Regeneron And Sanofi Announce Publication Of Positive Phase 2b Dupilumab Data In The Lancet
Study Evaluated Adult Patients with Moderate-to-Severe Atopic Dermatitis who were Inadequately Controlled by Topical Therapy
Regeneron Pharmaceuticals, Inc. and Sanofi recently announced the publication in The Lancet of results from a Phase 2b 16-week, dose-ranging study of dupilumab, an investigational therapy, in 380 adult patients with moderate-to-severe atopic dermatitis who were not adequately controlled on topical corticosteroids. Dupilumab is an investigational therapy that inhibits signaling of IL-4 and IL-13, two key cytokines required for the T helper 2 (Th2) immune response.
"Moderate-to-severe atopic dermatitis is a chronic disease with limited treatment options and is associated with debilitating itching, widespread rash, sleep disturbance and other issues," said Diamant Thaçi, M.D., Professor, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany and lead author of The Lancet paper. "Observations in this study suggest that selective inhibition of the IL-4 and IL-13 cytokines with investigational monoclonal antibody dupilumab may improve severity and symptoms of this difficult-to-treat disease."
The topline results of this study were announced in July 2014. Please refer to today’s online publication (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00388-8/abstract) for additional results from this study.
Results from Phase 3 studies of dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis that is not adequately controlled with topical atopic dermatitis medications are expected in the first half of 2016. Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
About Atopic Dermatitis
Atopic dermatitis – a serious form of eczema – is a chronic inflammatory disorder characterized by itchy, inflamed skin that can be present on any part of the body.1,2 Though symptoms appear externally, atopic dermatitis is fueled by underlying activation of the immune system.3 Atopic dermatitis affects approximately 5-7 million adults in the U.S.4,5 and it is estimated that 20 percent experience moderate-to-severe disease.6 Worldwide, 1 to 3 percent of adults are impacted.7 Though symptoms may vary, moderate-to-severe disease can be burdensome to patients, often characterized by pruritus (itch), cutaneous dryness, and skin lesions marked by redness, crusting/oozing and lichenification (skin thickening) with periods of lesion exacerbation 8,9,10. Intense itching, scratching and skin damage can lead to secondary infections, as well as anxiety, depression, and feelings of social isolation.11,12,13,14,15
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris and in New York.
About Regeneron Pharmaceuticals, Inc.
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases, and a rare inflammatory condition and have product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain and infectious diseases. For more information, visit www.regeneron.com.
1 World Allergy Association 2004:http://www.worldallergy.org/professional/allergic_diseases_center/atopiceczema/. Accessed September 2, 2015.
2 Bieber T. Mechanisms of disease: atopic dermatitis. N Engl J Med 2008;358:1483-9
3 Leung DYM, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004;113:651-657.
4 Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis. Section 1. J Am Acad Dermatol. 2014;70:338-51.
5 United States Census. 2013 population estimates for US atopic dermatitis: adults ages 18 and older (242,542,967). Note: prevalence figures given in text are rounded from multiplying the adult population by the 2% - 3% prevalence figures in Reference 4.
6 Hamilton, Jennifer D. et al. 2014. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. Journal of Allergy and Clinical Immunology, Volume 134, Issue 6 , 1293 – 1300.
7 Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8–16.
8 NIH 2014: http://www.niams.nih.gov/health_info/atopic_dermatitis/atopic_dermatitis_ff.asp. Accessed August 11, 2015.
9 Misery L, Finlay AY, Martin N, et al. Atopic dermatitis: impact on the quality of life of patients and their partners. Dermatology. 2007;215:123-129.
10 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. J Allergy Clin Immunol. 2006;118:226-232.
11 Simpson EL. Comorbidity in atopic dermatitis. Curr Dermatol Rep. 2012;1:29-38.
12 Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998;139:846-850
13 Kimata H. Prevalence of suicidal ideation in patients with atopic dermatitis. Suicide Life Threat Behav. 2006;36:120-124.
14 Yarbrough KB, Neuhaus KJ, Simpson EL. The effects of treatment on itch in atopic dermatitis. Dermatol Ther. 2013;26:110-119.
15 Anderson RT, Rajagopalan R. Effects of allergic dermatosis on health-related quality of life. Curr Allergy Asthma Rep. 2011;1(4):309-315.
Source: Regeneron Pharmaceuticals, Inc.