Clinically meaningful improvements in cutaneous lesions and quality of life measures in patients with atopic dermatitis with greater pruritus reductions after treatment with 60 mg nemolizumab subcutaneously every 4 weeks: subgroup analysis from a phase 3, randomized, controlled trial

Abstract

Background

Data from the Japanese phase 3 Nemolizumab-JP01 study (JapicCTI-173740) found that nemolizumab in combination with topical treatments reduced pruritus associated with atopic dermatitis inadequately controlled with current therapies.

Methods

This post-hoc analysis examined associations between improvements in pruritus (visual analog scale [VAS]) and eczema (Eczema Area and Severity Index [EASI]), and achievement of other clinically relevant endpoints including the Insomnia Severity Index (ISI), Dermatology Life Quality Index (DLQI), and Patient-Oriented Eczema Measure (POEM).

Results

Pruritus VAS responders (≥50% improvement from baseline to week 16) showed greater improvements from baseline in these additional endpoints as early as week 1, compared with non-responders. Responders also had EASI improvement, and more than 80% achieved an ISI score ≤7, or had improvement in the DLQI or POEM. The percent change from baseline in VAS and EASI scores at week 16 was in favor of nemolizumab in all subgroups based on baseline characteristics. No specific factor affecting treatment response to nemolizumab was identified.

Conclusions

In this post-hoc analysis, nemolizumab-treated patients who had greater pruritus reductions also showed improvements in other eczema symptoms; pruritus alleviation appeared to be responsible for the improvements in eczema, sleep and daily life.

Keywords:

• Atopic dermatitis
• nemolizumab
• pruritus
• quality of life

Acknowledgments

The authors would like to thank Hiroshi Komazaki (Department of Clinical Development, Maruho, Kyoto) for assistance with the statistical analyses. The authors also wish to acknowledge editorial assistance provided by Sally-Anne Mitchell, Ph.D. and publication management provided by Hisanori Yoshida (both of McCANN HEALTH CMC, Japan), funded by Maruho Co., Ltd., Osaka, Japan.

Disclosure statement

Kenji Kabashima has received grants from Japan Tobacco Inc., Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, ONO PHARMACEUTICAL, POLA PHARMA, TAIHO PHARMA, Torii Pharmaceutical, and The Procter & Gamble Company, and has received personal fees from Maruho. Takayo Matsumura and Yoshiteru Hayakawa are employees of Maruho. Makoto Kawashima has received personal fees from Maruho.

Data availability statement

The authors are unable to provide individual patient data as consent for distribution of personal information was not obtained in the clinical trial.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This study was funded by Maruho Co., Ltd., Osaka, Japan.