Abstract:
The management of moderate to severe ulcerative colitis has undergone significant changes over the past 15 years due to the regulatory approval of several new drugs. In particular, following the approval of the first biological, i.e. infliximab, a number of further biological drugs, such as adalimumab, golimumab, vedolizumab and ustekinumab, and small molecules, such as tofacitinib, have been approved, thus enriching the therapeutic armamentarium for ulcerative colitis. Choice of therapy must take into consideration not only the need to induce and maintain disease remission according to the patient\'s profile, but also age, co-morbidities, and prior treatments. To guide these decisions, the Italian Group for the Study of Inflammatory Bowel Disease has developed clinical guidelines that supersede its earlier document from 2011. These new guidelines were developed following the GRADE methodology for rating the quality of the evidence and for determining the strength of the recommendations. This article presents the methodology and results, in the form of 20 statements with commentary on the use of the five biologics and tofacitinib for managing the intestinal manifestations of active ulcerative colitis and for maintaining remission. A separate technical review reports the analyses of the evidence upon which the present recommendations are based.
摘要:
在过去的15年中,由于监管机构批准了几种新药,中度至重度溃疡性结肠炎的管理发生了重大变化。特别是,在第一个生物批准后,即英夫利昔单抗,一些进一步的生物药物,比如阿达木单抗,戈利木单抗,维多珠单抗和ustekinumab,和小分子,如托法替尼,已被批准,从而丰富了溃疡性结肠炎的治疗性医疗设备。治疗的选择必须考虑到不仅需要诱导和维持疾病缓解根据患者的概况,还有年龄,合并症,和先前的治疗。为了指导这些决定,意大利炎症性肠病研究小组制定了临床指南,取代了2011年之前的文件.这些新的指南是根据GRADE方法制定的,用于对证据质量进行评级并确定建议的强度。本文介绍了方法和结果,以20份声明的形式,对使用五种生物制剂和托法替尼治疗活动性溃疡性结肠炎的肠道表现和维持缓解进行了评论。单独的技术审查报告了对本建议所依据的证据的分析。