NRS), 5-level itch scale, Investigator's Global Assessment (IGA), the number of PN nodules, Insomnia Severity Index, Dermatology Life Quality Index, and use of topical corticosteroids. Safety measures included the frequency of treatment-emergent adverse events (TEAEs).

Results: In the modified intention-to-treat population (n=226), nemolizumab provided sustained and continuing improvements in efficacy between weeks 16 and 68. In patients who received nemolizumab 30 mg, the PP-NRS had decreased by 60.5% at week 16 and 78.6% at week 68; respective decreases in the 60-mg group were 55.1% and 76.5%. Across all treatment groups, a large proportion of patients had improvements indicating a reduction from moderate-to-severe to mild pruritus, IGA improvements indicating a reduction in PN severity, a decrease in the number of nodules, and rapid and durable improvements in sleep and daily life activities. Nemolizumab-treated patients were also able to reduce the daily quantity of medium-potency and higher topical corticosteroids used by at least half. There was no indication of relapse in pruritus, PN severity, or quality of life scores following treatment cessation. Most TEAEs were mild and were similar to those reported in prior studies.

Conclusions: Nemolizumab elicited continuous and durable improvements across multiple measures of pruritus, PN severity, and quality of life over 68 weeks of treatment, with no new safety concerns. (Funded by Maruho; jRCT number, 2011200017).