Efficacy and safety of nemolizumab and topical corticosteroids for prurigo nodularis: results from a randomized double-blind placebo-controlled phase II/III clinical study in patients aged ≥ 13 years
Authors: Yokozeki Hiroo , Murota Hiroyuki , Matsumura Takayo , Komazaki Hiroshi ,   for the Nemolizumab-JP11 Study Group, Abe Masatoshi , Abe Riichiro , Amano Hiroo , Ansai Shin-ichi , Arase Noriko , Asahina Akihiko , Chinuki Yuko , Fujimoto Manabu , Fujita Nobuhiro , Fukumoto Takeshi , Fukunaga Atsushi , Fukuzawa Masao , Hamada Toshihisa , Hattori Tomoyasu , Hayashi Ken , Higuchi Tetsuya , Honda Tetsuya , Idezuki Takeo , Igarashi Atsuyuki , Igawa Ken , Igawa Satomi , Imafuku Shinichi , Kamiya Hideki , Kanazawa Nobuo , Katagiri Kazumoto , Kataoka Yoko , Kato Atsuko , Katoh Norito , Katsunuma Toshio , Kawachi Yasuhiro , Kume Akihiro , Manabe Keiko , Maruyama Ryuji , Matsumoto Kentaro , Matsuyama Takashi , Mitsui Hiroshi , Miyagaki Tomomitsu , Mizukawa Yoshiko , Mizutani Yuki , Morita Akimichi , Moriwaki Shinichi , Muto Jun , Nagano Tohru , Nakahara Takeshi , Nishie Haruko , Ogita Azusa , Oiso Naoki , Otsuka Atsushi , Sakai Hiroyuki , Satoh Takahiro , Seishima Mariko , Shibata-Kikuchi Satoko , Shirasaki Fumiaki , Suga Yasushi , Sugiura Kazumitsu , Taguchi Shijima , Takagi Hajime , Takahashi Hidetoshi , Takahashi Shogo , Takahashi Toshiya , Tanaka Akio , Tanizaki Hideaki , Toyofuku Kazutomo , Tsukamoto Katsuhiko , Umebayashi Yoshihiro , Urabe Kazunori , Watanabe Daisuke , Watanabe Hideaki , Watanabe Ken , Yagami Akiko 
Published: April 2024

Abstract

Background
Prurigo nodularis (PN), a chronic inflammatory skin condition, adversely affects the quality of life of affected individuals. Current treatment options for PN in Japan are limited.

Objectives
To evaluate the optimal dose, efficacy and safety of long-term treatment with nemolizumab in patients with PN in Japan.

Methods
In a 16-week double-blind phase II/III study, patients aged ≥ 13 years with PN were randomly assigned (1 : 1 : 1) to nemolizumab 30-mg, 60-mg or placebo groups, with concomitant topical corticosteroids, every 4 weeks. The primary efficacy endpoint was the percentage change in the weekly mean Peak Pruritus Numerical Rating Scale (PP-NRS) score (range 0–10, with higher scores indicating worse itching) from baseline to week 16. Secondary efficacy endpoints assessed the impact of treatment on pruritus, PN severity, sleep and quality of life.

Results
At week 16, the least-squares mean percentage change from baseline in the PP-NRS score was −61.1% in the nemolizumab 30-mg group (n = 77), −56.0% in the 60-mg group (n = 76), and −18.6% in the placebo group (n = 76). Differences between both nemolizumab groups and placebo were significant; the difference between the 30-mg and placebo groups was −42.5% [95% confidence interval (CI) −51.9 to −33.1; P &lt; 0.0001], and between the 60-mg and placebo groups was −37.4% (95% CI −46.7 to −28.1; P &lt; 0.0001). Patients treated with nemolizumab also had greater improvements in the number and severity of prurigo nodules, and in sleep and quality of life compared with the placebo group. Both nemolizumab doses were well tolerated.

Conclusions
Improvements in PN were greater following nemolizumab treatment, despite continuation of topical corticosteroids in both groups.