Tuberculosis Associated with Infliximab, a Tumor Necrosis Factor-alpha Antagonist

The New England Journal of Medicine in a recent issue, reported on a review of adverse events in patients treated with infliximab (Remicade TM), published by Keane J, and colleagues. According to the review, of the 147,000 patients throughout the world who had received infliximab, there were 70 reported cases of tuberculosis after treatment. Of the 70 reports, 64 were from countries with a low incidence of tuberculosis.

"We may be at a crossroads similar to that of clinicians of a previous generation, during which the initial use of corticosteroids was hailed as the "cure" of rheumatic disease but later the development of complications taught us steroids' limitations and how to better access the risks and benefits of treatment with a particular dose," commented Dr. Keane. Adverse effects can be reported in the US by phone to Centecor at 800-457-6399, and to the FDA MedWatch reporting system at 800-FDA-1088 or the MedWatch web site at www.fda.gov/medwatch.

Rheumatologists recently received warning letters about the risks of reactivation of tuberculosis in patients receiving the inhibitors of tumor necrosis factor-alpha (TNF-alpha), infliximab (Remicade) or etanercept (Enbrel).

Long-Term NSAID Use Tied to Reduced Risk of Alzheimer's Disease

Reuters Health - The risk of Alzheimer's disease is reported to be significantly reduced in subjects who use nonsteroidal anti-inflammatory drugs (NSAIDs) for a least 2 years, according to results of a prospective study puvlished in the New England Journal of Medicine for November 22.

In a baseline between 1990 and 1993, the study, by Dr. Bas, A of Erasmus Medical Center in Rotterdam, Netherlands, involved a total of 6,989 patients, at least 55 years of age, and free of dementia initially. The patients were followed until they died or were diagnosed with dementia, up until 1998.

According to computerized pharmacy records, approximately 83% of the prescriptions were for the NSAIDS diclofenac, ibuprofen, or naproxen.

Etanercept (Enbrel) Shows Promise for Patients with Ankylosing Spondylitis

San Francisco, 65th annual meeting of the American College of Rheumatology. Researchers conducting the first study to investigate whether the drug etanercept (Enbrel) is effective in patients with ankylosing spondylitis, presented the results of phase ll during these meetings. Dr. Jennifer D. Gorman, University of California at San Francisco, co-principal investigator of the study, told attendees that etanercept has shown to be effective in reducing the joint pain, swelling and stiffness in patients with ankylosing spondylitis.

Seattle based Immunex Corp, the makers of the drug, has announced it has already begun a large, multi-center phase lll clinical study of the drug for the treatment of ankylosing spondylitis.

Novel Concepts of Severity Mechanisms in AS

The Journal of Rheumatology, current issue, features a provocative report of AS that concludes that, "age at onset, itself, does not influence disease severity". The report concludes that hip involvement in young onset of the disease is a marker of worse future outcomes, whereas the development of hip disease at later ages may itself be a secondary manifestation of more severe AS.

Other conclusions of the report were, the lack of association between severity and age of onset, which lead to the hypothesis that the three clearly distinct independent factors influencing severity are: the environment, and both susceptibility and severity genes operating in AS.

Critical analysis of these newly reported findings promise to provide basis knowledge about the course and cause of Ankylosing Spondylitis. Further accurate and discriminating data will be needed to support these challenging proposals.

A Phase l Study of Ethyl Acetate (EA) Extract of a Chinese Antirheumatic Herb in Rheumatic Disease

The Journal of Rheumatology currently reports on the results of an open label, dose escalation Phase l study in 13 patients with rheumatoid arthritis with the Chinese herb Tripterygium wilfordii Hook (TWHF). Rheumatoid arthritis is an inflammatory rheumatic disease that has some similar characteristics to AS.

The conclusions of the study were that TWHF at dosages up to 570 mg/day appeared to be safe, and doses > 360 mg/day were associated with clinical benefit in patients with RA. Most of the patients in the study had previously failed DMARD therapy, all of which had been discontinued for at least 4 weeks.

The safety and efficacy of EA extract of TWHF is currently being evaluated in a double blind controlled Phase ll study.