Kavanaugh A, Antoni C, Krueger G G, Yan S, Bala M, Dooley L T, Beutler A, Guzzo C, Gladman D
Center for Innovative Therapy, Division of Rheumatology, Allergy, and Immunology, University of California at San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0943, USA.
Ann Rheum Dis. 2006 Apr;65(4):471-7. doi: 10.1136/ard.2005.040196. Epub 2005 Aug 11.
To evaluate the effect of infliximab on health related quality of life (HRQoL) and physical function in patients with active psoriatic arthritis (PsA) in the IMPACT 2 trial.
200 patients with PsA unresponsive to conventional treatment were randomised to intravenous infusions of infliximab 5 mg/kg or placebo at weeks 0, 2, 6, 14, and 22; patients with inadequate response entered early escape at week 16. HRQoL was assessed using the Short Form-36 (SF-36) at weeks 0, 14, and 24. Functional disability was assessed using the Health Assessment Questionnaire (HAQ) at every visit through week 24. Associations between changes in quality of life (SF-36) and articular (American College of Rheumatology (ACR)) and dermatological (Psoriasis Area and Severity Index (PASI)) responses were examined.
Mean percentage improvement from baseline in HAQ was 48.6% in the infliximab group compared with worsening of 18.4% in the placebo group at week 14 (p < 0.001). Furthermore, 58.6% and 19.4% of infliximab and placebo treated patients, respectively, achieved a clinically meaningful improvement in HAQ (that is, > or = 0.3 unit decrease) at week 14 (p < 0.001). Increases in physical and mental component summary (PCS and MCS) scores and all eight scales of the SF-36 in the infliximab group were greater than those in the placebo group at week 14 (p < or = 0.001). These benefits were sustained through week 24. Patients achieving ACR20 and PASI75 responses had the greatest improvements in PCS and MCS scores.
In patients with PsA, infliximab 5 mg/kg significantly improved HRQoL and physical function compared with placebo through 24 weeks.
在IMPACT 2试验中评估英夫利昔单抗对活动性银屑病关节炎（PsA）患者健康相关生活质量（HRQoL）和身体功能的影响。
200例对传统治疗无反应的PsA患者在第0、2、6、14和22周被随机分为静脉输注5 mg/kg英夫利昔单抗或安慰剂；反应不足的患者在第16周提前退出。在第0、14和24周使用简短健康调查问卷（SF-36）评估HRQoL。在直至第24周的每次就诊时使用健康评估问卷（HAQ）评估功能残疾情况。研究生活质量（SF-36）变化与关节（美国风湿病学会（ACR））和皮肤病学（银屑病面积和严重程度指数（PASI））反应之间的关联。
在第14周时，英夫利昔单抗组HAQ自基线的平均改善百分比为48.6%，而安慰剂组恶化了18.4%（p<0.001）。此外，在第14周时，分别有58.6%和19.4%接受英夫利昔单抗和安慰剂治疗的患者在HAQ方面取得了具有临床意义的改善（即降低≥0.3单位）（p<0.001）。在第14周时，英夫利昔单抗组的身体和心理成分汇总（PCS和MCS）得分以及SF-36的所有八个量表的增加均大于安慰剂组（p≤0.001）。这些益处持续至第24周。达到ACR20和PASI75反应的患者在PCS和MCS得分方面改善最大。
在PsA患者中，与安慰剂相比，5 mg/kg英夫利昔单抗在24周内显著改善了HRQoL和身体功能。
