Eli Lilly and Company and Incyte announced positive data for Olumiant 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-naïve, 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.
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. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY
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.