With availability of Olumiant™ (baricitinib), Lilly brings new oral treatment option for Canadians living with rheumatoid arthritis

TORONTO, Nov. 1, 2018 /CNW/ - "You would never know by looking at me," says Angela Vance, a Lilly employee, "that I have rheumatoid arthritis (RA)."

RA is a chronic autoimmune disease characterized by inflammation, pain, stiffness and progressive joint destruction, and affects roughly 300,000 Canadians.¹ It is associated with higher rates of illness and premature death and, when RA is moderate to severe, the disease can reduce a life span by as much as a dozen years if untreated.²

"It's a horrible disease," she says. "It rears its head with sharp unexplained pain that won't fade, and a feeling of being wiped most of the time, like I've stayed up 36 hours straight."

"Rheumatoid arthritis can progress very quickly into a debilitating condition," said Edward Keystone, MD, FRCP(C), Professor of Medicine, University of Toronto.  "Early diagnosis and referral to a rheumatologist for treatment is essential in order to get individuals' RA well controlled or in remission, quickly reduce pain, and avoid permanent damage to joints."

Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission. Research shows that fewer than half of patients in clinical practice will sustain remission for more than 1 year.³ There remains an important need to provide additional treatments to improve overall patient care.⁴ The overall goals of treatment are to stop inflammation, relieve symptoms, prevent damage to joints and organs, improve physical function and overall well-being, and reduce long-term complications.⁵

Eli Lilly Canada Inc. is pleased to announce the availability of Olumiant™ (baricitinib), a once-daily, 2 mg oral tablet. Olumiant, 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 may be used as monotherapy in cases of intolerance to MTX.^{6 7}

"New oral options like Olumiant (also known as baricitinib) are key to helping rheumatologists like myself bring active rheumatoid arthritis under control—or even achieve remission—so patients can get back to enjoying their lives," says Dr. Janet Pope, Professor of Medicine, University of Western Ontario & Chair Division of Rheumatology St. Joseph's Health Care London.

"I'm proud of Lilly's longstanding research in autoimmunity, which has led to the approval of Olumiant so that people living with the devastating impact of RA, like me, have a new option," says Angela Vance from Lilly.

The research behind Olumiant:

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, which is called inflammation. Olumiant inhibits the action of JAK enzymes and thereby helps to reduce the swelling and tenderness in people with RA.^{6, 7}   

Olumiant was studied in patients with moderately to severely active RA who had an inadequate response or intolerance to conventional disease-modifying antirheumatic drugs (cDMARDs), in the RA-BUILD study, and in patients who had an inadequate response or intolerance to one or more biologic therapies (including Tumor Necrosis Factor (TNF) inhibitor) despite ongoing treatment with cDMARDs, in the RA-BEACON study.⁶

Results from both the RA-BUILD study and the RA-BEACON study demonstrated that patients treated with Olumiant 2 mg once daily had statistically significantly higher ACR20, ACR50 and ACR70 response rates at 12 weeks compared to placebo-treated patients (ACR = American College of Rheumatology score; ACR20/50/70 represents at least a 20/50/70 percent improvement across selected measures of disease activity). In both studies, higher ACR20 response rates were observed as early as one week with Olumiant 2 mg versus placebo. Patients treated with Olumiant 2 mg also had higher rates of clinical remission and achieved a DAS28 – hsCRP – a measure of RA disease activity – below 2.6 (indicating disease remission) versus placebo-treated patients at Week 12.⁶ In addition, in both studies, compared to placebo, patients treated with Olumiant 2 mg demonstrated greater improvement from baseline in the physical component summary (PCS) score and the physical function, bodily pain, vitality, and general health domains at Week 12.⁶

"For many people living with arthritis, the act of opening a medicine bottle or picking up a tablet can be extremely difficult, and Lilly designed the Olumiant tablet, bottle and cap with this in mind," says Bruce Watson, Arthritis Society Director of Business and Foundation Development. "We are pleased to give Olumiant our Ease of Use designation, which recognizes products that are designed to make life easier for people with arthritis."

"Olumiant is an innovative oral medicine that represents an evolution in the treatment of RA," said Lisa Matar, President and General Manager of Lilly Canada. "At Lilly, we focus on the whole person, so the patient's voice is front and centre. We are dedicated to ongoing collaboration with the community to identify solutions that help people with RA thrive."

Lilly received a Notice of Compliance for Olumiant from Health Canada on August 17, 2018.

Notes to Editors:

About Olumiant™

Olumiant™ (baricitinib), a once-daily, 2 mg oral tablet, provides a new approved treatment option for adult patients living with RA in Canada.⁶  Olumiant, 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 may be used as monotherapy in cases of intolerance to MTX.⁶

Olumiant is believed to interfere with the activity of JAK enzymes. The four known JAK enzymes include: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases. Normally JAK enzymes help turn on your immune system when you need it. The immune system then causes swelling and tenderness, which is called inflammation. Olumiant inhibits the action of JAK enzymes and thereby helps to reduce the swelling and tenderness in people with RA.^{6, 7} Olumiant is approved in more than 50 countries.

For more information about Olumiant refer to the product monograph.  

About Rheumatoid Arthritis (RA)

As a chronic autoimmune disease characterized by inflammation, pain, stiffness and progressive joint destruction, RA is a significant population health concern, affecting 300,000 Canadians, and is associated with higher rates of illness and death.³

RA affects women two to three times more often than men, and while the disease can occur at any age, its onset is most common between the ages of 40 and 60. Although its cause is still unknown, RA is believed to be the result of a malfunctioning immune system.³

About Eli Lilly Canada Inc.

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 those 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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¹ Rheumatoid Arthritis: What is Rheumatoid Arthritis? https://www.arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/rheumatoid-arthritis. Accessed September 2018.

² Spotlight on Rheumatoid Arthritis. http://jointhealth.org/aboutarthritis-diseasespotlight.cfm?id=10&locale=en-CA. Accessed September 2018.

³Sustained rheumatoid arthritis remission is uncommon in clinical practice. Accessed September 2018. https://arthritis-research.biomedcentral.com/articles/10.1186/ar3785

⁴ Van dan Hoek, J., Bozhuizen HC, Roorda LD, et al. Mortality in patients with rheumatoid arthritis: a 15-year prospective cohort study. Accessed September 2018.

⁵ Rheumatoid Arthritis Treatment. https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. Accessed September 2018.

⁶ OLUMIANT™ Product Monograph http://pi.lilly.com/ca/olumiant-ca-pm.pdf.

⁷ OLUMIANT™ Product Monograph; Patient Medication Information http://pi.lilly.com/ca/olumiant-ca-pm.pdf.

SOURCE Eli Lilly Canada

Media Contact: Kelly Baita, GCI Group, 416-486-5922, [email protected]; Jane Lee Cheung, Eli Lilly Canada Inc., [email protected], 416-576-8781