Baricitinib significantly reduces joint damage progression in rheumatoid arthritis in patients who do not respond to conventional DMARDs
"Together with the improvement of clinical and quality of life symptoms, which are so important for rheumatoid arthritis patients, a key goal of treatment is to restrict the structural damage rheumatoid arthritis causes to joints, a hallmark of the disease," said
In RA-BEYOND, patients who completed the pivotal 24-week RA-BUILD study continued to receive baricitinib at the same dose of either 2 mg or 4 mg, received at the end of RA-BUILD. Patients receiving placebo at the end of RA-BUILD were switched to baricitinib 4 mg in RA-BEYOND. Following 24 weeks of treatment, baricitinib was superior to placebo in preventing progressive radiographic structural joint damage. These treatment benefits were maintained through 48 weeks of therapy. The most robust benefits across measures of progressive joint damage were observed for the 4 mg baricitinib dose.
"We are pleased to present these data from the RA-BEYOND study, which reinforce our belief in baricitinib as a next generation potential therapy for rheumatoid arthritis," said
"Findings from this long-term extension study suggest that, if approved, baricitinib has the potential to bring hope to patients with rheumatoid arthritis who deserve better treatment options," said
At the time of the present evaluation, the ongoing RA-BEYOND study had enrolled more than 2,600 patients who completed previous baricitinib trials, including RA-BUILD. The RA-BUILD study enrolled 684 patients with RA who previously had an inadequate response to, or were intolerant of, at least one conventional DMARD and had not received a biologic DMARD. Patients completing RA-BUILD and entering RA-BEYOND continued to receive the baricitinib dose received at the end of RA-BUILD. Patients receiving placebo at the end of RA-BUILD were switched to 4 mg baricitinib in RA-BEYOND.
Structural joint damage was evaluated using
In RA-BUILD, the incidence of treatment-emergent adverse events and serious adverse events was similar between baricitinib and placebo. Discontinuation or interruption in treatment due to adverse events were also similar between baricitinib and placebo in RA-BUILD.
Baricitinib is a once-daily oral highly 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 JAK3 in kinase assays.
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
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About Eli Lilly and Company
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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-BUILD and RA-BEYOND trials, and reflects Lilly and
i American College of Rheumatology, Rheumatoid Arthritis, http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp (Accessed: May 16, 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: May 16, 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 May 16, 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: May 16, 2016)
v Rheumatoid arthritis,
vi Sustained rheumatoid arthritis remission is uncommon in clinical practice,
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