Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, South Korea.
Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.
BMC Gastroenterol. 2024 Sep 11;24(1):306. doi: 10.1186/s12876-024-03403-8.
Numerous studies have compared the efficacy of ustekinumab (UST) and anti-TNF agents [infliximab (IFX) or adalimumab(ADA)] in moderate to severe Crohn's disease (CD) patients. This study aims to compare the efficacy of UST, IFX, and ADA while differentiating between bio-naïve and bio-experienced patients, which is an underexplored aspect, particularly in Asia.
We conducted a retrospective multi-center study from 2012 to 2023, categorizing patients into bio-naïve and bio-experienced groups. We evaluated clinical remission rates after induction therapy and clinical outcomes, including CD-related hospitalization, intestinal resection, and drug discontinuation during maintenance therapy.
Among the 214 bio-naïve CD patients, 60 received UST, 108 received IFX, and 46 received ADA. After 1:1 propensity score matching between UST and anti-TNF agents groups, 59 patients were analyzed in each group (45 in the IFX group and 14 in the ADA group). We found no significant differences in clinical remission rates (P = 0.071), CD-related hospitalization (P = 0.800), intestinal resection (P = 0.390), or drug discontinuation (P = 0.052) between the UST, IFX, and ADA groups in bio-naïve CD patients. In bio-experienced CD patients, with 35 in the UST group and 13 in the anti-TNF agents group, the UST group showed a lower risk of drug discontinuation (P = 0.004) than the anti-TNF agents group.
This study suggests that UST, IFX, and ADA are equally effective in bio-naïve CD patients, while in bio-experienced patients, mostly with previous exposure to anti-TNF agents, UST may offer superior drug durability.
许多研究比较了乌司奴单抗（UST）和抗 TNF 药物[英夫利昔单抗（IFX）或阿达木单抗（ADA）]在中重度克罗恩病（CD）患者中的疗效。本研究旨在比较 UST、IFX 和 ADA 的疗效，同时区分生物初治和生物经验患者，这是一个尚未充分探索的方面，特别是在亚洲。
我们进行了一项回顾性多中心研究，时间为 2012 年至 2023 年，将患者分为生物初治和生物经验组。我们评估了诱导治疗后的临床缓解率和临床结局，包括 CD 相关住院、肠道切除和维持治疗期间药物停药。
在 214 例生物初治 CD 患者中，60 例接受 UST 治疗，108 例接受 IFX 治疗，46 例接受 ADA 治疗。在 UST 和抗 TNF 药物组之间进行 1:1 倾向评分匹配后，每组分析 59 例患者（IFX 组 45 例，ADA 组 14 例）。我们发现生物初治 CD 患者中 UST、IFX 和 ADA 组之间的临床缓解率（P=0.071）、CD 相关住院率（P=0.800）、肠道切除率（P=0.390）或药物停药率（P=0.052）无显著差异。在生物经验 CD 患者中，UST 组 35 例，抗 TNF 药物组 13 例，UST 组药物停药风险低于抗 TNF 药物组（P=0.004）。
本研究表明，在生物初治 CD 患者中，UST、IFX 和 ADA 同样有效，而在生物经验患者中，大多数患者先前曾接触过抗 TNF 药物，UST 可能具有更好的药物持久性。
