Roche and Biogen Idec has decided to discontinue the ocrelizumab clinical development programme in patients with rheumatoid arthritis (RA).
Following a detailed analysis of the efficacy and safety results from the RA programme, the companies 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) naïve.
Steps are being taken to inform physicians involved in RA clinical trials to continue patient monitoring as defined in the study termination protocols.
Results from the phase-III ocrelizumab RA programme will be made available to the medical community at an appropriate medical forum.
Ocrelizumab is also being evaluated for relapsing remitting multiple sclerosis (RRMS). Treatment in the ocrelizumab RRMS phase-II study is ongoing and data from this study will be submitted for presentation at the upcoming ECTRIMS conference.
“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,” said Hal Barron, executive vice president, Global Development and chief medical officer, Roche.
In March, Roche and Biogen Idec announced the suspension of treatment in the ocrelizumab RA program. This 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 US Food and Drug Administration (FDA) placed the RA studies on clinical hold.
Ocrelizumab is a humanised molecule which selectively targets CD20 positive B cells and has been developed specifically for use in autoimmune diseases such as RA.