SAN DIEGO, Nov 13, 2005 /PRNewswire-FirstCall via COMTEX News Network/ -- New data from a subgroup analysis at 12 weeks of the Research in Active Rheumatoid Arthritis (ReAct) study in more than 800 patients show HUMIRA(R) (adalimumab) was promising in treating those battling rheumatoid arthritis (RA) who failed previous therapy with other anti-tumor necrosis factor (TNF) treatment. Failure of previous therapy was defined as no response, loss of response, or intolerance to therapy. Of those who previously failed anti-TNF therapy on etanercept and/or infliximab, a majority (61 percent) showed a clinical response with HUMIRA. The data, being presented tomorrow at the annual American College of Rheumatology meeting, provides evidence indicating that patients failing one anti-TNF therapy may have a favorable clinical response to HUMIRA.

Anti-TNF therapies are targeted therapies that work to inhibit and block the activity of inflammatory cytokines including TNF-alpha. TNF-alpha is a molecule directly involved in the pathogenesis of RA. These therapies are designed specifically to target and bind to TNF-alpha, ultimately reducing inflammation and slowing the progression of joint damage. Anti-TNF therapies have an established clinical record of efficacy and safety with approximately 12 years of post-marketing experience and clinical data. HUMIRA has clinical experience into the seventh year.

HUMIRA was first approved in 2002 for the treatment of patients with moderately to severely active RA who had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs). In October 2005, Abbott received FDA approval to market HUMIRA as a first-line treatment for recent onset moderate to severe RA.

"This study showed that failure on one anti-TNF may not indicate failure with another TNF blocker," said Stefano Bombardieri, M.D., ReAct study investigator and Professor of Rheumatology, Department of Internal Medicine, University of Pisa, Pisa, Italy. "These findings are encouraging for patients who have been battling RA for years and have had to discontinue anti-TNF therapy due to lack of response or intolerance."

ReAct Study Results

ReAct was an open label study of 6,610 patients with moderate to severe RA who had an insufficient response to standard anti-rheumatic therapies. Patients were treated with HUMIRA 40 mg every other week (eow) in addition to or as a replacement for their pre-existing therapy. Patients were observed at weeks 2, 6, 12, 28, 36 and 52 to evaluate ACR responses and mean change in DAS 28. American College of Rheumatology (ACR) scores measure the percentage of improvement in tender and swollen joint count and several other clinical measures. The Disease Activity Score (DAS) measures disease activity responses in RA by assessing tender and swollen joint counts, general health status and an inflammatory marker. Outcomes from this study were analyzed at week 12 for the subgroup of patients who previously failed anti-TNF therapy.

Of the 819 patients who had previously failed etanercept and/or infliximab, nearly two-thirds of patients (61 percent) achieved ACR 20 and one-third (33 percent) achieved ACR 50 after 12 weeks of HUMIRA 40 mg eow. Of this group, 14 patients had previously been treated unsuccessfully with both etanercept and infliximab, three of which had ACR 50 responses to HUMIRA at week 12.

Thirteen percent of the 819 patients who previously failed etanercept and/or infliximab achieved clinical remission after 12 weeks of HUMIRA 40 mg eow, as measured by DAS28<2.6. The mean improvement in health-related quality of life from baseline for patients with previous anti-TNF failure was similar to patients naive to TNF therapy (- 0.49 and - 0.55 respectively). Health-related quality of life is measured by the Health Assessment Questionnaire Disability Index (HAQ DI), which is designed to capture patients' assessment of the ability to carry out activities of daily living such as grooming, dressing and walking. HAQ DI scores range from 0-3, with lower scores indicating higher levels of physical function.

Among the 819 patients with previous anti-TNF failure the most frequent severe adverse events were musculoskeletal disorders (2 percent), infections (1 percent) and skin disorders (0.6 percent). Of the 160 etanercept and/or infliximab intolerant patients, eight discontinued HUMIRA due to adverse events, one of them due to hypersensitivity.

"In the ReAct study the majority (61 percent) of patients who previously failed other anti-TNF therapies showed a clinical response with HUMIRA," said Alejandro Aruffo, Ph.D., vice president, Global Pharmaceutical Development, Abbott. "These results, along with the recent approval of HUMIRA as a first-line treatment for moderate to severe RA, provide rheumatologists an effective treatment option for recent-onset as well as established RA patients."

The ReAct study provides potentially useful information to practitioners because a wide spectrum of adult patients with moderate-to-severe RA were included, with varying disease durations and treatment backgrounds. ReAct captured data from a broad patient population representing individuals from 450 sites in 11 European countries and Australia.

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, potentially resulting in 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 .

Important Safety Information

Cases of tuberculosis (TB) have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Treatment with HUMIRA should not be initiated in patients with active infections. The combination of HUMIRA and anakinra is not recommended.

TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents. More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately four fold higher rate of lymphoma in combined controlled and uncontrolled open label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known.

The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.

The safety profile for patients with psoriatic arthritis treated with HUMIRA in the clinical trials has been similar to the safety profile seen in patients with RA.

About HUMIRA

HUMIRA is the only fully human monoclonal antibody approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate (MTX) or other DMARDS (disease-modifying anti-rheumatic drugs).

HUMIRA is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with DMARDS.

Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases.

Abbott's Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases. More information about Abbott Immunology and HUMIRA, including full prescribing information, is available on the Web site http://www.rxabbott.com or in the United States by calling Abbott Medical Information at 1-800-633-9110.

About Abbott

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 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 .

SOURCE Abbott

U.S. Media, Liz Shea, +1-847-989-0174, or Media Outside the U.S., Rand Walton,
+1-847-938-8848, or Financial Community, John Thomas, +1-847-938-2655, all of Abbott

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