Healthcare Evaluation Unit, Institute of Social & Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
J Crohns Colitis. 2013 Nov;7(10):820-6. doi: 10.1016/j.crohns.2013.04.013. Epub 2013 May 9.
Safety and economic issues have increasingly raised concerns about the long term use of immunomodulators or biologics as maintenance therapies for Crohn's disease (CD). Despite emerging evidence suggesting that stopping therapy might be an option for low risk patients, criteria identifying target groups for this strategy are missing, and there is a lack of recommendations regarding this question.
Multidisciplinary European expert panel (EPACT-II Update) rated the appropriateness of stopping therapy in CD patients in remission. We used the RAND/UCLA Appropriateness Method, and included the following variables: presence of clinical and/or endoscopic remission, CRP level, fecal calprotectin level, prior surgery for CD, and duration of remission (1, 2 or 4 years).
Before considering withdrawing therapy, the prerequisites of a C-reactive protein (CRP) and fecal calprotectin measurement were rated as "appropriate" by the panellists, whereas a radiological evaluation was considered as being of "uncertain" appropriateness. Ileo-colonoscopy was considered appropriate 1 year after surgery or after 4 years in the absence of prior surgery. Stopping azathioprine, 6-mercaptopurine or methotrexate mono-therapy was judged appropriate after 4 years of clinical remission. Withdrawing anti-TNF mono-therapy was judged appropriate after 2 years in case of clinical and endoscopic remission, and after 4 years of clinical remission. In case of combined therapy, anti-TNF withdrawal, while continuing the immunomodulator, was considered appropriate after two years of clinical remission.
A multidisciplinary European expert panel proposed for the first time treatment stopping rules for patients in clinical and/or endoscopic remission, with normal CRP and fecal calprotectin levels.
安全性和经济性问题日益引起人们对免疫调节剂或生物制剂作为克罗恩病（CD）维持治疗的长期使用的关注。尽管有新的证据表明停止治疗可能是低风险患者的一种选择，但缺乏确定该策略目标人群的标准，并且对此问题缺乏建议。
多学科欧洲专家小组（EPACT-II 更新）评估了缓解期 CD 患者停止治疗的适宜性。我们使用 RAND/UCLA 适宜性方法，包括以下变量：临床和/或内镜缓解、C 反应蛋白（CRP）水平、粪便钙卫蛋白水平、CD 既往手术以及缓解持续时间（1、2 或 4 年）。
在考虑停止治疗之前，专家组成员认为 CRP 和粪便钙卫蛋白测量的前提是“适宜”的，而放射学评估被认为是“不确定”的适宜性。在手术后 1 年或无既往手术时 4 年后，回结肠镜检查被认为是适宜的。在临床缓解 4 年后，停用巯嘌呤、6-巯基嘌呤或甲氨蝶呤单药治疗被认为是适宜的。在临床和内镜缓解的情况下，停用抗 TNF 单药治疗被认为是适宜的，在临床缓解 4 年后也是如此。在联合治疗的情况下，在临床缓解 2 年后继续使用免疫调节剂时，停用抗 TNF 被认为是适宜的。
一个多学科的欧洲专家小组首次提出了针对临床和/或内镜缓解、CRP 和粪便钙卫蛋白水平正常的患者的治疗停止规则。
