December 21, 2020
By Douglas L. Jennings, PharmD, FACC, FAHA, FCCP, FHFSA, BCPS
The pandemic continued its deadly ascent in America this week, shattering once-unthinkable numbers: a single-day caseload of more than 251,000 new coronavirus infections, 1 million new ones in just five days and more than 3,600 deaths in a single day. While the deployment of a second COVID-19 vaccine this weekend comes as welcome news, it will take months for the impact of these vaccines to curb infections, and in the meantime the healthcare system will be forced to continue to explore drug therapy options to combat the pandemic.
On December 11th, the results of an NIH-sponsored trial evaluating the combination of baricitinib, an anti-inflammatory drug, and remdesivir, an antiviral, were published in the New England Journal of Medicine. This latest clinical trial is the second iteration of the NIH Adaptive COVID-19 Treatment Trial (ACTT-2), a study protocol to evaluate therapeutics for people hospitalized with COVID-19. Remdesivir is a broad-spectrum antiviral treatment which was recently covered in another of my blogs. Baricitinib, marketed under the brand name Olumiant, is a Janus kinase inhibitor that acts by blocking the subtypes JAK1 and JAK2. It is approved in more than 70 countries as a treatment for adults with moderately-to-severely active rheumatoid arthritis. Researchers hypothesized that because many severe symptoms of COVID-19 result as a sequela of an over-exaggerated immune response, a therapeutic agent designed to target inflammation could be helpful for patients.
This study enrolled a total of 1,033 volunteer participants who were randomized to receive a treatment regimen of either baricitinib or placebo in combination with remdesivir. The combination of baricitinib and remdesivir reduced median time to recovery in hospitalized COVID-19 patients from eight days to seven days. Importantly, patients who required high-flow oxygen or non-invasive ventilation during their hospitalization appeared to have had the largest benefit: their median time to recovery was shortened from 18 days to ten days. In addition, participants’ conditions at day 15 of the study (as measured by an eight-category ordinal scale which ranked the severity of their condition) was significantly improved when they received the two therapeutics combined. Overall, side effects were comparable between groups.
On the heels of this publication, the FDA granted an Emergency Use Authorization for baricitinib for COVID-19 disease. While none of the major medical societies like the NIH and the WHO have updated guidelines to reflect this new data, I suspect that all will provide some recommendations for use. Unfortunately, I find the results of this new study to be fairly underwhelming, and I believe the that NIH and the WHO will recommend this agent purely because we are still struggling to discover truly effective agents to manage patient’s infected with COVID-19. My premonition (and my secret hope) is that in a year or so we’ll have much more effective drug therapies at our disposal (or we won’t need them due to widespread vaccination), and we’ll be wondering why we ever entertained using agents like baricitinib and remdesivir.
Dr Jennings is currently an Associate Professor of Pharmacy at Long Island University and the clinical pharmacist for the Heart Transplant and LVAD teams at NewYork- Presbyterian Hospital Columbia University Irving Medical Center. He is an active researcher in his field, and he has published over 120 peer-reviewed abstracts and manuscripts, primarily focusing on the pharmacotherapy of patients under mechanical circulatory support. As a recognized expert in this area, he has been invited to speak at numerous national and international venues, including meetings in France, Saudia Arabia, India. Finally, Dr. Jennings has been active in professional organizations throughout his career. He is a fellow of the American College of Clinical Pharmacy, the American College of Cardiology, the Heart Failure Society of America, and the American Heart Association.
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Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19 [published online ahead of print, 2020 Dec 11]. N Engl J Med. 2020;10.1056/NEJMoa2031994. doi:10.1056/NEJMoa2031994