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Lilly and Incyte Announce Positive Top-Line Results from the North American Phase 3 Study (BREEZE-AD5) of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate- to Severe Atopic Dermatitis

19:00 EST 10 Feb 2020 | Globe Newswire
  • Study met the primary endpoint of at least 75% improvement of skin inflammation and key secondary endpoints
  • Safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis
  • Results from this study conducted in North America continue to support regulatory submissions

TORONTO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Eli Lilly and Company and Incyte announced that baricitinib met the primary endpoint in BREEZE-AD5, an investigational Phase 3, randomized, placebo-controlled study evaluating the safety and efficacy of baricitinib for the treatment of adult patients with moderate- to severe atopic dermatitis (AD). 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.

“Atopic dermatitis is chronic skin condition which affects approximately one to three percent of adults worldwide.6 We appreciate the distressing impact this condition can have on a person’s quality of life and the need for additional treatment options," says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Eli Lilly Canada. "We are pleased that baricitinib met the primary endpoint in the BREEZE-AD5 study, and we will continue to focus on patient-centered solutions."  

BREEZE-AD5 is a multicenter, double-blind, randomized, placebo-controlled study designed for and conducted in North America and which evaluated the efficacy and safety of the 1-mg and 2-mg doses of baricitinib monotherapy for the treatment of adult patients with moderate- to severe AD. In this study, the 2-mg dose of baricitinib met the primary endpoint as defined by the proportion of participants achieving EASI75 at Week 16. Baricitinib also met key secondary endpoints including another measure of skin inflammation defined by clear or almost clear skin and at least 2 points improvement on the validated Investigator's Global Assessment for AD (vIGA 0 or 1 at Week 16), and it reduced itch severity.

    
 Placebo
(n=147)
Baricitinib 1-mg
(n=147)
Baricitinib 2-mg
(n=146)
EASI75 at Week 16, n (%)12 (8.2)19 (12.9) ǂ43 (29.5)***
vIGAa of 0 or 1 at Week 16, n (%)8 (5.4)19 (12.9)*35 (24.0)***
4-point improvement in Itch NRS at Week 16, n (%)7 (5.7)21 (15.9)*33 (25.2)***

ǂ P n.s. * P £ 0.05, and *** P £ 0.001 for baricitinib compared to placebo by analysis unadjusted for multiplicity. Non-responder imputation upon rescue with Topical corticosteroid (TCS).
avIGA = validated Investigator's Global Assessment.

The safety profile in BREEZE-AD5 was consistent with the known safety findings of baricitinib in AD. The most common treatment-emergent adverse events (TEAEs) included upper respiratory tract infections, nasopharyngitis, and diarrhea. No venous thromboembolic events (VTEs) or deaths were reported in the trial. The full results from the BREEZE-AD5 study will be disclosed at future scientific venues and in peer-reviewed journals.

"These positive top-line results show that baricitinib could be an effective treatment option for patients living with moderate- to severe AD whose needs have remained unmet,” says Dr. Gooderham, Dermatologist and study investigator.

About BREEZE-AD5
BREEZE-AD5, a multicenter, double-blind, randomized, placebo-controlled, Phase 3 study in adult patients with moderate- to severe atopic dermatitis (AD). BREEZE-AD5, which was designed for and conducted in North America, evaluated the efficacy and safety of the 1-mg and 2-mg doses of baricitinib monotherapy for the treatment of adult patients with moderate to severe AD. The primary endpoint was defined by the proportion of participants achieving Eczema Area and Severity Index 75 (EASI75) at Week 16. BREEZE-AD5 completes the read out from the BREEZE development program, following the recent topline results from BREEZE-AD4.  BREEZE-AD1, -AD2 and -AD7 results were disclosed in 2019.

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.1 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 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.2 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.3,4 AD affects approximately 1-3% of adults worldwide.5

Moderate- to severe AD is characterized by intense itching, resulting in visibly damaged skin.6 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.7

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 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.

For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA

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.

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

REFERENCES

                                                       
1 OLUMIANT Product Monograph
2 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.
3 Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.
4 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.
5 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.
6 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.
7 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122. 

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