REGEN-COV® 在患有 2019 年冠状病毒病（COVID-19）和与免疫缺陷相关的抗体疾病的患者中的同情使用。
Compassionate Use of REGEN-COV® in Patients With Coronavirus Disease 2019 (COVID-19) and Immunodeficiency-Associated Antibody Disorders.
机构信息
Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
出版信息
Clin Infect Dis. 2022 Aug 24;75(1):e509-e515. doi: 10.1093/cid/ciab1059.
BACKGROUND
Patients with immunodeficiency-associated antibody disorders are at a higher risk of prolonged/persistent COVID-19 infection, having no viable treatment options.
METHODS
A retrospective analysis of patients with primary and/or secondary immunodeficiency-associated antibody disorders who received casirivimab and imdevimab (REGEN-COV®) under emergency compassionate use. Objective were to describe safety and response to REGEN-COV, focusing on the subset of patients who had COVID-19 duration ≥21 days before treatment.
RESULTS
Quantitative (change in oxygenation status and/or viral load) and/or qualitative (physician-reported clinical status) outcomes data are reported from 64 patients. Improvement in ≥1 outcome was observed in 90.6% of the overall patient group. Thirty-seven of these had COVID-19 duration ≥21 days before treatment; median time from diagnosis to REGEN-COV treatment was 60.5 days. Of the 29 patients with COVID-19 duration ≥21 days before treatment and available outcome data, 96.6% showed improvement in ≥1 outcome. In the 14 patients with post-treatment reverse transcription-polymerase chain reaction (RT-PCR) results available, 11 (78.6%) reported a negative RT-PCR following treatment, with 5 (45.5%) and 8 (72.7%) patients reporting a negative RT-PCR within 5 days and 21 days of treatment, respectively. Ten of 85 patients (11.8%) experienced serious adverse events; only one was an infusion-related reaction, possibly related to REGEN-COV. Two deaths were reported; neither were attributed to REGEN-COV.
CONCLUSIONS
In this retrospective analysis of immunodeficient patients granted REGEN-COV under emergency compassionate use, REGEN-COV treatment was associated with rapid viral clearance and clinical improvement in patients with longstanding COVID-19. Adverse events were consistent with COVID-19 and its associated complications, and due to patients' concurrent medical conditions.
背景
免疫缺陷相关抗体疾病患者发生 COVID-19 感染持续时间延长/持续的风险较高，且无可行的治疗选择。
方法
对接受卡司瑞韦单抗和伊米德韦单抗（REGEN-COV®）紧急同情用药的原发性和/或继发性免疫缺陷相关抗体疾病患者进行回顾性分析。目的是描述 REGEN-COV 的安全性和疗效，重点关注 COVID-19 持续时间≥21 天的患者亚组。
结果
报告了 64 例患者的定量（氧合状态和/或病毒载量变化）和/或定性（医生报告的临床状态）结局数据。整体患者组中 90.6%观察到≥1 项结局改善。其中 37 例患者 COVID-19 持续时间≥21 天；从诊断到 REGEN-COV 治疗的中位时间为 60.5 天。在 COVID-19 持续时间≥21 天且可获得结局数据的 29 例患者中，96.6%的患者≥1 项结局改善。在可获得治疗后逆转录聚合酶链反应（RT-PCR）结果的 14 例患者中，11 例（78.6%）报告治疗后 RT-PCR 结果为阴性，5 例（45.5%）和 8 例（72.7%）患者分别在治疗后 5 天和 21 天内报告 RT-PCR 结果为阴性。85 例患者中有 10 例（11.8%）发生严重不良事件；仅有 1 例为与 REGEN-COV 相关的输液相关反应。报告了 2 例死亡；均与 REGEN-COV 无关。
结论
在这项对免疫缺陷患者接受 REGEN-COV 紧急同情用药的回顾性分析中，REGEN-COV 治疗与 COVID-19 持续时间较长的患者病毒快速清除和临床改善相关。不良事件与 COVID-19 及其相关并发症一致，与患者的合并症有关。
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