Department of Rheumatology, Ghent University Hospital, Ghent, Belgium.
VIB Inflammation Research Center, Ghent University, Ghent, Belgium.
Ann Rheum Dis. 2017 Aug;76(8):1389-1395. doi: 10.1136/annrheumdis-2016-210775. Epub 2017 Feb 17.
To evaluate the efficacy and safety of golimumab to induce clinical remission in patients with very early, active peripheral spondyloarthritis (pSpA).
Clinical REmission in peripheral SPondyloArthritis is a monocentric study of golimumab treatment in patients with pSpA. All patients fulfilled the Assessment of SpondyloArthritis international Society classification criteria for pSpA, with a symptom duration ≤12 weeks. Patients were randomised 2:1 to receive golimumab 50 mg every 4 weeks or matching placebo for 24 weeks. The primary end point was the percentage of patients achieving clinical remission at week 24, defined as absence of arthritis, enthesitis and dactylitis. Secondary end points included joint and enthesis counts, patient-reported outcomes, erythrocyte sedimentation rate and C reactive protein. From week 12, non-responders were allowed to receive rescue medication with golimumab. Adverse events were recorded.
60 patients were randomised with similar baseline characteristics. At week 24, a significantly higher percentage of patients receiving golimumab achieved clinical remission compared with placebo (75% (30/40) vs 20% (4/20); p<0.001). At week 12, similar results were observed (70% (28/40) vs 15% (3/20); p<0.001). All secondary end points were met at week 24. Rescue medication was necessary in 50% in the placebo group opposed to only 10% in the golimumab arm. Rates of adverse events were low and similar in both groups.
Markedly high remission induction rates were noted with golimumab in very early pSpA. Of interest, in placebo-treated patients, very low spontaneous remission rates were observed.
NCT01426815; Results.
评估戈利木单抗诱导早期活动性外周脊柱关节炎（pSpA）患者临床缓解的疗效和安全性。
外周脊柱关节炎的临床缓解是戈利木单抗治疗 pSpA 的一项单中心研究。所有患者均符合评估脊柱关节炎国际协会（ASAS）pSpA 分类标准，且症状持续时间≤12 周。患者按 2:1 随机分组，分别接受戈利木单抗 50mg 每 4 周 1 次或匹配安慰剂治疗 24 周。主要终点为第 24 周时达到临床缓解的患者比例，定义为关节炎、附着点炎和指（趾）炎均消失。次要终点包括关节和附着点计数、患者报告结局、红细胞沉降率和 C 反应蛋白。从第 12 周开始，未应答者可接受戈利木单抗解救治疗。记录不良事件。
60 例患者随机分组，基线特征相似。第 24 周时，接受戈利木单抗治疗的患者达到临床缓解的比例显著高于安慰剂组（75%（30/40）比 20%（4/20）；p<0.001）。第 12 周时也观察到相似的结果（70%（28/40）比 15%（3/20）；p<0.001）。第 24 周时所有次要终点均达到。安慰剂组有 50%的患者需要解救治疗，而戈利木单抗组仅 10%。两组不良反应发生率均较低且相似。
在早期 pSpA 中，戈利木单抗可显著诱导缓解。有趣的是，在安慰剂治疗的患者中，观察到非常低的自发缓解率。
NCT01426815；结果。
