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Results of phase III DEVENT trial show improved survival outcomes with ruxolitinib in U.S. participants
Ruxolitinib is a JAK1/2 inhibitor currently approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.1 During the worldwide coronavirus pandemic, the agent has been under investigation for use in patients with COVID-19. The phase III DEVENT trial (NCT04377620) is currently evaluating the efficacy and safety of ruxolitinib 5 mg and 15 mg plus standard of care (SoC) compared with SoC alone in patients with COVID-19-associated acute respiratory distress syndrome (ARDS) on mechanical ventilation.
Results announced recently1 indicate that the primary endpoint of mortality due to any cause up to Day 29 was not met when comparing the two treatment arms versus placebo in the overall study population (N = 211), despite an encouraging trend in favor of ruxolitinib. However, there was a clinically meaningful and statistically significant improvement in mortality rates at both ruxolitinib doses compared with placebo when analyzing the U.S. population only (n = 191), which represented 91% of the overall study population:
- 46.7% ruxolitinib 5 mg vs 69.1% SoC (OR, 0.39; 95% CI, 0.157–0.948; p = 0.0189)
- 47.1% ruxolitinib 15 mg vs 66.7% SoC (OR, 0.43; 95% CI, 0.188–0.974; p = 0.0215)
In addition, post hoc analysis performed with pooled data from both ruxolitinib arms compared with placebo demonstrated a statistically significant improvement in mortality:
- 53.6% ruxolitinib vs 70.7% SoC (OR, 0.47; 95% CI, 0.219–0.996; p = 0.0244)
The safety profile was consistent with patients hospitalized with COVID-19 and with ruxolitinib treatment. The most common adverse events in the ruxolitinib arms versus placebo included anemia (20.7% vs 22.2%), elevated alanine aminotransferase (14.6% vs 13.3%), elevated aspartate transaminase (14.0% vs 8.9%), and hypertension (11.6% vs 11.1%), respectively.
In the light of these findings, access to ruxolitinib for patients with COVID-19-associated ARDS via an Expanded Access Program (EAP) will be discussed with the U.S. Food and Drug Administration (FDA).
In another phase III RUXCOVID trial, ruxolitinib did not show a clinical benefit compared with placebo in preventing complications in patients with COVID-19-associated cytokine storm.
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