Summary of COVID-19 sarilumab studies

1. Hermine et al., 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

81 patient sarilumab late treatment RCT: 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.
Feb 2022, European Respiratory J., http://erj.ersjournals.com/lookup/doi/10.1183/13993003.02523-2021, https://c19p.org/hermine

2. Gordon et al., Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19

442 patient sarilumab late treatment RCT: 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 estimate for the combined drugs. The concurrent event counts for sarilumab may be more accurate.
Apr 2021, New England J. Medicine, http://www.nejm.org/doi/10.1056/NEJMoa2100433, https://c19p.org/gordon4

3. Mariette et al., Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial

144 patient sarilumab late treatment RCT: 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.
Jan 2022, The Lancet Rheumatology, https://www.sciencedirect.com/science/article/pii/S2665991321003155, https://c19p.org/mariette

4. Lescure et al., Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial

257 patient sarilumab late treatment RCT: 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.
May 2021, The Lancet Respiratory Medicine, https://www.sciencedirect.com/science/article/pii/S2213260021000990, https://c19p.org/lescure

5. Sancho-López et al., Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia: A Randomized, Phase III Clinical Trial (SARTRE Study)

201 patient sarilumab late treatment RCT: 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.
Oct 2021, Infectious Diseases and Therapy, https://link.springer.com/10.1007/s40121-021-00543-2, https://c19p.org/sancholopez

6. Merchante et al., Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial

78 patient sarilumab late treatment RCT: 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, with sarilumab 400mg compared to standard of care.
Feb 2022, Antimicrobial Agents and Chemotherapy, https://journals.asm.org/doi/10.1128/aac.02107-21, https://c19p.org/merchante

7. Mastrorosa et al., 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)

176 patient sarilumab late treatment RCT: 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.
Mar 2023, eClinicalMedicine, https://www.sciencedirect.com/science/article/pii/S258953702300072X, https://c19p.org/mastrorosa

8. Sivapalasingam et al., Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial

1,365 patient sarilumab late treatment RCT: 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 receiving corticosteroids at baseline. Phase 2 and phase 3 results are listed separately [Sivapalasingam, Sivapalasingam].
Feb 2022, Clinical Infectious Diseases, https://academic.oup.com/cid/article/75/1/e380/6537638, https://c19p.org/sivapalasingamp2

9. Sivapalasingam et al., Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial

1,365 patient sarilumab late treatment RCT: 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 receiving corticosteroids at baseline. Phase 2 and phase 3 results are listed separately [Sivapalasingam, Sivapalasingam].
Feb 2022, Clinical Infectious Diseases, https://academic.oup.com/cid/article/75/1/e380/6537638, https://c19p.org/sivapalasingamp3

10. García-Vicuña et al., Subcutaneous IL-6 Inhibitor Sarilumab vs. Standard Care in Hospitalized Patients With Moderate-To-Severe COVID-19: An Open Label Randomized Clinical Trial

30 patient sarilumab late treatment RCT: 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 2022, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2022.819621/full, https://c19p.org/garciavicuna

11. Branch-Elliman et al., Subcutaneous sarilumab for the treatment of hospitalized patients with moderate to severe COVID19 disease: A pragmatic, embedded randomized clinical trial

50 patient sarilumab late treatment RCT: 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 2022, PLOS ONE, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0263591, https://c19p.org/branchelliman

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