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: Hiroo Yokozeki, Hiroyuki Murota, Takayo Matsumura, Hiroshi Komazaki, Masatoshi Abe, Riichiro Abe, Hiroo Amano, Shin-ichi Ansai, Noriko Arase, Akihiko Asahina, Yuko Chinuki, Manabu Fujimoto, Nobuhiro Fujita, Takeshi Fukumoto, Atsushi Fukunaga, Masao Fukuzawa, Toshihisa Hamada, Tomoyasu Hattori, Ken Hayashi, Tetsuya Higuchi, Tetsuya Honda, Takeo Idezuki, Atsuyuki Igarashi, Ken Igawa, Satomi Igawa, Shinichi Imafuku, Hideki Kamiya, Nobuo Kanazawa, Kazumoto Katagiri, Yoko Kataoka, Atsuko Kato, Norito Katoh, Toshio Katsunuma, Yasuhiro Kawachi, Akihiro Kume, Keiko Manabe, Ryuji Maruyama, Kentaro Matsumoto, Takashi Matsuyama, Hiroshi Mitsui, Tomomitsu Miyagaki, Yoshiko Mizukawa, Yuki Mizutani, Akimichi Morita, Shinichi Moriwaki, Jun Muto, Tohru Nagano, Takeshi Nakahara, Haruko Nishie, Azusa Ogita, Naoki Oiso, Atsushi Otsuka, Hiroyuki Sakai, Takahiro Satoh, Mariko Seishima, Satoko Shibata-Kikuchi, Fumiaki Shirasaki, Yasushi Suga, Kazumitsu Sugiura, Shijima Taguchi, Hajime Takagi, Hidetoshi Takahashi, Shogo Takahashi, Toshiya Takahashi, Akio Tanaka, Hideaki Tanizaki, Kazutomo Toyofuku, Katsuhiko Tsukamoto, Yoshihiro Umebayashi, Kazunori Urabe, Daisuke Watanabe, Hideaki Watanabe, Ken Watanabe, Akiko Yagami
Journal: British Journal of Dermatology (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 &amp;lt; 0.0001], and between the 60-mg and placebo groups was −37.4% (95% CI −46.7 to −28.1; P &amp;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.