ABBOTT PARK, Illinois, April 2 /PRNewswire/ --
- Two Clinical Trials Demonstrate Promising Results in Psoriasis, theFifth Autoimmune Disease Submission for HUMIRA
Abbott announced it has simultaneously submitted a supplemental BiologicsLicense Application (sBLA) with the U.S. Food and Drug Administration (FDA)and a Type II Variation to the European Medicines Agency (EMEA) seekingapproval to market HUMIRA(R) (adalimumab) as a treatment for moderate tosevere chronic plaque psoriasis. Psoriasis affects 125 million peopleworldwide and is the fifth autoimmune disease targeted for HUMIRA therapy inboth the United States and Europe.
Psoriasis is a non-contagious, chronic autoimmune disease that causes thebody to attack itself and create raised, inflamed, scaly, red skin lesionsknown as plaques, which may crack and bleed. Psoriasis is more than skinlesions; it is painful and can impact many aspects of a person's life fromprofessional and social activities to personal relationships. People withpsoriasis may also suffer from poor self-image and social isolation.
The global submissions are based on the results of two double-blind,placebo-controlled trials of HUMIRA -- REVEAL and CHAMPION. In both trials,reduction in disease activity was determined by the Psoriasis Area andSeverity Index (PASI) score, which measures the extent and severity ofpsoriasis.
"With the global submissions for HUMIRA in psoriasis, patients are closerto gaining a biologic treatment option that may provide clearance frompainful and disfiguring skin lesions," said Alan Menter, M.D., chairman ofthe Division of Dermatology at Baylor University Medical Center, Dallas. "Weexpect that patients living with psoriasis, their families and their healthcare providers will welcome the results from HUMIRA clinical trials and theconvenience of a self-administered injection."
About HUMIRA Psoriasis Clinical Trials -- 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 of their disease at 16 weeks when treated with HUMIRA; specifically, almost three out of four patients (71 percent) receiving HUMIRA achieved PASI 75 or better, compared to only 6.5 percent of patients receiving placebo. One in five (20 percent) patients receiving HUMIRA achieved PASI 100 (complete clearance), compared to less than 1 percent of patients receiving placebo. -- In CHAMPION, a 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, twice the percentage (80 percent) of patients treated with HUMIRA achieved PASI 75 compared to patients treated with methotrexate (36 percent), a standard systemic treatment for psoriasis, and four times more than patients treated with placebo (19 percent). Nearly 17 percent of patients treated with HUMIRA achieved PASI 100 at week 16, compared to 7 percent of patients receiving methotrexate and 2 percent of patients receiving placebo. In addition, a mean PASI improvement of 57 percent was achieved at week four in patients receiving HUMIRA, compared to baseline.
"With almost 20 percent of patients achieving PASI 100, or completeclearance, in these two clinical trials, HUMIRA shows tremendous promise forphysicians and people living with this condition, which has no cure," saidEugene Sun, M.D., vice president, Global Pharmaceutical Clinical Developmentat Abbott.
The adverse events observed in REVEAL and CHAMPION were similar to thoseobserved in previous HUMIRA studies. The most commonly reported adverseevents in HUMIRA psoriasis trials were upper respiratory tract infection,nasopharyngitis (inflammation of the nose and pharynx) and headache.
HUMIRA has almost ten years of clinical experience. More than 180,000patients worldwide are currently being treated with HUMIRA. HUMIRA is alsoapproved to treat psoriatic arthritis, a form of arthritis that affects up to30 percent of people with psoriasis.
More Information About Psoriasis
Psoriasis is a chronic autoimmune disease that speeds the growth cycle ofskin cells and results in thick scaly areas of skin. The most common form ofpsoriasis appears as red, raised areas of skin covered with flaky whitescales, which may itch or burn. Psoriasis most commonly appears on the scalp,knees, elbows, lower back, hands and feet, though it can develop anywhere onthe skin. It may even occur in the fingernails, toenails and in the joints.While psoriasis can occur in people of all ages, it typically appears inpatients between the ages of 15 and 35. The severity of the disease variesfrom person to person. Currently, there is no cure for psoriasis.
Important Safety Information
Globally, prescribing information varies; refer to the individual countryproduct label for complete information.
Serious infections, sepsis, tuberculosis (TB) and rare cases ofopportunistic infections, including fatalities, have been reported with theuse of TNF-blocking agents, including HUMIRA. Many of these seriousinfections have occurred in patients also taking other immunosuppressiveagents that in addition to their underlying disease could predispose them toinfections. Treatment with HUMIRA should not be initiated in patients withactive infections. TNF-blocking agents, including HUMIRA, have beenassociated with reactivation of hepatitis B (HBV) in patients who are chroniccarriers of this virus. Some cases have been fatal. Patients at risk for HBVinfections should be evaluated for prior evidence of HBV infections beforeinitiating HUMIRA. The combination of HUMIRA and anakinra is not recommended.
