Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis: Results from the PEARL trial
Journal
Journal of Drugs in Dermatology
Journal Volume
11
Journal Issue
8
Pages
943-949
Date Issued
2012
Author(s)
Song M.
Shen Y.-K.
Schenkel B.
Choe Y.-B.
Kim N.-I.
Lee J.-H.
Lee J.-H.
Song H.-J.
Youn J.-I.
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. Copyright ? 2012 Journal of Drugs in Dermatology.
SDGs
Other Subjects
placebo; ustekinumab; adult; article; Asian; controlled study; disease severity; double blind procedure; drug effect; ethnic difference; female; human; major clinical study; male; outcome assessment; phase 3 clinical trial; psoriasis; quality of life; randomized controlled trial; scoring system; self report; South Korea; statistical significance; treatment duration; treatment outcome; Adult; Antibodies, Monoclonal; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Quality of Life; Republic of Korea; Self Report; Severity of Illness Index; Statistics, Nonparametric; Taiwan
Type
journal article