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Impact of ustekinumab on health-related quality of life in Japanese patients with moderate-to-severe plaque psoriasis: Results from a randomized, double-blind, placebo-controlled phase 2 / 3 trial


  • Author disclosure: This study was funded by Janssen Pharmaceutical K. K. (Tokyo, Japan), a part of the Johnson & Johnson family of companies. H. Nakagawa and A. Igarashi serve as consultants and trial investigators for Janssen Pharmaceutical, and portions of the work reported here were performed under contract with Janssen Pharmaceutical. B. Schenkel is an employee of, and owns stock in, Johnson & Johnson, which provided funding for this trial. M. Kato and T. Kato are employees of Janssen Pharmaceutical, and own stock in Johnson & Johnson.

Hidemi Nakagawa, M.D., Ph.D., 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan. Email:


This study evaluates the effect of ustekinumab on health-related quality of life (HRQoL) in Japanese patients with moderate-to-severe plaque psoriasis through 64 weeks. A total of 158 patients were randomized to receive subcutaneous injections of ustekinumab 45 mg (= 64) or 90 mg (= 62) at weeks 0, 4, and every-12-weeks, or placebo (= 32) with crossover to ustekinumab at week 12. Secondary study endpoints included change in Dermatology Life Quality Index (DLQI) at week 12. Other assessments included the 36-item Short Form health survey to assess Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, and Psoriasis Disability Index (PDI), a psoriasis-specific instrument to assess HRQoL. Baseline demographic and disease characteristics were similar across randomized treatment groups. Ustekinumab-treated patients had significantly greater mean improvements in DLQI from baseline to week 12 (45 mg: 8.0 ± 6.5; 90 mg: 7.4 ± 6.5) than placebo-treated patients (0.3 ± 5.3; < 0.0001 for each), and these improvements were maintained through week 64. Also at week 12, significant improvements from baseline in PDI scores were observed in ustekinumab-treated patients (45 mg: 8.6 ± 9.6; 90 mg: 12.0 ± 11.8) compared with placebo-treated patients (−0.1 ± 4.2). Improvements in the PCS (45 mg: 7.8 ± 14.5; 90 mg: 5.1 ± 12.0) and MCS (45 mg: 5.3 ± 9.8; 90 mg: 5.8 ± 10.5) scores were also observed in ustekinumab-treated patients at week 12. Placebo-treated patients who crossed-over to ustekinumab achieved improvements in HRQoL comparable to those observed in patients originally randomized to ustekinumab. Ustekinumab significantly improves HRQoL in Japanese patients with moderate-to-severe plaque psoriasis through week 64.