Baricitinib Superior to Methotrexate in Reducing Signs and Symptoms in Pivotal Phase 3 Study in Patients with Rheumatoid Arthritis
"Too many people with rheumatoid arthritis who are treated with methotrexate - commonly used across the disease continuum for 25 years - do not achieve adequate disease control, which can cause disability and impede productivity," said
David Ricks, Lilly senior vice president, and president of Lilly Bio-Medicines. "People living with RA who achieve adequate disease control can be more active with their families, in their careers and in their communities - emphasizing the importance of effective treatment options."
The RA-BEGIN study included patients who had limited or no prior treatment with methotrexate, and were na?ve to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs). Part of a larger Phase 3 program of more than 3,000 RA patients at various points in the RA treatment continuum, RA-BEGIN enrolled nearly 600 patients who were randomized to one of the following treatment groups:
- Once-weekly oral methotrexate monotherapy
- 4 mg once-daily oral baricitinib monotherapy
- 4 mg once-daily oral baricitinib in combination with once-weekly oral methotrexate
"The superiority of baricitinib over methotrexate in the treatment of patients with early RA adds to the positive data already seen for baricitinib in RA patients with inadequate responses to traditional DMARDs (RA-BUILD) and biological therapies (RA-BEACON)," said
Rich Levy, M.D., chief drug development officer of
In RA-BEGIN, the incidence of treatment-emergent adverse events and serious adverse events, including serious infections, was similar across treatment groups. No cases of tuberculosis or gastrointestinal perforation were reported during the study. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Discontinuations due to adverse events were more common in patients receiving the combination of baricitinib plus methotrexate. A large majority of patients completing RA-BEGIN opted to participate in a long-term extension study.
Baricitinib is a once-daily, oral, selective JAK1 and JAK2 inhibitor. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK 3 in kinase assays.
About Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease[i] characterized by inflammation and progressive destruction of joints.[ii] More than 23 million people worldwide suffer from RA.[iii] Approximately three times as many women as men have the disease. Patients and physicians indicate there remains an important opportunity to improve patient care. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral disease-modifying anti-rheumatic drugs such as methotrexate, and injectable biological response modifiers that target selected mediators implicated in the pathogenesis of RA.[iv]
About Baricitinib Phase 3 Trials
Incyte Corporation is a Wilmington,
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels. (P-LLY)
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for patients with rheumatoid arthritis and reflects Lilly and
[iii] WHO Global Burden of Disease Report, (table 7, page 32) 2004, http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf (Accessed