TNF-blocking agents, including HUMIRA, have been associated in rare caseswith demyelinating disease and severe allergic reactions. Infrequent reportsof serious blood disorders have been reported with TNF-blocking agents. Morecases of malignancies have been observed among patients receiving TNFblockers, including HUMIRA, compared to control patients in clinical trials.These malignancies, other than lymphoma and non-melanoma skin cancer, weresimilar in type and number to what would be expected in the generalpopulation. There was an approximately four fold higher rate of lymphoma incombined controlled and uncontrolled open-label portions of HUMIRA clinicaltrials. The potential role of TNF-blocking therapy in the development ofmalignancies is not known.
Worsening congestive heart failure (CHF) has been observed withTNF-blocking agents, including HUMIRA, and new onset CHF has been reportedwith TNF-blocking agents. Treatment with HUMIRA may result in the formationof autoantibodies and rarely, in development of a lupus-like syndrome.
The most frequent adverse events seen in the placebo-controlled clinicaltrials in rheumatoid arthritis (HUMIRA vs. placebo) were injection sitereactions (20 percent vs. 14 percent), upper respiratory infection (17percent vs. 13 percent), injection site pain (12 percent vs. 12 percent),headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) andsinusitis (11 percent vs. 9 percent). Discontinuations due to adverse eventswere 7 percent for HUMIRA and 4 percent for placebo. As with any treatmentprogram, the benefits and risks of HUMIRA should be carefully consideredbefore initiating therapy.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritisand Crohn's disease, the safety profile for patients treated with HUMIRA wassimilar to the safety profile seen in patients with rheumatoid arthritis.
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved for thetreatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), andankylosing spondylitis (AS) in the United States and Europe. HUMIRA resemblesantibodies normally found in the body. It works by blocking tumor necrosisfactor alpha (TNF-α), a protein that when produced in excess, plays acentral role in the inflammatory responses of many immune-mediated diseases.To date, HUMIRA has been approved in 67 countries and more than 180,000people worldwide are currently being treated with HUMIRA.
Clinical trials are currently under way evaluating the potential ofHUMIRA in other immune-mediated diseases. Abbott plans to begin trials ofHUMIRA in children and adolescents with psoriasis later this year.
In the United States, HUMIRA is approved by the FDA for reducing signsand symptoms, inducing major clinical response, inhibiting the progression ofjoint structural damage, and improving physical function in adult patientswith moderately to severely active RA. HUMIRA is indicated for reducing thesigns and symptoms of active arthritis, inhibiting the progression ofstructural damage and improving physical function in patients with psoriaticarthritis. HUMIRA can be used alone or in combination with methotrexate orother disease-modifying anti-rheumatic drugs (DMARDs). HUMIRA is alsoapproved for reducing signs and symptoms in patients with active AS. On Feb.27, 2007 HUMIRA was approved for reducing the signs and symptoms and inducingand maintaining clinical remission in adults with moderately to severelyactive Crohn's disease who have had an inadequate response to conventionaltherapy.
In Europe, HUMIRA, in combination with methotrexate (MTX), is indicatedfor the treatment of moderate to severe, active RA in adult patients when theresponse to disease-modifying anti-rheumatic drugs (DMARDs) including MTX hasbeen inadequate, and for the treatment of severe, active and progressive RAin adults not previously treated with MTX. HUMIRA can be given as monotherapyin case of intolerance to MTX or when continued treatment with MTX isinappropriate. HUMIRA has been shown to reduce the rate of progression ofjoint damage as measured by x-ray and to improve physical function, whengiven in combination with MTX.
Additionally, HUMIRA is indicated for the treatment of active andprogressive PsA in adults when the response to previous DMARD-therapy hasbeen inadequate and for the treatment of severe, active AS in adults who havehad an inadequate response to conventional therapy.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovativetreatments for immunologic diseases. The Abbott Bioresearch Center, foundedin 1989 in Worcester, Mass., United States, is a world-class discovery andbasic research facility committed to finding new treatments for autoimmunediseases.
More information about HUMIRA, including full prescribing information, isavailable on the Web site www.HUMIRA.com or in the United States by callingAbbott Medical Information at +1-800-633-9110.
About Abbott
Abbott is a global, broad-based health care company devoted to thediscovery, development, manufacture and marketing of pharmaceuticals andmedical products, including nutritionals, devices and diagnostics. Thecompany employs 65,000 people and markets its products in more than 130countries.
Abbott's news releases and other information are available on thecompany's Web site at www.abbott.com.
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