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

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Abbott Statement On Journal Of The American Medical Association Publication

On Anti-TNF Agents

http://www.medicalnewstoday.com/medicalnews.php?newsid=43767 & nfid=nl

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 ls 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

http://www.HUMIRA.com. 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 http://www.HUMIRA.com, 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.

http://www.abbott.com