Background
death, chronic autoimmune diseases
DISEASE PROGRESSION, DISEASE, EMA
Baricitinib is an oral Janus kinase (JAK) 1/2 inhibitor, approved by the European Medicines Agency (EMA) for several chronic autoimmune diseases [Five randomised controlled trials (RCTs) of baricitinib in COVID-19 have been published with promising results, although study design and effect estimates have varied [The manufacturer-sponsored double-blind, placebo-controlled COV-BARRIER trial investigated baricitinib or placebo added to standard of care (SoC), with approximately 80% receiving systemic corticosteroids. The trial failed to show a difference in the primary endpoint, occurrence of disease progression to high-flow oxygen/non-invasive ventilation, invasive mechanical ventilation, or death by day 28. However, a significant decrease of 28-day mortality in baricitinib recipients was observed, particularly in severe disease [EU-SolidAct is a pan-European multicentre, adaptive platform trial, with its first sub-study Bari-SolidAct investigating baricitinib in patients with severe/critical COVID-19. The primary objective was to evaluate the effect of baricitinib vs. placebo, given in addition to SoC, on the occurrence of death within 60 days.