Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Korea.
Korean J Intern Med. 2020 Sep;35(5):1104-1113. doi: 10.3904/kjim.2020.001. Epub 2020 Apr 21.
BACKGROUND/AIMS: The optimal timing for initiation of anti-tumor necrosis factor (TNF) therapy in Crohn's disease (CD) is still debated. Little is known about the clinical outcomes of early versus late administration of anti-TNF agents, especially in Asian CD patients. We aimed to evaluate the impact of early anti-TNF therapy on clinical outcomes in Korean CD patients.
Using the Korean National Health Insurance Claims database, we collected data on patients diagnosed with CD who received anti-TNF therapy for more than 6 months between 2010 and 2016. Early initiation of anti-TNF therapy was defined as those starting infliximab or adalimumab therapy within 1 year of diagnosis. The following outcomes were assessed using a Cox proportional hazard model: abdominal surgery, CD-related emergency room (ER) visit, CD-related hospitalization, and new corticosteroid use.
Among 1,207 patients, 609 were early initiators of anti-TNF. Late anti-TNF initiation (> 1 year after diagnosis) was associated with increased risk of surgery (adjusted hazard ratio [aHR], 1.64; 95% confidence interval [CI], 1.05 to 2.55) and tended to be associated with increased risk of ER visit (aHR, 1.38; 95% CI, 0.99 to 1.94). However, there were no significant differences in the risk of hospitalization and corticosteroid use between early and late initiators.
Early anti-TNF therapy among Korean CD patients within 1 year of diagnosis was associated with better clinical outcomes than late therapy, such as lower surgery and ER visit rates. Our results suggest that aggressive medical intervention in the early stages of CD may potentially change the course of this disease.
背景/目的:在克罗恩病(CD)中,启动抗肿瘤坏死因子(TNF)治疗的最佳时机仍存在争议。对于早期与晚期使用抗 TNF 药物的临床结果,知之甚少,特别是在亚洲 CD 患者中。我们旨在评估韩国 CD 患者早期抗 TNF 治疗对临床结果的影响。
使用韩国国家健康保险索赔数据库,我们收集了 2010 年至 2016 年间接受抗 TNF 治疗超过 6 个月的 CD 患者的数据。早期启动抗 TNF 治疗定义为在诊断后 1 年内开始使用英夫利昔单抗或阿达木单抗治疗。使用 Cox 比例风险模型评估以下结局:腹部手术、CD 相关急诊就诊、CD 相关住院治疗和新使用皮质类固醇。
在 1207 名患者中,609 名患者为早期抗 TNF 治疗的启动者。晚期抗 TNF 治疗(>诊断后 1 年)与手术风险增加相关(调整后的危险比 [aHR],1.64;95%置信区间 [CI],1.05 至 2.55),且与急诊就诊风险增加相关(aHR,1.38;95% CI,0.99 至 1.94)。然而,早期和晚期启动者在住院和皮质类固醇使用风险方面没有显著差异。
在韩国 CD 患者诊断后 1 年内早期使用抗 TNF 治疗与晚期治疗相比,具有更好的临床结局,如手术和急诊就诊率较低。我们的结果表明,在 CD 的早期阶段积极进行医学干预可能会改变疾病的进程。