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
{"title":"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","authors":"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","doi":"10.1093/immhor/vlaf023","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":94037,"journal":{"name":"ImmunoHorizons","volume":"9 7","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of acalabrutinib with best supportive care versus best supportive care in patients with COVID-19 requiring hospitalization.\",\"authors\":\"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\",\"doi\":\"10.1093/immhor/vlaf023\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":94037,\"journal\":{\"name\":\"ImmunoHorizons\",\"volume\":\"9 7\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-05-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ImmunoHorizons\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1093/immhor/vlaf023\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ImmunoHorizons","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/immhor/vlaf023","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
摘要
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。
Efficacy and safety of acalabrutinib with best supportive care versus best supportive care in patients with COVID-19 requiring hospitalization.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
