Pfizer’s BioNTech-partnered COVID-19 vaccine Comirnaty may be getting all the attention these days, but the pharma giant’s anti-inflammatory drug Xeljanz just chalked up a win in treating patients hospitalized with the disease.
Xeljanz reduced the risk of death or respiratory failure among hospitalized patients with COVID-19 pneumonia who didn’t require ventilation, according to data published in The New England Journal of Medicine.
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The data come from the STOP-COVID study, which enrolled 289 hospitalized patients across 15 sites in Brazil. After 28 days of treatment, death or respiratory failure had occurred in 18.1% of patients on Xeljanz, compared with 29% for those who received placebo. All patients also received other standard-of-care treatments, including corticosteroids, which were given to nearly 90% of patients in both trial arms.
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Xeljanz, a JAK inhibitor, is currently approved in the U.S. for inflammatory diseases including rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. The idea behind STOP-COVID is that JAK inhibition could reduce the release of cytokines, which can cause serious inflammation-driven lung injury or even death in hospitalized COVID-19 patients.
Before Xeljanz’s win, Incyte and Novartis’ JAK inhibitor Jakafi narrowly failed to significantly reduce the risk of death among patients on mechanical ventilation through 29 days of treatment in a separate trial. In U.S. patients, who made up 91% of that study, Jakafi demonstrated what Incyte called a “clinically and statistically significant” improvement in death.
In the Xeljanz study, 2.8% of patients who got the Pfizer drug had died through day 28, compared with 5.5% for the placebo.
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Meanwhile, Pfizer’s Xeljanz faces safety questions after a postmarketing study flagged heart risks. The FDA, under the impression that it’s a class-wide problem, has recently delayed decisions on multiple JAK drugs in various indications.
Because of that safety concern, the STOP-COVID trial excluded patients with a known history of blood clots. All told, investigators recorded four specific heart-related side effects of interest in the Xeljanz group. Hemorrhagic stroke and cardiogenic shock happened in one patient each in the placebo group.