Lilly and Incyte Announce Positive Top-Line Results From Phase 3 Trial of Baricitinib in Moderate to Severe Rheumatoid Arthritis
"People with rheumatoid arthritis who have had an inadequate response to TNF inhibitors are generally considered to be the least responsive to subsequent treatments," said
"We are very pleased by these results," said
The RA-BEACON study enrolled 527 patients who had previously failed at least one anti-TNF therapy, and included a high percentage who had also received prior treatment with one or several non-anti-TNF biologic agents. Patients received either 1 of 2 doses of once daily baricitinib or placebo in addition to their background conventional disease-modifying anti-rheumatic drug therapy (cDMARDs).
The incidence of serious adverse events with baricitinib treatment, including serious infections, was similar to placebo. There were no opportunistic infections or gastrointestinal perforations in the study. A higher incidence of treatment-emergent adverse events was observed with baricitinib compared to placebo. The most common adverse events observed with baricitinib were headache, upper respiratory tract infection and nasopharyngitis. Discontinuation rates due to adverse events were similar between treatment groups. A large majority of patients completing this 6-month trial opted to participate in a long-term extension study.
Detailed data from the RA-BEACON study will be presented at scientific meetings in 2015. Lilly and
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 (RA) is an autoimmune diseasei 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,
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.
This press release contains forward-looking statements 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
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