优特克单抗可改善韩国和台湾中重度银屑病患者的健康相关生活质量：PEARL试验结果
Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis: results from the PEARL trial.
作者信息
Tsai Tsen-Fang, Song Michael, Shen Yaung-Kaung, Schenkel Brad, Choe Yong-Beom, Kim Nack-In, Lee Joo-Heung, Lee Ju-Hee, Song Hae-Jun, Youn Jai-Il
机构信息
Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan.
出版信息
J Drugs Dermatol. 2012 Aug;11(8):943-9.
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.
背景
PEARL研究表明，与安慰剂相比，接受优特克单抗治疗的银屑病患者达到主要终点（银屑病面积和严重程度指数从基线到第12周改善至少75%）的比例显著更高。关于银屑病及其治疗对亚洲患者健康相关生活质量（HRQoL）影响的数据很少。
目的
在III期随机双盲安慰剂对照的PEARL研究中，评估优特克单抗对韩国/台湾中重度银屑病患者HRQoL的影响。
方法
在PEARL研究中，121例患者被随机分为在第0、4和16周接受45mg优特克单抗治疗组（n = 61）或在第0和4周接受安慰剂治疗并在第12和16周交叉接受优特克单抗治疗组（n = 60）。一个主要次要终点是第12周时皮肤病生活质量指数（DLQI）相对于基线的变化。其他终点包括各DLQI领域的变化、第12周时DLQI≤1（无负面影响）的患者比例以及DLQI降低≥5分（具有临床意义的改善）的患者比例。
结果
在基线时，银屑病对HRQoL有非常大的影响（平均DLQI为15.7）。在第12周时，接受45mg优特克单抗治疗的患者与安慰剂相比，DLQI评分从基线有显著更大的改善（平均降低，11.2对0.5，P<0.001）。同样，接受45mg优特克单抗和安慰剂治疗的患者分别有32.2%和1.7%达到DLQI≤1，81.4%和18.3%达到降低≥5分（与安慰剂相比均P<0.001）。与安慰剂相比，优特克单抗组的各DLQI领域有显著改善（P<0.001）。对于随机接受优特克单抗治疗的患者，HRQoL的改善持续到第28周。交叉接受优特克单抗治疗的安慰剂组患者与随机接受优特克单抗治疗的患者有相似的改善。
结论
优特克单抗显著改善韩国/台湾中重度银屑病患者的HRQoL。
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