- Eli Lilly and Incyte are in late-stage development of baricitinib, a JAK1/JAK2 inhibitor for treatment of RA. They presented long-term (52-week) results from their pivotal trials at this year's Annual European Congress of Rheumatology in London.
- Treatment-naive and treatment-experienced patients who took baricitinib experienced significantly significant improvements in outcomes related to pain, fatigue, physical function and physical health-related quality of life. Comparators included placebo, oral methotrexate and Humira (adalimumab).
- In addition, in the study, at the one-year mark, baricitinib was superior to placebo at preventing progressive radiographic structural joint damage
If this year's EULAR meeting is any sign, Lilly and Incyte are getting close to finalizing its baricitinib submission for the RA indication.
Lilly/Incyte's clinical development program for baricitinib is extensive and includes more than 40,000 patients worldwide. The phase 3 program includes roughly 3,000 patients is based on four separate pivotal trials, and is designed to investigate the treatment benefits of baricitinib across the spectrum of patients with rheumatoid arthritis, including newly diagnosed patients, patients who have failed to respond to conventional disease-modifying anti-rheumatic drugs (DMARDs), and patients who have failed multiple injectable biologic DMARD therapies.
Some of the highlighted data include data from the study evaluating the use of baricitinib in treatment-naive patients, compared with placebo, methotrexate and a fourth arm combining baricitinib and methotrexate. At 52 weeks, 68% of patients treated with baricitinib alone saw clinically meaningful improvements in physical function, while 72% of the combo group also had clinically meaningful improvements---compared with 57% in the methotrexate monotherapy group.
When researchers looked at the same endpoint in treatment-experienced patients who had failed multiple therapies, including biologics, at the one-year mark, 68% of baricitinib-patients experienced clinically meaningful improvements, compared with 58% of Humira-treated patients. The results were deemed statistically significant.
Lilly plans to file by the end of this year.