Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial

Abstract

AbstractBackgroundTocilizumab and baricitinib have proven efficacy in COVID-19. There were no randomized-controlled trials comparing these compounds in patients with COVID-19.Materials/Patients and MethodsIn this open label, randomized controlled trial, we assigned 251 patients with COVID-19 and PaO2/FiO2<200 to receive either tocilizumab (n=126) or baricitinib (n=125) plus standard of care. To determine whether baricitinib was non-inferior to tocilizumab, we assessed if the upper boundary of the two-sided 95% confidence interval of the hazard ratio did not exceed 1.50. The primary outcome was mechanical ventilation or death by day 28. Secondary outcomes included time to hospital discharge by day 28 and change in WHO progression scale at day 10.ResultsBaricitinib was non-inferior to tocilizumab for the primary composite outcome of mechanical ventilation or death by day 28 (HR 0.83, 95% CI: 0.56 to 1.21, p=0.001 for non-inferiority). Baricitinib was non-inferior to tocilizumab for the time to hospital discharge within 28 days (discharged alive-tocilizumab: 52.4% vs baricitinib: 58.4%; HR 0.85, (95% CI: 0.61 to 1.18), p<0.001 for non-inferiority). There was no significant difference between baricitinib and tocilizumab arm in the change in WHO scale at day 10 [0.0 (95% CI: 0.0 to 0.0) vs 0.0 (95% CI: 0.0 to 1.0), p=0.83].ConclusionBaricitinib was non-inferior to tocilizumab with regards to the composite outcome of mechanical ventilation or death by day 28 and the time to discharge by day 28 in patients with severe COVID-19. Cost-effectiveness should be taken into account to avoid a dramatic upswing in health system budgets.