An experimental drug for rheumatoid arthritis being developed by Eli Lilly and Incyte is attracting attention having outperformed standard of care methotrexate in a late-stage clinical trial.
Top-line data from the Phase III RA-BEGIN trial show that baricitinib was not only non-inferior to methotrexate in reducing the signs and symptoms of RA (the primary endpoint, as measured by the ACR20 response after 24 weeks’ treatment) - but also beat it.
And on the safety side, the incidence of treatment-emergent side effects and serious adverse events, including serious infections, was similar across treatment groups, the firms noted.
The experimental once-daily JAK inhibitor has already shown efficacy in RA patients with inadequate responses to traditional disease-modifiying anti-rheumatic drugs (in the RA-BUILD trial) and biological therapies (in RA-BEACON).
"The sum of these results further illustrates the therapeutic profile of baricitinib,” said Rich Levy, chief drug development officer of Incyte. “If approved, we believe that baricitinib has the potential to be used across multiple lines of therapy in rheumatoid arthritis”.