Efficacy and safety of nemolizumab and topical corticosteroids for prurigo nodularis: Results from a randomised, double-blind, placebo-controlled, phase II/III clinical study in patients aged ≥13 years
Hiroo Yokozeki, Hiroyuki Murota, Takayo Matsumura, Hiroshi Komazaki, Daisuke Watanabe, Hiroyuki Sakai, Satomi Igawa, Hideki Kamiya, Toshio Katsunuma, Akihiro Kume, Ken Igawa, Kazumoto Katagiri, Jun Muto, Akiko Yagami, Kazumitsu Sugiura, Shinichi Imafuku, Mariko Seishima, Yuki Mizutani, Atsuko Kato, Tetsuya Honda, Tomoyasu Hattori, Akio Tanaka, Nobuo Kanazawa, Masao Fukuzawa, Hiroo Amano, Ken Hayashi, Akihiko Asahina, Yasushi Suga, Hideaki Tanizaki, Shogo Takahashi, Naoki Oiso, Atsushi Otsuka, Tohru Nagano, Atsushi Fukunaga, Takeshi Fukumoto, Yoshiko Mizukawa, Satoko Shibata-Kikuchi, Takeshi Nakahara, Ryuji Maruyama, Shijima Taguchi, Akimichi Morita, Takahiro Satoh, Haruko Nishie, Kazunori Urabe, Riichiro Abe, Shin-ichi Ansai, Azusa Ogita, Takeo Idezuki, Atsuyuki Igarashi, Hajime Takagi, Yoko Kataoka, Shinichi Moriwaki, Manabu Fujimoto, Noriko Arase, Masatoshi Abe, Yuko Chinuki, Fumiaki Shirasaki, Kentaro Matsumoto, Hideaki Watanabe, Tomomitsu Miyagaki, Nobuhiro Fujita, Hidetoshi Takahashi, Toshihisa Hamada, Keiko Manabe, Tetsuya Higuchi, Toshiya Takahashi, Takashi Matsuyama, Yoshihiro Umebayashi, Yasuhiro Kawachi, Hiroshi Mitsui, Norito Katoh, Katsuhiko Tsukamoto, Kazutomo Toyofuku, Ken Watanabe,- Dermatology
Abstract
Background
Prurigo nodularis, a chronic inflammatory skin condition, adversely affects the quality of life of affected individuals. Current treatment options for prurigo nodularis in Japan are limited.
Objectives
To evaluate the optimal dose, efficacy, and safety of long-term treatment with nemolizumab in patients with prurigo nodularis in Japan.
Methods
In a 16-week, double-blind, phase II/III study, patients aged ≥13 years with prurigo nodularis 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 end point was the percentage change in the weekly mean Peak Pruritus Numerical Rating Scale (PP-NRS) score (range, 0 to 10, with higher scores indicating worse itching) from baseline to week 16. Secondary efficacy end points assessed the impact of treatment on pruritus, prurigo nodularis 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<0·0001), and between the 60 mg and placebo groups was −37·4% (95% CI, −46·7 to −28·1; P<0·0001). Nemolizumab-treated patients 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 prurigo nodularis were greater following nemolizumab treatment, despite continuation of topical corticosteroids in both groups. (Funded by Maruho; jRCT number, 2011200017.)