Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies.

Raja Atreya, Marc Ferrante, Remo Panaccione, Brian Feagan, Oksana Shchukina, Vipul Jairath, Florian Rieder, Tadakazu Hisamatsu, Britta Siegmund, Kristina Kligys, Alexandra Song, Javier Zambrano, Madhuja Mallick, Yafei Zhang, Alessandro Armuzzi, Geert D'Haens
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Abstract

Background and aims: Normalization of high-sensitivity C-reactive protein [hs-CRP] and fecal calprotectin [FCP] are suggested Crohn's disease [CD] intermediate treatment targets. This analysis evaluates achievement of biomarker normalization and the relationship between improvements in biomarker concentrations and clinical and endoscopic outcomes among patients treated with risankizumab.

Methods: This post hoc analysis included patients with moderately to severely active CD and elevated baseline hs-CRP [> 5 mg/L] or FCP [> 250 µg/g] concentrations from the 12-week ADVANCE and MOTIVATE induction studies, and the 52-week FORTIFY maintenance study. We assessed the proportion of patients achieving biomarker normalization, defined as hs-CRP ≤ 5 mg/L and FCP ≤ 250 µg/g, and the association between achieving biomarker normalization and improved clinical and endoscopic outcomes.

Results: Among 748 patients with elevated baseline hs-CRP or FCP concentrations, higher proportions of patients treated with risankizumab vs placebo achieved normalization of hs-CRP [week 12: placebo, 17.5%; risankizumab 600 mg, 48.5%; week 52: placebo, 29.5%; risankizumab 180 mg, 45.2%; risankizumab 360 mg, 40.8%] and FCP [week 12: placebo, 9.1%; risankizumab 600 mg, 26.0%; week 52: placebo, 28.0%; risankizumab 180 mg, 43.0%; risankizumab 360 mg, 44.0%; nominal p < 0.05 vs placebo for all comparisons]. Achievement of both clinical or endoscopic outcomes and improvement of biomarker concentrations occurred at higher rates among patients treated with risankizumab vs placebo, regardless of prior exposure to biologic therapies.

Conclusions: Risankizumab treatment led to sustained normalization of inflammatory biomarkers with improved clinical and endoscopic results.

利桑珠单抗与克罗恩病患者生物标志物的正常化有关:ADVANCE、MOTIVATE 和 FORTIFY 3 期研究结果。
背景和目的:高敏C反应蛋白[hs-CRP]和粪钙蛋白[FCP]的正常化是克罗恩病[CD]的中期治疗目标。本分析评估了生物标志物正常化的实现情况以及生物标志物浓度的改善与利桑珠单抗治疗患者的临床和内窥镜结果之间的关系:这项事后分析纳入了12周ADVANCE和MOTIVATE诱导研究以及52周FORTIFY维持研究中的中度至重度活动性CD患者,以及基线hs-CRP[> 5 mg/L]或FCP[> 250 µg/g]浓度升高的患者。我们评估了实现生物标志物正常化(定义为 hs-CRP ≤ 5 mg/L,FCP ≤ 250 µg/g)的患者比例,以及实现生物标志物正常化与临床和内窥镜结果改善之间的关联:结果:在基线hs-CRP或FCP浓度升高的748名患者中,利坦珠单抗与安慰剂相比,有更高比例的患者实现了hs-CRP正常化[第12周:安慰剂,17.5%;利坦珠单抗600毫克,48.5%;第52周:安慰剂,29.第 12 周:安慰剂,9.1%;利桑珠单抗 600 毫克,26.0%;第 52 周:安慰剂,28.0%;利桑珠单抗 180 毫克,43.0%;利桑珠单抗 360 毫克,44.0%;与安慰剂相比,所有比较的名义 P <0.05]。与安慰剂相比,无论之前是否接受过生物疗法,利坦珠单抗治疗患者的临床或内窥镜结果以及生物标志物浓度的改善率都更高:结论:利桑珠单抗治疗可使炎症生物标志物持续恢复正常,并改善临床和内窥镜结果。
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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