PDF(Pubmed)
Abstract：
BACKGROUND: Regdanvimab, a monoclonal antibody pharmaceutical, is the first Korean drug approved for treating coronavirus disease 2019 (COVID-19). We analyzed the therapeutic efficacy of regdanvimab in patients with the COVID-19 delta variant infection.
METHODS: We retrospectively reviewed the electronic medical records of patients hospitalized at two Korean tertiary COVID-19 hospitals with COVID-19 delta variant infection between May 26, 2021, and January 30, 2022. To analyze the therapeutic efficacy of regdanvimab, the patients were divided into regdanvimab and non-regdanvimab groups and were 1:1 propensity-score (PS)-matched on age, severity at admission, and COVID-19 vaccination history.
RESULTS: Of 492 patients, 262 (53.3%) and 230 (46.7%) were in the regdanvimab and non-regdanvimab groups, respectively. After PS matching the groups on age, severity at admission, and COVID-19 vaccination history, each group comprised 189 patients. The 30-day hospital mortality rates (0.0% vs. 1.6%, p = 0.030), proportions of patients with exacerbated conditions to severe/critical/died (9.5% vs. 16.4%, p = 0.047), proportions who received oxygen therapy because of pneumonia exacerbation (7.4% vs. 16.4%, p = 0.007), and proportions with a daily National Early Warning Score ≥ 5 from hospital day 2 were significantly lower in the regdanvimab group.
CONCLUSIONS: We showed that regdanvimab reduced the exacerbation rates of conditions and mortality in patients with the COVID-19 delta variant infection. Thus, it is recommended to streamline the drug approval system during epidemics of new variant viruses to improve the availability and usage of therapeutics for patients. To facilitate this, relevant institutional support is required.
METHODS: We retrospectively reviewed the electronic medical records of patients hospitalized at two Korean tertiary COVID-19 hospitals with COVID-19 delta variant infection between May 26, 2021, and January 30, 2022. To analyze the therapeutic efficacy of regdanvimab, the patients were divided into regdanvimab and non-regdanvimab groups and were 1:1 propensity-score (PS)-matched on age, severity at admission, and COVID-19 vaccination history.
RESULTS: Of 492 patients, 262 (53.3%) and 230 (46.7%) were in the regdanvimab and non-regdanvimab groups, respectively. After PS matching the groups on age, severity at admission, and COVID-19 vaccination history, each group comprised 189 patients. The 30-day hospital mortality rates (0.0% vs. 1.6%, p = 0.030), proportions of patients with exacerbated conditions to severe/critical/died (9.5% vs. 16.4%, p = 0.047), proportions who received oxygen therapy because of pneumonia exacerbation (7.4% vs. 16.4%, p = 0.007), and proportions with a daily National Early Warning Score ≥ 5 from hospital day 2 were significantly lower in the regdanvimab group.
CONCLUSIONS: We showed that regdanvimab reduced the exacerbation rates of conditions and mortality in patients with the COVID-19 delta variant infection. Thus, it is recommended to streamline the drug approval system during epidemics of new variant viruses to improve the availability and usage of therapeutics for patients. To facilitate this, relevant institutional support is required.
摘要：
背景：Regdanvimab，一种单克隆抗体药物，是韩国第一种批准用于治疗2019年冠状病毒病的药物（COVID-19）。我们分析了regdanvimab对COVID-19δ变异体感染患者的治疗效果。
方法：我们回顾性回顾了2021年5月26日至2022年1月30日在韩国两家三级COVID-19医院住院的COVID-19三角洲变异型感染患者的电子病历。分析regdanvimab的治疗效果，将患者分为regdanvimab和非regdanvimab组，并在年龄上进行1：1倾向评分（PS）匹配，入院时的严重程度，和COVID-19疫苗接种史。
结果：在492名患者中，regdanvimab和非regdanvimab组262例(53.3%)和230例(46.7%)，分别。PS匹配年龄组之后，入院时的严重程度，和COVID-19疫苗接种史，每组189名患者.30天住院死亡率（0.0%vs.1.6%,p=0.030),病情恶化的患者占严重/危重/死亡的比例(9.5%vs.16.4%,p=0.047),因肺炎加重而接受氧疗的比例(7.4%vs.16.4%,p=0.007),在regdanvimab组中,从住院第2天开始每日国家早期预警评分≥5分的比例显著降低.
结论：我们发现regdanvimab降低了COVID-19δ变异体感染患者的病情加重率和死亡率。因此，建议在新变种病毒流行期间简化药物审批系统，以改善患者治疗方法的可用性和使用。为了促进这一点，需要相关的机构支持。
方法：我们回顾性回顾了2021年5月26日至2022年1月30日在韩国两家三级COVID-19医院住院的COVID-19三角洲变异型感染患者的电子病历。分析regdanvimab的治疗效果，将患者分为regdanvimab和非regdanvimab组，并在年龄上进行1：1倾向评分（PS）匹配，入院时的严重程度，和COVID-19疫苗接种史。
结果：在492名患者中，regdanvimab和非regdanvimab组262例(53.3%)和230例(46.7%)，分别。PS匹配年龄组之后，入院时的严重程度，和COVID-19疫苗接种史，每组189名患者.30天住院死亡率（0.0%vs.1.6%,p=0.030),病情恶化的患者占严重/危重/死亡的比例(9.5%vs.16.4%,p=0.047),因肺炎加重而接受氧疗的比例(7.4%vs.16.4%,p=0.007),在regdanvimab组中,从住院第2天开始每日国家早期预警评分≥5分的比例显著降低.
结论：我们发现regdanvimab降低了COVID-19δ变异体感染患者的病情加重率和死亡率。因此，建议在新变种病毒流行期间简化药物审批系统，以改善患者治疗方法的可用性和使用。为了促进这一点，需要相关的机构支持。
