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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; Ng Gong, Michelle; Saggar, Suraj; Sperber, Steven J; Menon, Vidya; Stein, David K; [...]

Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial

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  • Medientyp: E-Artikel
  • Titel: Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial
  • Beteiligte: 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; Ng Gong, Michelle; Saggar, Suraj; Sperber, Steven J; Menon, Vidya; Stein, David K; [...]
  • Erschienen: Oxford University Press (OUP), 2022
  • Erschienen in: Clinical Infectious Diseases
  • Sprache: Englisch
  • DOI: 10.1093/cid/ciac153
  • ISSN: 1058-4838; 1537-6591
  • Schlagwörter: Infectious Diseases ; Microbiology (medical)
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trials Registration</jats:title> <jats:p>NCT04315298.</jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang