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- Title
Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial.
- Authors
Sivapalasingam, Sumathi; Lederer, 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; Gong, Michelle Ng
- Abstract
Background Open-label platform trials and a prospective meta-analysis suggest efficacy of anti–interleukin (IL)-6R therapies in hospitalized patients with coronavirus disease 2019 (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 received intravenous sarilumab 400 mg or placebo. The phase 3 primary analysis population included patients with critical COVID-19 receiving mechanical ventilation (MV). 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 MV (n = 298; 28.2% on corticosteroids), the proportion with ≥1-point improvement in clinical status (alive, not receiving MV) at day 22 was 43.2% for sarilumab and 35.5% for placebo (risk difference, +7.5%; 95% confidence interval [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 MV, the hazard ratio for death for sarilumab vs placebo was 0.76 (95% CI,.51 to 1.13) overall and 0.49 (95% CI,.25 to.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. Clinical Trials Registration NCT04315298.
- Subjects
THERAPEUTIC use of monoclonal antibodies; RELATIVE medical risk; COVID-19; INTRAVENOUS therapy; CONFIDENCE intervals; ADRENOCORTICAL hormones; MONOCLONAL antibodies; TREATMENT effectiveness; RANDOMIZED controlled trials; PRE-tests &; post-tests; COMPARATIVE studies; HOSPITAL care; BLIND experiment; DESCRIPTIVE statistics; STATISTICAL sampling
- Publication
Clinical Infectious Diseases, 2022, Vol 75, Issue 1, pe380
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciac153