Ocrelizumab RA programme suspended

Taken from NRAS magazine, Spring 2010

Roche and Biogen Idec announced on 8 March 2010 their decision to suspend Ocrelizumab treatment of patients in the RA programme. The decision follows the recommendation of the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB) based on their assessment of the studies in RA and lupus.

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

"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." said Hal Barron, MD Executive Vice President and Chief Medical Officer at Roche.

A detailed analysis of all of the data will be conducted to help further inform the future of the Ocrelizumab RA clinical programme.