van der Heijde Désirée, Dijkmans Ben, Geusens Piet, Sieper Joachim, DeWoody Kimberly, Williamson Paul, Braun Jürgen
University Hospital Maastricht, Maastricht, The Netherlands.
Arthritis Rheum. 2005 Feb;52(2):582-91. doi: 10.1002/art.20852.
OBJECTIVE: The signs and symptoms of ankylosing spondylitis (AS) respond inadequately to nonsteroidal antiinflammatory drugs, corticosteroids, and disease-modifying antirheumatic drugs in quite a number of patients. Tumor necrosis factor inhibitors have demonstrated success in reducing AS disease activity in a limited number of clinical trials. The objective of this multicenter, randomized, placebo-controlled study was to evaluate the efficacy and safety of infliximab in patients with AS. METHODS: Patients were randomly assigned to receive infusions of placebo or 5 mg/kg infliximab at weeks 0, 2, 6, 12, and 18. Efficacy was assessed using the ASsessment in Ankylosing Spondylitis (ASAS) International Working Group criteria, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), night pain, patient's global assessment, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), chest expansion, the Mander enthesis index, the total swollen joint index, the C-reactive protein level, and the Short Form 36 (SF-36) health survey questionnaire. The primary end point in this study was the proportion of patients with a 20% improvement response according to the ASAS International Working Group criteria (ASAS20 responders) at week 24. RESULTS: Of the 357 patients screened, 201 were assigned to receive 5 mg/kg infliximab and 78 were assigned to receive placebo. After 24 weeks, 61.2% of patients in the infliximab group were ASAS20 responders compared with 19.2% of patients in the placebo group (P < 0.001). Clinical benefit was observed in patients receiving infliximab as early as week 2 and was maintained over the 24-week study period. Patients receiving infliximab also showed significant improvements in the BASDAI, BASFI, BASMI, chest expansion, and physical component summary score of the SF-36. Adverse events were reported by 82.2% of patients receiving infliximab and by 72.0% of patients receiving placebo; however, most adverse events in both treatment groups were mild or moderate in severity. CONCLUSION: Infliximab was well tolerated and effective in a large cohort of patients with AS during a 24-week study period.
目的：在相当多的患者中，强直性脊柱炎（AS）的体征和症状对非甾体类抗炎药、皮质类固醇及改善病情抗风湿药反应欠佳。肿瘤坏死因子抑制剂在有限数量的临床试验中已证明能成功降低AS疾病活动度。这项多中心、随机、安慰剂对照研究的目的是评估英夫利昔单抗对AS患者的疗效和安全性。 方法：患者在第0、2、6、12和18周被随机分配接受安慰剂或5mg/kg英夫利昔单抗静脉输注。使用强直性脊柱炎评估（ASAS）国际工作组标准、巴斯强直性脊柱炎疾病活动指数（BASDAI）、夜间疼痛、患者整体评估、巴斯强直性脊柱炎功能指数（BASFI）、巴斯强直性脊柱炎计量指数（BASMI）、胸廓活动度、曼德附着点指数、肿胀关节总数指数、C反应蛋白水平及健康调查简表36（SF-36）问卷评估疗效。本研究的主要终点是在第24周时根据ASAS国际工作组标准有20%改善反应的患者比例（ASAS20反应者）。 结果：在357例筛查患者中，201例被分配接受5mg/kg英夫利昔单抗，78例被分配接受安慰剂。24周后，英夫利昔单抗组61.2%的患者为ASAS20反应者，而安慰剂组为19.2%（P<0.001）。早在第2周接受英夫利昔单抗治疗的患者即观察到临床获益，且在24周研究期间持续存在。接受英夫利昔单抗治疗的患者在BASDAI、BASFI、BASMI、胸廓活动度及SF-36的躯体健康评分方面也有显著改善。接受英夫利昔单抗治疗的患者中有82.2%报告了不良事件，接受安慰剂治疗的患者中有72.0%报告了不良事件；然而，两个治疗组中的大多数不良事件严重程度为轻度或中度。 结论：在为期24周的研究期间，英夫利昔单抗在一大群AS患者中耐受性良好且有效。
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