Riis Ase, Martinsen Tom C, Waldum Helge L, Fossmark Reidar
Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
Scand J Gastroenterol. 2012 Jun;47(6):649-57. doi: 10.3109/00365521.2012.672591. Epub 2012 Apr 4.
Patients with Crohn's disease (CD) may need anti-inflammatory drugs for decades. Anti-TNF-α agents have good efficacy and adverse events similar to placebo in randomized controlled trials (RCTs), but there are still questions about long-term safety and efficacy. In this respect, reports from clinical practice may be useful. We currently report on the clinical experience with infliximab and adalimumab in a single-center cohort of patients with CD.
Patients with CD treated with infliximab or adalimumab from 2000 to 2010 were reviewed. Patient and disease characteristics at start, reason for discontinuation, and adverse events were recorded retrospectively. Corticosteroid use, the need for hospitalization, and surgeries before and during anti-TNF-α therapy were recorded.
Eighty-three patients had received anti-TNF-α treatment against CD, median treatment duration was 11.4 months (0.2-99.5), and follow-up time 59 months (8-135). Eighteen of 43 patients using corticosteroids at treatment start discontinued corticosteroids during TNF-α therapy. Need for hospitalizations (6.13 vs. 3.28 days/year, p < 0.001) and surgeries (0.56 vs. 0.16 operations/year, p < 0.001) were lower during anti-TNF-α therapy than before treatment. Twenty-six percent discontinued therapy due to adverse events and 26% due to lack or loss of response. Two of four deaths observed during follow-up were believed to be related to anti-TNF-α treatment.
Anti-TNF-α therapy was beneficial in many patients with CD, but the majority of patients discontinued treatment during follow-up. Reports from clinical experience with anti-TNF-α treatment may be valuable for clinicians treating patients with CD.
克罗恩病（CD）患者可能需要数十年的抗炎药物治疗。在随机对照试验（RCT）中，抗TNF-α药物疗效良好，不良事件与安慰剂相似，但长期安全性和疗效仍存在疑问。在这方面，临床实践报告可能会有所帮助。我们目前报告了英夫利昔单抗和阿达木单抗在单中心CD患者队列中的临床经验。
回顾了2000年至2010年接受英夫利昔单抗或阿达木单抗治疗的CD患者。回顾性记录开始治疗时的患者和疾病特征、停药原因及不良事件。记录抗TNF-α治疗前及治疗期间的皮质类固醇使用情况、住院需求及手术情况。
83例患者接受了抗TNF-α治疗CD，中位治疗持续时间为11.4个月（0.2 - 99.5），随访时间为59个月（8 - 135）。43例治疗开始时使用皮质类固醇的患者中有18例在TNF-α治疗期间停用了皮质类固醇。抗TNF-α治疗期间的住院需求（6.13天/年 vs. 3.28天/年，p < 0.001）和手术需求（0.5个手术/年 vs. 0.16个手术/年，p < 0.001）低于治疗前。26%的患者因不良事件停药，26%的患者因缺乏或丧失反应停药。随访期间观察到的4例死亡中有2例被认为与抗TNF-α治疗有关。
抗TNF-α治疗对许多CD患者有益，但大多数患者在随访期间停药。抗TNF-α治疗的临床经验报告对治疗CD患者的临床医生可能有价值。
