Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis
-- Once-daily oral baricitinib significantly improved all seven components of ACR response versus injectable adalimumab
-- Patient-reported pain, joint stiffness, fatigue and physical function scores significantly improved with baricitinib compared to adalimumab
-- Detailed results from pivotal phase 3 study RA-BEAM presented at the
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Improvements in mean number of swollen and tender joints and a reduction in pain were seen as early as one week for baricitinib versus placebo. At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients' pain and improving physical function. Patient-reported outcomes, including degree of tiredness and the severity and duration of morning joint stiffness, assessed daily for the first 12 weeks of the study, were all significantly improved with baricitinib compared to adalimumab.
At week 52, structural changes in the joints, as measured by changes in the modified Total Sharp Score, were significantly improved for both baricitinib and adalimumab compared with placebo. Lilly and
"Rheumatoid arthritis is a lifelong condition, but it can be managed with treatment to help control symptoms, including joint inflammation and fatigue, to slow the progression of the disease and improve a patient's quality of life," said
RA-BEAM was a 52-week trial of 1,305 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to placebo once daily (n=488), baricitinib 4 mg once daily (n=487) or adalimumab 40 mg biweekly (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.
"This is the first phase 3 study showing that a once-daily, oral treatment significantly improved clinical outcomes compared with injectable adalimumab for patients with active RA who were also receiving treatment with methotrexate," said
Serious adverse event rates were similar for baricitinib compared with placebo and lower for adalimumab, while serious infection rates were similar across groups.** There were no cases of gastrointestinal perforations. One event of tuberculosis was reported, in the adalimumab group. Four deaths occurred, one in the placebo arm, two in the baricitinib arm and one in the adalimumab arm. Two potential opportunistic infections occurred in the baricitinib arm; neither were considered serious. Temporary interruptions in treatment due to adverse events occurred with similar frequency across treatment groups.
"The positive results of the RA-BEAM trial reinforce the potential of baricitinib to quickly improve RA signs and symptoms, physical function and patient-reported outcomes, while inhibiting joint damage," said Rich Levy, M.D., chief drug development officer,
Lilly and Incyte announced top-line results in December 2014 for the first phase 3 trial of baricitinib, RA-BEACON; in February 2015 for the second, RA-BUILD; in
Detailed data from the long-term extension study, RA-BEYOND, also will be submitted for presentation in scientific meetings and publication in peer-reviewed journals in 2016.
Baricitinib is the only once-daily oral selective JAK1 and JAK2 inhibitor currently in late-stage clinical studies for inflammatory and autoimmune diseases. 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
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 AbbVie and not a trademark of
**Safety data are reported for patients receiving initial assigned treatment and prior to any rescue or switching.
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
i American College of Rheumatology, Rheumatoid Arthritis, http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp (Accessed: October 20, 2015)
ii Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis,http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf (Accessed: October 20, 2015)
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 October 20, 2015)
iv Arthritis Foundation, Medications for Rheumatoid Arthritis, http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php (Accessed: October 20, 2015)
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