Pfizer’s JAK inhibitor Xeljanz reduced the risk of severe outcomes in hospitalised adult patients with COVID-19 pneumonia who were not on ventilation, according to new study data.
The STOP-COVID trial was conduction by Pfizer and the ARO from the Hospital Israelita Albert Einstein in Sao Paolo, Brazil, which was also the trial coordinating centre.
Patients were randomised to receive either Xeljanz (tofacitinib) 10mg twice daily plus standard of care (SoC) or placebo twice daily plus SoC for up to 14 days or until hospital discharge.
The trial demonstrated a reduced cumulative incidence of death or respiratory failure through day 28 with Xeljanz (18.1%) compared to placebo (29.9%).
In addition, death from any cause occurred in 2.8% of Xeljanz-treated patients compared to 5.5% in the placebo group.
In the study, serious adverse groups occurred in 14.1% of patients in the Xeljanz group and 12% in the placebo group.
Protocol-specified adverse events of special interest included deep vein thrombosis, acute myocardial infarction, ventricular tachycardia, and myocarditis in the Xeljanz group.
Meanwhile, haemorrhagic stroke and cardiogenic shock occurred in one patient each in the placebo group.
“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, 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 analyse the full dataset from this study and assess next steps,” he added.