Baminercept was being investigated for use in RA patients who did not respond to treatment with conventional disease modifying anti-rheumatic drugs (DMARD), such as methotrexate. The primary endpoint was the measurement of patients who achieved a 50% improvement in the number of swollen, tender joints, as well as other clinical measures at week 14.

The secondary endpoints were defined as the proportion of patients with a 20% improvement and a 70% improvement in the number of swollen and tender joints as well as other quality of life measures.

The first Phase II study, known as 104RA202, included 380 patients with active rheumatoid arthritis did not have and adequate response to conventional DMARD therapy. This was a double-blind, placebo-controlled, multicenter trial designed to assess the efficacy of 5 different dosages of baminercept in combination with methotrexate over a 12 week period.

The second Phase II study, known as 104RA203, included about 120 patients with active RA that did not have an adequate response to tumor necrosis factor (TNF) inhibitors. This was also a randomized, double-blind, placebo-controlled, multicenter trial. It was designed to assess the efficacy of a 200 mg dose of baminercept over a 12 week period in combination with methotrexate.

Based on the results of these 2 trials, Biogen has decided to discontinue development of baminercept for treating rheumatoid arthritis. However, the company indicated that baminercept did have potential uses for treating other inflammatory diseases, such as Crohn’s disease and multiple sclerosis. As of now, there are no clinical trials scheduled for these conditions.

Originally posted 2008-10-23 11:36:26. Republished by Blog Post Promoter

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Spanish researchers who are presenting their research at the American College of Rheumatology’s annual meeting in San Francisco say their studies do not support that conclusion.

The researchers, from the Fundacion Espanola de Reumatologia in Madrid, Spain based their findings on two studies which used health data extracted from two Spanish databases of patients.

The first study involved almost 4,500 people who had been taking anti-TNF drugs between 2001 and 2007. The second study included data collected between 1999 and 2005 on 800 people with rheumatoid arthritis who were not taking anti_TNFs.

Ultimately they determined there were only 70 cases of cancer among those that were taking the drugs compared to 29 cases among those that did not take the drugs.

“Despite foreseen fears, blocking the tumor necrosis factor does not make patients more prone to develop cancer,” said Dr. Loreto Carmona of the Fundacion Espanola de Reumatologia.

Originally posted 2008-10-27 12:50:46. Republished by Blog Post Promoter

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