比较乌司奴单抗和维得利珠单抗治疗对肿瘤坏死因子治疗应答不佳的克罗恩病患者的短期和长期疗效。
Comparison of short- and long-term effectiveness between ustekinumab and vedolizumab in patients with Crohn's disease refractory to anti-tumour necrosis factor therapy.
机构信息
Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastroentérologie, Clermont-Ferrand, France.
Department of Gastroenterology, Hospices Civils de Lyon, Lyon-Sud Hospital, Pierre Bénite, and INSERM U1111 - CIRI, Lyon, France.
出版信息
Aliment Pharmacol Ther. 2021 Jun;53(12):1289-1299. doi: 10.1111/apt.16377. Epub 2021 Apr 28.
BACKGROUND
The best option between vedolizumab and ustekinumab after anti-tumour necrosis factor (TNF) failure remains unclear in Crohn's disease.
AIMS
To compare the short- and long-term effectiveness of vedolizumab and ustekinumab in Crohn's disease patients with prior anti-TNF exposure.
METHODS
All Crohn's disease patients treated with ustekinumab or vedolizumab after exposure to at least one anti-TNF agent were included from two referral centres. Primary endpoint was corticosteroid-free clinical remission defined as Crohn's disease activity index <150 at week 54. Deep remission (corticosteroid-free clinical remission and faecal calprotectin <100 µg/g) was assessed at week 14. Propensity-matched analyses were applied to make the two groups comparable.
RESULTS
Overall, 312 patients (ustekinumab = 224 and vedolizumab = 88) were included. After propensity score analysis, ustekinumab was more effective to achieve corticosteroid-free clinical remission at week 54 (49.3% vs 41.2%, P = 0.04) and deep remission at Week 14 (25.9% vs 3.8%, P = 0.02) than vedolizumab. The rate of primary nonresponders (6.7% vs 14.8%, P = 0.034) and the long-term risk of drug discontinuation due to therapeutic failure (HR = 1.53 [1.04-2.07], P = 0.029) were lower in patients treated with ustekinumab compared with vedolizumab. Predictors of ustekinumab failure were complicated phenotype (odds ratio [OR] = 2.35 [1.31-4.22]; P = 0.004) and anti-TNF primary non-response (OR = 2.55 [1.27-5.12]; P = 0.008). We did not find any predictor of corticosteroid-free clinical remission in patients treated with vedolizumab. Vedolizumab was less effective than ustekinumab in patients >35 years old (OR = 0.41 [0.19-0.87]), with noncomplicated phenotype (OR=0.42 [0.18-0.96]), no prior bowel resection (OR = 0.49 [0.24-0.96]), and no steroids at baseline (OR=0.47 [0.23-0.97]).
CONCLUSION
Ustekinumab was more effective to achieve early and long-term effectiveness than vedolizumab in Crohn's disease patients who previously failed response to anti-TNF agents.
背景
在抗肿瘤坏死因子（TNF）治疗失败后，对于克罗恩病患者，选择使用维得利珠单抗还是乌司奴单抗仍是一个悬而未决的问题。
目的
比较维得利珠单抗和乌司奴单抗在既往接受过抗 TNF 治疗的克罗恩病患者中的短期和长期疗效。
方法
从两个转诊中心纳入所有接受乌司奴单抗或维得利珠单抗治疗的既往至少使用过一种抗 TNF 药物的克罗恩病患者。主要终点是第 54 周时无皮质类固醇的临床缓解定义为克罗恩病活动指数（CDAI）<150。第 14 周时评估深度缓解（无皮质类固醇的临床缓解和粪便钙卫蛋白<100μg/g）。采用倾向性评分分析使两组具有可比性。
结果
总体而言，纳入了 312 例患者（乌司奴单抗 224 例，维得利珠单抗 88 例）。经过倾向性评分分析，乌司奴单抗在第 54 周时更能达到无皮质类固醇的临床缓解（49.3% vs 41.2%，P=0.04）和第 14 周时的深度缓解（25.9% vs 3.8%，P=0.02），优于维得利珠单抗。初治无应答者的比例（6.7% vs 14.8%，P=0.034）和因治疗失败而停药的长期风险（HR=1.53[1.04-2.07]，P=0.029）均低于乌司奴单抗治疗组。乌司奴单抗治疗失败的预测因素包括复杂表型（比值比 [OR]2.35[1.31-4.22]；P=0.004）和抗 TNF 初治无应答（OR 2.55[1.27-5.12]；P=0.008）。我们未发现维得利珠单抗治疗患者中预测无皮质类固醇临床缓解的因素。乌司奴单抗在年龄>35 岁的患者（OR 0.41[0.19-0.87]）、非复杂表型（OR=0.42[0.18-0.96]）、无既往肠切除术（OR 0.49[0.24-0.96]）和基线时无类固醇（OR 0.47[0.23-0.97]）的患者中，疗效不如维得利珠单抗。
结论
乌司奴单抗在抗 TNF 治疗失败的克罗恩病患者中，在早期和长期疗效方面优于维得利珠单抗。
Zotero 插件