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Roche safety fears over RA treatment

Roche has suspended Ocrelizumab treatment in its rheumatoid arthritis (RA) development programme following serious safety risks

Roche and research partner Biogen Idec have suspended the use of monoclonal antibody Ocrelizumab in their rheumatoid arthritis (RA) development programme following serious safety risks.

These risks included "serious and opportunistic infections, some of which were fatal" according to a statement from Roche.

The decision to suspend development comes after recommendation from the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB) who assessed several Roche studies involving RA, known as SCRIPT, FEATURE, FILM and STAGE, as well as two trials focusing on Lupus.

It was concluded by the DSMB that the safety risk of using Ocrelizumab "outweighs the benefits observed in these specific patient populations at this time".

Dr Hal Barron, executive vice president and chief medical officer at Roche confirmed the progamme's suspension: "Patient safety is of the utmost importance in all of our drug development programmes. In light of the DSMB recommendations we have decided to suspend Ocrelizumab treatment in the RA clinical development programme."

Issues involving the RA development programme have already been faced by Roche, with the FILM study, which involved MTX-naïve RA patients, having previously been placed on hold following an assessment of benefit to risk in this specific RA patient population.

The BELONG study, involving lupus nephritis patients, had also previously been suspended due to "serious and opportunistic infection signals".

Roche have said "a detailed analysis of all of the data will be conducted to help further inform the future of the Ocrelizumab RA clinical programme."

The company also confirmed that the evaluation of Ocrelizumab for relapsing remitting multiple sclerosis (RRMS) in a phase II study is still ongoing.


 

8th March 2010

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