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Abbott's HUMIRA(R) (Adalimumab) Shown to Improve Quality of Life for Psoriatic Arthritis Patients
Vienna, Austria (ots/PRNewswire) -
- Data from ADEPT study showed HUMIRA slowed progression of structural joint damage
Results from Abbott's Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) show that HUMIRA(R) (adalimumab) treated both joint and skin aspects of the disease and improved the quality of life measurements in patients with moderate to severely active psoriatic arthritis. The data were presented today at the annual congress of the European League Against Rheumatism (EULAR).
Improving quality of life is important for psoriatic arthritis patients because the disease can limit both physical and social function, causing pain, disability and emotional problems. Psoriatic arthritis is a chronic disease that combines the symptoms of arthritis, including joint pain and inflammation, with the symptoms of psoriasis, such as dry, scaly skin.
Data from patients in ADEPT receiving HUMIRA (n=151) showed that quality of life improved considerably during a 24-week period, using multiple assessment tools. In a standard eight-category questionnaire, the Short Form-36 Health Status Survey (SF-36), patients treated with HUMIRA at week 24 showed clinically significant improvement versus placebo (n=162) in seven of eight categories (physical and social functioning, physical role limitations, bodily pain, general medical health, mental health and vitality). Clinically significant improvements in SF-36 categories have not yet been defined for psoriatic arthritis, but when rheumatoid arthritis (RA) definitions are applied the improvements observed with HUMIRA were deemed statistically significant in six of the seven categories.
"Psoriatic arthritis can be a devastating disease to all areas of a patient's life - physically, socially and emotionally," said Philip Mease, M.D., lead study investigator, of Swedish Medical Center and the University of Washington School of Medicine in Seattle, Washington. "At the end of the ADEPT study, patients' quality of life was improved, which means they were able to take part in normal activities again, such as wearing short sleeves, experiencing intimacy, or climbing a flight of stairs - activities that are taken for granted by most people. But for someone with moderate to severe psoriatic arthritis, these activities can be embarrassing or painful."
Quality of Life Improvements Seen with Dermatology Life Quality Index (DLQI)
ADEPT study patients with psoriasis covering 3 percent or more of their body surface area completed the DLQI, a questionnaire used to evaluate how skin disease impacts daily life. The DLQI collects information on pain and itching, as well as feedback regarding whether their psoriasis causes a patient to be embarrassed, affects their ability to work or play, or inhibits personal or sexual relationships. The possible range for DLQI is zero to 30. In 132 patients evaluated, the HUMIRA-treated patients had a -6.1 point improvement versus only -0.7 points for those taking placebo.
The study also measured improvement in patients' fatigue levels using the Functional Assessment of Chronic Illness Therapy fatigue score (FACIT-F). This measurement tool gathers patient feedback about energy level, listlessness and the ability to start or finish activities. At week 24, patients receiving HUMIRA experienced mean improvement seven points higher than patients taking placebo (7.1 versus 0.1, respectively) on a scale of zero to 52. Clinically meaningful improvements in the FACIT-F scale have not been specifically defined for psoriatic arthritis. In rheumatoid arthritis, meaningful improvement is defined as a four-point change.
"Psoriatic arthritis impedes quality of life by attacking patients on two fronts - their joints and their skin," said Mark Weinberg, M.D., global medical director, Immunology Development, Abbott. "The ADEPT findings are very encouraging because they show the potential HUMIRA has in addressing this devastating combination of symptoms."
HUMIRA Data Showed Inhibition of Joint and Skin Aspects of the Disease
ADEPT researchers also presented promising new HUMIRA data that addressed the joint aspects of psoriatic arthritis. The study evaluated arthritic progression by using X-rays of the hands and feet of adult patients with moderate to severely active psoriatic arthritis. Patients in the first 24 weeks of the ADEPT study received 40 mg HUMIRA every other week or placebo, and all patients participating in the 24-week extension received 40 mg HUMIRA every other week.
At week 24, modified Total Sharp Scores (mTSS), a measurement used to assess changes in bone erosion and joint-space narrowing, showed that approximately three times as many patients receiving placebo had an increase in their scores (increase in mTSS >0.5 units) than patients treated with HUMIRA (28.9 percent vs. 9 percent, respectively). Patients treated with HUMIRA had significantly less change in mTSS than patients treated with placebo at week 24 and new data from the open-label extension showed that the inhibition of disease progression at week 24 achieved in patients taking HUMIRA was maintained through week 48.
The skin results for ADEPT show that in patients with more than 3 percent body surface area involvement, 42 percent of patients taking HUMIRA achieved a PASI 90 response at week 24 versus zero percent of patients treated with placebo. PASI 90 reflects at least 90 percent improvement in psoriasis symptoms assessed by the Psoriasis Area and Severity Index (PASI).
In December 2004, Abbott 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 for psoriatic arthritis.
More About ADEPT
ADEPT, a 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). The primary joint results for ADEPT show that 58 percent of patients treated with HUMIRA achieved ACR 20 at week 12 versus 14 percent of patients treated with placebo. This response was sustained through week 24. The American College of Rheumatology score (ACR 20) indicates a 20 percent or greater improvement in tender and swollen joint count and other relevant clinical measures.
More than 80 percent of the patients had been treated with at least one disease-modifying antirheumatic drug (DMARD) prior to the trial. Patients whose psoriasis covered more than 3 percent of their body surface area (n=140) were evaluated for the treatment's impact on skin symptoms. Patients received placebo or 40 mg of HUMIRA administered subcutaneously every other week, the same dose as the rheumatoid arthritis indication. Patients who completed the 24-week trial were eligible to enroll in an open-label extension study in which all patients receive HUMIRA for an additional 120 weeks.
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 (affecting at least 5 percent of patients) were upper respiratory infection, nasopharyngitis, injection site reaction, headache and hypertension.
About Psoriatic Arthritis
Psoriatic arthritis 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 3 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 less than or equal to 1/10) at least possibly causally related to HUMIRA in RA patients 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 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.
Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events, including worsening CHF and new onset CHF, have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA.
HUMIRA is the only fully human monoclonal antibody approved by the EMEA and the FDA for the treatment of moderate to severe, active RA in adult patients when the response to DMARDs including methotrexate (MTX) has been inadequate. In this population, 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. To ensure maximum efficacy, HUMIRA is given in combination with MTX. HUMIRA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
To date, HUMIRA has been approved in 57 countries and prescribed to more than 100,000 patients suffering from RA worldwide. Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases.
Abbott (NYSE: ABT) 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 60,000 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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