Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital IBD Group, Toronto, Ontario, Canada; Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.
J Crohns Colitis. 2018 Mar 28;12(4):458-464. doi: 10.1093/ecco-jcc/jjx176.
Golimumab is approved for the treatment of moderate-to-severely active ulcerative colitis. However, there have been no formal trials to assess its utility in Crohn's disease [CD]. Our aim was to determine the efficacy and safety of golimumab in patients with anti-tumour necrosis factor [TNF] refractory CD.
Patients with CD treated with golimumab between 2010 and 2017 were included in a retrospective observational study. The vast majority of patients failed two anti-TNF agents. Clinical response was defined as a significant reduction in symptoms and biochemical markers of CD, and no requirement for surgery or introduction of immune-suppressants.
Forty-five patients were included, with a median follow-up of 22 months [interquartile range 12-34] following initiation of golimumab. Induction and maintenance regimens were generally higher than standard dosing with first month cumulative doses of 400 mg and above in 75% of the patients. Monthly maintenance doses ≥200 mg were administered in 52% of patients. Clinical response at 3 months was achieved in 35/45 [77.7%] patients. The cumulative probabilities that patients with an initial response maintained their clinical response for 12 and 36 months after introduction of golimumab were 81% and 64%, respectively. Endoscopic improvement and mucosal healing at 12 months was achieved in 73% and 47% of patients, respectively.
This study demonstrates the efficacy of golimumab in anti-TNF refractory CD patients. Further studies should be performed in CD to formally assess the efficacy of golimumab in a randomized controlled trial and to establish the optimal dosing regimen.
戈利木单抗已获批准用于治疗中重度活动溃疡性结肠炎。然而，目前尚未有正式的临床试验评估其在克罗恩病[CD]中的应用。我们旨在确定戈利木单抗在抗肿瘤坏死因子[TNF]治疗抵抗的 CD 患者中的疗效和安全性。
纳入 2010 年至 2017 年接受戈利木单抗治疗的 CD 患者进行回顾性观察性研究。绝大多数患者两种抗 TNF 药物治疗失败。临床缓解定义为症状和 CD 的生化标志物显著减轻，无需手术或引入免疫抑制剂。
共纳入 45 例患者，自起始戈利木单抗治疗后中位随访 22 个月[四分位距 12-34]。诱导和维持方案通常高于标准剂量，75%的患者首月累积剂量达到 400mg 或以上。52%的患者给予每月维持剂量≥200mg。3 个月时临床缓解的患者有 35/45[77.7%]例。初始缓解的患者在引入戈利木单抗后 12 个月和 36 个月维持临床缓解的累积概率分别为 81%和 64%。12 个月时分别有 73%和 47%的患者内镜改善和黏膜愈合。
本研究表明戈利木单抗在抗 TNF 治疗抵抗的 CD 患者中有效。应在 CD 中开展进一步研究，以正式评估戈利木单抗在随机对照试验中的疗效，并确定最佳剂量方案。
