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英夫利昔单抗可改善银屑病关节炎患者的健康相关生活质量和身体功能。

Infliximab improves health related quality of life and physical function in patients with psoriatic arthritis.

作者信息

Kavanaugh A, Antoni C, Krueger G G, Yan S, Bala M, Dooley L T, Beutler A, Guzzo C, Gladman D

机构信息

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.

出版信息

Ann Rheum Dis. 2006 Apr;65(4):471-7. doi: 10.1136/ard.2005.040196. Epub 2005 Aug 11.

Abstract

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

In patients with PsA, infliximab 5 mg/kg significantly improved HRQoL and physical function compared with placebo through 24 weeks.

摘要

目的

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。

方法

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。

结果

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。

结论

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。

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