Department of Internal Medicine, Hospital Universitario "12 de Octubre", Instituto de Investigación Sanitaria Hospital "12 de Octubre" (imas12), Madrid, Spain.
Unit of Infectious Diseases, Hospital Universitario "12 de Octubre", Instituto de Investigación Sanitaria Hospital "12 de Octubre" (imas12), Madrid, Spain; Department of Medicine, School of Medicine, Universidad Complutense, Spain.
Int J Infect Dis. 2021 Apr;105:319-325. doi: 10.1016/j.ijid.2021.02.041. Epub 2021 Feb 13.
A subgroup of patients with SARS-CoV-2 infection was thought to have developed cytokine release syndrome and were treated with tocilizumab; however, a significant percentage of patients evolved. This study aimed to determine the usefulness of anakinra as a rescue treatment for patients with tocilizumab-refractory COVID-19 disease.
A prospective cohort of patients with COVID-19 pneumonia who received anakinra as salvage therapy after failure of tocilizumab were compared (1:1) with selected controls in a historical cohort of patients treated with tocilizumab. Cases and controls were matched by age, comorbidities, pulse oximetry oxygen saturation to fraction of inspired oxygen (SpO2/FiO2) ratio at baseline, and time elapsed since the initiation of treatment with tocilizumab. The primary outcome was the improvement in clinical status measured by a 6-point ordinal scale, from baseline to day 21.
The study included 20 cases and 20 controls (mean age 65.3 ± 12.8 years, 65% males). No differences were found in the clinical improvement rates at 7, 14 and 21 days of follow-up. The in-hospital mortality rate for patients receiving anakinra was 55% vs. 45% in the control group (P = 0.527).
Treatment with anakinra was not useful in improving the prognosis of patients with tocilizumab-refractory severe COVID-19.
据认为，一小部分 SARS-CoV-2 感染患者发生了细胞因子释放综合征，并接受了托珠单抗治疗；然而，仍有很大一部分患者病情进展。本研究旨在确定阿那白滞素作为托珠单抗治疗无效的 COVID-19 疾病患者的挽救治疗的有效性。
对接受阿那白滞素挽救治疗的 COVID-19 肺炎患者进行前瞻性队列研究，将其与接受托珠单抗治疗的历史队列中选择的对照组（1:1）进行比较。病例和对照组通过年龄、合并症、脉搏血氧饱和度/吸入氧分数（SpO2/FiO2）比值在基线时的比值以及从开始托珠单抗治疗到开始治疗的时间进行匹配。主要结局是通过 6 分序贯量表从基线到第 21 天评估的临床状态改善。
该研究包括 20 例病例和 20 例对照组（平均年龄 65.3±12.8 岁，65%为男性）。在 7、14 和 21 天的随访中，临床改善率无差异。接受阿那白滞素治疗的患者的住院死亡率为 55%，对照组为 45%（P=0.527）。
对于托珠单抗治疗无效的严重 COVID-19 患者，阿那白滞素治疗不能改善预后。
