Eli Lilly & Co. and Incyte Corp. reported on Sept. 29 that baricitinib bested the first-line rheumatoid arthritis (RA) standard of care methotrexate in a late-stage clinical trial, so now the partners must complete just one more Phase III trial before seeking regulatory approvals for the JAK inhibitor.
Baricitinib met the primary endpoint in the Phase III RA-BEGIN study by achieving non-inferiority compared with methotrexate based on ACR20 response rates at 24 weeks of treatment. Lilly's and Incyte's oral, once-daily selective inhibitor of JAK1 and JAK2 also performed better than the generic RA standby treatment. If approved, baricitinib will compete directly with Pfizer Inc