Baricitinib plus remdesivir improve outcomes for patients with COVID-19 vs. remdesivir alone
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Patients with COVID-19 who were treated with baricitinib and remdesivir had a lower median time to hospital discharge and lower mortality rates than patients treated with remdesivir alone, Eli Lilly & Co. and Incyte announced in a press release.
John Beigel, MD, associate director for clinical research in the National Institute of Allergy and Infectious Diseases’ division of microbiology and infectious diseases, presented the new findings from the Adaptive COVID-19 Treatment Trial (ACTT-2) at the International Society for Influenza and other Respiratory Virus Diseases Antiviral Group’s virtual Therapeutics for COVID-19 conference.
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New efficacy and safety data from the ACTT-2 showed that fewer patients treated with baricitinib (Olumiant, Eli Lilly & Co.) and remdesivir (Gilead Sciences Inc.) died (5.1% vs. 7.8%; HR = 0.65; 95% CI, 1.08) compared with remdesivir alone. Patients who required supplemental oxygen (60% lower) or high-flow oxygen/non-invasive ventilation (43% lower) saw the most significant reductions in mortality.
According to the release, the ACTT-2 also found the combination of baricitinib and remdesivir reduced time to hospital discharge from 8 days to 7 days (IR = 1.16; 95% CI, 1.01-1.32), improved odds of clinical status improvement at day 15 by 30% (OR = 1.3; 95% CI, 1.0-1.6) and fewer deaths at day 29 (5.1% vs. 7.8%; HR=0.65; 95% CI, 0.39-1.08) compared with remdesivir alone.
“We are excited that these results add to the potential role for baricitinib to treat hospitalized COVID-19 patients,” Ilya Yuffa, senior vice president of Eli Lilly and president of Lilly Bio-Medicines. “Lilly is committed to identifying impactful preventions and treatments, and we are engaged in discussions with the FDA regarding the potential to make baricitinib available to hospitalized patients as quickly as possible.”
Eli Lilly said in the release that it is “continuing conversations” with the FDA regarding an emergency use authorization to treat COVID-19 with baricitinib. Baricitinib’s efficacy and safety in treating COVID-19 has not been established, per the release.
Perspective
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Amiel Y. Tokayer, MD, FACR
Inhibition of Janus kinases (JAK) in effort to control the cytokine release syndrome further highlights the unique role rheumatologists play in understanding the pathophysiologic process of SARS -CoV-2 (COVID-19). This study is an example of an ever-evolving attack strategy against the deadly ‘cytokine storm’ seen in COVID-19. The rheumatologist is not only familiar with the responsible cytokines, but also with its treatments.
Baricitinib, the second FDA-approved JAK inhibition treatment of rheumatoid arthritis, is an effective addition to the rheumatologist’s treatment repertoire. As the name suggests, cytokine storm involves many cytokines, not just one. Further studies may highlight an individual cytokine that plays a key role, but for now, targeting intracellular signaling pathways mediated by JAK makes the most sense.
In the U.S., the FDA-approved baricitinib dose for RA is 2 mg. Higher rates of venous and arterial thrombotic events were seen in their 4 mg dose. Knowing the higher rate of thrombotic events in COVID-19 patients, it would be interesting to see if the 14-day course of baracitinib 4 mg in this study showed any uptick in deep vein thrombosis compared to the remdesivir vs. placebo arm.
Despite the higher rates of infections seen in patients being treated with targeted immune modulators, this study further emphasizes the relative safety and importance of continuation of these treatments during this COVID-19 pandemic.
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