Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial

Kenji Kabashima; Takayo Matsumura; Hiroshi Komazaki; Makoto Kawashima; Nemolizumab-JP01 Study Group

doi:10.1007/s13555-023-00901-7

Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial

Dermatol Ther (Heidelb). 2023 Apr;13(4):997-1011. doi: 10.1007/s13555-023-00901-7. Epub 2023 Mar 11.

Authors

Kenji Kabashima¹, Takayo Matsumura², Hiroshi Komazaki², Makoto Kawashima³; Nemolizumab-JP01 Study Group

Affiliations

¹ Department of Dermatology, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawahara, Sakyo-ku, Kyoto, 606-8507, Japan. kaba@kuhp.kyoto-u.ac.jp.
² Clinical Development Department, Maruho Co., Ltd., Kyoto, Japan.
³ Tokyo Women's Medical University, Tokyo, Japan.

Abstract

Introduction: Atopic dermatitis (AD), with its signs and symptoms of pruritus, dryness, and erythema, severely reduces the quality of life (QOL) of affected patients. We investigated the impact of nemolizumab 60 mg on QOL in Japanese patients aged ≥ 13 years with AD and inadequately controlled moderate-to-severe pruritus, using data derived from patient-reported outcome (PRO) measures.

Methods: PROs were the Insomnia Severity Index (ISI), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), and Work Productivity and Activity Impairment: Atopic Dermatitis questionnaire (WPAI-AD). Correlations between PRO scores and symptom severity, assessed by the pruritus visual analog scale (VAS) and the Eczema Area and Severity Index (EASI), were explored.

Results: The mean percent change (standard error) from baseline in the pruritus VAS and EASI scores at week 16 was, respectively, -45.6% (2.7) and -46.0% (3.2) in the nemolizumab group, and -24.1% (3.7) and -33.2% (4.9) in the placebo group. By week 16, significantly more patients in the nemolizumab group versus the placebo group had an ISI score of 0 for difficulty falling asleep (41.6% versus 13.1%, nominal p < 0.01) or difficulty staying asleep (45.4% versus 10.9%; nominal p < 0.01). Similarly, more nemolizumab- than placebo-treated patients had a DLQI score of 0 for interference with shopping, or home/garden activities (45.2% versus 18.6%, nominal p < 0.01), and 0 days per week of nighttime sleep disturbance (50.8% versus 16.9%, nominal p < 0.01) or bleeding skin (43.4% versus 7.5%, nominal p < 0.01) measured by POEM at week 16. Based on WPAI-AD scores, long-term administration of nemolizumab also improved the ability to conduct work activities.

Conclusions: Subcutaneous administration of nemolizumab ameliorated pruritus and skin signs, and thereby produced improvement in patient QOL across multiple PRO measures, including sleep, interpersonal relationships, and the ability to conduct social or work activities.

Clinical trial registration: JapicCTI-173740 (registered 20 October 2017).

Keywords: Atopic dermatitis; Nemolizumab; Patient-reported outcomes; Pruritus; Quality of life.