Swann Rachael, Boal Alan, Squires Seth Ian, Lamb Carly, Clark Laura Louise, Lamont Selina, Naismith Graham
Department of Gastroenterology, Royal Alexandra Hospital, NHS Greater Glasgow and Clyde Division, Glasgow, UK.
Frontline Gastroenterol. 2020 Jan;11(1):16-21. doi: 10.1136/flgastro-2018-101135. Epub 2019 May 3.
Inflammatory bowel disease (IBD) is increasingly managed with the use of biologic therapies. National guidelines (National Institute for Health and Care Excellence (NICE)) suggest considering cessation after 1 year of therapy but lack detailed criteria for this. We aimed to describe clinical outcomes from the introduction of a biologic review panel (BRP) to implement modified criteria for cessation of antitumour necrosis factor (anti-TNF) therapy and step down to single-agent immunomodulator.
Retrospective review of patient outcomes following BRP implementation.
All patients on biologic therapy discussed in the BRP within a 5-year period.
Single IBD network covering three hospital sites.
Modified criteria for biologic cessation were based on published evidence; they excluded individuals with no suitable maintenance immunomodulator, previous surgery or evidence of active disease, additional indications for anti-TNF therapy and previous relapse on biologic cessation. All patients with IBD on a biologic were discussed at the BRP.
Relapse following IBD cessation and relative cost of BRP.
136 patients with IBD were reviewed, with 45 patients meeting the NICE guideline criteria for cessation. The BRP and modified criteria affected decision to withdraw therapy in 38% of these. Therapy was withdrawn in 27 patients, with a 20% 24-month relapse rate. Younger age at cessation was significantly associated with relapse (p=0.01).
The BRP approach has proved a safe and effective means of decision making in stopping biologic therapy. Future work to inform exclusion criteria is required.
炎症性肠病(IBD)越来越多地采用生物疗法进行治疗。国家指南(英国国家卫生与临床优化研究所(NICE))建议在治疗1年后考虑停药,但缺乏对此的详细标准。我们旨在描述引入生物制剂审查小组(BRP)以实施抗肿瘤坏死因子(抗TNF)治疗停药和降级为单药免疫调节剂的修改标准后的临床结果。
对BRP实施后患者结局的回顾性研究。
5年内BRP讨论的所有接受生物疗法的患者。
覆盖三个医院站点的单一IBD网络。
生物制剂停药的修改标准基于已发表的证据;排除了没有合适的维持免疫调节剂、既往有手术史或有活动性疾病证据、抗TNF治疗的其他指征以及既往生物制剂停药后复发的个体。所有接受生物制剂治疗的IBD患者都在BRP进行了讨论。
IBD停药后的复发情况和BRP的相对成本。
对136例IBD患者进行了评估,其中45例符合NICE指南的停药标准。BRP和修改后的标准影响了其中38%患者的停药决定。27例患者停药,24个月复发率为20%。停药时年龄较小与复发显著相关(p=0.01)。
BRP方法已被证明是停止生物疗法决策的一种安全有效的手段。需要开展进一步工作以完善排除标准。