Efficacy and safety of acalabrutinib with best supportive care versus best supportive care in patients with COVID-19 requiring hospitalization.

Q3 Medicine

ImmunoHorizons Pub Date : 2025-05-30 DOI:10.1093/immhor/vlaf023

Phillip Scheinberg, Matt R Khoshnevis, Philip A Robinson, Alfredo Guerreros, Victor A H Sato, Benedito A L Fonseca, Hans W Prozesky, José Omar Chacón Romero, Laura Fogliatto, Barry R Meisenberg, David J Park, Ashok Gupta, Priti Patel, Danielle M Townsley, Lianqing Zheng, Veerendra Munugalavadla

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Abstract

The efficacy and safety of acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, was evaluated in 2 phase 2 studies in hospitalized patients with coronavirus disease 2019 (COVID-19) who received acalabrutinib + best supportive care (BSC) versus BSC alone (Clinicaltrials.gov: NCT04380688 and NCT04346199). The primary endpoint was the percentage of patients alive and free of respiratory failure on day 14 (rest of the world [RoW] study) and day 28 (US study). In the RoW study, 177 patients were randomized (acalabrutinib + BSC: n = 89; BSC: n = 88); in the US study, 62 patients were randomized (acalabrutinib + BSC: n = 31; BSC: n = 31). The percentage of patients who met the primary endpoint was similar in both studies (RoW study: acalabrutinib + BSC: 83.1%, BSC: 90.9%; US study: acalabrutinib + BSC: 80.6%, BSC: 83.9%). No new safety concerns were reported. Overall, no significant clinical benefit of adding acalabrutinib to BSC in patients hospitalized with COVID-19 was observed.

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阿卡拉布替尼与最佳支持治疗在需要住院治疗的COVID-19患者中的疗效和安全性

布鲁顿酪氨酸激酶（BTK）抑制剂阿卡拉布替尼（acalabrutinib）的有效性和安全性在2项2期研究中进行了评估，这些患者接受阿卡拉布替尼+最佳支持治疗（BSC）与单独BSC （Clinicaltrials.gov: NCT04380688和NCT04346199）。主要终点是第14天（世界其他地区[RoW]研究）和第28天（美国研究）存活且无呼吸衰竭的患者百分比。在RoW研究中，177例患者被随机分配(阿卡拉布替尼+ BSC: n = 89；BSC: n = 88)；在美国的研究中，62例患者被随机分配(阿卡拉布替尼+ BSC: n = 31；BSC: n = 31)。两项研究中达到主要终点的患者百分比相似(RoW研究：阿卡拉布替尼+ BSC: 83.1%, BSC: 90.9%；美国研究：acalabrutinib + BSC: 80.6%, BSC: 83.9%)。没有新的安全隐患报告。总体而言，未观察到在COVID-19住院患者的BSC中添加阿卡拉布替尼的临床获益。

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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