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Adalimumab Receives FDA Approval for Inhibiting Structural Joint Damage in Patients With Psoriatic Arthritis

ABBOTT PARK, Ill., Nov. 14 /PRNewswire-FirstCall/ -- Abbott announced today that the U.S. Food and Drug Administration (FDA) approved an expanded indication for HUMIRA(R) (adalimumab) that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis (PsA). The expanded indication is in addition to the psoriatic arthritis approval granted in October 2005.

HUMIRA is also approved in the U.S. for use in moderate to severe rheumatoid arthritis (RA) and active ankylosing spondylitis (AS).

PsA is a chronic disease that combines symptoms of arthritis, including joint pain and inflammation, and those of psoriatic skin disease, such as painful, raised red lesions covered by silvery white scales. Approximately one million men and women suffer from PsA in the United States and, when left untreated, the disease can be potentially disabling. Early recognition, diagnosis and treatment of PsA can relieve pain and inflammation and possibly help inhibit extensive joint involvement and damage in later stages of the disease.

"Psoriatic arthritis can be debilitating for many people, hindering everyday activities. For these people, and others, the new indication for HUMIRA is welcome news to our community," said Gail Zimmerman, president and CEO of the National Psoriasis Foundation.

Study Results
The expanded indication is based on results from an extension of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), the largest randomized, placebo-controlled biologic trial in PsA. ADEPT was a Phase III, controlled study in 313 patients with moderate to severe PsA, who had an inadequate response to NSAID (non-steroidal anti-inflammatory drug) therapy. Patients were randomized to receive either HUMIRA 40 mg every other week or placebo. At week 24, 285 patients elected to enroll in a 24-week open-label extension.

Progression of Structural Joint Damage
Patients taking HUMIRA experienced significantly less joint damage than patients taking placebo. Joint damage was assessed with X-rays taken at baseline and weeks 24 and 48, using the modified total Sharp score (mTSS), a measure of joint damage progression. A smaller change in mTSS reflects less progression of joint damage, with a positive score indicating worse radiographic damage. At week 24, the co-primary endpoint (the average change in joint damage, as measured by a mean change in mTSS) was 10 times greater in the placebo arm than in the HUMIRA arm (0.9 and -0.1, respectively; p Physical Function
Patients taking HUMIRA showed significant improvement in physical function as assessed by the Health Assessment Questionnaire Disability Index (HAQ) score and the Short Form-36 Health Status Survey (SF-36). HAQ scores assess a patient's ability to perform daily activities such as getting dressed, walking and climbing stairs. Statistically significant improvements in HAQ were achieved by patients in the HUMIRA group compared to placebo at week 24 (p Joint and Skin Symptoms
The October 2005 FDA approval of HUMIRA for active arthritis in psoriatic arthritis was based on two studies including ADEPT 24-week results measuring joint symptoms with American College of Rheumatology (ACR) scores and skin disease symptoms with the Psoriasis Area Severity Index (PASI). Patients' arthritic symptoms responded to HUMIRA, with nearly 60 percent of patients achieving ACR20 through week 24. An ACR20 score indicates a 20 percent or greater improvement in tender and swollen joint counts and several other clinical measures. The primary endpoint was ACR20 at week 12 in the ADEPT trial.

ADEPT also studied the ability of HUMIRA to improve the psoriatic skin symptoms associated with PsA. Sixty-nine patients in the HUMIRA group had skin lesions on greater than 3 percent of their body skin surface at the onset of the trial. (The palm of an adult hand represents approximately 1 percent.) Of these patients, approximately three out of five achieved 75 percent improvement, and more than two out of five achieved 90 percent improvement at 24 weeks (called PASI 75 or 90 responses, respectively in the study; p Joint results were maintained for patients in the HUMIRA group through week 48. Patients in the placebo group achieved similar results after receiving HUMIRA from week 24 through week 48. Skin results were also maintained in the HUMIRA group through week 48, when nearly three out of five patients achieved PASI 75 skin clearance and nearly one out of two patients achieved PASI 90 skin clearance response at week 48. Patients in the placebo group achieved similar results after receiving HUMIRA in the 24-week, open- label extension.

"Psoriatic arthritis is a multifaceted disease in which patients can experience joint and skin symptoms that may lead to disability and decreased quality of life," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "HUMIRA effectively treats multiple aspects of the disease, making it a promising comprehensive treatment for these patients."

About Psoriatic Arthritis
Psoriatic arthritis combines skin symptoms, such as dry, scaly skin and painful 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 skin involvement 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 (the part of the tendon that attaches to the bone) and arthritis of the spine. Psoriatic arthritis is 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 RA, 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.

Source: Abbott

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