(1888PressRelease)
December 21, 2007 - ABBOTT PARK, Ill. — Abbott has received marketing authorization from the European Commission for the use of HUMIRA® (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. HUMIRA is the first fully human, self-injectable biologic for the treatment of psoriasis. In one clinical trial, more than 80 percent of patients taking HUMIRA achieved skin clearance of 75 percent or better and in another, almost three quarters of patients achieved 75 percent clearance. In both trials, nearly half of the patients taking HUMIRA achieved 90 percent clearance as early as 16 weeks into treatment. Psoriasis is the fifth approved indication for HUMIRA in the European Union. A regulatory application for HUMIRA to treat psoriasis is also under review with the U.S. Food and Drug Administration.
''Psoriasis is not only a skin disease – it is a systemic, autoimmune disorder that, in its more severe forms, may require systemic treatment,'' said Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. ''HUMIRA is the first and only biologic that has been compared to methotrexate, and this approval brings an important new option for dermatologists to treat this disease.''
Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than painful skin lesions; data also suggest an association with other health conditions, including psoriatic arthritis. Patients may also suffer from poor self-image and social isolation.
''Patients taking HUMIRA for psoriasis experienced rapid, significant skin clearance and maintained improvement for up to a year,'' said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. ''This fifth indication for HUMIRA demonstrates its versatility in effectively treating multiple autoimmune disorders from rheumatoid arthritis to Crohn’s disease and now psoriasis.''
About HUMIRA Psoriasis Clinical Trials
The approval is primarily based on the results of two randomized, controlled, multi-center clinical trials in adult patients: CHAMPION and REVEAL. In both trials, the signs and symptoms of psoriasis were measured and evaluated using the Psoriasis Area and Severity Index (PASI) among other measures. CHAMPION was the first head-to-head study comparing a biologic medication to methotrexate, a standard systemic treatment for psoriasis.
In CHAMPION, a pivotal 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, HUMIRA-treated patients experienced a significant reduction in the signs and symptoms of their disease compared with methotrexate or placebo-treated patients. More than twice the percentage (80 percent) of patients treated with HUMIRA achieved a PASI 75 response (75 percent or better improvement in PASI), compared to patients treated with methotrexate (36 percent), a standard systemic treatment for psoriasis, and more than four times the percentage of patients treated with placebo (19 percent). Nearly 17 percent of patients treated with HUMIRA achieved a PASI 100 response at week 16, compared to 7 percent of patients receiving methotrexate and 2 percent of patients receiving placebo. In addition, a mean percentage PASI improvement of 57 percent was achieved at week four in patients receiving HUMIRA, compared to baseline.
In REVEAL, a pivotal 52-week trial, the short-term and sustained clinical efficacy and safety of HUMIRA were evaluated in more than 1,200 patients from the United States and Canada with moderate-to-severe chronic plaque psoriasis. Patients experienced a significant reduction in the signs and symptoms of their disease at 16 weeks when treated with HUMIRA. Specifically, almost three out of four patients (71 percent) receiving HUMIRA achieved PASI 75 compared to 6.5 percent of patients receiving placebo. One in five patients (20 percent) receiving HUMIRA achieved PASI 100 (complete clearance), compared to 1 percent of patients receiving placebo. For patients who maintained a PASI 75 response after eight months of continuous HUMIRA therapy, patients were either continued on HUMIRA or administered placebo for the remainder of the study. Significantly fewer patients (5 percent) on HUMIRA lost response (1/10 patients) at least possibly causally related to HUMIRA is injection site reaction (including pain, swelling, redness or pruritus). Other common adverse events (reported by >1/100 patients) at least possibly causally related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infection (including urinary tract infections), upper respiratory infection, dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias), cough, nasopharyngeal pain, diarrhea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, pruritus, musculoskeletal pain, pyrexia and fatigue (including asthenia and malaise).
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and Crohn′s disease in the United States and Europe. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-α), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. To date, HUMIRA has been approved in 73 countries and more than 190,000 people worldwide are currently being treated with HUMIRA.
In May 2007, Abbott announced it had submitted E.U. and U.S. regulatory applications for HUMIRA to treat juvenile rheumatoid arthritis, also known as juvenile idiopathic arthritis. Clinical trials are underway evaluating the potential of HUMIRA in ulcerative colitis.
In the United States, HUMIRA is approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of joint structural damage, and improving physical function in adult patients with moderately to severely active RA. HUMIRA is indicated for reducing the signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs). HUMIRA is also approved for reducing signs and symptoms in patients with active AS. In February 2007, HUMIRA was approved for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy and in reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
In Europe, HUMIRA, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX has been inadequate, and for the treatment of severe, active and progressive RA in adults not previously treated with MTX. HUMIRA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. HUMIRA has been shown to reduce the rate of progression of joint damage as measured by
x-ray and to improve physical function, when given in combination with MTX.
Also in Europe, HUMIRA is indicated for the treatment of active and progressive PsA in adults when the response to previous DMARD therapy has been inadequate and for the treatment of severe, active AS in adults who have had an inadequate response to conventional therapy. HUMIRA is indicated for treatment of severe, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, HUMIRA should be given in combination with cortiocosteroids. HUMIRA can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate. With today's announcement, HUMIRA is now indicated for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases.
More information about HUMIRA, including full prescribing information, is available on the Web site www.HUMIRA.com.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
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