Seo Gi Hyeon, Jung Sung Hoon
Department of Healthcare Review and Assessment Committee, Health Insurance Review and Assessment Service, Ministry of Health and Welfare, Wonju 26465, Republic of Korea.
Department of Internal Medicine, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Seoul 03312, Republic of Korea.
J Clin Med. 2023 Mar 20;12(6):2397. doi: 10.3390/jcm12062397.
Biologics play an important role in the treatment of moderate to severe Crohn's disease (CD). Ustekinumab was approved for such patients in the Republic of Korea on 1 December 2018. Therefore, we need to compare the efficacy of ustekinumab and anti-TNF inhibitors.
We compared one-year persistence rates between anti-TNF inhibitors and ustekinumab in moderate-to-severe CD patients using Korean National Health Insurance Service data from 1 December 2016 to 30 November 2021. We also analysed the risk factors for the non-persistence of biologics.
The one-year persistence rates with index therapy in bio-naïve and bio-experienced patients were 87.7% and 69.7% for infliximab ( < 0.001), 85.1% and 72.8% for adalimumab ( < 0.001), and 92.1% and 89.8% for ustekinumab ( = 0.333), respectively. The risk factors for non-persistence were older age, non-use of an immune modulator, and previous biologic exposure in both the infliximab and adalimumab groups. The one-year persistence rate of ustekinumab was higher than that of anti-TNF inhibitors in bio-naïve patients (hazard ratio [HR] 0.53; 95% confidence interval [CI] 0.35-0.81; = 0.003) and bio-experienced patients (HR 0.32; 95% CI 0.22-0.45; < 0.001).
Ustekinumab was superior in bio-naïve CD patients compared to anti-TNF inhibitors. However, the follow-up time was relatively short; further studies should continuously collect and analyse data.
生物制剂在中重度克罗恩病（CD）的治疗中发挥着重要作用。优特克单抗于2018年12月1日在韩国被批准用于此类患者。因此，我们需要比较优特克单抗和抗TNF抑制剂的疗效。
我们使用2016年12月1日至2021年11月30日的韩国国民健康保险服务数据，比较了中重度CD患者中抗TNF抑制剂和优特克单抗的一年持续率。我们还分析了生物制剂停用的危险因素。
初治患者和经治患者中，英夫利昔单抗的一年指数治疗持续率分别为87.7%和69.7%（<0.001），阿达木单抗分别为85.1%和72.8%（<0.001），优特克单抗分别为92.1%和89.8%（=0.333）。在英夫利昔单抗和阿达木单抗组中，停用的危险因素均为年龄较大、未使用免疫调节剂和既往有生物制剂暴露史。在初治患者中，优特克单抗的一年持续率高于抗TNF抑制剂（风险比[HR]0.53；95%置信区间[CI]0.35 - 0.81；=0.003），在经治患者中也是如此（HR 0.32；95%CI 0.22 - 0.45；<0.001）。
与抗TNF抑制剂相比，优特克单抗在初治CD患者中更具优势。然而，随访时间相对较短；进一步的研究应持续收集和分析数据。
