Enbrel safe, effective for arthritis in long term

NEW YORK (Reuters Health) - Etanercept treatment of rheumatoid arthritis is safe and effective in some patients for 7 years or more, according to a report in The Journal of Rheumatology.

Etanercept, sold under the trade name Enbrel, is a drug with anti-inflammatory effects that has been shown to be safe and effective for rheumatoid arthritis, the authors explain, but most published studies have followed patients for only a few years.

Dr. Larry W. Moreland from the University of Alabama at Birmingham and colleagues evaluated the safety and effectiveness of etanercept in 344 rheumatoid arthritis patients who were enrolled in initial clinical trials and were "continuing to receive etanercept as of the cutoff date for this report. The longest individual treatment was for 8.2 years.

Long-term use of etanercept did not increase the risk of serious infections. Likewise, the cancer risk did not exceed that expected for the general population, the results indicate, and death rates were similar to those in the general population.

More than two thirds of the patients had a treatment response at year 1, the researchers note, and disease activity decreased significantly by year 1 and remained lower through year 7.

"In most patients that enrolled in the extension, there was sustained improvement in rheumatoid arthritis," the authors conclude. "In this selected population, etanercept was well tolerated with no increase in the rates of serious adverse events."

Although the results are reassuring, "it is still early, and further data are required before we can be confident in our knowledge of the true risks of these agents," write Dr. Kimme L. Hyrich and Dr. Alan J. Silman from the University of Manchester, UK in a related editorial. "We still have more to learn about the risks of infections."

"The possibility is real that long-term control of disease activity will result in improved prognoses for patients with rheumatoid arthritis," the editorial concludes. "Only through long-term observation of patients receiving these agents will issues be addressed."

SOURCE: The Journal of Rheumatology, May 2006.