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Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial.
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; Sobieszczyk, Magdalena E; Park, William; Aberg, Judith A; Brown, Samuel M; Kosmicki, Jack A; Horowitz, Julie E; Ferreira, Manuel A; Baras, Aris; Kowal, Bari; Thomas DiCioccio, A; Akinlade, Bolanle; Nivens, Michael C; Braunstein, Ned; Herman, Gary A; Yancopoulos, George D; Weinreich, David M.
  • Sivapalasingam S; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Lederer DJ; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Bhore R; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Hajizadeh N; Institute for Clinical Outcomes Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, New York, and Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York, New York, USA.
  • Criner G; Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, USA.
  • Hosain R; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Mahmood A; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Giannelou A; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Somersan-Karakaya S; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • O'Brien MP; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Boyapati A; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Parrino J; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Musser BJ; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Labriola-Tompkins E; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Ramesh D; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Purcell LA; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Gulabani D; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Kampman W; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Waldron A; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Ng Gong M; Department of Medicine, Montefiore-Moses, Bronx, New York, USA.
  • Saggar S; Department of Infectious Disease, Holy Name Medical Center, Teaneck, New Jersey, USA.
  • Sperber SJ; Department of Infectious Disease, Hackensack Meridian School of Medicine and Hackensack University Medical Center, Hackensack, New Jersey, USA.
  • Menon V; Department of Medicine, NYC Health + Hospitals/Lincoln, Bronx, New York, USA.
  • Stein DK; Department of Medicine, Jacobi Medical Center, Bronx, New York, USA.
  • Sobieszczyk ME; Department of Medicine, Columbia University, New York, New York, USA.
  • Park W; Pulmonary and Sleep Disorder Clinic, Valley Medical Center, Renton, Washington, USA.
  • Aberg JA; Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York, USAand.
  • Brown SM; Department of Internal Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah, USA.
  • Kosmicki JA; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Horowitz JE; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Ferreira MA; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Baras A; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Kowal B; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Thomas DiCioccio A; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Akinlade B; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Nivens MC; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Braunstein N; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Herman GA; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Yancopoulos GD; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
  • Weinreich DM; Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Clin Infect Dis ; 75(1): e380-e388, 2022 08 24.
Article in English | MEDLINE | ID: covidwho-1886374
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews Topics: Long Covid Limits: Adult / Humans Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: Cid

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews Topics: Long Covid Limits: Adult / Humans Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: Cid