17.12.2004 – 14:09
Abbott Announces European and U.S. Regulatory Submissions for Humira(R) as Treatment for Psoriatic Arthritis
Abbott Park, Illinois (ots/PRNewswire)
- First expansion into new disease for rheumatoid arthritis drug HUMIRA
Abbott (NYSE: ABT) announced it has simultaneously submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) and a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) seeking approval to market HUMIRA(R) (adalimumab) for psoriatic arthritis, an autoimmune disorder that combines symptoms of psoriasis, such as dry, scaly skin with arthritis symptoms, including joint pain and inflammation.
The filings are based on two placebo-controlled studies, including data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), a Phase III clinical trial showing patients on HUMIRA achieved significant improvement in both arthritic and psoriatic signs and symptoms. Results from the ADEPT trial were recently reported at the American College of Rheumatology congress in San Antonio, Texas, in October.
"HUMIRA has been an effective treatment for people with rheumatoid arthritis and our research shows great promise for treating psoriatic arthritis and other inflammatory autoimmune conditions," said Alejandro Aruffo, Ph.D., president, Abbott Bioresearch Center and Immunoscience Development Center, Abbott. "This is encouraging news for the millions of people afflicted with such diseases worldwide. Abbott will continue to research the potential of HUMIRA and other compounds as part of our commitment to use scientific innovation to address major unmet medical needs."
HUMIRA is currently approved by the EMEA and the FDA for the treatment of moderate to severe rheumatoid arthritis (RA) in adult patients when the response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate.
"This news is encouraging for psoriatic arthritis patients and for the dermatologists and rheumatologists who have limited therapeutic options for treating this difficult disease," said Philip Mease, M.D., lead study investigator, Swedish Medical Center and University of Washington School of Medicine, Seattle. "The HUMIRA data shows patients experienced significant relief from joint symptoms along with a marked improvement in skin symptoms. For those with significant psoriasis, about seven out of 10 patients achieved clear or almost clear skin."
About the ADEPT Trial
The placebo-controlled, double-blind study assessed the efficacy and tolerability of HUMIRA in 313 adults with active psoriatic arthritis (defined as three or more swollen joints and three or more tender joints) who had an inadequate response to therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). Patients received placebo or 40 mg of HUMIRA administered subcutaneously every other week, the same dose as the RA indication.
The study found that patients' psoriatic arthritis skin symptoms showed a significant response to HUMIRA. Of the 69 patients with greater than three percent of body surface involvement who were treated with HUMIRA, 42 percent achieved a PASI 90 response at 24 weeks, which reflects at least a 90 percent improvement in psoriasis symptoms assessed by the Psoriasis Area and Severity Index (PASI). Nearly one-third of patients achieved a PASI 90 by week 12, which was maintained through the study.
Patients' arthritic symptoms exhibited a rapid response to HUMIRA, with nearly 60 percent of patients achieving ACR20 at week 12, one of the study's primary endpoints, and sustaining response through week 24. American College of Rheumatology (ACR) scores measure the percentage of improvement in tender and swollen joint count and other clinical measures. At the 24-week follow-up, nearly one-fourth of these patients achieved ACR70, which means patients had a 70 percent improvement in arthritis signs and symptoms.
The rates of adverse events and serious adverse events in the study were comparable between HUMIRA and placebo. Among patients taking HUMIRA, the most common adverse events (those affecting at least five percent of patients) were upper respiratory infection, nasopharyngitis, injection site reaction, headache and hypertension. The safety profile of HUMIRA in the psoriatic arthritis population was similar to that observed with HUMIRA in the rheumatoid arthritis population.
About Psoriatic Arthritis
Psoriatic arthritis is an autoimmune disorder that combines symptoms of psoriasis, such as dry, scaly skin and patches of red, raised skin known as plaques, with arthritis symptoms including joint pain and inflammation. Common symptoms of psoriatic arthritis include varying degrees of psoriasis activity along with stiffness, pain, swelling and tenderness of the joints that can lead to a reduced range of motion and potential severe joint destruction.
Left untreated, psoriatic arthritis can be a progressively disabling disease. The arthritic manifestations often include debilitating disease of the hands and feet, as seen in rheumatoid arthritis; as well as painful inflammation of the tendon insertions and arthritis of the spine. Psoriatic arthritis is most often found in patients who suffer from psoriasis, a chronic skin disease that affects nearly three percent of the world's population. It is estimated that up to 30 percent of people with psoriasis also develop psoriatic arthritis.
Like rheumatoid arthritis, psoriatic arthritis is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-alpha), has been suggested to play a role in disease development. HUMIRA, which is a fully human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking TNF-alpha.
Important Safety Information
Common adverse events ( > 1/100 and < / = 1/10) at least possibly causally related to HUMIRA include headache, dizziness, respiratory tract and urinary tract infection, nausea, diarrhea, sore throat, herpes simplex, abdominal pain, rash, pruritis and anemia. Injection site pain was reported by >1/10 of patients.
Patients must be monitored closely for infections, including tuberculosis (TB), before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.
TNF-antagonists, including HUMIRA, have been associated in rare cases with exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Prescribers should exercise caution in considering the use of HUMIRA in patients with pre-existing or recent-onset central nervous system demyelinating disorders.
HUMIRA should be used with caution in patients with mild heart failure, and is contraindicated in patients with moderate or severe heart failure. HUMIRA must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
HUMIRA is the only fully human monoclonal antibody approved by the FDA and EMEA for reducing the signs and symptoms, inhibiting the progression of structural damage and improving physical function in adults with moderately to severely active RA who have had insufficient response to one or more DMARDs. HUMIRA can be used alone or in combination with methotrexate or other DMARDs. HUMIRA offers convenient every-other-week dosing by subcutaneous injection (shot beneath the skin) via a specially designed, pre-filled syringe.
Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases, including juvenile rheumatoid arthritis (JRA), psoriasis, psoriatic arthritis, Crohn's disease and ankylosing spondylitis.
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 more than 55,000 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 http://www.abbott.com .
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