Additional results from pivotal RA-BEAM study published in New England Journal of Medicine show baricitinib-treated patients demonstrated sustained improvement in rheumatoid arthritis compared to adalimumab and placebo
The
A significantly higher proportion of patients taking baricitinib had low disease activity, assessed by the 28-joint Disease Activity Score (using high-sensitivity C reactive protein [DAS28-CRP]), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) scores, compared to adalimumab at weeks 12 and 52.
Lilly and
"This is an exciting time for rheumatology, with potential new treatments for rheumatoid arthritis on the horizon. The RA-BEAM study of baricitinib is the first phase 3 trial showing that a once-daily, oral treatment significantly improved clinical outcomes compared with a current standard of care, injectable adalimumab used with background methotrexate therapy," said
The 52-week RA-BEAM study included more than 1,300 patients with inadequate response to methotrexate, all of whom continued to receive methotrexate through the study period. Patients were randomized to placebo once daily (n=488), baricitinib 4 mg once daily (n=487) or adalimumab 40 mg biweekly (n=330). At week 24, patients taking placebo were crossed over to the baricitinib treatment group. The design of the head-to-head study and statistical analysis plan included prespecified and controlled for multiple testing for both non-inferiority and superiority of baricitinib compared with adalimumab.
Detailed safety results from the trial show that the percentage of patients stopping therapy due to adverse events through week 24 were 3 percent in placebo, 5 percent in baricitinib and 2 percent in the adalimumab group. Serious adverse event rates through 24 weeks were similar with placebo and baricitinib (5 percent each) and lower with adalimumab (2 percent).
Through the 52-week period, serious adverse event rates were 8 percent for baricitinib and 4 percent for adalimumab. Patients stopping therapy due to adverse events from baseline through week 52 were 7 percent for baricitinib and 4 percent for adalimumab. Major adverse cardiovascular events (MACE) were reported in less than 1 percent of patients in both the baricitinib and adalimumab groups (baseline through 52 weeks). A total of 5 deaths were reported in the study (1 placebo, 2 baricitinib, 1 adalimumab and 1 placebo rescued to baricitinib).
Baricitinib, an investigational medicine for the treatment of moderate-to-severe RA, is in the late stages of regulatory review in
About Baricitinib
Baricitinib is a 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.
In
About Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease characterized by inflammation and progressive destruction of joints.i,ii More than 23 million people worldwide suffer from RA.iii Approximately three times as many women as men have the disease. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral conventional disease-modifying antirheumatic drugs (cDMARDs), such as methotrexate - the current standard of care - and injectable, biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.iv Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission.v,vi There remains an important need to provide additional treatments to improve overall patient care.
About Baricitinib Phase 3 Trials
Lilly and
For additional information on this clinical trial program, please visit www.clinicaltrials.gov.
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About
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 a not trademark of
(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 rheumatoid arthritis and the RA-BEAM trial, and reflects Lilly and
i American College of Rheumatology, Rheumatoid Arthritis, http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp (Accessed: September 15, 2016)
ii Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf (Accessed: September 15, 2016)
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 September 15, 2016)
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: September 15, 2016)
v Rheumatoid arthritis,
vi Sustained rheumatoid arthritis remission is uncommon in clinical practice,
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