Eli Lilly and Incyte’s rheumatoid arthritis therapy baricitinib has proved to be superior to methotrexate in a Phase III trial, the third of four studies in its development programme.
Top-line results from the BEGIN trial in patients with moderately-to-severely active RA exceeded its primary objective of showing non-inferiority of baricitinib to methotrexate based on an ACR20 response rate (20% improvement in signs and symptoms of RA) after 24 weeks of treatment. It also demonstrated superiority to methotrexate based on ACR20 response and its side effects profile was good.
Baricitinib is a once-daily, oral Janus kinase (JAK) inhibitor and if approved for marketing would compete with Pfizer’s Xeljanz (tofacitinib). It has already shown efficacy in RA patients with inadequate responses to traditional disease-modifiying anti-rheumatic drugs and biological therapies.
The fourth trial is a head-to-head comparison with AbbVie’s TNF-targeting antibody Humira (adalimumab) and is due to report by the end of the year.