Baricitinib arm results from RECOVERY study on hospitalized COVID-19 patients

The Ph2/3 RECOVERY trial announced results (medRxiv pre-print can be found here) that demonstrated baricitinib (JAK 1/2 inhibitor, 4mg QD for 10 days, brand name Olumiant) reduces the risk of death used to treat hospitalized patients with severe COVID-19. Below are the key details of the data readout; additional details are provided below my signature:

• At randomization, 95% of patients were receiving a corticosteroid such as dexamethasone, 23% were receiving tocilizumab, and 20% were remdesivir.
• Treatment with baricitinib significantly reduced deaths. 12% of the patients in the baricitinib group died within 28 days compared with 14% patients in the usual care group, representing an 0.87 age adjusted rate ratio (RR) (p=0.026).
• In a subgroup analysis, patients treated with baricitinib and remdesivir as part of ‘usual care’ had a 0.71 RR (statistically significant) in 28-day mortality compared to ‘usual care’ alone while patients treated with baricitinib without remdesivir as part of ‘usual care’ had a 0.91 RR (not statistically significant) in 28-day mortality compared to ‘usual care’ alone. However, the pre-print article does not acknowledge this observed benefit and instead states, “The benefits of baricitinib were also consistent regardless of concomitant treatment with remdesivir, a systemic corticosteroid and/or an IL-6 receptor blocker.”

Results from a study of this size could potentially influence guidelines on whether to combine remdesivir with baricitinib, so it is noteworthy that the pre-print manuscript appears to disregard the additional benefit when the two therapies are used together to treat hospitalized COVID-19 patients.

Additional details on RECOVERY baricitinib trial readout

• Patients in this arm were enrolled between Feb and Dec 2021, 4008 patients randomly allocated to ‘usual care’ alone were compared with 4148 patients who were randomly allocated to ‘usual care’ plus baricitinib.
• 68% of patients were receiving oxygen and 27% were receiving additional respiratory support.
• Patients receiving baricitinib were also more likely to be discharged alive within 28 days (80% vs. 78%; p<0.001).
• Among patients not on invasive mechanical ventilation when entering the trial, baricitinib reduced the chance of progressing to invasive mechanical ventilation or death from 17% to 16% (p=0.026).