Lilly announces top-line Phase 3 results for baricitinib in patients with moderate to severe atopic dermatitis
TORONTO, ON – February 4, 2019 - Eli Lilly and Company and Incyte Corporation announced today that baricitinib met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase 3 studies evaluating the efficacy and safety of baricitinib monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis (AD). In both investigational trials, compared to patients treated with placebo, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint at Week 16 defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear (IGA 0,1). These are two of five studies that will be part of the placebo-controlled data program intended to support global registrations.
In the 16-week placebo-controlled phase of BREEZE-AD1 and BREEZE-AD2, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment was similar to placebo, and the most common treatment-emergent adverse events observed were nasopharyngitis and headache. No venous thromboembolic events (VTEs), major adverse cardiovascular events (MACE), or deaths were reported.
“Chronic inflammatory skin diseases like atopic dermatitis often create a negative cascade in a patient’s life, and oral options to treat it are few and far between,” says Doron Sagman, Vice President, Medical Affairs, Lilly Canada. “The results from the BREEZE AD1 and AD2 trials are encouraging, and we look forward to seeing the collective results for all five studies.”
Lilly plans to share the full data results from both the BREEZE-AD1 and BREEZE-AD2 studies at future scientific venues and in peer-reviewed journals, and to share the topline data from other ongoing Phase 3 trials later this year.
Leading Canadian dermatologist Dr. Charles Lynde comments on the announcement, “these clinical trial results showing safety and efficacy of baricitinib for people with atopic dermatitis are exciting news. People suffer considerably from this condition and new evidence that shows symptom relief is welcome.”
About BREEZE-AD1 and BREEZE-AD2
The BREEZE-AD1 and BREEZE-AD2 clinical trials are multicentre, randomized, double-blind, placebo-controlled, Phase 3 studies to evaluate the efficacy and safety of baricitinib monotherapy in adult patients with moderate to severe atopic dermatitis. Significant improvement in disease activity was determined by the proportion of patients on baricitinib achieving clear (0) or almost clear skin (1) with a greater than or equal to 2-point improvement as measured by the 5-point Investigator's Global Assessment for AD (IGA) scale at 16 weeks of treatment.
About OLUMIANT TM
Baricitinib is approved in Canada to reduce 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. i, ii
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.
For more information about Olumiant, refer to the product monograph at www.lilly.ca.
About Atopic Dermatitis
Atopic dermatitis (AD), a serious form of eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body. AD is a heterogeneous disease, both clinically and biologically, but may be characterized by chronic baseline symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations. AD affects approximately 1-3 per cent of adults worldwide.
Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin and sleep loss. Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.
About Lilly in Immunology
Lilly is bringing our heritage of championing groundbreaking, novel science to immunology, and we are 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 our 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 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.
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the company’s website at www.incyte.com.
i. OLUMIANT TM Product Monograph http://pi.lilly.com/ca/olumiant-ca-pm.pdf.
ii. OLUMIANT TM Product Monograph; Patient Medication Information http://pi.lilly.com/ca/olumiant-ca-pm.pdf.