Dermatologikum Hamburg, Hamburg, Germany.
J Dermatolog Treat. 2011 Dec;22(6):337-47. doi: 10.3109/09546634.2010.499931. Epub 2010 Oct 31.
To assess the effect of ustekinumab on productivity and work limitations among 1230 psoriasis patients treated with ustekinumab 45 mg or 90 mg or placebo during the Phase III PHOENIX 2 trial.
The self-administered Work Limitations Questionnaire (WLQ) was used to determine the on-the-job limitations at baseline and weeks 12 and 24. Productivity was assessed using a Visual Analog Scale (VAS), and the number of work days missed due to psoriasis was recorded.
At baseline, work limitations and productivity were similar across treatment groups. At week 12, improvement in productivity VAS scores was significantly (p < 0.001) higher in the 45 mg (72.6%) and 90 mg (71.4%) ustekinumab groups versus placebo (no change), and the proportion of patients who missed work days was significantly lower (2.0% for each ustekinumab group vs 8.3% for placebo; p < 0.001). Mean improvements from baseline to week 12 were greater with ustekinumab than with placebo for WLQ domains, including time management (6.6/9.1 vs -0.7), mental-interpersonal (7.8/7.5 vs -1.1), and output demands (6.8/7.0 vs -1.1) (p < 0.001 for ustekinumab 45 mg/90 mg vs placebo). Improvements were maintained through week 24.
Ustekinumab 45 mg or 90 mg significantly increased productivity, reduced work days missed, and improved work limitations compared with placebo in patients with moderate-to-severe psoriasis.
评估乌司奴单抗对接受乌司奴单抗 45mg 或 90mg 或安慰剂治疗的 1230 例银屑病患者的生产力和工作限制的影响,该研究来自于 III 期 PHOENIX 2 试验。
采用自我管理的工作限制问卷(WLQ)在基线和第 12 周、24 周评估工作限制。采用视觉模拟量表(VAS)评估生产力,并记录因银屑病而错过的工作日数。
基线时,各组治疗间的工作限制和生产力相似。第 12 周,乌司奴单抗 45mg(72.6%)和 90mg(71.4%)组的生产力 VAS 评分改善显著(p<0.001)高于安慰剂组(无变化),错过工作日的患者比例显著降低(乌司奴单抗组各为 2.0%,安慰剂组为 8.3%;p<0.001)。与安慰剂相比,乌司奴单抗组从基线到第 12 周时,WLQ 各领域的评分均有显著改善,包括时间管理(6.6/9.1 vs -0.7)、心理人际交往(7.8/7.5 vs -1.1)和工作产出需求(6.8/7.0 vs -1.1)(乌司奴单抗 45mg/90mg 组优于安慰剂组,p<0.001)。这些改善在第 24 周时仍持续存在。
乌司奴单抗 45mg 或 90mg 可显著提高生产力,减少因银屑病而错过的工作日数,并改善中度至重度银屑病患者的工作限制。