Review of trial data found that Ocrelizumab therapy is associated with sometimes fatal infections.
Roche and Biogen Idec have halted their Phase III program for Ocrelizumab (RG1594) as a treatment for rheumatoid arthritis due to ongoing safety concerns. A trial evaluating Ocrelizumab in lupus nephritis patients had previously been put on hold due to concerns about serious and opportunistic infections.
Phase II evaluation of Ocrelizumab in the treatment of relapsing-remitting multiple sclerosis is currently ongoing, the companies point out.
The decision to suspend the RA program follows recommendations by the independent Ocrelizumab RA and Lupus Data and Safety Monitoring Board (DSMB). The DSMB’s review included the SCRIPT, FEATURE, FILM, and STAGE trials in RA as well as the BELONG and BEGIN trials in lupus patients.
Ocrelizumab is a humanized anti-CD20 mAb. In December 2009, Roche and Biogen Idec reported positive data from STAGE, the first Phase III study evaluating Ocrelizumab in combination with methotrexate in RA patients. However, the trial data suggested that while overall adverse events were comparable between the Ocrelizumab and placebo treatment groups, a higher percentage of serious infections was observed in the pooled Ocrelizumab groups compared with the placebo group.
Also in December 2009, Roche and Biogen Idec reported positive data from a Phase II trial evaluating Ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS). The study found that in comparison with placebo, treatment using Ocrelizumab resulted in statistically significant reductions in the signs of disease activity as measured by brain lesions.