Recently, new data showing significant improvement in patient-reported outcomes with baricitinib for rheumatoid arthritis (RA) were published in the Annals of the Rheumatic Diseases. The data is from from Eli Lilly and Company and Incyte Corporation‘s RA-BEACON trial, a pivotal phase 3 global study of baricitinib, a once-daily oral treatment currently under regulatory review for the treatment of moderate-to-severe rheumatoid arthritis (RA).
The study showed that baricitinib treatment improved most patient-reported outcomes and health related quality of life measures significantly compared with placebo, and patients receiving baricitinib 4 mg had a quicker and greater improvement than those receiving baricitinib 2 mg.
National Pain Report reached out to James McGill, M.D., distinguished medical fellow and global brand development leader for Lilly Bio-Medicines, to ask a few questions:
National Pain Report: Will this be an OTC or prescription application?
James McGill, M.D.: It is an application for a prescription medicine. Lilly submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of oral once-daily baricitinib for the treatment of moderate-to-severe rheumatoid arthritis (RA) in January 2016. Regulatory submission for baricitinib underscores Lilly’s commitment to developing a treatment that can improve patient outcomes in RA. We are hopeful that, if approved, baricitinib will help people living with this chronic disease.
National Pain Report: Why is this exciting for RA patients?
James McGill, M.D.: RA affects 23 million people worldwide, including more than one million people in the United States. While RA is a chronic systemic inflammatory syndrome with no cure, treatment can help control joint inflammation, a key to reducing pain and suffering, and preventing irreversible structural joint damage in the long-term.
Despite treatment advancements in the last two decades, a large portion of patients do not achieve low disease activity or remission, the ultimate goal in treating RA. RA is a very individualized disease, therefore, not every treatment works for every individual. Continuous innovation is necessary to fulfill unmet medical needs and help improve patient outcomes. Making life better for people with chronic conditions like RA is our goal.
Data from the phase 3 RA-BEACON study demonstrated baricitinib’s ability to significantly improve patient-reported outcomes, such as health-related quality of life (HRQOL), fatigue, pain and duration of morning joint stiffness, compared with placebo. Patients receiving baricitinib 4 mg showed the most rapid and greatest magnitude of improvement. These positive results reinforce baricitinib’s potential to address an unmet need for patients with rheumatoid arthritis, including those whose previous treatment with biologics failed.
National Pain Report: How does it differ from other current treatments, is/and why is it better?
James McGill, M.D.: Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), such as methotrexate, oral treatment options (including targeted synthetic drugs), such as tofacitinib, and injectable biological drugs, such as adalimumab.
Baricitinib is the only oral once-daily selective JAK1 and JAK 2 inhibitor currently being investigated for people with moderate-to-severe RA. JAK inhibitors target one or more of the four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. These enzymes are critical components of signaling mechanisms used by a number of cytokines and growth factors, including several that are elevated in patients with RA. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, including RA.
National Pain Report: I also understand that it has been, or is being, studied for psoriasis and diabetic nephropathy – do you intend on pursuing any other indications, especially pain-related, in the future?
James McGill, M.D.: Lilly has recently had approved a very effective medication for the treatment of psoriasis Taltz. Significant unmet medical need exists in many prevalent autoimmune diseases, which are complex syndromes involving multiple cell types. Lilly has several antibodies in early-phase development to explore how these unmet needs could be addressed.
We continue to evaluate different therapeutic areas where baricitinib could add value. Baricitinib is currently in phase 2 development for atopic dermatitis and systemic lupus erythematosus. Now that phase 3 RA clinical trials are complete, Lilly will meet with regulatory authorities to discuss a pediatric program to investigate baricitinib for juvenile RA/idiopathic arthritis.
National Pain Report: When are they hoping it will be available to people with RA?
James McGill, M.D.: We are currently working with global regulatory authorities, including in the U.S. (U.S. Food and Drug Administration]), European Union (European Medicines Agency) and Japan (Pharmaceuticals and Medical Devices Agency) following the Q1 2016 submissions for the approval of baricitinib, and believe that it may be an effective treatment option for rheumatoid arthritis patients.
National Pain Report: Is there anything else you would like to share?
James McGill, M.D.: Lilly and Incyte collaborated to produce a rigorous phase 3 clinical trial program, which investigated the benefit and safety of baricitinib across the spectrum of patients with RA, including newly diagnosed patients, patients who had failed to respond to conventional disease-modifying antirheumatic drugs (DMARDs), and patients who had failed multiple injectable biologic DMARD therapies.
The phase 3 program included two 52-week studies that incorporated either methotrexate or adalimumab as active comparators to provide useful information for therapeutic use of baricitinib. In these studies, baricitinib was statistically superior to methotrexate and to adalimumab in improving signs and symptoms, physical function, and important patient reported outcomes including pain, fatigue and joint stiffness.