Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19: A Randomized Clinical Trial
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Post-printDate
2022-03-21Author
Sivapalasingam, SumathiLederer, David J.
Bhore, Rafia
Hajizadeh, Negin
Criner, Gerard
Hosain, Romana
Mahmood, Adnan
Giannelou, Angeliki
Somersan-Karakaya, Selin
O'Brien, Meagan P.
Boyapati, Anita
Parrino, Janie
Musser, Bret J.
Labriola-Tompkins, Emily
Ramesh, Divya
Purcell, Lisa A.
Gulabani, Daya
Kampman, Wendy
Waldron, Alpana
Ng Gong, Michelle
Saggar, Suraj
Sperber, Steven J.
Menon, Vidya
Stein, David K.
Sobieszczyk, Magdalena E.
Park, William
Aberg, Judith A.
Brown, Samuel M.
Kosmicki, Jack A.
Horowitz, Julie E.
Ferreira, Manuel A.
Baras, Aris
Kowal, Bari
DiCioccio, A. Thomas
Akinlade, Bolanle
Nivens, Michael C.
Braunstein, Ned
Herman, Gary A.
Yancopoulos, George D.
Weinrich, David M.
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Sarilumab-COVID-19 Study TeamDepartment
MedicinePermanent link to this record
http://hdl.handle.net/20.500.12613/7558
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https://doi.org/10.1093/cid/ciac153Abstract
Background: Open-label platform trials and a prospective meta-analysis suggest efficacy of anti–IL-6R therapies in hospitalized patients with COVID-19 receiving corticosteroids. This study evaluated the efficacy and safety of sarilumab, an anti–IL-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 ≥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 ≥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, –7.4 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, .51–1.13) overall and 0.49 (95% CI, .25–.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.Citation
Sumathi Sivapalasingam, David J Lederer, Rafia Bhore, Negin Hajizadeh, Gerard Criner, Romana Hosain, Adnan Mahmood, Angeliki Giannelou, Selin Somersan-Karakaya, Meagan P O’Brien, 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.Citation to related work
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http://dx.doi.org/10.34944/dspace/7536
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