Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Korea.
Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Yonsei Med J. 2020 Jan;61(1):48-55. doi: 10.3349/ymj.2020.61.1.48.
Data on the comparative effectiveness of infliximab (IFX) or adalimumab (ADA) in patients with ulcerative colitis (UC) are extremely limited, especially in the Asian population. We compared clinically important outcomes [colectomy, UC-related emergency room (ER) visits, UC-related hospitalizations, and need for corticosteroids] for these two biologics in biologic-naïve Korean patients with UC.
Using National Health Insurance claims, we collected data on patients who were diagnosed with UC and exposed to IFX or ADA between 2010 and 2016.
A total of 862 new users of biologics were included, of whom 630 were treated with IFX and 232 were treated with ADA. Over a median follow-up of 1.8 years after starting biologic therapy, there were no significant differences in the risk of colectomy [adjusted hazard ratio (aHR), 1.87; 95% confidence interval (CI), 0.30-11.63], ER visits (aHR, 1.58; 95% CI, 0.79-3.16), hospitalizations (aHR, 0.83; 95% CI, 0.59-1.17), and corticosteroid use (aHR, 1.16; 95% CI, 0.76-1.78) between IFX and ADA users. These results were stable even when only patients who used biologics for ≥6 months were analyzed. Additionally, these results were unchanged in patients treated with biologic monotherapy or combination therapy with immunomodulators.
In this nationwide population-based study, there was no significant difference in the risk of colectomy, ER visits, hospitalizations, and corticosteroid use between IFX and ADA users. Our findings indicate that IFX and ADA have comparable effectiveness in biologic-naïve Korean patients with UC.
关于英夫利昔单抗(IFX)或阿达木单抗(ADA)在溃疡性结肠炎(UC)患者中的比较疗效的数据极为有限,特别是在亚洲人群中。我们比较了这两种生物制剂在韩国初治 UC 患者中的临床重要结局(结肠切除术、UC 相关急诊就诊、UC 相关住院和皮质类固醇需求)。
使用国家健康保险索赔数据,我们收集了 2010 年至 2016 年间被诊断为 UC 并接受 IFX 或 ADA 治疗的患者的数据。
共纳入 862 名新使用生物制剂的患者,其中 630 名接受 IFX 治疗,232 名接受 ADA 治疗。在开始生物治疗后中位随访 1.8 年后,两组在结肠切除术(调整后的危险比 [aHR],1.87;95%置信区间 [CI],0.30-11.63)、急诊就诊(aHR,1.58;95%CI,0.79-3.16)、住院(aHR,0.83;95%CI,0.59-1.17)和皮质类固醇使用(aHR,1.16;95%CI,0.76-1.78)方面均无显著差异。当仅分析使用生物制剂治疗≥6 个月的患者时,这些结果仍然稳定。此外,在接受生物制剂单药治疗或与免疫调节剂联合治疗的患者中,这些结果也没有改变。
在这项基于全国人群的研究中,IFX 和 ADA 使用者在结肠切除术、急诊就诊、住院和皮质类固醇使用方面的风险无显著差异。我们的研究结果表明,IFX 和 ADA 在韩国初治 UC 患者中的疗效相当。