Ustekinumab Improves Health-Related Quality of Life in Korean and Taiwanese Patients With Moderate to Severe Psoriasis: Results from the PEARL Trial
August 2012 | Volume 11 | Issue 8 | Original Article | 943 | Copyright © August 2012
Tsen-Fang Tsai MD,a Michael Song MD,b Yaung-Kaung Shen PhD,b Brad Schenkel MS,c Yong-Beom Choe MD,d Nack-In Kim MD,e Joo-Heung Lee MD,f Ju-Hee Lee MD,g Hae-Jun Song MD,h and Jai-Il Youni on behalf of the PEARL investigators
aDepartment of Dermatology, National Taiwan University Hospital, Taipei, Taiwan bJanssen Research & Development, LLC, Spring House, PA cJanssen Scientific Affairs, LLC, Horsham, PA dKonkuk University School of Medicine, Seoul, South Korea eKyung Hee University Medical Center, Seoul, South Korea fSamsung Medical Center, Sungkyunkwan University, Seoul, South Korea gYonsei University College of Medicine Severence Hospital, Seoul, South Korea hKorea University Guro Hospital, Seoul, South Korea iSeoul National University, Seoul, South Korea
Abstract
Background: The PEARL study showed that the proportion of psoriasis patients achieving the primary endpoint (at least 75% improvement from baseline to week 12 in the Psoriasis Area and Severity Index) was significantly higher in ustekinumab-treated patients compared with placebo. There is a paucity of data regarding the impact of psoriasis and its treatment on health-related quality of life (HRQoL) in Asian patients.
Objectives: To evaluate the effect of ustekinumab on HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis enrolled in the phase III, randomized, double-blind, placebo-controlled PEARL study.
Methods: In the PEARL study, 121 patients were randomized to receive ustekinumab 45 mg at weeks 0, 4, and 16 (n=61) or placebo at weeks 0 and 4 with crossover to ustekinumab at weeks 12 and 16 (n=60). A major secondary endpoint was the change in Dermatology Life Quality Index (DLQI) from baseline at week 12. Other endpoints included the change in individual DLQI domains, proportion of patients achieving DLQI ≤ 1 (no negative effect), and proportion of patients achieving ≥ 5-point reduction in DLQI (clinically meaningful improvement) at week 12.
Results: At baseline, psoriasis had a very large effect on HRQoL (average DLQI, 15.7). At week 12, patients treated with ustekinumab 45 mg had significantly greater improvement from baseline in DLQI scores compared with placebo (mean decrease, 11.2 vs 0.5 (P<0.001). Likewise, 32.2% and 1.7% of patients receiving ustekinumab 45 mg and placebo, respectively, achieved a DLQI ≤ 1, and 81.4% and 18.3% achieved ≥5-point reduction (both P<0.001 vs placebo). Individual DLQI domains in the ustekinumab group were significantly improved compared with placebo (P<0.001). For ustekinumab-randomized patients, HRQoL improvements were sustained through week 28. Placebo patients who crossed over to ustekinumab experienced similar improvements compared with those randomized to ustekinumab.
Conclusions: Ustekinumab significantly improves HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis.
J Drugs Dermatol. 2012;11(8):943-949.
INTRODUCTION
Psoriasis is a chronic, inflammatory, immune-mediated disease
of the skin that is often associated with co-morbidities
such as depression, psoriatic arthritis, diabetes, and cardiovascular disease.1-5 Psychosocial co-morbidities, which may be attributable to psychological stress and physical limitations,
are common among psoriasis patients.6-8 In addition, due to the visibility of the disease, psoriasis patients often experience
embarrassment, stigmatization, and social rejection, which can profoundly affect their participation in school, work, social events, and other activities of daily living.9-11 A holistic assessment
of the detrimental effects of psoriasis as well as the therapeutic
effect of psoriasis treatment, therefore, should comprise evaluations of both clinical symptoms and psychosocial burden.
Psoriasis, a common disease that occurs at a global prevalence of 2% to 3%, is less prevalent in Asian countries than in Europe and in other Western countries.5,12-18 Though the pathophysiology
of psoriasis appears to be similar across Western and Asian patient populations,19 differences in disease prevalence—and perhaps even treatment response—may be at least partially
