Real-World Comparison of the Effectiveness between Ustekinumab and Vedolizumab in Patients with Ulcerative Colitis Exposed to at least One Anti-TNF Agent.

Mathurin Fumery, Mélanie Serrero, Guillaume Bouguen, Aurélien Amiot, Romain Altwegg, Maria Nachury, Lucine Vuitton, Xavier Treton, Ludovic Caillo, Bruno Pereira, Antony Buisson
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Abstract

Background: Both vedolizumab and ustekinumab can be considered for the treatment of ulcerative colitis [UC], but head-to-head trials are lacking.

Aim: We aimed to compare the effectiveness of vedolizumab and ustekinumab after anti-tumour necrosis factor [anti-TNF] failure in UC patients.

Patients and methods: In this multicentre study, we included consecutive adult patients with UC, with partial Mayo score >2 and prior anti-TNF exposure, treated with vedolizumab or ustekinumab between January 2019 and August 2022. Comparisons were performed using propensity score analyses [inverse probability of treatment weighting].

Results: Among a total of 293 patients included, 151 and 142 received vedolizumab and ustekinumab, respectively. After propensity score analysis, steroid-free clinical remission [SFCR] [partial Mayo score ≤2] was achieved at week 16 in 38.0% and 40.3% of patients treated with vedolizumab and ustekinumab, respectively (adjusted odds ratio [aOR] = 1.11, 95% confidence interval [0.39-3.13], p = 0.85). Rates of SFCR in patients exposed to one, two, and three lines of biologics/small molecules among patients treated with vedolizumab and ustekinumab were respectively 53.3% vs 62.1% [p = 0.52], 44.4% vs 33.8% [p = 0.52], and 2.6% vs 19.1% [p = 0.027]. Endoscopic remission [SFCR and endoscopic Mayo score ≤1] and histological remission [SFCR, endoscopic remission, and Nancy histological index ≤1] at week 16 were achieved in respectively 5.3% vs 17.5% (aOR = 3.77 [1.25-11.36], p = 0.018) and 2.1% vs 11.1% (aOR = 5.85 [1.47-23.30], p = 0.012) in the vedolizumab and ustekinumab groups. No difference regarding the risk of drug discontinuation between the two groups (aHR = 1.03 [0.51-2.08], p = 0.92) was observed. While no factor was identified for vedolizumab, primary failure to at least one biologic/small molecule (OR = 0.31 [0.11-0.82], p = 0.018) was significantly associated with a decreased rate of SFCR among patients treated with ustekinumab.

Conclusion: While no difference in terms of short-term clinical remission was observed, ustekinumab appears to be more effective than vedolizumab in inducing endoscopic and histological remission at week 16 after failure of anti-TNFs in UC.

乌司替尼和韦多珠单抗对至少使用过一种抗肿瘤坏死因子药物的溃疡性结肠炎患者疗效的真实世界比较。
背景:目的:我们旨在比较UC患者抗TNF失败后使用维多珠单抗和乌斯特库单抗的疗效:在这项多中心研究中,我们纳入了在2019年1月至2022年8月期间接受维多珠单抗或乌司他珠单抗治疗的连续成年UC患者,他们的部分梅奥评分大于2分,且之前接受过抗TNF治疗。比较采用倾向评分分析法(治疗加权反概率):在纳入的293名患者中,分别有151名和142名患者接受了维多珠单抗和乌斯特单抗治疗。经过倾向分数分析,在第16周时,分别有38.0%和40.3%的患者接受了维多珠单抗和乌斯特库单抗治疗,实现了无类固醇临床缓解(SFCR)(梅奥评分部分≤2)(aOR = 1.11 [0.39-3.13],p = 0.85)。接受过一线、二线和三线生物制剂/小分子药物治疗的患者中,接受维多珠单抗和乌司替尼治疗的患者的SFCR率分别为53.3% vs 62.1%(p=0.52)、44.4% vs 33.8%(p=0.52)和2.6% vs 19.1%(p=0.027)。维多珠单抗组和乌司替尼组在W16时达到内镜缓解(SFCR和内镜梅奥评分≤1)和组织学缓解(SFCR、内镜缓解和南希组织学指数≤1)的比例分别为5.3% vs 17.5%(aOR = 3.77 [1.25-11.36],p=0.018)和2.1% vs 11.1%(aOR = 5.85 [1.47-23.30],p=0.012)。两组患者的停药风险无差异(aHR = 1.03 [0.51-2.08],p = 0.92)。虽然未发现韦多珠单抗的影响因素,但至少一种生物制剂/小分子药物的初治失败(OR=0.31,95%CI [0.11-0.82],p=0.018)与使用乌司替珠单抗治疗的患者SFCR率下降显著相关:结论:虽然在短期临床缓解方面未观察到差异,但在抗肿瘤坏死因子治疗UC失败后第16周时,乌司替尼似乎比韦多珠单抗更能诱导内镜和组织学缓解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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