Itch as a critical factor in impaired health-related quality of life in patients with plaque psoriasis achieving clear or almost-clear skin: Analysis of the single-arm, open-label, multicenter, prospective ProLOGUE study

Takuya Miyagi; Yasumasa Kanai; Kenta Murotani; Yukari Okubo; Masaru Honma; Satomi Kobayashi; Mariko Seishima; Yoko Mizutani; Hiroki Kitabayashi; Shinichi Imafuku

doi:10.1016/j.jdin.2022.06.013

Itch as a critical factor in impaired health-related quality of life in patients with plaque psoriasis achieving clear or almost-clear skin: Analysis of the single-arm, open-label, multicenter, prospective ProLOGUE study

JAAD Int. 2022 Jun 22:8:146-153. doi: 10.1016/j.jdin.2022.06.013. eCollection 2022 Sep.

Authors

Affiliations

¹ Department of Dermatology, University of the Ryukyus, Okinawa, Japan.
² Medical Affairs, Kyowa Kirin Co, Ltd, Tokyo, Japan.
³ Biostatistics Center, Kurume University, Fukuoka, Japan.
⁴ Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
⁵ Department of Dermatology, Asahikawa Medical University, Hokkaido, Japan.
⁶ Department of Dermatology, Seibo International Catholic Hospital, Tokyo, Japan.
⁷ Department of Dermatology, Gifu University Graduate School of Medicine, Gifu, Japan.
⁸ Department of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.

Abstract

Background: Patients with psoriasis report impaired health-related quality of life (HRQoL; Dermatology Life Quality Index score ≥ 2) even after achieving clear or almost-clear skin with biologic treatment.

Objective: To assess the effectiveness of brodalumab in HRQoL improvement and the factors associated with incomplete HRQoL improvement in Japanese patients with psoriasis.

Methods: As a part of the single-arm, open-label, multicenter, prospective ProLOGUE study (Japan Registry of Clinical Trials identifier: jRCTs031180037), patients were treated with 210 mg of subcutaneous brodalumab in daily clinical practice until week 48. The absolute Psoriasis Area and Severity Index scores and patient-reported outcomes were assessed at baseline and weeks 12 and 48.

Results: Seventy-three patients (male, 82.2%; median age, 54.0 years) were enrolled. The Dermatology Life Quality Index and European Quality of Life 5-Dimension 5-Level Utility Index scores significantly improved from baseline to weeks 12 and 48. At week 48, all 13 patients with a Dermatology Life Quality Index score of ≥2 and an absolute Psoriasis Area and Severity Index score of 0 to ≤2 reported itching.

Limitations: Unclear generalizability of the results to other biologics.

Conclusion: Treatment with brodalumab improved HRQoL in patients with psoriasis. Itching may contribute to incomplete HRQoL improvement in patients who have achieved clear or almost-clear skin.

Keywords: DLQI, Dermatology Life Quality Index; EQ-5D-5L UI, European Quality of Life 5-Dimension 5-Level Utility Index; HRQoL, health-related quality of life; NRS, Numerical Rating Scale; PASI, Psoriasis Area and Severity Index; PRO, patient-reported outcome; RCT, randomized controlled trial; absolute PASI; brodalumab; health-related quality of life; itching; plaque psoriasis; real-life patients.