A phase 3 study evaluating the efficacy and safety of ruxolitinib (Jakafi; Incyte), a Janus kinase JAK1/JAK/2 inhibitor, for the treatment of coronavirus disease 2019 (COVID-19) associated cytokine storm did not meet its primary end point.
The global, double-blind, placebo-controlled RUXCOVID study compared ruxolitinib to placebo, in addition to standard of care, in 432 patients aged 12 years and older with COVID-19 associated cytokine storm. Patients were randomized to receive oral ruxolitinib 5mg twice daily or placebo for a total of 14 days; an additional 14 days of study therapy could be administered to those whose symptoms did not improve or worsened after 14 days of treatment.
Results showed that treatment with ruxolitinib was not associated with a reduction in the proportion of patients who experienced death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit by day 29, when compared with placebo (12% vs 11.8%, respectively; odds ratio 0.91; 95% CI: 0.48-1.73; P =0.769). Moreover, ruxolitinib failed to demonstrate clinical benefit for secondary and exploratory end points, including mortality rate by day 29 and time to recovery.
“Given the urgent nature of the COVID-19 pandemic and the need for treatments for patients hospitalized with severe COVID-19 associated cytokine storm, the results of the RUXCOVID study are disappointing,” said Steven Stein, MD, Chief Medical Officer, Incyte. “However, we hope that these findings will contribute to the scientific understanding of this complex disease and to the collective efforts of the biopharma industry to find solutions that improve outcomes for patients with COVID-19.”
The findings of this study do not affect other ongoing non-COVID-19 related ruxolitinib clinical trials or approved uses of ruxolitinib.
For more information visit incyte.com.
Incyte announces results of phase 3 RUXCOVID study of ruxolitinib (Jakafi®) as a treatment for patients with COVID-19 associated cytokine storm. [press release]. Wilmington, DE: Incyte; December 14, 2020