Armuzzi Alessandro, Pugliese Daniela, Danese Silvio, Rizzo Gianluca, Felice Carla, Marzo Manuela, Andrisani Gianluca, Fiorino Gionata, Nardone Olga Maria, De Vitis Italo, Papa Alfredo, Rapaccini Gian Lodovico, Guidi Luisa
*IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy; and †IBD Center, Gastroenterology, IRCCS Humanitas, Rozzano, Milan, Italy.
Inflamm Bowel Dis. 2014 Aug;20(8):1368-74. doi: 10.1097/MIB.0000000000000115.
Infliximab (IFX) has demonstrated effectiveness for inducing 12-month steroid-free clinical remission in patients with steroid-dependent ulcerative colitis (UC), but long-term data are lacking. The aim of the study was to describe the long-term outcome of IFX treatment in steroid-dependent UC and investigate if predictors of sustained clinical response and colectomy could be identified.
Consecutive patients with steroid-dependent UC treated with IFX were studied. The coprimary prespecified outcomes were sustained clinical response in patients who achieved clinical remission or response after IFX induction and colectomy-free survival. Secondary analyses were addressed to look for predictors of sustained clinical response and colectomy.
After induction, 76% (96/126) of patients achieved clinical benefit. The median duration of follow-up on IFX maintenance therapy was 41.5 months (interquartile range, 26-45). Sixty-four percent (46/96) of patients had sustained clinical response at median follow-up. Colectomy-free survival was 77% at median follow-up. Combination therapy of IFX with thiopurines was an independent predictor of sustained clinical response (P < 0.0001; hazard ratio [HR], 3.98; 95% confidence interval [CI], 1.73-9.14). Independent predictors of colectomy were Mayo endoscopic subscore of 3 at baseline (P = 0.04; HR, 2.77; 95% CI, 1.09-7.05) and high C-reactive protein after induction (P = 0.001; HR, 5.65; 95% CI, 2.03-15.7). Thiopurine naive status (P = 0.025; HR, 0.34; 95% CI, 0.13-0.87) was protective from colectomy.
Long-term IFX treatment is effective in inducing sustained clinical response in patients with steroid-dependent UC. Combination therapy is predictive of sustained clinical response in the long-term. Patients with more severe endoscopic lesions at baseline and high C-reactive protein after induction are at higher risk of colectomy. Conversely, thiopurine naive status is protective from colectomy.
英夫利昔单抗（IFX）已被证明可有效诱导激素依赖型溃疡性结肠炎（UC）患者实现12个月无激素临床缓解，但缺乏长期数据。本研究的目的是描述IFX治疗激素依赖型UC的长期结局，并调查是否可以确定持续临床反应和结肠切除术的预测因素。
对接受IFX治疗的连续激素依赖型UC患者进行研究。共同预先设定的主要结局是在IFX诱导后实现临床缓解或反应的患者的持续临床反应以及无结肠切除术生存率。进行次要分析以寻找持续临床反应和结肠切除术的预测因素。
诱导后，76%（96/126）的患者获得临床益处。IFX维持治疗的中位随访时间为41.5个月（四分位间距，26 - 45）。在中位随访时，64%（46/96）的患者有持续临床反应。中位随访时无结肠切除术生存率为77%。IFX与硫唑嘌呤联合治疗是持续临床反应的独立预测因素（P < 0.0001；风险比[HR]，3.98；95%置信区间[CI]，1.73 - 9.14）。结肠切除术的独立预测因素是基线时梅奥内镜亚评分为3（P = 0.04；HR，2.77；95% CI，1.09 - 7.05）以及诱导后高C反应蛋白（P = 0.001；HR，5.65；95% CI，2.03 - 15.7）。未使用过硫唑嘌呤的状态（P = 0.025；HR，0.34；95% CI，0.13 - 0.87）对结肠切除术有保护作用。
长期IFX治疗可有效诱导激素依赖型UC患者的持续临床反应。联合治疗可预测长期的持续临床反应。基线内镜病变较严重且诱导后C反应蛋白高的患者结肠切除术风险更高。相反，未使用过硫唑嘌呤的状态对结肠切除术有保护作用。
