- Results show HUMIRA is safe and effective for the treatment of severe chronic plaque psoriasis in pediatric patients
- HUMIRA is the only biologic approved in Europe for children and adolescents from four years of age with severe chronic plaque psoriasis who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies
NORTH CHICAGO, Illinois, June 9, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced new results from a pivotal Phase 3 study of HUMIRA® (adalimumab) demonstrating significant and clinically meaningful efficacy over methotrexate in children and adolescents with severe chronic plaque psoriasis. The results were presented as part of the 23rd World Congress of Dermatology (WCD) in Vancouver. This pivotal Phase 3 study supports the European Commission (EC) marketing authorization for HUMIRA as the only biologic treatment approved in Europe for children and adolescents from four years of age with severe chronic plaque psoriasis who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.1
"Psoriasis can have significant physical and psychological effects on the young patients it impacts," said Kim Papp, M.D., Ph.D., study investigator, founder and president, Probity Medical Research, Waterloo, Ontario. "These findings support HUMIRA as a safe and efficacious first-line option for the treatment of severe pediatric plaque psoriasis when topical or phototherapies don't work."
Results from the multi-site, international study found that at 16 weeks, a significantly higher proportion of pediatric patients with severe chronic plaque psoriasis treated with HUMIRA 0.8mg/kg every other week achieved a Psoriasis Area Severity Index (PASI) 75 response as compared to patients treated with methotrexate (57.9 percent (22/38) versus 32.4 percent (12/37), p=.027). Approximately 20 percent more patients treated with HUMIRA (0.8mg/kg) achieved a Physicians Global Assessment (PGA) score of clear or minimal (0/1) at 16 weeks compared to those treated with methotrexate (60.5 percent (23/38) versus 40.5 percent (15/37), p=.083).2 Additionally, a high percentage of patients who initially responded to study treatment, but later progressed after treatment withdrawal, regained PGA clear or minimal response following treatment with HUMIRA during the 16 week retreatment phase (55.6 percent (15/27) with 0.8mg/kg re-achieved PGA 0/1).3 HUMIRA treatment had a similar safety profile to methotrexate with no new safety risks identified. 2-3
"Research and treatment options are limited for this young population, so we are pleased to share new data that address a significant need in the treatment of pediatric plaque psoriasis," said John Medich, Ph.D., vice president, clinical development, immunology, AbbVie. "These Phase 3 data build on more than 16 years of clinical research in HUMIRA, further establishing its safety and efficacy profile, even in young patients."
Additional HUMIRA data to be presented at WCD include poster presentations on moderate to severe plaque psoriasis, including a five-year interim analysis from a 10-year post-marketing surveillance patient registry (ESPRIT) as well as a subgroup analysis evaluating efficacy of HUMIRA across body weight and body mass index in Chinese patients. Investigational studies of HUMIRA for the treatment of moderate to severe Hidradenitis Suppurtativa (HS) will also be presented. An oral presentation will report the impact of HUMIRA on overall pain and duration of pain response in patients with HS. Additionally, featured posters will highlight HUMIRA pharmacokinetics and an integrated analysis from the HS Phase 3 clinical trials.
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 850,000 patients worldwide4 across 12 globally approved indications.1,5
About the Pivotal Phase 3 Pediatric Plaque Psoriasis Study
This multi-site, international, double-blind Phase 3 study evaluated the safety and efficacy of 0.8mg/kg and 0.4mg/kg every other week dose from week 1 after initial HUMIRA dose compared with methotrexate in 114 patients, aged 4-18 years, with severe chronic plaque psoriasis. Primary endpoints included PASI75 response and PGA clear or minimal (0/1) at Week 16.2 The effect of 16 weeks of retreatment with HUMIRA was also evaluated in patients who initially responded to treatment but later experienced loss of disease control.3
Treatment emergent adverse events (TEAEs) were reported by 73.7% of patients in the study. In period A, TEAEs were reported by 75.7% of patients receiving methotrexate; 76.9% of patients receiving HUMIRA 0.4mg/kg; and 68.4% of patients receiving HUMIRA 0.8mg/kg. TEAEs of infection were reported in 54.1% of patients who received methotrexate; 56.4% who received HUMIRA 0.4mg/kg; and 47.4% who received HUMIRA 0.8mg/kg. Serious TEAEs were reported in 7.7% of patients receiving HUMIRA 0.4mg/kg during Period A.2 In Period C, TEAEs were reported by 65.8% of patients overall (45.5% retreated with HUMIRA 0.4mg/kg; 74.1% retreated with HUMIRA 0.8mg/kg). No serious TEAEs were reported in Period C.3
About Pediatric Chronic Plaque Psoriasis
According to estimates from the World Health Organization, pediatric psoriasis occurs in 0.70 percent of the pediatric population,6 with no significant difference by gender.7 The chronic autoimmune disease is characterized by the rapid and excessive accumulation of skin cells, which form patches of inflamed, scaly skin.8 Pediatric psoriasis has similar characteristics to adult psoriasis, but in children, the psoriatic lesions are typically smaller, thinner, and less scaly.7 Beyond the physical challenges of managing the chronic skin disorder, it is also considered to have significant emotional and psychological effects.9
HUMIRA EU Therapeutic Indications1
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 and moderately to severely active ulcerative colitis. 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 SmPC for full indications.
Important EU Safety Information1
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: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124)
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/A, 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.
- HUMIRA [summary of product characteristics]. AbbVie Inc.; March 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124. Updated May 12, 2015. Accessed May 27, 2015.
- Efficacy and Safety of Adalimumab versus Methotrexate Treatment in Pediatric Patients with Severe Chronic Plaque Psoriasis: Results from the 16-Week Randomized, Double-Blind Period of a Phase 3 Study. Abstract #2970552. 23rd World Congress of Dermatology (WCD 2015), Vancouver, Canada, 2015.
- Efficacy and Safety of Adalimumab versus Methotrexate Treatment in Pediatric Patients with Severe Chronic Plaque Psoriasis: Results from the Treatment Withdrawl and Double-Blind Retreatment Periods of a Phase 3 Study. Abstract #2970612. 23rd World Congress of Dermatology (WCD 2015), Vancouver, Canada, 2015.
- AbbVie Data on File.
- Pharmaceutical and Medicine Devices Agency (PMDA) website. New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed May 27, 2015.
- Psoriasis. Report by the Secretariat. World Health Organization. 5 April 2013. Available at: http://apps.who.int/gb/ebwha/pdf_files/EB133/B133_5-en.pdf. Accessed May 27, 2015.
- Fotiadou C, Lazaridou E, Ioannides D. Management of psoriasis in adolescence. Adolesc Health Med Ther. 2014; 5: 25-34. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3961070/. Accessed May 27, 2015.
- Psoriasis Fact Sheet. National Institutes of Health. 2010. Available at: http://www.report.nih.gov/nihfactsheets/Pdfs/Psoriasis%28NIAMS%29.pdf. Accessed May 27, 2015.
- Seyhan M, Coskun B.K., Saglam H, Ozcan H, Karincaoglu Y. Psoriasis in childhood and adolescence: evaluation of demographic and clinical features. Pediatrics International. 2006; 48: 525–530.