An Evaluation of Efficacy and Safety of Tofacitinib, A JAK Inhibitor in the Management of Hospitalized Patients with Mild to Moderate COVID-19 - An Open-Label Randomized Controlled Study

Abstract

Several systemic anti-inflammatory and immunomodulatory agents were tried in the management of hyper inflammatory manifestations of COVID 19. JAK inhibitors have been widely deployed in rheumatology due to their benefits in managing uncontrolled inflammation. Tofacitinib is one of the most widely studied immunomodulators in rheumatology. We assessed the safety and efficacy of Tofacitinib in an open-labeled randomized control study, in addition to the standard of care (SOC) in hospitalized adults with mild to moderate COVID-19 pneumonia. Patients (n=100) with COVID 19 pneumonia admitted during October -December 2020 were randomly assigned to either control (N=50) (SOC treatment alone) or to study groups (N=50) receiving Tofacitinib in addition. Patients, reporting positive RT-PCR for SARS-COV2 and radiological evidence of pneumonia were hospitalized for over 7 days. The study group received Tofacitinib for 14 days irrespective of the discharge status and was followed up to 28 days. There was a greater relative reduction in levels of important markers of inflammation in the Tofacitinib group than in the control group (CRP:78% vs 45%; Ferritin:15% vs 10%; D. Dimer: 37% vs 15%) although there were no differences in duration of hospitalizations or oxygen requirement. Tofacitinib, 10 mg was well-tolerated and was devoid of any serious adverse event. We are the first to record the benefits of Tofacitinib in India to our knowledge although a Brazilian study conducted around the same time showed mortality benefit in severe COVID. We conclude that Tofacitinib use is safe and aids in the reduction of the overwhelming inflammatory response during COVID-19 infections.