Martineau C, Flourié B, Wils P, Vaysse T, Altwegg R, Buisson A, Amiot A, Pineton de Chambrun G, Abitbol V, Fumery M, Hébuterne X, Viennot S, Laharie D, Beaugerie L, Nancey S, Sokol H
Saint Antoine Hospital, Assistance Publique des Hôpitaux de Paris (APHP), CHU, Paris, France.
Lyon Sud Hospital, Hospices Civils de Lyon, CHU, Lyon, France.
Aliment Pharmacol Ther. 2017 Dec;46(11-12):1077-1084. doi: 10.1111/apt.14371. Epub 2017 Oct 13.
Anti-tumour necrosis factor (TNF) agents have improved the care of Crohn's disease (CD). After the first anti-TNF discontinuation, it is possible to switch to another anti-TNF. Three anti-TNF agents are available for ulcerative colitis (infliximab, adalimumab and golimumab), but only the first 2 have been approved for CD because golimumab has not been studied for this indication.
To report the efficacy and safety of golimumab in CD.
Crohn's disease patients who received golimumab were identified in 12 French tertiary centres and were retrospectively analysed. The primary endpoint was the duration of golimumab treatment before escalation or discontinuation. The clinical response was defined as a decrease of more than 3 points in the Harvey-Bradshaw index or by global physician assessment.
One hundred and fifteen patients were included. The golimumab treatment duration was 9.8 months (0.55-44), and 48.7% of the patients were still under treatment at the end of follow-up. Clinical response was observed in 55.8% of the patients after a mean duration of 3.8 months. The probability of remaining under treatment without escalation at 6, 12 and 24 months was 54.6%, 34.9% and 19.3% respectively. In multivariate analysis, discontinuation of the first anti-TNF agent due to intolerance (odds ratio, OR = 2.16; 95% CI, confidence interval [1.25-3.86]; P = .005) and co-immunosuppression for more than 6 months (OR = 3.98; 95% CI [2.3-7.1]; P < .0001) were predictive factors of efficacy. Six per cent of the patients discontinued treatment due to intolerance.
After failure of infliximab or adalimumab for Crohn's disease, golimumab was safe and seemed beneficial in half of the patients.
抗肿瘤坏死因子（TNF）药物改善了克罗恩病（CD）的治疗。首次停用抗TNF药物后，可换用另一种抗TNF药物。有三种抗TNF药物可用于溃疡性结肠炎（英夫利昔单抗、阿达木单抗和戈利木单抗），但只有前两种被批准用于CD，因为戈利木单抗尚未针对该适应症进行研究。
报告戈利木单抗治疗CD的疗效和安全性。
在法国12个三级中心识别接受戈利木单抗治疗的克罗恩病患者，并进行回顾性分析。主要终点是升级或停药前戈利木单抗的治疗持续时间。临床缓解定义为哈维-布拉德肖指数下降超过3分或经医生整体评估确定。
纳入115例患者。戈利木单抗治疗持续时间为9.8个月（0.55 - 44个月），48.7%的患者在随访结束时仍在接受治疗。平均3.8个月后，55.8%的患者出现临床缓解。在6个月、12个月和24个月时仍在接受治疗且未升级的概率分别为54.6%、34.9%和19.3%。多因素分析显示，因不耐受停用第一种抗TNF药物（比值比，OR = 2.16；95%置信区间[1.25 - 3.86]；P = 0.005）以及联合免疫抑制超过6个月（OR = 3.98；95%置信区间[2.3 - 7.1]；P < 0.0001）是疗效的预测因素。6%的患者因不耐受停药。
对于克罗恩病患者，在英夫利昔单抗或阿达木单抗治疗失败后，戈利木单抗是安全的，且似乎对半数患者有益。
