Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Aliment Pharmacol Ther. 2024 Aug;60(3):389-400. doi: 10.1111/apt.18102. Epub 2024 Jun 12.
The impact of continuing or stopping 5-aminosalicylates (5-ASA) after commencing anti-tumour necrosis factor (anti-TNF) therapy in patients with inflammatory bowel disease (IBD) remains unclear.
To compare the outcomes of patients with IBD who stopped or continued 5-ASA after starting anti-TNF therapy.
We analysed data from the Korean National Health Insurance claims database between 2007 and 2020. We compared the clinical outcomes of patients who stopped or continued 5-ASA within 90 days of anti-TNF initiation. The primary outcome was any adverse clinical event defined as a composite of new corticosteroid use, IBD-related hospitalisation, or intestinal surgery.
Among 7442 patients included for analysis (4479 [60.2%] with Crohn's disease [CD] and 2963 [39.8%] with ulcerative colitis [UC]), 1037 (13.9%) discontinued 5-ASA within 90 days of starting anti-TNF therapy. During a median 4.3-year follow-up, discontinuation of 5-ASA was not associated with an increased risk of adverse clinical events (adjusted hazard ratio 1.01, 95% confidence interval 0.93-1.10). The cumulative incidence of each adverse clinical event and the composite outcome were not significantly different between groups (all, p > 0.05). Additionally, separate analyses in CD and UC cohorts revealed no differences in adverse clinical outcomes between the 5-ASA continuation and discontinuation groups. Subgroup analyses by presumed risk factors for disease relapse showed no significant differences in the risk of adverse events between groups.
In this nationwide population-based study, discontinuing 5-ASA after starting anti-TNF therapy was not associated with an increased risk of adverse events in patients with IBD.
在开始使用抗肿瘤坏死因子(anti-TNF)治疗炎症性肠病(IBD)后,继续或停止使用 5-氨基水杨酸(5-ASA)的影响仍不清楚。
比较开始使用抗 TNF 治疗后停止或继续使用 5-ASA 的 IBD 患者的结局。
我们分析了 2007 年至 2020 年期间韩国国家健康保险索赔数据库的数据。我们比较了在开始使用抗 TNF 后 90 天内停止或继续使用 5-ASA 的患者的临床结局。主要结局是任何不良临床事件,定义为新使用皮质类固醇、IBD 相关住院或肠道手术的复合事件。
在纳入分析的 7442 名患者中(4479 名[60.2%]患有克罗恩病[CD]和 2963 名[39.8%]患有溃疡性结肠炎[UC]),有 1037 名(13.9%)在开始使用抗 TNF 治疗后 90 天内停止使用 5-ASA。在中位 4.3 年的随访期间,停止使用 5-ASA 与不良临床事件的风险增加无关(调整后的危险比 1.01,95%置信区间 0.93-1.10)。两组之间的每个不良临床事件和复合结局的累积发生率均无显著差异(所有,p>0.05)。此外,在 CD 和 UC 队列的单独分析中,5-ASA 继续和停止使用组之间的不良临床结局无差异。根据疾病复发的假定危险因素进行亚组分析,两组之间不良事件的风险无显著差异。
在这项全国性基于人群的研究中,在开始使用抗 TNF 治疗后停止使用 5-ASA 与 IBD 患者不良事件的风险增加无关。