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    银屑病关节炎治疗的IMPACT临床试验
    发布时间:[2013-06-07 10:37] 点击次数:
    IMPACT研究,即Infliximab Multinational Psoriatic Arthritis Controlled Trial   
     
            目的:研究infliximab(类克)治疗银屑病关节炎超过2年的长期疗效和安全性。方法:最早有104例患者随机双盲输注infliximab 5mg/kg或安慰剂(0, 2, 6和14周),16周时所有患者改为infliximab 5 mg/kg,每8周1次,直到46周。87例患者中有78例完成了第一年的输注,之后进入开放的长期治疗。患者分别于54、 62、70、78、86和94周接受infliximab 5 mg/kg治疗,其主要疗效观察终点是98周获得至少20%改善(ACR20改善)患者的比例,应用修订的Sharp得分标准对患者的放射线改变进行评估(n=43)。结果:98周时,62%(48/78)、45%(35/78)和35%(27/78)的infliximab治疗患者分别获得了ACR20 、ACR50和ACR 70疗效。基线时银屑病区和严重性指数得分≥2.5的患者中,有64%(16/25)的患者获得了>75%的改善。与基线相比,infliximab治疗的平均每年放射学进展估测值明显降低。结论:用infliximab 5 mg/kg治疗难治性银屑病关节炎患者94周可使关节和皮肤症状持续改善,并可抑制放射线进展和具有良好的益处/风险比。
     
            原文:OBJECTIVE: To investigate longterm efficacy/safety of infliximab over 2 years in patients with active psoriatic arthritis (PsA). METHODS: Initially, 104 patients were randomized to receive blinded infusions of infliximab 5 mg/kg or placebo at Weeks 0, 2, 6, and 14. At Week 16, all patients received infliximab 5 mg/kg every 8 weeks through Week 46. Seventy-eight of the 87 patients completing the first year continued into the open-label longterm extension and received infliximab 5 mg/kg at Weeks 54, 62, 70, 78, 86, and 94. The primary efficacy endpoint for the study extension was the proportion of patients with at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at Week 98. Radiographic progression was assessed by the PsA-modified van der Heijde-Sharp score in patients with radiographs available at baseline and Week 98 (n = 43). RESULTS: At Week 98, 62% (48/78) of infliximab-treated patients achieved an ACR20 response; 45% (35/78) and 35% (27/78) of patients achieved ACR50 and ACR70 responses, respectively. Among patients with baseline Psoriasis Area and Severity Index scores >or= 2.5, 64% (16/25) achieved > 75% improvement from baseline to Week 98. The average estimated annual radiographic progression with infliximab treatment was significantly reduced versus the estimated baseline rate of progression. No new safety issues were observed during the second year of the study. CONCLUSION: Therapy with infliximab 5 mg/kg through Week 94 produced sustained improvement in joint and skin symptoms, inhibited radiographic progression, and continued to exhibit a favorable benefit-risk ratio in this population with treatment-refractory PsA.(摘自:Antoni CE, Kavanaugh A, van der Heijde D, et al.Two-year efficacy and safety of infliximab treatment in patients with active psoriatic arthritis: findings of the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT). J Rheumatol. 2008,35(5):869-76.)
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