Abbott announced that it has received approval from the European Commission to market HUMIRA® (adalimumab) as a treatment for psoriatic arthritis and early rheumatoid arthritis (RA) in Europe.

"Until today, the options for patients and physicians seeking an effective medication to treat both the joint and skin aspects of psoriatic arthritis were limited," said Serge Steinfeld, M.D., Ph.D., professor of medicine, Erasme University Hospital, Brussels, Belgium. "This approval brings a new option and new hope in treating the potentially devastating physical aspects of a disease that can be accompanied by significant emotional elements."

HUMIRA will be available immediately to patients with psoriatic arthritis in Germany, United Kingdom, Spain, Finland and Denmark. Availability in other European Union countries will occur in subsequent months as each country adopts pricing and reimbursement policies.

"In addition to HUMIRA being approved for psoriatic arthritis, the approval for first-line use in RA opens the door for patients with severe, active and progressive RA to have the opportunity to experience the benefits of HUMIRA earlier in the treatment phase," said Alejandro Aruffo, Ph.D., vice president, Global Pharmaceutical Development and Abbott Bioresearch Center, Abbott . "This is important because the earlier we can treat RA with HUMIRA, the better the chances for slowing the progression of the disease."

The approval for psoriatic arthritis marks the second indication for HUMIRA, while the early RA approval establishes HUMIRA as a first-line treatment for severe, active and progressive RA in adults not previously treated with methotrexate. HUMIRA was previously approved for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying antirheumatic drugs including methotrexate has been inadequate.

A decision regarding the FDA's approval of HUMIRA for these expanded indications in the United States is anticipated by the end of 2005.

HUMIRA in Psoriatic Arthritis

Psoriatic arthritis combines the symptoms of arthritis, including joint inflammation, which leads to pain and possible damage, with the symptoms of psoriasis, such as dry, scaly skin. Psoriasis affects nearly 3 percent of the world's population and it is estimated that as many as 10-30 percent of psoriasis sufferers may develop psoriatic arthritis.

Abbott previously released clinical trial data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) showing HUMIRA's ability to treat both the joint and skin symptoms associated with psoriatic arthritis. Patients' arthritic symptoms exhibited a response to HUMIRA, with nearly 60 percent of patients achieving ACR 20 at week 12, one of the study's primary endpoints, and with a sustained response through week 24. American College of Rheumatology (ACR) scores measure the percentage of improvement in tender and swollen joint count and a minimum of three out of five other clinical measures.

The study's second primary endpoint examined the change in modified Total Sharp Score (mTSS), a measurement used to assess changes in bone erosion and joint-space narrowing in X-rays, at week 24. Patients treated with HUMIRA had significantly less change in mTSS than patients treated with placebo at week 24. Approximately three times as many patients receiving placebo had worsening in their scores (increase in mTSS >0.5 units) than patients treated with HUMIRA (28.9 percent vs. 9 percent, respectively) at week 24. Data from the open-label extension showed that the inhibition of disease progression in patients taking HUMIRA at week 24 was maintained through week 48 ; two-year data will be collected for a future submission to European Medicines Agency (EMEA).

In addition, in this clinical study, among the 69 patients in the trial who had greater than 3 percent body surface involvement who were treated with HUMIRA, 42 percent achieved a PASI 90 response at 24 weeks, which reflects at least 90 percent improvement in psoriasis symptoms assessed by the Psoriasis Area and Severity Index (PASI).

HUMIRA as a First-Line Treatment for Severe Early RA

The first-line treatment approval gives patients with severe, active and progressive RA the opportunity to begin HUMIRA treatment after diagnosis. The PREMIER clinical trial, on which the approval was based, also demonstrated that the combination therapy of HUMIRA and methotrexate successfully inhibited radiographic progression (joint damage) in patients with recently diagnosed, severe RA (less than three years disease duration).

One of the study's co-primary endpoints was ACR 50. This measure indicates 50 percent or greater improvement in tender and swollen joint count and a minimum of three out of five other relevant clinical measures. At 52 weeks, approximately 62 percent of the patients on combination therapy achieved ACR 50, compared to 46 percent in the group receiving only methotrexate. PREMIER is the first RA study to achieve ACR 50 as a primary endpoint.

PREMIER's second primary endpoint, inhibition of radiographic progression, was measured by the change in mTSS. The HUMIRA-methotrexate combination achieved significantly more favorable results than methotrexate alone in inhibiting radiographic disease progression. After one year, the mean change from baseline in mTSS score for the combination arm was 1.3 as compared to 5.7 in the methotrexate alone arm. After two years, the mean change from baseline in mTSS score for patients in the combination arm was 1.9, while patients in the methotrexate-only group experienced five times the radiographic progression, with mean clinically significant change from baseline in mTSS scores of 10.4. In addition, approximately two times more patients in the combination therapy group were without radiographic disease progression versus methotrexate alone (61 percent vs. 34 percent) at the end of year two. No radiographic progression was defined as <0.5 units change from baseline in mTSS.

PREMIER data also showed that nearly one in two (49 percent) of the early RA patients receiving combination therapy achieved clinical remission at two years, as defined by DAS28<2.6, compared to 25 percent of patients taking methotrexate alone. The Disease Activity Score (DAS) measures disease activity responses in RA by assessing tender and swollen joint count, general health status and an inflammatory marker. Additionally, one-year data showed approximately 43 percent of patients receiving combination therapy in PREMIER achieved a measure of clinical remission at 52 weeks as defined by DAS28<2.6, compared to 21 percent on methotrexate alone.

The recommended dose of HUMIRA for psoriatic arthritis and the usual dose in RA is 40 mg every-other-week by subcutaneous injection (a shot beneath the skin). HUMIRA is packaged in specially designed pre-filled syringes, which feature handles and plunger heads designed for use by patients whose hands have been affected by their disease.

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 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 as many as 10-30 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-Éø), 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-.

About RA

More than five million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of the hands, feet and wrists, and often leads to the destruction of joints. Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, resulting in eventual destruction of the joints' interior and the surrounding bone.

More information on RA and current treatment options can be found at http://www.RA.com.