INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) and Incyte announced today positive data for Olumiant (baricitinib) will be presented at ACR Convergence 2020, the American College of Rheumatology's virtual annual meeting taking place November 5-9, 2020.
The Olumiant data being presented at this year's meeting include new long-term studies in adult patients living with rheumatoid arthritis (RA), along with real-world evidence (RWE) on safety and efficacy.
At this year's meeting, results from a post-hoc analysis evaluating the long-term efficacy of Olumiant for patients with active RA who were inadequate responders (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or biologic DMARDs (bDMARD) (Abstract #0224) will be shared. In this analysis, 27.5% of the csDMARD-IR and 18.4% of the bDMARD-IR patients had Low Disease Activity defined by Simple Disease Activity Index (LDA; SDAI 11) after 2.3 years (at week 120) in a Non-responder Imputation analysis. For those patients who remained in the study, 85% and 86% of csDMARD-IR and bDMARD-IR respectively, maintained low disease activity at 2.3 years. No new safety concerns were identified.
'In this analysis of the long-term studies of Olumiant in adults with RA, the medicine demonstrated efficacy over more than two years as measured by the proportion of patients who achieved low disease activity,' said Alvin Wells, M.D., Ph.D., director of the Aurora Rheumatology and Immunotherapy Center. 'The safety and efficacy from this study helps support Olumiant 2-mg once daily as a long-term treatment for patients with moderate to severe RA.'
Lilly will also highlight data from a long-term extension study that evaluated radiographic progression of structural joint damage in adult patients with active RA over 5 years of treatment with Olumiant (Abstract # 1235). The study enrolled patients who had completed treatment in one of three Phase 3 trials, including patients who were DMARD-naive, csDMARD-IR and methotrexate (MTX)-IR, and assessed baricitinib 4-mg once daily as monotherapy or in combination with MTX or other csDMARDs and baricitinib 2-mg once daily in combination with other csDMARD. The data suggest that the different RA patient populations treated with baricitinib for up to 5 years can maintain low rates of radiographic progression, as assessed by the van der Heijde modified Total Sharp Score (mTSS).
'We are pleased with the data being presented at this year's virtual ACR meeting highlighting the depth of Lilly's immunology portfolio and the potential impact our medicines may have for patients,' said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. 'Furthermore, the data being showcased at this meeting demonstrate our commitment to ongoing evaluation of the long-term safety and efficacy of Olumiant in patients living with RA.'
Additionally, Lilly will showcase RWE from a postmarketing safety surveillance study (Abstract # 0203). Results include 24-week safety data from 1,992 patients consecutively prescribed Olumiant in Japan. No new safety signals were observed during the initial analysis, and the study will continue to collect serious adverse events for three years.
An integrated safety analysis of pooled data from nine clinical trials of Olumiant is also being presented (Abstract # 0202). Across the trials, 3,770 patients with RA received Olumiant for a total of 13,148 patient-years of exposure with a median time on treatment of 4.2 years and up to a maximum of 8.4 years. The data reinforce the safety profile of Olumiant in the treatment of RA, with no new safety concerns reported in the analysis.
Olumiant, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte.
About OLUMIANT
OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 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.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1 OLUMIANT is approved in more than 70 countries.
In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
About Lilly in Immunology
Lilly is bringing our heritage of championing groundbreaking, novel science to immunology and is driven to change what's possible for people living with autoimmune diseases. There are still significant unmet needs, as well as personal and societal costs, for people living with a variety of autoimmune diseases and our goal is to minimize the burden of disease. Lilly is investing in leading-edge clinical approaches across its immunology portfolio in hopes of transforming the autoimmune disease treatment experience. We've built a deep pipeline and are focused on advancing cutting edge science to find new treatments that offer meaningful improvements to support the people and the communities we serve.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that 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.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with rheumatoid arthritis reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee the future study results will be consistent with the results to date, that OLUMIANT will receive additional regulatory approvals, or that it will be commercially successful.
Contact:
Michael Booth
Tel: +1-302-498-5914
Email: mbooth@incyte.com
ELI LILLY AND COMPANY 
