COVID Unit, Azienda Socio Sanitaria Territoriale di Cremona, Cremona, Italy; Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Italy.
Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Italy.
Int J Infect Dis. 2021 Mar;104:433-440. doi: 10.1016/j.ijid.2020.12.073. Epub 2020 Dec 29.
Canakinumab is an IL-1β antibody that neutralises the activity of IL-1β. This study examined the efficacy and safety of canakinumab in patients with moderate COVID-19-related pneumonia.
This study aimed to evaluate the reduction in duration of hospitalisation with adequate oxygen status. Forty-eight patients with moderate COVID-19-related pneumonia were asked to participate in the prospective case-control study: 33 patients (cases) signed informed consent and received canakinumab (Cohort 1) and 15 patients (Controls) refused to receive the experimental drug and received institutional standard of care (Cohort 2).
Hospital discharge within 21 days was seen in 63% of patients in Cohort 1 vs. 0% in Cohort 2 (median 14 vs. 26 days, respectively; p < 0.001). There was significant clinical improvement in ventilation regimes following administration of canakinumab compared with Cohort 2 (Stuart-Maxwell test for paired data, p < 0.001). Patients treated with canakinumab experienced a significant increase in PaO:FiO (p < 0.001) and reduction in lung damage by CT (p = 0.01), along with significant decreases in immune/inflammation markers that were not observed in Cohort 2. Only mild side-effects were seen in patients treated with canakinumab; survival at 60 days was 90.0% (95% CI 71.9-96.7) in patients treated with canakinumab and 73.3% (95% CI 43.6-89.1) for Cohort 2.
Treatment with canakinumab in patients with COVID-19-related pneumonia rapidly restored normal oxygen status, decreased the need for invasive mechanical ventilation, and was associated with earlier hospital discharge and favourable prognosis versus standard of care.
卡那单抗是一种白细胞介素-1β（IL-1β）抗体，可中和 IL-1β 的活性。本研究评估了卡那单抗治疗 COVID-19 相关中度肺炎患者的疗效和安全性。
本研究旨在评估降低氧合状态正常的住院时间。48 例 COVID-19 相关中度肺炎患者被要求参加前瞻性病例对照研究：33 例患者（病例组）签署知情同意书并接受卡那单抗治疗（队列 1），15 例患者（对照组）拒绝接受实验药物并接受机构标准治疗（队列 2）。
队列 1 中 63%的患者在 21 天内出院，而队列 2 中无患者出院（中位时间分别为 14 天和 26 天，p<0.001）。与队列 2 相比，给予卡那单抗后通气治疗方案的临床改善显著（配对数据 Stuart-Maxwell 检验，p<0.001）。与队列 2 相比，接受卡那单抗治疗的患者 PaO:FiO 显著增加（p<0.001），CT 显示肺损伤减少（p=0.01），且未观察到免疫/炎症标志物增加，而队列 2 中则观察到免疫/炎症标志物增加。接受卡那单抗治疗的患者仅出现轻微副作用；接受卡那单抗治疗的患者 60 天生存率为 90.0%（95%CI 71.9-96.7），而队列 2 为 73.3%（95%CI 43.6-89.1）。
在 COVID-19 相关肺炎患者中使用卡那单抗治疗可迅速恢复正常氧合状态，降低有创机械通气的需求，与标准治疗相比，可更早出院并获得更好的预后。
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