Following a detailed analysis of the efficacy and safety results from the RA programme, Roche and Biogen Idec have concluded that the overall benefit to risk profile of Ocrelizumab was not favourable in RA taking into account the currently available treatment options.
The Ocrelizumab RA program included four Phase III studies (Script, Film, Feature, and Stage). Most recent analysis included available safety and efficacy data from the Script Phase III study in patients with previous inadequate response (IR) to TNF-inhibitors and safety data from the Phase III Film study in patients who were methotrexate (MTX) naive.
The entities said that varoius steps are being taken to inform physicians involved in RA clinical trials to continue patient monitoring as defined in the study termination protocols.
Ocrelizumab is also being evaluated for relapsing remitting multiple sclerosis (RRMS). Treatment in Ocrelizumab RRMS Phase II study is ongoing and data from this study will be submitted for presentation at the upcoming ECTRIMS conference.
Earlier, in March, Roche and Biogen Idec have reported the suspension of treatment in the Ocrelizumab RA program. The decision followed a recommendation from the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB).
The DSMB concluded that the safety risk outweighed the benefits observed in these specific patient populations at that time based on an infection related safety signal which included serious infections, some of which were fatal, and opportunistic infections. Subsequently, the FDA placed the RA studies on clinical hold.
Hal Barron, executive vice president of global development and chief medical officer at Roche, said: “We thank the investigators and patients who participated in the RA clinical studies. Although this outcome is disappointing for patients, Roche remains committed to the development of treatments for RA.”