– Study met primary endpoint of at least 75% improvement of skin inflammation
– Safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis (AD)
– Study was conducted outside of the U.S. and is the first and only report of a JAK inhibitor in patients who failed, were intolerant, or contraindicated to cyclosporine
INDIANAPOLIS, IN, USA I January 27, 2020 I Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that baricitinib met the primary endpoint in BREEZE-AD4, an investigational Phase 3, randomized, placebo-controlled study evaluating the safety and efficacy of baricitinib in combination with topical corticosteroids (TCS) for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who were inadequate responders, intolerant or had contraindication to treatment with cyclosporine. The primary endpoint was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at Week 16.
“There is a high need for additional treatment options for patients living with moderate to severe AD, particularly those who failed conventional systemic treatments like cyclosporine,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. “As we look to progress our treatment portfolio for chronic skin conditions, the continued insights from the development program in AD further the potential of baricitinib to pursue this indication and to reach patients.”
BREEZE-AD4 is a multicenter, double-blind, randomized, placebo-controlled study conducted outside of the U.S. The study evaluated the efficacy and safety of the 1-mg, 2-mg and 4-mg doses of baricitinib in combination with TCS in patients with moderate to severe AD who have experienced failure to cyclosporine or are intolerant to—or have contraindication to—cyclosporine. In this study, the 4-mg dose of baricitinib plus TCS met the primary endpoint as defined by the proportion of participants achieving EASI75 at Week 16.
| All arms in combination with TCS |
Placebo (n=93) |
Baricitinib 1-mg (n=93) |
Baricitinib 2-mg (n=185) |
Baricitinib 4-mg (n=92) |
| EASI75 at Week 16, n (%) | 16 (17.2) | 21 (22.6) ǂ | 51 (27.6) ǂ | 29 (31.5)* |
| vIGAa of 0 or 1 at Week 16, n (%) | 9 (9.7) | 12 (12.9) ǂ | 28 (15.1) ǂ | 20 (21.7)* |
| 4-point improvement in Itch NRS at Week 16, n (%) | 7 (8.2) | 18 (23.1)* | 38 (22.9)** | 29 (38.2)*** |
| ǂ P n.s. * P ≤ 0.05, ** P≤0.01, and *** P≤0.001 for baricitinib compared to placebo by analysis unadjusted for multiplicity. Non-responder imputation upon rescue with high/very high potency TCS. avIGA = validated Investigator’s Global Assessment |
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The safety profile was consistent with the known safety findings of baricitinib in AD. The most common treatment-emergent adverse events (TEAEs) included nasopharyngitis, headache, and influenza. No venous thromboembolic events (VTEs) or deaths were reported in the trial.
Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate to severe atopic dermatitis and plans to submit for approval in the U.S. and Japan in 2020. Full results from the BREEZE-AD4 study will be disclosed at future scientific venues and in peer-reviewed journals.
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-AD4
BREEZE-AD4 is a long-term, multicenter, double-blind, randomized, placebo-controlled, Phase 3 study in adult patients with moderate to severe atopic dermatitis (AD). BREEZE-AD4, conducted outside of the U.S., evaluated the efficacy and safety of the 1-mg, 2-mg and 4-mg doses of baricitinib in combination with topical corticosteroids in participants with moderate to severe AD who have experienced failure to cyclosporine or are intolerant to—or have contraindication to—cyclosporine. The primary endpoint was defined by the proportion of participants achieving Eczema Area and Severity Index 75 (EASI75) at Week 16. BREEZE-AD1, -AD2 and -AD7 results were disclosed in 2019.
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.1 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.1 OLUMIANT is approved in more than 60 countries.
About Atopic Dermatitis
Atopic dermatitis (AD), or 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.3 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.4,5 AD affects approximately 1-3% of adults worldwide.6
Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.7 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8
About Lilly in Dermatology
By following the science through unchartered territory, we continue Lilly’s legacy of delivering innovative medicines that address unmet needs and have significant impacts on people’s lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people’s lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.
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. P-LLY
About Incyte
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. For additional information on Incyte, please visit Incyte.com and follow @Incyte.
SOURCE: Eli Lilly
