- Abstracts include new data on the impact and treatment of hidradenitis suppurativa (HS) following recent regulatory approvals of HUMIRA® (adalimumab) as the first and only treatment for moderate to severe HS in adults
NORTH CHICAGO, Illinois, Oct. 5, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that 26 abstracts on HUMIRA® (adalimumab) and hidradenitis suppurativa (HS), psoriasis and psoriatic arthritis will be presented at the European Academy of Dermatology and Venereology (EADV) Congress, Oct. 7 – 11, in Copenhagen, Denmark.
Data expand on previous research around HS, a painful, chronic inflammatory skin disease;1 provide new insights into the treatment of severe pediatric chronic plaque psoriasis with adalimumab; and explore psoriasis and psoriatic arthritis patient beliefs, concerns, attitudes and adherence toward TNF inhibitors and selected conventional therapies. The breadth and depth of abstracts presented demonstrate AbbVie's leadership in impacting care for patients with serious dermatologic diseases.
HUMIRA was recently approved for the treatment of moderate to severe hidradenitis suppurativa by multiple health authorities including the European Medicines Agency, U.S. Food and Drug Administration (FDA) and the Ministry of Health in Bosnia.
Abstracts of Interest
Hidradenitis Suppurativa (AbbVie-Sponsored) Abstracts of Interest
- Clinical Meaningfulness of the Hidradenitis Suppurativa Clinical Response Endpoint to Assess Inflammation and Treatment Response in Two Phase 3, Randomized, Placebo-Controlled Trials (PIONEER I & II) [Poster ID P0030]
- Risk of Flare in Patients with Hidradenitis Suppurativa Treated With Adalimumab for 12 Weeks During PIONEER I and PIONEER II: Two Phase 3, Randomized, Placebo-Controlled Trials [Poster ID P0031]
- Time to Response in Patients with Moderate-to-Severe Hidradenitis Suppurativa Who Were Treated With Adalimumab: Results from Two Phase 3, Randomized, Placebo-Controlled Trials [Poster ID P0032]
- Progression of Hidradenitis Suppurativa: Outcomes of Placebo-Treated Patients in a Phase 3, Randomized, Placebo-Controlled Trial (PIONEER II) [Poster ID P0045]
Psoriasis and Psoriatic Arthritis (AbbVie-Sponsored) Abstracts of Interest
- Association Between Attitudes Towards Conventional Systemic Therapy and Tumor Necrosis Factor Inhibitors and Treatment Adherence in Patients with Psoriasis and Psoriatic Arthritis: Results from the ALIGN Study [Poster ID FC03.07 – Oral Presentation]
- Six-Year Interim Results from the ESPRIT 10-Year Postmarketing Surveillance Registry of Adalimumab for Moderate to Severe Psoriasis [Poster ID P1624]
- Safety and Efficacy for Pediatric Patients with Chronic Plaque Psoriasis Who Did Not Respond to 16 Weeks of Double-Blind Methotrexate Treatment and Switched to Adalimumab [Poster ID FC02.06 – Oral Presentation]
- Adalimumab Long-term Safety/Efficacy Results for Pediatric Patients with Chronic Plaque Psoriasis from a Phase 3, Randomized Study [Poster ID FC02.04 – Oral Presentation]
- Adalimumab Dose Escalation, De-Escalation, and Re-Escalation in Patients in the REVEAL Study [Poster ID P1731]
- Consistent High Efficacy Adalimumab PASI75 Responders: A Post Hoc Analysis of REVEAL [Poster ID P1733]
- Safety and Efficacy of Adalimumab in Combination With Different Doses of Methotrexate in Patients With Psoriatic Arthritis: Subanalysis of ADEPT [Poster ID 1756]
Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 940,000 patients worldwide2 across 13 globally approved indications.3-4 HUMIRA is one of the most comprehensively studied biologics available, and is distinguished by 18 years of clinical trial experience in immunology beginning with rheumatoid arthritis.5-6
About HUMIRA in the European Union
HUMIRA EU Therapeutic Indications3
HUMIRA is approved for use in adults with moderate to severe 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 and active moderate to severe hidradenitis suppurativa. HUMIRA is approved for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, severe active Crohn's disease, and active polyarticular juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy. See Summary of Product Characteristics (SmPC) for full indication.
Important EU Safety Information3
HUMIRA is contraindicated in patients with active tuberculosis or other severe infections and in patients with moderate to severe heart failure. 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 a TNF-antagonist. 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, abdominal pain, nausea, rash and musculoskeletal pain.
(See SmPC for full details at https://www.medicines.org.uk/emc/medicine/21201)
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.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
- Dufour DN, Emtestam L, Jemec GB. Hidradenitis Suppurativa: A Common and Burdensome, Yet Under-Recognised, Inflammatory Skin Disease. Postgrad Med J. 2014; 90 (1062):216-21.
- AbbVie Data on File.
- HUMIRA [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.medicines.org.uk/emc/medicine/21201. Published August 3, 2015. Accessed September 16, 2015.
- Pharmaceutical and Medical Devices Agency (PMDA) website. New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed September 8, 2015.
- Burmester GR, Mease P, Dijkmans BAC, et al. Adalimumab Safety and Mortality Rates from Global Clinical Trials of Six Immune-Mediated Inflammatory Diseases. Ann Rheum Dis. 2009; 68 (12):1863-1869.
- Burmester GR, Panaccione R, Gordon KB, et al. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease. Ann Rheum Dis. 2013;72 (4):517-524.