Reich Kristian, Nestle Frank O, Wu Ying, Bala Mohan, Eisenberg Debra, Guzzo Cynthia, Li Shu, Dooley Lisa T, Griffiths Christopher E M
Department of Dermatology, Georg-August University; Von-SieboldStrasse 3, 37075, Göttingen, Germany.
Eur J Dermatol. 2007 Sep-Oct;17(5):381-6. doi: 10.1684/ejd.2007.0234. Epub 2007 Aug 2.
This study examined the impact of infliximab maintenance therapy on productivity in patients with moderate-to-severe psoriasis. Patients from the multicentre, double-blind, placebo-controlled EXPRESS study (n = 378) were randomised to receive infusions of placebo or infliximab 5 mg/kg at weeks 0, 2, and 6 and every 8 weeks through week 46, with placebo crossover to infliximab at week 24. Main outcome measures were a 10-cm productivity visual analog scale (VAS), role-physical and role-emotional domain scores of the Short Form 36-Item questionnaire (SF-36), and Dermatology Life Quality Index (DLQI) scores. The productivity VAS score was 5.9 cm at baseline. Mean change through week 10 with infliximab was significantly greater than that with placebo (2.7 cm vs. - 0.1 cm) and was sustained through week 24. Similar trends were observed for SF-36 scores. The proportion of patients whose skin condition prevented them from working and/or studying per DLQI scores decreased through week 10 with infliximab (12.1% and 1.4%, respectively), but increased slightly with placebo (9.1% and 11.6%, respectively). At week 50, improvements in productivity and SF-36 scores were sustained with infliximab. In placebo patients who crossed over to infliximab, these scores improved and approached those seen with infliximab at week 50. Infliximab significantly improved productivity and ability to work in psoriasis patients.
本研究考察了英夫利昔单抗维持治疗对中重度银屑病患者生产力的影响。来自多中心、双盲、安慰剂对照的EXPRESS研究(n = 378)的患者被随机分组,在第0、2和6周接受安慰剂或5mg/kg英夫利昔单抗输注,之后每8周输注一次,直至第46周,安慰剂组在第24周交叉换用英夫利昔单抗。主要结局指标为10厘米生产力视觉模拟量表(VAS)、简短健康调查问卷36项(SF-36)的角色-身体和角色-情感领域得分以及皮肤病生活质量指数(DLQI)得分。生产力VAS得分在基线时为5.9厘米。至第10周,英夫利昔单抗组的平均变化显著大于安慰剂组(2.7厘米对 -0.1厘米),且这种差异持续至第24周。SF-36得分也观察到类似趋势。根据DLQI得分,因皮肤状况导致无法工作和/或学习的患者比例,至第10周,英夫利昔单抗组有所下降(分别为12.1%和1.4%),而安慰剂组略有上升(分别为9.1%和11.6%)。在第50周,英夫利昔单抗组的生产力和SF-36得分持续改善。在交叉换用英夫利昔单抗的安慰剂组患者中,这些得分有所改善,并接近第50周英夫利昔单抗组的水平。英夫利昔单抗显著提高了银屑病患者的生产力和工作能力。