Ocrelizumab is also being evaluated for relapsing remitting multiple sclerosis (RRMS). The treatment in the Ocrelizumab RRMS Phase II study is on-going at this time.
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.
Reportedly, the Film study in MTX-naive RA patients was placed on clinical hold following an assessment of benefit to risk in this specific RA patient population. In addition, the Belong study in lupus nephritis patients was previously halted due to serious and opportunistic infection signals.
The Script trial in patients who inadequately responded to one or more TNF antagonists and the Film trial remain blinded. A detailed analysis of all of the data will be conducted to help further inform the future of the Ocrelizumab RA clinical programme.
Hal Barron, executive vice president and chief medical officer at Roche, said: “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.”