肠外表现经常发生在炎症性肠病(IBD)患者中,并且仍然是诊断和治疗的挑战。炎症性肠病试验中肠外表现终点(EXTRA)计划的目的是就如何评估IBD试验中的这些表现达成国际专家共识。进行了系统的文献综述,以确定诊断IBD患者肠外表现和评估治疗结果的方法。由41名与会者组成的协商一致会议,包括胃肠病学家和转诊专家,作为国际炎症性肠病研究组织倡议的一部分,于2021年3月31日举行。小组同意,在将患者纳入IBD试验之前,需要专家的专业知识来确认肠外表现的诊断,除了轴性脊柱关节炎,对于典型的症状和MRI可以是足够的。确定了易于测量的终点,以评估肠外表现对治疗的反应,而无需专家参与。对于葡萄膜炎,周围型脊柱关节炎,关节痛,端点测量需要专业知识。对于个别肠外表现,讨论了终点测量的时机。EXTRA共识提出了关于如何彻底评估IBD试验中的肠外表现的指南。并建议在未来的试验中实施这些指南,以便对这些表现进行前瞻性评估,并在研究之间进行比较.
Extraintestinal manifestations occur frequently in patients with inflammatory bowel disease (IBD) and remain a diagnostic and therapeutic challenge. The aim of the Endpoints for Extraintestinal Manifestations in Inflammatory Bowel Disease Trials (EXTRA) initiative was to achieve international expert
consensus on how to assess these manifestations in IBD trials. A systematic literature review was done to identify methods to diagnose extraintestinal manifestations in patients with IBD and measure treatment outcomes. A
consensus meeting involving a panel of 41 attendees, including gastroenterologists and referral specialists, was held on March 31, 2021, as part of an International Organization for the Study of Inflammatory Bowel Diseases initiative. The panel agreed that a specialist\'s expertise is needed to confirm the diagnosis of extraintestinal manifestations before the inclusion of a patient in IBD trials, except for axial spondyloarthritis, for which typical symptoms and MRI can be sufficient. Easy-to-measure endpoints were identified to assess the response of extraintestinal manifestations to treatment without needing specialist involvement. For uveitis, peripheral spondyloarthritis, and arthralgia, endpoint measurements need specialist expertise. The timing of endpoint measurements was discussed for individual extraintestinal manifestations. The EXTRA
consensus proposes
guidelines on how to thoroughly evaluate extraintestinal manifestations within IBD trials, and recommends that these
guidelines are implemented in future trials to enable prospective assessment of these manifestations and comparison between studies.