Angelison L, Almer S, Eriksson A, Karling P, Fagerberg U, Halfvarson J, Thörn M, Björk J, Hindorf U, Löfberg R, Bajor A, Hjortswang H, Hammarlund P, Grip O, Torp J, Marsal J, Hertervig E
Helsingborg, Sweden.
Stockholm, Sweden.
Aliment Pharmacol Ther. 2017 Feb;45(4):519-532. doi: 10.1111/apt.13893. Epub 2016 Dec 27.
Real-life long-term data on infliximab treatment in ulcerative colitis are limited.
To study the long-term efficacy and safety of infliximab in chronic active ulcerative colitis and possible predictors of colectomy and response were also examined.
A retrospective multi-centre study of infliximab treatment in 250 patients with chronic active ulcerative colitis with inclusion criteria: age ≥18 years, ambulatory treated, steroid-dependent or intolerant and/or immunomodulator refractory or intolerant.
Steroid-free clinical remission was achieved by 123/250 patients (49.2%) at 12 months and in 126/250 patients at a median follow-up of 2.9 years (50.4%). Primary response at 3 months was achieved by 190/250 (76.0%) patients and associated with a high probability of response 168/190 (88.4%) at 12 months and 143/190 (75.3%) at follow-up. Long-term rate of colectomy in primary responders was 6/190 (3.2%) at 12 months and 27/190 (14.2%) at last follow-up. Failure to achieve response at 3 months was associated with a high risk of subsequent colectomy, 29/60 (48.3%) at 12 months and 41/60 (68.3%) at follow-up. Response at 12 months was associated with a low risk of subsequent colectomy, 14/181 (7.7%) compared with non-response 19/34 (55.9%) (P < 0.0001). Non-response at 3 months was an independent predictor of subsequent colectomy (HR = 9.40, 95% CI = 5.10-17.35, P < 0.001). Concomitant azathioprine therapy did not influence outcome in terms of colectomy.
Long-term efficacy of infliximab treatment in chronic active ulcerative colitis is excellent especially in patients who respond to induction treatment. Conversely, non-response at 3 months predicts a poor outcome, with a high risk of subsequent colectomy.
关于英夫利昔单抗治疗溃疡性结肠炎的实际长期数据有限。
研究英夫利昔单抗治疗慢性活动性溃疡性结肠炎的长期疗效和安全性，并探讨结肠切除术和反应的可能预测因素。
一项对250例慢性活动性溃疡性结肠炎患者进行英夫利昔单抗治疗的回顾性多中心研究，纳入标准为：年龄≥18岁，门诊治疗，依赖类固醇或不耐受，和/或对免疫调节剂难治或不耐受。
123/250例患者（49.2%）在12个月时实现无类固醇临床缓解，126/250例患者在中位随访2.9年时实现无类固醇临床缓解（50.4%）。190/250例（76.0%）患者在3个月时达到主要反应，且在12个月时168/190例（88.4%）、随访时143/190例（75.3%）有较高的反应概率。主要反应者的长期结肠切除率在12个月时为6/190例（3.2%），末次随访时为27/190例（14.2%）。3个月时未达到反应与随后结肠切除的高风险相关，12个月时为29/60例（48.3%），随访时为41/60例（68.3%）。12个月时的反应与随后结肠切除的低风险相关，反应者为14/18例（7.7%），无反应者为19/34例（55.9%）（P< 0.0001）。3个月时无反应是随后结肠切除的独立预测因素（HR = 9.40，95%CI = 5.10 - 17.35，P< 0.001）。同时使用硫唑嘌呤治疗对结肠切除的结局无影响。
英夫利昔单抗治疗慢性活动性溃疡性结肠炎的长期疗效极佳，尤其是对诱导治疗有反应的患者。相反，3个月时无反应预示结局不佳，随后结肠切除风险高。
