A subset of patients with ulcerative colitis (UC) present with, or progress to, moderate to severe disease activity. These patients are at high risk for colectomy, hospitalization, corticosteroid dependence, and serious infections. The risk of life-threatening complications and emergency colectomy is particularly high among those patients hospitalized with acute severe ulcerative colitis. Optimal management of outpatients or inpatients with moderate to severe UC often requires the use of immunomodulator and/or biologic therapies, including thiopurines, methotrexate, cyclosporine, tacrolimus, TNF-α antagonists, vedolizumab, tofacitnib, or ustekinumab, either as monotherapy or in combination (with immunomodulators), to mitigate these risks. Decisions about optimal drug therapy in moderate to severe UC are complex, with limited guidance on comparative efficacy and safety of different treatments, leading to considerable practice variability. Therefore, the American Gastroenterological Association prioritized development of clinical guidelines on this topic. To inform the clinical guidelines, this technical review was completed in accordance with the Grading of Recommendations Assessment, Development and Evaluation framework. Focused questions in adult outpatients with moderate to severe UC included: (1) overall and comparative efficacy of different medications for induction and maintenance of remission in patients with or without prior exposure to TNF-α antagonists, (2) comparative efficacy and safety of biologic monotherapy vs combination therapy with immunomodulators, (3) comparative efficacy of top-down (upfront use of biologics and/or immunomodulator therapy) vs step-up therapy (acceleration to biologic and/or immunomodulator therapy only after failure of 5-aminosalicylates, and (4) role of continuing vs stopping 5-aminosalicylates in patients being treated with immunomodulator and/or biologic therapy for moderate to severe UC. Focused questions in adults hospitalized with acute severe ulcerative colitis included: (5) overall and comparative efficacy of pharmacologic interventions for inpatients refractory to corticosteroids, in reducing risk of colectomy, (6) optimal dosing regimens for intravenous corticosteroids and infliximab in these patients, and (7) role of adjunctive antibiotics in the absence of confirmed infections.

中文翻译：

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AGA 中度至重度溃疡性结肠炎治疗技术审查。


一部分溃疡性结肠炎 (UC) 患者出现或进展为中度至重度疾病活动。这些患者面临结肠切除术、住院治疗、皮质类固醇依赖和严重感染的高风险。因急性重症溃疡性结肠炎住院的患者发生危及生命的并发症和紧急结肠切除术的风险特别高。中度至重度 UC 门诊患者或住院患者的最佳治疗通常需要使用免疫调节剂和/或生物疗法，包括硫嘌呤、甲氨蝶呤、环孢素、他克莫司、TNF-α 拮抗剂、维多珠单抗、托法尼布或优特克单抗，作为单一疗法或联合疗法（与免疫调节剂），以减轻这些风险。关于中度至重度 UC 的最佳药物治疗的决定很复杂，对不同治疗的疗效和安全性比较的指导有限，导致实践中存在相当大的差异。因此，美国胃肠病学协会优先制定有关该主题的临床指南。为了向临床指南提供信息，本次技术审查是根据建议评估、制定和评估框架的分级完成的。 中度至重度 UC 成人门诊患者的重点问题包括：(1) 不同药物对于既往是否接触过 TNF-α 拮抗剂的患者诱导和维持缓解的总体疗效和比较疗效，(2) 生物制剂的疗效和安全性比较单一疗法与免疫调节剂联合治疗，(3) 自上而下（预先使用生物制剂和/或免疫调节剂治疗）与逐步治疗（仅在 5-氨基水杨酸盐​​失败后加速生物制剂和/或免疫调节剂治疗）的疗效比较，以及(4) 继续使用 5-氨基水杨酸盐​​与停止使用 5-氨基水杨酸盐​​对于接受免疫调节剂和/或生物疗法治疗中度至重度 UC 的患者的作用 对于因急性严重溃疡性结肠炎住院的成人患者，重点问题包括：(5) 药物干预的总体效果和比较效果。对于皮质类固醇难治的住院患者，降低结肠切除术的风险，(6) 这些患者静脉注射皮质类固醇和英夫利昔单抗的最佳剂量方案，以及 (7) 在没有确诊感染的情况下辅助抗生素的作用。