Baricitinib Demonstrates Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis in Pivotal Phase 3 Study
The study met its primary objective of demonstrating superiority compared to placebo after 12 weeks of treatment based on ACR20 response – a standard clinical measure that represents at least a 20 percent improvement in RA disease activity. Baricitinib was also superior to adalimumab on key secondary objectives of ACR20 response and improvement in DAS28-hsCRP score after 12 weeks of treatment. Following 24 weeks of treatment, baricitinib was superior to placebo in preventing progressive radiographic structural joint damage. These treatment benefits with baricitinib observed at 12 and 24 weeks were maintained through 52 weeks of therapy.
"RA-BEAM is the first study to demonstrate that a once-daily oral treatment was superior in improving signs and symptoms of rheumatoid arthritis compared to the current injectable standard of care," said
"Combined results of these four Phase 3 studies give us confidence that, if approved, baricitinib could represent a valuable new treatment option for patients with RA," said
RA-BEAM evaluated the safety and efficacy of baricitinib in patients with active disease despite treatment with methotrexate, compared to placebo for 24 weeks or adalimumab (Humira®)* for 52 weeks. Part of a larger Phase 3 program of more than 3,000 RA patients at various points in the RA treatment continuum, RA-BEAM enrolled more than 1,300 patients who were randomized to one of three treatment groups:
- 4 mg oral once-daily baricitinib on background methotrexate
- 40 mg injectable every-other-week adalimumab on background methotrexate
- placebo on background methotrexate
Compared to placebo, serious adverse events rates were similar for baricitinib and lower for adalimumab; serious infection rates were similar across groups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported in each of the baricitinib and adalimumab groups. Rates of treatment-emergent adverse events, including infections, were higher for baricitinib and adalimumab compared to placebo. The most common adverse events observed with baricitinib were nasopharyngitis and bronchitis. Discontinuations due to adverse events occurred with similar frequency across treatment groups. A large majority of patients completing this trial 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 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,
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.
*The brand listed is a trademark of
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
ii Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf (Accessed:
iiiWHO 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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