Pfizer's RA Drug Reduces Death, Respiratory Failure in COVID-19-Related Pneumonia
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Treatment with Pfizer’s oral rheumatoid arthritis drug Xeljanz (tofacitinib) was associated with a reduction in death or respiratory failure in hospitalized patients with COVID-19-related pneumonia, according to findings from a study in Brazil.
Findings from the placebo-controlled STOP-COVID study, published Wednesday in the New England Journal of Medicine, suggest the oral Janus kinase (JAK) inhibitor tofacitinib could be a potential contender in the race to identify benefit for COVID-19 in already approved therapies. The therapy is currently approved for rheumatoid arthritis but not for COVID-19 or COVID-19-related pneumonia.
Researchers in the study assessed the safety and efficacy of Pfizer’s rheumatoid arthritis drug in 289 hospitalized adults with COVID-19-related pneumonia who were not on ventilation. The study focused on patients from 15 sites in Brazil.
Treatment with Xeljanz was associated with a significantly lower cumulative incidence of death or respiratory failure through 28 days compared with placebo (18.1% vs. 29.0%, respectively; p=0.04). Approximately 2.8% of patients in the Xeljanz arm and 5.5% of patients in the placebo group died from any cause by day 28.
Serious adverse events were reported in 14.1% and 12.0% of patients in the Xeljanz and placebo groups, respectively. Deep vein thrombosis, acute myocardial infarction, ventricular tachycardia, and myocarditis occurred in one patient each in the placebo arm. A lower proportion of serious infections were reported in the tofacitinib group (3.5% vs. 4.2%).
“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 at Hospital Israelita Albert Einstein, the trial’s coordinating center. “The study builds on the hypothesis that JAK inhibition could mitigate systemic and alveolar inflammation in patients with COVID-19-related pneumonia.”
Other therapies in the running to treat COVID-19 and its effects on the body include several monoclonal antibodies. One therapy, Humanigen’s lenzilumab, has shown promise in late-stage research for the prevention and treatment of cytokine storm, an immune hyper-response to COVID-19.
Data from the Phase III LIVE-AIR clinical study, for instance, demonstrated that treatment with lenzilumab led to a 54% relative improvement in the likelihood of survival without ventilation compared with the use of a placebo. Patients who received lenzilumab in conjunction with corticosteroids and remdesivir in this study also had a 92% improvement in the relative likelihood of survival without ventilation.
“It is amazing to see what targeted treatments can do when their use can be properly characterized as we observed in the LIVE-AIR clinical trial,” said Vincent Marconi, MD, of Emory University School of Medicine, where lenzilumab was studied as part of the National Institutes of Health (NIH) ACTIV-5 trial. “We are pleased to be part of the effort that might provide physicians in multiple countries with lenzilumab for the treatment of hospitalized COVID-19 patients.
Findings from the LIVE-AIR trial were recently submitted alongside an Emergency Use Authorization request to the U.S. Food and Drug Administration for the therapy. Humanigen also announced this week that it had sent the trial data with a Marketing Authorization in COVID-19 request to the U.K.’s Medicines and Healthcare Products Regulatory Agency.