On May 1st, the [...] No related posts.]]> Etanercept, marketed under the name Enbrel, is a drug that belongs to the class of drugs known as tumor necrosis factor (TNF)-alpha blocker. It is used primarily to treat rheumatoid arthritis, but has also been approved for use in treating polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and psoriasis.

On May 1st, the U.S. Food and Drug Administration (FDA) announced that it has required a warning label be added to Enbrel to increase the awareness of the risk of infections, particularly tuberculosis. The updated warning recommends screening for latent tuberculosis infection (LTBI) before beginning treatment with Enbrel.

It also warns that patients be monitored for possible antimicrobial treatment if the develop an infection and to stop taking Enbrel if a serious infection develops.

“Tuberculosis has been observed in patients receiving TNF-blocking agents, including Enbrel,” according to the warning. “Tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbel.”

The warning’s section on adverse events now says, “In global clinical studies of 20,070 patients (28,308 patient-years of therapy), tuberculosis was observed in approximately 0.01% of patients. In 15,438 patients (23,524 patient-years of therapy) from clinical studies in the U.S. and Canada, tuberculosis was observed in approximately 0.007% of patients. These studies include reports of pulmonary and extra-pulmonary tuberculosis.”

The changes were distributed to clinicians in a letter from Amgen and Wyeth, which market the drug for the manufacturer, Immunex.

Originally posted 2008-05-03 21:47:03. Republished by Blog Post Promoter

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Nearly 550 RA patients from Europe, Asia, Australia and Latin America, none of whom [...] No related posts.]]> Rheumatoid arthritis (RA) patients have been treated with several different drugs, including Enbrel (etanercept) and methotrexate. Now a study conducted in the United Kingdom indicates that treatment with a combination of Enbrel (an anti-TNF), and methotrexate increases the remission rate.

Nearly 550 RA patients from Europe, Asia, Australia and Latin America, none of whom had used methotrexate, were chosen at random for treatment with methotrexate alone, or with 50 mg. of Enbrel weekly. All of these patients had early moderate to severe rheumatoid arthritis for less than 2 years.

Results from the first year of the study shows that close to 50% of the patients receiving the combination of drugs went into remission. 94% of them had at least good to moderate improvements. Conversely, only 28% of the methotrexate only patients went into remission.

The researchers also noted that the combination of drugs stopped disease progression in 80% of the patients, as compared with 59% who took methotrexate alone.

Results were determined by measuring disease activity in 28 joints and progression of the disease identified in X-rays.

Another benefit for patients is that those on the combination therapy had a 300% reduction in work loss compared to methotrexate alone.

The study was led by Professor Paul Emery at the Leeds Institute of Molecular Medicine and was published in the British medical journal The Lancet.

Originally posted 2008-07-16 22:02:26. Republished by Blog Post Promoter

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Prior to the injection the patient was in relatively good health but he was agitated and could not remember what [...] No related posts.]]> Fascinating news today about an 81 year-old retired physician with Alzheimer’s disease who received an injection of etanercept, under the brand name of Enbrel, a medication that is used to treat rheumatoid arthritis (RA).

Prior to the injection the patient was in relatively good health but he was agitated and could not remember what state he was in, his birthday or the names of his doctors. Within 10 minutes of receiving an injection into his spine he was calmer and was able to recall the state he was in as well as his birthday and his doctors names.

He continued to experience improvements in cognitive functions for 2 hours after the injection.

This case was published in the Journal of Neuroinflammation by Dr. Edward L. Tobinick from UCLA and Dr. Hyman Gross from USC. The observations of Drs. Tobinick and Gross are similar to those from a study they conducted in 2006. In that study, 15 Alzheimer’s patients with mild to severe symptoms were given weekly injections of etanercept over a 6 month period during which time the patients experienced significant improvements in mental function.

Previous studies have suggested that etanercept, and potentially similar medications, may interrupt the inflammation caused by a protein known as tumor necrosis factor alpha, or TNF-alpha. TNF-alpha is the compound that is active in causing rheumatoid arthritis. TNF-alpha may also interfere with the way neurons communicate, so etanercept may help the brain cell transmit messages.

“This absolutely has the potential to be a disease-modifying treatment,” said Dr. Tobinick. “Since this report, our patient has received several other doses, and he’s continued to show a therapeutic benefit.”

Originally posted 2008-01-11 23:03:40. Republished by Blog Post Promoter

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