Komagamine Junpei, Yabuki Taku, Yoshihara Satsuki, Tanaka Nao
Department of Internal Medicine National Hospital Organization Tochigi Medical Center Utsunomiya Japan.
J Gen Fam Med. 2021 Dec 19;23(3):158-163. doi: 10.1002/jgf2.516. eCollection 2022 May.
Recent randomized trials have revealed that neutralizing monoclonal antibodies can reduce disease progression in mild-moderate COVID-19 patients. However, no studies have investigated the effect of neutralizing monoclonal antibodies on clinical outcomes in Japan.
A single-center retrospective and prospective cohort study was conducted. All consecutive febrile nonsevere COVID-19 patients with at least one risk factor were included. The primary outcome was progression to severe COVID-19. Severe COVID-19 cases were defined as patients requiring oxygen therapy and dexamethasone. The differences in the primary outcomes between the patients who were treated with casirivimab with imdevimab (treatment group) and those who were not (control group) were compared using the chi-squared test.
A total of 128 patients were included. Of those, the mean age was 53.6 years old (SD 9.9), and 52 (40.6%) were women. Fifty-three patients were treated with casirivimab with imdevimab, and 75 patients were given the standard treatment only. The primary outcome occurred in eight (15.1%) of the 53 patients in the treatment group and 33 (44.0%) of the 75 patients in the control group (odd ratio [OR] 0.23, 95% CI 0.09 to 0.55). The multivariate analysis revealed that the use of casirivimab with imdevimab (OR 0.21, 95% CI 0.08 to 0.54) was the only independent risk factor associated with progression to severe COVID-19. No patients died during hospitalization in either group.
Similar to other countries, casirivimab with imdevimab significantly reduced disease progression in early nonsevere COVID-19 patients with fever and risk factors in Japan.
近期的随机试验表明，中和性单克隆抗体可降低轻中度新冠肺炎患者的疾病进展。然而，在日本尚无研究调查中和性单克隆抗体对临床结局的影响。
开展了一项单中心回顾性和前瞻性队列研究。纳入所有连续的伴有至少一项风险因素的发热非重症新冠肺炎患者。主要结局为进展为重症新冠肺炎。重症新冠肺炎病例定义为需要吸氧治疗和使用地塞米松的患者。使用卡瑞丽维单抗联合英夫利昔单抗治疗的患者（治疗组）和未使用的患者（对照组）在主要结局方面的差异采用卡方检验进行比较。
共纳入128例患者。其中，平均年龄为53.6岁（标准差9.9），女性52例（40.6%）。53例患者接受了卡瑞丽维单抗联合英夫利昔单抗治疗，75例患者仅接受标准治疗。主要结局在治疗组的53例患者中有8例（15.1%）出现，在对照组的75例患者中有33例（44.0%）出现（比值比[OR]0.23，95%置信区间0.09至0.55）。多因素分析显示，使用卡瑞丽维单抗联合英夫利昔单抗（OR 0.21，95%置信区间0.08至0.54）是与进展为重症新冠肺炎相关的唯一独立风险因素。两组均无患者在住院期间死亡。
与其他国家类似，在日本，卡瑞丽维单抗联合英夫利昔单抗可显著降低早期伴有发热和风险因素的非重症新冠肺炎患者的疾病进展。
