Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis - Results from the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT)
Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis - Results from the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT)
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DOI：
10.1002/art.20967
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发表时间：
2005-04-01
影响因子：
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通讯作者：
Smolen, J
中科院分区：
文献类型：
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作者：
Antoni, CE;Kavanagh, A;Smolen, J
Objective.研究英夫利西单抗治疗活动性银屑病关节炎（PsA）的关节和皮肤表现的疗效和耐受性。104例PsA患者既往至少接受过1种缓解病情的抗风湿药物（DMARD）治疗失败，被纳入本研究，该研究为多中心、随机、双盲、安慰剂对照临床试验。在研究的初始设盲部分，患者在第0、2、6和14周接受英夫利西单抗（5 mg/kg）或安慰剂输注。第16周后，最初分配接受安慰剂的患者交叉接受英夫利西单抗5 mg/kg，每8周一次，直至第50周，而最初随机分配接受英夫利西单抗的患者继续接受相同剂量的活性治疗，直至第50周。主要疗效结局是在第16周达到美国风湿病学会类风湿性关节炎改善20%标准（ACR 20）。其他预定义的临床疗效评估包括银屑病面积和严重程度指数（PASI）评分、ACR 50和ACR 70标准、28个关节的疾病活动性评分、健康评估问卷、附着点炎和指端炎评分以及银屑病关节炎反应标准评分。第16周时达到ACR 20应答的英夫利昔单抗治疗患者比例（65%）显著高于达到该应答的安慰剂治疗患者比例（10%）。此外，46%的英夫利昔单抗治疗患者达到了ACR 50应答，29%的患者达到了ACR 70应答;没有安慰剂治疗患者达到这些终点。在基线PASI评分≥ 2.5的患者中，68%的英夫利昔单抗治疗患者在第16周PASI评分改善≥ 75%，而安慰剂治疗患者无一改善。英夫利西单抗持续治疗导致持续改善关节和皮肤病表现的PsA，直到第50周。两组不良事件发生率相似。英夫利西单抗5 mg/kg剂量治疗显著改善了对DMARD治疗耐药的活动性PsA患者的关节炎、银屑病、趾炎和附着点炎的体征和症状。继续英夫利西单抗治疗，获益持续至50周。在本研究人群中，获益风险比似乎有利。
Objective. To investigate the efficacy and tolerability of infliximab therapy for the articular and dermatologic manifestations of active psoriatic arthritis (PsA).Methods. One hundred four patients with PsA in whom prior therapy with at least 1 disease-modifying antirheumatic drug (DMARD) had failed were recruited into this investigator-initiated, multicenter, randomized, double-blind, placebo-controlled clinical trial. During the initial blinded portion of the study, patients received infusions of infliximab (5 mg/kg) or placebo at weeks 0, 2, 6, and 14. After week 16, patients initially assigned to receive placebo crossed over to receive infliximab 5 mg/kg every 8 weeks through week 50, while patients initially randomized to infliximab continued to receive active treatment at the same dose through week 50. The primary efficacy outcome was achievement of the American College of Rheumatology 20% criteria for improvement in rheumatoid arthritis (ACR20) at week 16. Additional predefined clinical efficacy assessments included the Psoriasis Area and Severity Index (PASI) score, the ACR50 and ACR70 criteria, the Disease Activity Score in 28 joints, the Health Assessment Questionnaire, ratings of enthesitis and dactylitis, and the Psoriatic Arthritis Response Criteria score.Results. The proportion of infliximab-treated patients who achieved an ACR20 response at week 16 (65%) was significantly higher than the proportion of placebo-treated patients who achieved this response (10%). In addition, 46% of infliximab-treated patients achieved an ACR50 response, and 29% achieved an ACR70 response; no placebo-treated patient achieved these end points. Among patients who had PASI scores of >= 2.5 at baseline, 68% of infliximab-treated patients achieved improvement of >= 75% in the PASI score at week 16 compared with none of the placebo-treated patients. Continued therapy with infliximab resulted in sustained improvement in articular and dermatologic manifestations of PsA through week 50. The incidence of adverse events was similar between the treatment groups.Conclusion. Therapy with infliximab at a dose of 5 mg/kg significantly improved the signs and symptoms of arthritis, psoriasis, dactylitis, and enthesitis in patients with active PsA that had been resistant to DMARD therapy. With continued infliximab treatment, benefits were sustained through 50 weeks. The benefit-to-risk ratio appeared favorable in this study population.