Protic Marijana, Seibold Frank, Schoepfer Alain, Radojicic Zoran, Juillerat Pascal, Bojic Daniela, Mwinyi Jessica, Mottet Christian, Jojic Njegica, Beglinger Christoph, Vavricka Stephan, Rogler Gerhard, Frei Pascal
Department of Gastroenterology, Spital Tiefenau, Tiefenaustrasse 112, 3004 Bern, Switzerland; Division of Clinical Pharmacology and Toxicology, University Hospital Zürich, Zürich, Switzerland.
Department of Gastroenterology, Spital Tiefenau, Tiefenaustrasse 112, 3004 Bern, Switzerland; Department of Gastroenterology, Inselspital, University Hospital Bern, Switzerland.
J Crohns Colitis. 2014 Nov;8(11):1427-37. doi: 10.1016/j.crohns.2014.05.004. Epub 2014 Jun 5.
Among patients with steroid-refractory ulcerative colitis (UC) in whom a first rescue therapy has failed, a second line salvage treatment can be considered to avoid colectomy.
To evaluate the efficacy and safety of second or third line rescue therapy over a one-year period.
Response to single or sequential rescue treatments with infliximab (5mg/kg intravenously (iv) at week 0, 2, 6 and then every 8weeks), ciclosporin (iv 2mg/kg/daily and then oral 5mg/kg/daily) or tacrolimus (0.05mg/kg divided in 2 doses) in steroid-refractory moderate to severe UC patients from 7 Swiss and 1 Serbian tertiary IBD centers was retrospectively studied. The primary endpoint was the one year colectomy rate.
60% of patients responded to the first rescue therapy, 10% went to colectomy and 30% non-responders were switched to a 2(nd) line rescue treatment. 66% of patients responded to the 2(nd) line treatment whereas 34% failed, of which 15% went to colectomy and 19% received a 3(rd) line rescue treatment. Among those, 50% patients went to colectomy. Overall colectomy rate of the whole cohort was 18%. Steroid-free remission rate was 39%. The adverse event rates were 33%, 37.5% and 30% for the first, second and third line treatment respectively.
Our data show that medical intervention even with 2(nd) and 3(rd) rescue treatments decreased colectomy frequency within one year of follow up. A longer follow-up will be necessary to investigate whether sequential therapy will only postpone colectomy and what percentage of patients will remain in long-term remission.
在首次挽救治疗失败的激素难治性溃疡性结肠炎(UC)患者中,可考虑二线挽救治疗以避免结肠切除术。
评估二线或三线挽救治疗在一年期间的疗效和安全性。
回顾性研究了来自7个瑞士和1个塞尔维亚三级IBD中心的激素难治性中度至重度UC患者接受英夫利昔单抗(第0、2、6周静脉注射(iv)5mg/kg,然后每8周一次)、环孢素(静脉注射2mg/kg/天,然后口服5mg/kg/天)或他克莫司(0.05mg/kg分2次给药)进行单次或序贯挽救治疗的反应。主要终点是一年结肠切除率。
60%的患者对首次挽救治疗有反应,10%接受了结肠切除术,30%无反应者转而接受二线挽救治疗。66%的患者对二线治疗有反应,而34%失败,其中15%接受了结肠切除术,19%接受了三线挽救治疗。在这些患者中,50%接受了结肠切除术。整个队列的总体结肠切除率为18%。无激素缓解率为39%。一线、二线和三线治疗的不良事件发生率分别为33%、37.5%和30%。
我们的数据表明,即使采用二线和三线挽救治疗,药物干预也能在随访一年内降低结肠切除频率。需要更长时间的随访来研究序贯治疗是否只会推迟结肠切除术以及有多少患者将保持长期缓解。