EULAR 2020: Lilly Shares New Data for OLUMIANT® in Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE)

Data from OLUMIANT recognize its potential to help patients living with RA and SLE

June 10, 2020 15:19 ET | Source: Eli Lilly Canada

TORONTO, June 10, 2020 (GLOBE NEWSWIRE) -- Eli Lilly and Company presented new data for OLUMIANT ® (baricitinib) at the virtual European Congress of Rheumatology (EULAR 2020). Highlights from OLUMIANT data presented at the virtual meeting included new long-term data in patients living with rheumatoid arthritis (RA) as well as data from an investigational trial in patients with systemic lupus erythematosus (SLE).

“Our commitment to patients includes the continuous evaluation of treatment options to help people live better lives. Lilly is pleased to present long-term safety and efficacy data in patients treated with OLUMIANT for rheumatoid arthritis," says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Eli Lilly Canada.

At this year’s meeting, Lilly shared results from a long-term study that evaluated the efficacy of OLUMIANT in patients with moderate- to severe RA during three years of treatment. The study measured the achievement of clinically relevant outcomes, including low disease activity (LDA) as measured by the simplified disease activity index (SDAI ≤11), in DMARD-naïve patients and patients with an inadequate response to methotrexate (MTX-IR), from treatment initiation to three years. Patients in this study were treated with OLUMIANT 4-mg once daily, an approved dose outside of North America.

The study found that among patients with an inadequate response to MTX, 52% of patients initially treated with OLUMIANT (+MTX) were in a state of SDAI LDA at Week 24 and this rate was maintained through Week 148.

Lilly also shared an updated integrated safety analysis of OLUMIANT in the treatment of RA using data from 3,770 patients who were treated with the medicine for up to 8.4 years. The study found that OLUMIANT’s safety profile remains consistent with what has been previously reported, with no increase in the rates of safety topics of interest, including serious infections, herpes zoster, major adverse cardiovascular events, deep-vein thrombosis and/or pulmonary embolism, non-melanoma skin cancer (NMSC), and non-NMSC malignancies. No new safety signals were identified.

“The safety data from long-term extension of multiple baricitinib trials in rheumatoid arthritis, demonstrated ongoing safety of approximately 3,700 patients followed for up to 8.4 years. The analysis shows no new safety signals and is helpful to inform treatment decisions for people with active rheumatoid arthritis,” says Dr. Pope, Professor of Medicine, Western University and Division Head, Rheumatology, St. Joseph's Health Centre.

In addition, Lilly presented analyses from an investigational trial evaluating baricitinib in patients with SLE at EULAR. Data from its Phase 2 randomized, placebo-controlled, double-blind JAHH study was highlighted, which observed whether or not SLE patients experienced changes in their serum cytokine levels when being treated with the 4-mg dose of baricitinib.

For more information about the Lilly data presented at this year’s virtual EULAR congress, please visit https://www.congress.eular.org/scientific_programme.cfm .

About OLUMIANT ® OLUMIANT (baricitinib), in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of moderate- to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). OLUMIANT can be used as a monotherapy in cases of intolerance to MTX. 1

OLUMIANT is believed to interfere with the activity of an enzyme called Janus Kinase (JAK). Normally JAK enzymes help turn on your immune system when you need it. The immune system then causes swelling and tenderness. This is called inflammation. 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.

About Eli Lilly Canada Eli Lilly and Company 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 Colonel Eli Lilly, who was committed to creating high quality medicines that meet people’s needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world’s first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca .

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Media Contact: Samira Rehman Rehman_Samira@lilly.com 647-617-1994

REFERENCES 1 OLUMIANT Product Monograph, 2020. 2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.