Department of Rheumatology, Hospital General de Mexico Dr. Eduardo Liceaga, Mexico City, Mexico.
Faculty of Medicine, Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.
Arthritis Res Ther. 2022 Aug 8;24(1):187. doi: 10.1186/s13075-022-02877-9.
To assess the efficacy and safety of infliximab versus placebo in the treatment of patients with juvenile-onset spondyloarthritis (JoSpA).
Phase III, randomized, double-blind, placebo-controlled trial of 12 weeks that included patients ≤ 18 years old with JoSpA not responding to nonsteroidal anti-inflammatory drugs, sulfasalazine, or methotrexate. Patients were randomly assigned 1:1 to the infusion of infliximab 5mg/kg or placebo; completers entered then an open-label extension (OLE) period of 42 weeks. The primary endpoint was the number of active joints. Secondary outcomes included the assessment of disease activity, tender entheses, spinal mobility, serum C-reactive protein (CRP), the Bath Ankylosing Spondylitis Disease Activity and Functional Index, and the Childhood Health Assessment Questionnaire (CHAQ).
We randomized 12 patients to infliximab and 14 to placebo. No significant differences were found between groups at baseline. At week 12, the mean number of active joints was 1.4 (SD 2.4) in the infliximab group and 4.1 (SD 3.0) in the placebo group (p = 0.0002). A repeated-measures mixed model analysis that included all endpoints in the study demonstrated sustained favourable outcomes of infliximab for active joints, tender joints, swollen joints, and tender enthesis counts, as well as for CHAQ and CRP (p < 0.01). Adverse events were more frequent in the infliximab group, including infections and infusion reactions, but none of them was serious.
Infliximab is efficacious for patients with JoSpA with an inadequate response to conventional treatment. No serious adverse events with the use of infliximab were observed.
评估英夫利昔单抗对比安慰剂在治疗青少年发病型脊柱关节炎（JoSpA）患者中的疗效和安全性。
这是一项为期 12 周的 III 期、随机、双盲、安慰剂对照试验，纳入了对非甾体抗炎药、柳氮磺胺吡啶或甲氨蝶呤反应不佳的≤18 岁 JoSpA 患者。患者按 1:1 随机分配接受英夫利昔单抗 5mg/kg 或安慰剂输注；完成者随后进入 42 周的开放标签扩展（OLE）期。主要终点是活跃关节数。次要结局包括疾病活动度评估、压痛肌腱附着点、脊柱活动度、血清 C 反应蛋白（CRP）、巴斯强直性脊柱炎疾病活动度和功能指数以及儿童健康评估问卷（CHAQ）。
我们将 12 例患者随机分配至英夫利昔单抗组，14 例患者分配至安慰剂组。两组基线时无显著差异。在第 12 周，英夫利昔单抗组的平均活跃关节数为 1.4（SD 2.4），安慰剂组为 4.1（SD 3.0）（p = 0.0002）。包括研究中所有终点的重复测量混合模型分析显示，英夫利昔单抗在活跃关节、压痛关节、肿胀关节和压痛肌腱附着点计数以及 CHAQ 和 CRP 方面具有持续的良好疗效（p<0.01）。英夫利昔单抗组不良反应更常见，包括感染和输注反应，但均不严重。
英夫利昔单抗对常规治疗反应不佳的青少年发病型脊柱关节炎患者有效。使用英夫利昔单抗未观察到严重不良事件。
