Sarilumab for COVID-19: real-time analysis of 12 studies


Dec 7	Covid Analysis	Sarilumab for COVID-19: real-time meta analysis of 11 studies
	Meta analysis using the most serious outcome reported shows 0% [-17‑21%] higher risk, without reaching statistical significance. Currently all studies are RCTs. Control Sarilumab All data and sources to reproduce this analysis ..
Mar 6	Htet et al., British Journal of Clinical Pharmacology, doi:10.1002/bcp.70025	Adverse events associated with monoclonal antibodies used for treatment of COVID‐19: A systematic review and meta‐analysis
	Systematic review and meta-analysis of 16 RCTs with 19,797 COVID-19 patients, showing a statistically significant increased risk of hepatotoxicity and neutropenia associated with monoclonal antibody (mAb) treatments compared to standard o..
Mar 31 2023	Mastrorosa et al., eClinicalMedicine, doi:10.1016/j.eclinm.2023.101895	Sarilumab plus standard of care vs standard of care for the treatment of severe COVID-19: a phase 3, randomized, open-labeled, multi-center study (ESCAPE study)
	30% higher mortality (p=0.67), 7% greater improvement (p=0.69), and 8% worse viral clearance (p=1). RCT with 176 severe COVID-19 patients showing no significant difference in time to clinical improvement or 30 day mortality with sarilumab treatment.
Feb 26 2022	Sivapalasingam et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac153	Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial
	7% higher mortality (p=0.89) and 4% worse improvement (p=0.91). Phase 2 and phase 3 RCTs with 1,365 hospitalized COVID-19 patients showing no significant improvement with sarilumab vs placebo. Post-hoc analysis suggests a potential mortality benefit with sarilumab in mechanically ventilated patients r..
Feb 26 2022	Sivapalasingam et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac153	Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial
	8% higher mortality (p=0.59) and 6% worse improvement (p=0.47). Phase 2 and phase 3 RCTs with 1,365 hospitalized COVID-19 patients showing no significant improvement with sarilumab vs placebo. Post-hoc analysis suggests a potential mortality benefit with sarilumab in mechanically ventilated patients r..
Feb 25 2022	Branch-Elliman et al., PLOS ONE, doi:10.1371/journal.pone.0263591	Subcutaneous sarilumab for the treatment of hospitalized patients with moderate to severe COVID19 disease: A pragmatic, embedded randomized clinical trial
	350% higher mortality (p=0.05), 650% higher combined mortality/intubation (p=0.03), and 500% higher ventilation (p=0.16). RCT 50 hospitalized moderate-to-severe COVID-19 patients showing higher mortality with subcutaneous sarilumab compared to standard of care. The study was stopped early due to a high probability of futility and potential harm.
Feb 23 2022	García-Vicuña et al., Frontiers in Medicine, doi:10.3389/fmed.2022.819621	Subcutaneous IL-6 Inhibitor Sarilumab vs. Standard Care in Hospitalized Patients With Moderate-To-Severe COVID-19: An Open Label Randomized Clinical Trial
	300% higher mortality (p=0.54), 450% higher ventilation (p=0.53), and 33% worse 7-point scale results (p=0.36). RCT 30 hospitalized moderate-to-severe COVID-19 patients showing no significant difference in 30-day mortality, clinical improvement at day 7, or time to discharge with sarilumab compared to standard care.
Feb 15 2022	Merchante et al., Antimicrobial Agents and Chemotherapy, doi:10.1128/AAC.02107-21	Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial
	35% higher mortality (p=0.71), 22% higher ventilation (p=0.7), and 36% lower progression (p=0.23). RCT 115 hospitalized COVID-19 pneumonia patients in Spain showing a trend towards reduced progression to severe respiratory failure requiring high-flow oxygen, non-invasive ventilation, or mechanical ventilation, and reduced mortality, wi..
Feb 3 2022	Hermine et al., European Respiratory Journal, doi:10.1183/13993003.02523-2021	Effect of interleukin-6 receptor antagonists in critically ill adult patients with COVID-19 pneumonia: two randomised controlled trials of the CORIMUNO-19 Collaborative Group
	26% lower mortality (p=0.44). Two open-label RCTs of 97 and 91 critically ill COVID-19 patients in France showing no significant differences with tocilizumab or sarilumab.
Jan 31 2022	Mariette et al., The Lancet Rheumatology, doi:10.1016/S2665-9913(21)00315-5	Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial
	30% lower mortality (p=0.4), 1% worse recovery (p=1), and 10% higher progression (p=0.7). RCT 148 hospitalized patients with moderate-to-severe COVID-19 pneumonia in France showing no significant differences with sarilumab treatment.
Nov 30 2021	Abraham et al., Current Medicine Research and Practice, doi:10.4103/cmrp.cmrp_71_21	Tolerability of Sarilumab – An anti-interleukin-6 receptor monoclonal antibody is controversial for the management of COVID-19
	Review of sarilumab, an anti-interleukin-6 receptor monoclonal antibody, for the management of COVID-19. Authors report that sarilumab was proposed as a potential treatment to reduce mortality by abating the inflammatory cytokine storm in..
Oct 17 2021	Sancho-López et al., Infectious Diseases and Therapy, doi:10.1007/s40121-021-00543-2	Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia: A Randomized, Phase III Clinical Trial (SARTRE Study)
	3% higher mortality (p=0.98), 30% lower ICU admission (p=0.5), and 14% worse recovery (p=0.66). RCT 201 hospitalized COVID-19 pneumonia patients under standard oxygen therapy in Spain showing no significant difference with sarilumab treatment.
May 31 2021	Lescure et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(21)00099-0	Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial
	2% lower mortality (p=0.96), 5% higher ICU admission (p=0.89), and 8% greater improvement (p=0.47). RCT 416 hospitalized severe or critical COVID-19 patients showing no significant difference with intravenous sarilumab compared to placebo for clinical improvement, survival at day 29, or other secondary outcomes.
Apr 22 2021	Gordon et al., New England Journal of Medicine, doi:10.1056/NEJMoa2100433	Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19
	26% lower mortality (p=0.39). RCT 803 critically ill COVID-19 patients showing improved outcomes with tocilizumab and sarilumab. There was only 48 sarilumab patients and the model used shrinks the posterior distribution for each intervention effect toward the overall ..