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A Randomized Placebo-Controlled Trial of Sarilumab in Hospitalized Patients with Covid-19

S. Sivapalasingam,D. Lederer, R. Bhore,N. Hajizadeh,G. Criner, R. Hossain,A. Mahmood, A. Giannelou,S. Somersan-Karakaya,M. O'Brien,A. Boyapati,J. Parrino, B. Musser, E. Labriola-Tompkins,D. Ramesh,L. Purcell, D. Gulabani, W. Kampman, A. Waldron, M. Ng Gong, S. Saggar, S. Sperber, V. Menon, D. Stein,M. Sobieszczyk, W. Park,J. Aberg,S. Brown,J. Kosmicki, J. Horowitz,M. Ferreira, A. Baras,B. Kowal,A. T. DiCioccio,B. Akinlade, M. Nivens,N. Braunstein, G. Herman, G. Yancopoulos,D. Weinreich, Sarilumab-COVID- Study Team

medRxiv(2021)

Cited 16|Views4
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Abstract
BACKGROUND Sarilumab (anti-interleukin-6 receptor-alpha; monoclonal antibody) may attenuate the inflammatory response in Covid-19. METHODS We performed an adaptive, phase 2/3, randomized, double-blind, placebo-controlled trial of intravenous sarilumab 200 mg or 400 mg in adults hospitalized with Covid-19. The phase 3 primary analysis population (cohort 1) was patients with critical Covid-19 receiving mechanical ventilation (MV) randomized to sarilumab 400 mg or placebo. The primary end point for phase 3 was the proportion of patients with [≥]1-point improvement in clinical status from baseline to day 22. RESULTS Four-hundred fifty-seven (457) and 1365 patients were randomized and treated in phases 2 and 3, respectively. Among phase 3 critical patients receiving MV (n=289; 34.3% on corticosteroids), the proportion with [≥]1-point improvement in clinical status (alive not receiving MV) at day 22 was 43.2% in sarilumab 400 mg and 35.5% in placebo (risk difference [RD] +7.5%; 95% confidence interval [CI], - 7.4 to 21.3; P=0.3261), representing a relative risk improvement of 21.7%. Day 29 all-cause mortality was 36.4% in sarilumab 400 mg versus 41.9% in placebo (RD - 5.5%; 95% CI, -20.2 to 8.7; relative risk reduction 13.3%). In post hoc analyses pooling phase 2 and 3 critical patients receiving MV, the hazard ratio (HR) for death in sarilumab 400 mg compared with placebo was 0.76 (95% CI, 0.51 to 1.13) overall, improving to 0.49 (95% CI, 0.25 to 0.94) in patients receiving corticosteroids at baseline. CONCLUSION In hospitalized patients with Covid-19 receiving MV, numerical benefits with sarilumab did not achieve statistical significance, but benefit may be greater in patients receiving corticosteroids. A larger study is required to confirm this observed numerical benefit.
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Key words
sarilumab,hospitalized patients,placebo-controlled
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