Hidradenitis suppurativa, sometimes referred to as "acne inversa" by dermatologists, is a painful, debilitating, chronic inflammatory skin disease estimated to affect 1 – 4 percent of the world's population.1-2 The prevalence of HS among adolescents between the ages of 12 and 17 years is estimated to be 0.09 percent (298 adolescents diagnosed with HS out of 328,634 total adolescents sampled).3 The condition is characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts.1-2 HS can have considerable impact on patients' quality of life, physical activities and emotional state.1-2,4 The disease can be challenging to diagnose, with studies showing it can take up to eight years for people with HS to receive an accurate diagnosis.1-2,5
Since first gaining approval 13 years ago, HUMIRA has been approved in more than 90 countries across 14 globally approved indications,6-7 and is currently being used to treat more than a million patients worldwide.8
About HUMIRA in the European Union6
HUMIRA EU Therapeutic Indications
HUMIRA is approved for use in adults with moderate to severe active and progressive rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, active moderate to severe hidradenitis suppurativa and non-infectious intermediate, posterior and panuveitis in adults. HUMIRA is approved for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, moderately to severely active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. See Summary of Product Characteristics (SmPC) for full indication.
Important EU Safety Information6
HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.
(See SmPC for full details)
Globally, prescribing information varies; refer to the individual country product label for complete information.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
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- Dufour DN, Emtestam L, Jemec GB. Hidradenitis suppurativa: a common and burdensome, yet under-recognised, inflammatory skin disease. Postgrad Med J. 2014; 90:216-221.
- Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.
- European Medicines Agency decision P/0121/2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500144686.pdf. Accessed October 31, 2016.
- Esmann S, Jemec GB. Psychosocial impact of hidradenitis suppurativa: a qualitative study. Acta dermato-venereologica. 2011; 91(3):328-332.
- Guiding principles in Hidradenitis Suppurativa (HS) care. KPMG. Accessed October 31, 2016.
- HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://ec.europa.eu/health/documents/community-register/2016/20160624135201/anx_135201_en.pdf. Last updated Jun 24, 2016. Accessed October 31, 2016.
- Pharmaceutical and Medical Devices Agency (PMDA). New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed October 31, 2016.
- Data on File, AbbVie Inc. IMS NPA and IMS NSP cumulative data as of June 2016.
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