USA – Pfizer Inc. and The Academic Research Organization (ARO) from the Hospital Israelita Albert Einstein announced that the findings from the STOP-COVID study came out positive.
The New England Journal of Medicine published positive findings from the study evaluating the efficacy and safety of oral Janus kinase (JAK) inhibitor tofacitinib in 289 hospitalized adult patients with COVID-19 pneumonia who were not on ventilation.
Tofacitinib is a type of drug known as a Janus kinase (JAK) inhibitor that works by blocking the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of rheumatoid arthritis and psoriatic arthritis.
Pfizer has been committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.
The tofacitinib trial was a research collaboration between Pfizer and the ARO from the Hospital Israelita Albert Einstein in Sao Paulo, Brazil, though it has not been approved or authorized for use by any regulatory authority worldwide for the treatment of COVID-19.
The trial demonstrated a lower cumulative incidence of death or respiratory failure through day 28 for primary outcome of the study with tofacitinib (18.1%) compared to placebo (29.0%).
Serious adverse events occurred in 20 patients (14.1%) in the tofacitinib group and 17 (12.0%) in the placebo group.
Among protocol-specified adverse events of special interest, deep vein thrombosis, acute myocardial infarction, ventricular tachycardia, and myocarditis occurred in one patient each in the tofacitinib group; hemorrhagic stroke and cardiogenic shock occurred in one patient each in the placebo group.
Hence the incidence of serious infection was witnessed in 3.5% of the tofacitinib group and 4.2% of the placebo group.
“We are encouraged by the initial findings of our randomized trial of tofacitinib in patients hospitalized with COVID-19 pneumonia. These results provide new information which indicates that the use of tofacitinib when added to standard of care, which includes glucocorticoids, may further reduce the risk of death or respiratory failure in this patient population,” said Otavio Berwanger, M.D., Ph.D., Director of the Academic Research Organization, Hospital Israelita Albert Einstein.
“The study builds on the hypothesis that JAK inhibition could mitigate systemic and alveolar inflammation in patients with COVID-19-related pneumonia.”
“To effectively combat the COVID-19 pandemic, there remains a critical need for multiple therapeutic options to treat patients who have contracted the virus,” said Tamas Koncz, M.D., Ph.D., Chief Medical Officer, Pfizer Inflammation & Immunology.
“As outlined in Pfizer’s five-point plan at the onset of the COVID-19 pandemic, we are keenly focused on working across the healthcare ecosystem with partners like Hospital Israelita Albert Einstein. We look forward to our continued collaboration as we analyze the full dataset from this study and assess next steps.”
Overall, out of the adult patients hospitalized with COVID-19 pneumonia receiving standard care and under the multi-center, randomized, double-blinded placebo-controlled trial, 89.3% used glucocorticoids during hospitalization, predominantly dexamethasone.
Dexamethasone is a glucocorticoid used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects.