Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.
Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.
Am J Gastroenterol. 2024 Mar 1;119(3):565-575. doi: 10.14309/ajg.0000000000002552. Epub 2023 Oct 3.
This study compared real-world effectiveness between adalimumab (ADA) and infliximab (IFX) in children with Crohn's disease (CD).
Children enrolled into the prospective Canadian Children Inflammatory Bowel Disease Network National Inception Cohort between 2014 and 2020 who commenced ADA or IFX as first antitumor necrosis factor (anti-TNF) agent for luminal CD were included. Multivariate logistic regression modeled the propensity of commencing ADA; propensity score matching was used to match IFX-treated children to ADA-treated children. The primary outcome at 1 year was steroid-free clinical remission (SFCR). Secondary outcomes at 1 year were (i) combined SFCR and C-reactive protein remission, (ii) treatment intensification, and (iii) anti-TNF durability. Odds ratios (ORs) and hazard ratio adjusted for concomitant immunomodulator use with 95% confidence interval (CI) are reported.
In the propensity score-matched cohort of 147 ADA-treated and 147 IFX-treated children, 92 (63%) ADA-treated and 87 (59%) IFX-treated children achieved SFCR at 1 year (adjusted OR 1.4, 95% CI 0.9-2.4); 75 of 140 (54%) ADA-treated and 85 of 144 (59%) IFX-treated children achieved combined SFCR and C-reactive protein remission (adjusted OR 1.0, 95% CI 0.6-1.6). ADA-treated children less frequently underwent treatment intensification (21 [14%]) compared with IFX-treated children (69 [47%]) ( P < 0.0001). Discontinuation of anti-TNF occurred in 18 (12%) ADA-treated and 15 (10%) IFX-treated children (adjusted hazard ratio 1.2, 95% CI 0.6-2.2).
Children with CD achieved favorable outcomes at 1 year with either ADA or IFX as first anti-TNF agents. Those receiving IFX did not have significantly superior outcomes compared with clinically similar children receiving ADA.
本研究比较了阿达木单抗（ADA）和英夫利昔单抗（IFX）在儿童克罗恩病（CD）中的真实世界疗效。
纳入 2014 年至 2020 年期间入组加拿大儿童炎症性肠病网络前瞻性全国发病队列的接受 ADA 或 IFX 作为首用抗肿瘤坏死因子（anti-TNF）药物治疗腔肠 CD 的患儿。多变量逻辑回归分析了起始 ADA 的倾向；采用倾向评分匹配将 IFX 治疗的患儿与 ADA 治疗的患儿相匹配。1 年时的主要结局是无激素临床缓解（SFCR）。1 年时的次要结局为（i）联合 SFCR 和 C 反应蛋白缓解，（ii）治疗强化，和（iii）抗 TNF 持续时间。报告了调整伴随免疫调节剂使用的比值比（OR）和风险比及其 95%置信区间（CI）。
在 147 例 ADA 治疗和 147 例 IFX 治疗患儿的倾向评分匹配队列中，92 例（63%）ADA 治疗和 87 例（59%）IFX 治疗患儿在 1 年时达到 SFCR（调整 OR 1.4，95%CI 0.9-2.4）；140 例 ADA 治疗和 144 例 IFX 治疗患儿中，75 例（54%）达到联合 SFCR 和 C 反应蛋白缓解（调整 OR 1.0，95%CI 0.6-1.6）。与 IFX 治疗的患儿相比，ADA 治疗的患儿更频繁地进行治疗强化（21 例[14%]比 69 例[47%]）（P < 0.0001）。18 例（12%）ADA 治疗和 15 例（10%）IFX 治疗的患儿停用抗 TNF（调整风险比 1.2，95%CI 0.6-2.2）。
ADA 或 IFX 作为首用抗 TNF 药物，儿童 CD 患者在 1 年时获得良好结局。接受 IFX 的患儿与接受临床相似 ADA 治疗的患儿相比，结局无显著优势。
