Four different clinical studies reveal that rheumatoid arthritis drug baricitinib may be effective in preventing cytokine storms—those severe immune system reactions in severe to critical COVID-19 cases—that can lead to patient morbidity and mortality.
What is Baricitinib?
Baricitinib was developed by Eli Lilly. Sold under the brand name Olumiant (and others), this is a drug for the treatment of rheumatoid arthritis in adults whose disease was not well controlled using standard RA medications called tumor necrosis factor antagonists. The drug acts as an inhibitor of janus kinase, blocking the subtypes JAK1 and JAK2. The drug is approved for use in both the European Union and the United States.
Hospital of Prato Study
The Hospital of Prato, Italy, treated 113 patients with baricitinib and compared them to a control group of 78 patients. The deaths in the baricitinib group were significantly lower; in fact, not one patient taking baricitinib died compared to five deaths in the control group. One patient in the baricitinib group had to be admitted to intensive care, while 14 in the control group went to intensive care. As reported in Sifted, the new media site for Europe’s innovators and entrepreneurs, 88 of the baricitinib patients were discharged from the hospital within two weeks compared to only 10 with the control group.
The Hospital of Prato study and three additional studies identified below point to the possible effectiveness of baricitinib. Sifted reports that the drug is currently under investigation in 12 clinical trials worldwide (TrialSite News found 13) while results from bigger studies sponsored by NIAID and Eli Lilly centered on a total of 1,200 patients should be disclosed within 1.5 to 2 months.
Baricitinib restrains the immune dysregulation in COVID-19 patients (data on 20 patents administered the drug); Bronte et al., Department of Medicine, University and Hospital Trust of Verona, Italy; Date: 26 June 2020
Baricitinib therapy in COVID-19: A pilot study on the safety and clinical impact (data on 12 patients administered baricitinib); Journal of Infection, Cantini et al., Rheumatology Department, Hospital of Prato, Italy; Date: 23 April 2020
Use of Baricitinib in Patients with Moderate and Severe COVID-19 (data on 15 patients administered baricitinib); Clinical Infectious Diseases; Titanji et al., Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, United States; Date: 29 June 2020.
Studies to Monitor
The Phase 3 Adaptive COVID-19 Treatment Trial (ACTT-II), sponsored by the National Institutes of Allergy and Infectious Diseases (NIAID), will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone in subjects hospitalized with COVID-19. The adaptive, randomized, double-blind placebo-controlled trial was established to evaluate the safety and efficacy of these novel therapeutic agents in hospitalized COVID-19 patients. The study involves up to 100 sites globally and up to 1,023 patients; the study commenced in May 2020 and runs ongoing until August 2023.
The University of Southern California in collaboration with the National Cancer Institute (NCI) initiated a Phase 2 study in May where the investigators, led by Heinz-Josef Lenz, MD, investigates the effect of baricitinib in combination with antiviral therapy (Hydroxychloroquine, Lopinavir/ritonavir/or remdesivir) for the treatment of patients with moderate to severe SARS-CoV-2 (COVID-19). With a target of 144 patients, the use of antiviral therapies is sought to treat against infections, while baricitinib is evaluated as a way to reduce lung inflammation. In total, investigating both classes of treatments in this study is investigated as a means of reducing the risk of the disease from worsening and may help prevent the need for the patient to be placed on a ventilator should the disease worsen compared to antiviral therapy alone.