Healthcare Industry News:  Methotrexate 


 News Release - June 23, 2006

New Phase III Data Demonstrate That Abbott's HUMIRA(R) (Adalimumab) Sustained Reduction in Signs and Symptoms Through One Year in Patients With Ankylosing Spondylitis

Second Analysis Demonstrates Improvement in Pain and Fatigue Through Six Months

AMSTERDAM, The Netherlands, June 23 (HSMN NewsFeed) -- Abbott announced today new results of two analyses from a major Phase III study of HUMIRA® (adalimumab) in ankylosing spondylitis (AS). The first analysis demonstrates the ability of HUMIRA to maintain the reduction of signs and symptoms in AS patients at 12 weeks through 52 weeks of treatment. A second analysis demonstrates that HUMIRA rapidly and significantly reduced pain and fatigue in patients with AS, an inflammatory disease of the spine and spinal joints, as early as two weeks compared with placebo and that the improvement was maintained for at least 24 weeks.

The data from the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS) study, presented today at the annual congress of the European League Against Rheumatism (EULAR), follow the recent approval by the European Commission of HUMIRA as a treatment for severe, active AS. AS is the third of six autoimmune diseases targeted for HUMIRA therapy, including rheumatoid arthritis and psoriatic arthritis. Abbott's application for HUMIRA for AS in the United States is currently under review.

"Pain, inflammation, fatigue and enthesitis are common symptoms of AS that can severely impact a patient's quality of life," said Joachim Sieper, M.D., Charite, Campus Benjamin Franklin, Berlin, Germany and ATLAS study investigator. "This study supports the role of HUMIRA in improving these AS symptoms."

Nearly three million people in Europe are affected by a spinal arthritic disease, such as AS. A chronic disease of the axial skeleton and large peripheral joints, AS causes inflammatory back pain and stiffness and it is associated with other inflammatory diseases of the skin, eyes and intestines. Unlike many other rheumatic conditions, AS affects mostly young men, and commonly begins before the age of 35. AS is difficult to diagnose in its early stages and is often an overlooked cause of persistent back pain in young adults. In severe cases, AS may result in complete spinal fusion, causing extreme physical limitation.

"HUMIRA is a strong option in the AS treatment marketplace through its efficacy, safety and convenient dosing," said Rebecca Hoffman, M.D., divisional vice president, Immunology Development, Abbott. "With its recent approval for AS in Europe and current indications in RA and PsA, HUMIRA is demonstrating benefits for patients facing these chronic and potentially disabling diseases."

Sustained Clinical Response

A randomized, placebo-controlled, double-blind, Phase III study, ATLAS assessed the ability to reduce signs and symptoms in 315 patients in Europe and the U.S. with active AS who were treated with 40 mg of HUMIRA every other week. Efficacy was measured using the Assessment in AS (ASAS) International Working Group Criteria, which includes inflammation, total back pain, patient's global assessment of disease activity, and function (for example, is a patient able to put on socks or tights without help).

New data from ATLAS show HUMIRA was effective in maintaining the reduction of the signs and symptoms of AS from 12 weeks through 52 weeks. The data reflects this effectiveness in patients with active AS who were treated with HUMIRA. At 12 weeks, approximately 60 percent of AS patients on HUMIRA achieved a 20 percent reduction in their signs and symptoms (ASAS 20), the study's primary endpoint. After completion of the blinded phase of the study at 24 weeks, all patients were given the option to enroll in the open label extension phase. Clinical response (ASAS 20) at one year was achieved by nearly three in four patients (74 percent). Eighty-nine percent of patients remained in ATLAS for one year, the length of the analysis.

Rapid and Significant Reductions in Pain, Fatigue and Enthesitis

In the second analysis, additional assessments were evaluated through 24 weeks using the Total Back Pain (TBP) and Nocturnal Pain (NP) Visual Analog Scales (VAS), the fatigue item of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Vitality and Bodily Pain domains of the Short Form-36 (SF-36) Health Survey.

Data show HUMIRA alleviated pain, fatigue and enthesitis (inflammation of the muscle-bone insertion) in patients with active AS. Results indicated that rapid and significant improvement in pain and fatigue symptoms occurred as early as two weeks in the HUMIRA group compared with the placebo group. Results were recorded at 12 weeks and sustained through 24 weeks of treatment.

Important Safety Information

Common adverse events (occurring in 1-10%) at least possibly related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), urinary tract infection, herpetic viral infection (including simplex and zoster), influenza, superficial fungal infections (including skin, nail and foot), lymphopenia, anemia, headache, dizziness, paraesthesias, hypertension, cough, nasopharyngeal pain, nasal congestion, nausea, abdominal pain, diarrhea, dyspepsia, mouth ulceration, rash rythematous, rash pruritic, hair loss, arthritis, fatigue (including asthenia and malaise), influenza like illness, hepatic enzymes increased (including alanine aminotransferase and aspartate aminotransferase), rash and pruritis. Upper respiratory infection and injection site reaction (including pain, swelling, redness or pruritis) was reported by more than 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.

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.


Rheumatoid Arthritis:

HUMIRA, in combination with Methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs including Methotrexate has been inadequate as well as for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with Methotrexate.

HUMIRA can be given as monotherapy in case of intolerance to Methotrexate or when continued treatment of Methotrexate is inappropriate.

HUMIRA has been shown to reduce the rate of progression of joint damage as measured by X-rays and to improve physical function when given in combination with Methotrexate.

Psoriatic Arthritis:

HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.

Ankylosing Spondylitis:

HUMIRA is indicated for the treatment of adults with severe, active ankylosing spondylitis who have had an inadequate response to at least one nonsteroidal anti-inflammatory drug or disease-modifying antirheumatic drug.

To date, HUMIRA has been approved in 65 countries. Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases.

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 65,000 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 .

Source: Abbott

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