by David Borenstein, MD Executive EditorTheSpineCommunity.com9/2020

Coronavirus 19 infection is a novel disease that has spread across the world. Since it is a new infection, all of the world’s population is at risk. A number of clinical trials are ongoing in an attempt to find the best combination of therapy to control this infection. In November 2019, the Food and Drug Administration (FDA) released an emergency use authorization (EUA) for a new combination of 2 agents for the treatment of hospitalized Covid patients.

Baricitinib is an oral janus kinase (JAK) inhibitor, which blocks a key signal-transduction pathway. The pathway mediates the biologic activity for a large number of inflammatory cytokines and mediators that are elevated in Covid-19 infection. Baricitinib is an oral, 2 mg tablet that is approved for the treatment of rheumatoid arthritis.

Remdesivir is an antiviral intravenous drug that is being utilized for adults and children 12 years of age and older for the treatment of Covid-19 requiring hospitalization.

The information supporting the combination baricitinib and remdesivir EUA was based on a clinical trial double-blind, placebo-controlled conducted by the National Institute of Allergy and Infectious Diseases (NIAID). The clinical trial evaluated whether barcitinib alone or in combination with remdesivir offered a better recovery for patients with Covid-19. Better recovery was defined as either being discharged from the hospital or not requiring supplemental oxygen. The trial group of 1033 patients were split between 515 individuals on the combination and 518 on remdesivir alone. The median time to recovery from Covid-19 was 7 days for the combination and 8 days for remdesivir alone. The odds of patients of progressing to death or being ventilated at day 29 were better with the combination and the odds of clinical improvement at day 15 were higher with the combination.

While this advance of the therapy for Covid-19 was approved for a EUA by the FDA, physicians at the Cleveland Clinic questioned the wisdom of adding a JAK inhibitor to the treatment of Covid-19. The concern was the safety of this drug class in critically ill patients when compared to the use of another agent, dexamethasone, that has also been approved for treatment of hospitalized Covid patients. A theoretical better combination could be the combination of baricitinib and dexamethasone. Dexamethasone reduces Covid deaths by 33%. However, infections other than Covid-19 may increase significantly with the combination without improving the outcome of Covid-19 significantly.

At this point, the optimal therapy for Covid-19 is to prevent the infection to begin with by wearing a mask, socially distance, and wash hands frequently. If hospitalized, the decision for optimal therapy corresponding to your condition and the therapies available will be made by your intensive care physician in the hospital.

References:

  1. Baricitinib EUA Letter of Authorization (https://www.fda.gove/media/143822/download)
  2. Keep Current With The Rheumatoid Arthritis Community Newsletter
  3. Connect With Others In The Rheumatoid Arthritis Community To Share Information And Support