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Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19: A Randomized Clinical Trial
Sivapalasingam, Sumathi Lederer, David J. Bhore, Rafia Hajizadeh, Negin Hosain, Romana Mahmood, Adnan Giannelou, Angeliki Somersan-Karakaya, Selin O'Brien, Meagan P.
Sivapalasingam, Sumathi
Lederer, David J.
Bhore, Rafia
Hajizadeh, Negin
Hosain, Romana
Mahmood, Adnan
Giannelou, Angeliki
Somersan-Karakaya, Selin
O'Brien, Meagan P.
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Post-print
Date
2022-03-21
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Medicine
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https://doi.org/10.1093/cid/ciac153
Abstract
Background: Open-label platform trials and a prospective meta-analysis suggest efficacy of antiāIL-6R therapies in hospitalized patients with COVID-19 receiving corticosteroids. This study evaluated the efficacy and safety of sarilumab, an antiāIL-6R monoclonal antibody, in the treatment of hospitalized patients with COVID-19. Methods: In this adaptive, phase 2/3, randomized, double-blind, placebo-controlled trial, adults hospitalized with COVID-19 (ClinicalTrials.gov: NCT04315298) received intravenous sarilumab or placebo. The phase 3 primary analysis population included patients with critical COVID-19 receiving mechanical ventilation randomized to sarilumab 400 mg or placebo. The primary outcome was proportion of patients with ā„1-point improvement in clinical status from baseline to day 22. Results: There were 457 and 1365 patients randomized and treated in phases 2 and 3, respectively. In phase 3, patients with critical COVID-19 receiving mechanical ventilation (n = 298; 28.2% on corticosteroids), the proportion with ā„1-point improvement in clinical status (alive, not receiving mechanical ventilation) at day 22 was 43.2% in sarilumab and 35.5% in placebo (risk difference +7.5%; 95% CI, ā7.4 to 21.3; P = .3261), a relative risk improvement of 21.7%. In post-hoc analyses pooling phase 2 and 3 critical patients receiving mechanical ventilation, the hazard ratio for death in sarilumab versus placebo was 0.76 (95% CI, .51ā1.13) overall and 0.49 (95% CI, .25ā.94) in patients receiving corticosteroids at baseline. Conclusions: This study did not establish the efficacy of sarilumab in hospitalized patients with severe/critical COVID-19. Post-hoc analyses were consistent with other studies that found a benefit of sarilumab in patients receiving corticosteroids.
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Sumathi Sivapalasingam, David J Lederer, Rafia Bhore, Negin Hajizadeh, Gerard Criner, Romana Hosain, Adnan Mahmood, Angeliki Giannelou, Selin Somersan-Karakaya, Meagan P OāBrien, Anita Boyapati, Janie Parrino, Bret J Musser, Emily Labriola-Tompkins, Divya Ramesh, Lisa A Purcell, Daya Gulabani, Wendy Kampman, Alpana Waldron, Michelle Ng Gong, Suraj Saggar, Steven J Sperber, Vidya Menon, David K Stein, Magdalena E Sobieszczyk, William Park, Judith A Aberg, Samuel M Brown, Jack A Kosmicki, Julie E Horowitz, Manuel A Ferreira, Aris Baras, Bari Kowal, A Thomas DiCioccio, Bolanle Akinlade, Michael C Nivens, Ned Braunstein, Gary A Herman, George D Yancopoulos, David M Weinreich, Sarilumab-COVID-19 Study Team, Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19: A Randomized Clinical Trial, Clinical Infectious Diseases, 2022;, ciac153.
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Oxford University Press
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Clinical Infectious Diseases
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