Rheumatoid arthritis treatment suspended

March 12, 2010
Stephanie Sutton
Pharmaceutical Technology Europe

Following a number of serious adverse events, including infections and fatalities, Roche and Biogen Idec have suspended the late-stage development of Ocrelizumab for the treatment of rheumatoid arthritis (RA).

Following a number of serious adverse events, including infections and fatalities, Roche and Biogen Idec have suspended the late-stage development of Ocrelizumab for the treatment of rheumatoid arthritis (RA). The decision follows a recommendation made by the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board based on studies in RA and lupus.

"The DSMB concluded that the safety risk outweighs the benefits observed in these specific patient populations at this time," explained a press statement. "The DSMB review detected an infection related safety signal, which included serious and opportunistic infections, some of which were fatal."

The press statement also adds that a detailed analysis of all data will be conducted to "further inform the future of the Ocrelizumab RA clinical programme".

This is the latest in a number of setbacks for the treatment. According to the press statement, the companies have also previously halted an Ocrelizumab study in lupus nephritis patients because of infection signals and placed a study involving MTX-naive RA patients on clinical hold following an assessment of benefit to risk in this specific RA population.

However, the drug is still being evaluated for relapsing remitting multiple sclerosis and is currently undergoing a Phase II study.

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