INDIANAPOLIS, IN, USA I August 23, 2019 I Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) announced today that baricitinib met the primary endpoint in BREEZE-AD7, the third pivotal Phase 3 trial in the BREEZE-AD program to be completed in 2019.
BREEZE-AD7, an investigational study evaluating the efficacy and safety of baricitinib, an oral JAK inhibitor, to treat moderate to severe atopic dermatitis (AD) in adults met its primary endpoint. Adding baricitinib to standard-of-care topical corticosteroids significantly improved disease severity, measured by the validated Investigator’s Global Assessment for AD (vIGA) score of “clear or almost clear” skin (vIGA 0, 1), the primary endpoint of the study at 16 weeks.
|
Placebo (N=109) |
Baricitinib 2-mg (N=109) |
Baricitinib 4-mg (N=111) |
|
| vIGA of 0 or 1 at Week 16, n (%) | 16 (14.7) | 26 (23.9) | 34 (30.6)** |
| EASI75 at Week 16, n (%) | 25 (22.9) | 47 (43.1)** | 53 (47.7)*** |
| 4-point improvement in Itch NRS at Week 16, n (%) | 21 (20.2) | 37 (38.1)** | 44 (44.0)*** |
| ** P≤0.01, and *** P≤0.001 for baricitinib compared to placebo by analysis unadjusted for multiplicty. | |||
BREEZE-AD7, conducted outside of the United States, is the third of five placebo-controlled trials in the Phase 3 program and recruited patients from Asia, Europe, South America and Australia.
Safety data were consistent with the known safety profile of baricitinib. The most common treatment-emergent adverse events observed were nasopharyngitis, upper respiratory tract infection and folliculitis. One pulmonary embolism was reported in the baricitinib group. One opportunistic infection was reported in the placebo group. No malignancies, major adverse cardiovascular events (MACE), or deaths were reported in the study.
“Despite recent scientific advances, moderate to severe atopic dermatitis remains a disease with significant unmet treatment needs. Atopic dermatitis is a chronic, relapsing condition that can vary greatly from person to person, and yet there are few medicines to address the different signs and symptoms in each patient,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. “Today’s baricitinib results in combination therapy reveal important additional clinical information in a chronic disease where patients currently have limited oral treatment options.”
Baricitinib 4 mg and 2 mg both met the primary endpoint on BREEZE-AD1 and BREEZE-AD2 clinical trials disclosed earlier this year. Lilly plans to share the detailed 16-week data and analyses from BREEZE-AD7 at future scientific venues and in peer-reviewed journals later this year. Top-line data from the remaining two Phase 3 trials will be announced later this year or early next year.
Baricitinib is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 60 countries, including the U.S., member states of the EU and Japan, and is marketed as OLUMIANT®.
Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients
OLUMIANT® (baricitinib) 2 mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
About BREEZE-AD7
The BREEZE-AD7 clinical trial is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of baricitinib in combination with topical corticosteroids in adult patients with moderate to severe atopic dermatitis. Two doses were evaluated separately such that the primary objective of the study could be met if one or both doses achieved the primary endpoint. The primary endpoint evaluated significant improvement in disease activity as 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 validated 5-point Investigator’s Global Assessment for AD (vIGA) scale at 16 weeks of treatment. BREEZE-AD7 is the third of five Phase 3 studies that make up the BREEZE-AD program. Lilly previously announced results for BREEZE-AD1 and BREEZE-AD2 earlier this year.
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. 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. 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. OLUMIANT is approved in more than 60 countries.
About Atopic Dermatitis
Atopic dermatitis (AD), a serious form of atopic 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 percent of adults worldwide.
Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin. 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 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 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 Eli Lilly and Company
Lilly is a global healthcare 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 www.lilly.com and newsroom.lilly.com/social-channels.
About Incyte
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.
SOURCE: Eli Lilly
