Abbott Statement On Journal Of The American Medical Association Publication On Anti-TNF Agents

The following is Abbott's statement on the article in the May 17th issue of the Journal of the American Medical Association (JAMA), "Anti-TNF Antibody Therapy in Rheumatoid Arthritis and the Risk of Serious Infections and Malignancies":


The conclusion in the JAMA article regarding risk of infection in those taking anti-TNF agents restates what has already been observed in the clinical trials of all three anti-TNFs. These data have been reviewed in a U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee meeting in March 2003, and routinely since that time. The information in the JAMA article on infections is well documented in the labeling of all three anti-TNF agents, including HUMIRA (adalimumab).


Abbott disagrees with the authors' conclusions that their analysis establishes an increased risk of malignancies attributable to the anti-TNF agents included in their meta-analysis. The potential role, if any, of TNF-blocking therapy in the development of malignancies is not known, and this is reflected in the labeling of all three agents.


-- The JAMA analysis is not consistent with other published studies examining the relationship between anti-TNF therapy in rheumatoid arthritis and malignancy. A Swedish Registry analysis published in the Annals of Rheumatic Disease, October 2005, followed more than 60,000 rheumatoid arthritis (RA) patients, of whom more than 4,000 were treated with anti-TNF therapy over a period of four years. The authors reported no increased risk of solid tumors among RA patients treated with TNF-blocking agents.


-- The JAMA paper based its conclusions on trials lasting one year or less, however cancer is a disease process that takes many years to develop. The assessment of malignancy risk should be based upon longer observation periods.


-- The JAMA paper based its conclusions on a dose-dependent increased risk of malignancies. The authors classified 20 mg of HUMIRA weekly and 40 mg of HUMIRA every other week as low-dose and high-dose groups, respectively, however, these two doses deliver the same amount of drug, making the dose-related conclusion questionable.


Abbott's top priority is the safety of patients taking our medicines. Guidance on safe and appropriate use of HUMIRA (adalimumab) is clearly outlined in the product labeling, which can be found on our Website at HUMIRA. Abbott shares safety information on HUMIRA with regulatory agencies, clinical investigators, physicians and, most importantly, patients, through product labeling, scientific publications, and educational materials.


The authors of the JAMA article acknowledged the importance of the anti-TNF agents in the treatment of RA: "striking effectiveness of TNF inhibition redefined therapy for RA, most notably because of the ability of these agents to improve measures of disease activity and prevent a disabling disease course in patients who fail to respond to conventional DMARD treatment. The reduction of joint destruction, gain in mobility, and increase in quality of life, even in patients with RA who have poor response to treatment prior to the introduction of anti-TNF therapy, must be taken into account when considering therapeutic risks and benefits in individual patients."
















Patients Taking HUMIRA


Patients taking HUMIRA should continue to take their medication and speak to their physicians about any concerns.



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.



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.



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, Massachusetts, United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases. More information about HUMIRA, including full prescribing information, is available on the Web site HUMIRA, or in the United States by calling Abbott Medical Information at 1-800-633-9110.



About Abbott


Abbott 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 100 countries.


abbott


View drug information on Humira.