Additional Data Support Ocrevus Safety, Efficacy in MS
Genentech announced new study data for Ocrevus (ocrelizumab) from four studies in patients with relapsing or primary progressive forms of multiple sclerosis. The findings were presented at the 69th American Academy of Neurology (AAN) Annual Meeting.
OPERA I and OPERA II were Phase 3, randomized, double-blind, double-dummy, global multicenter studies (n=1,656) that compared Ocrevus vs. interferon beta-1a in patients with relapsing forms of multiple sclerosis. In a pooled analysis of the OPERA I and OPERA II studies, treatment with Ocrevus lowered the relapse rate by over half (55%) vs. Rebif (interferon beta-1a) within the first 8 weeks (P=0.0045).
Ocrevus also showed an almost complete suppression of brain MRI activity at 8 weeks in another Phase 2 study of relapsing-remitting multiple sclerosis patients. T1 gadolinium-enhancing lesions and hyperintense T2 lesions were also almost fully suppressed with the use of Ocrevus compared to placebo.
Among patients with early relapsing multiple sclerosis patients, Ocrevus suppressed >90% of active MRI lesions over 2 years vs. interferon beta-1a (P<0.0001) in these patients as shown through other analyses from the OPERA I and II studies. For the same patient population, the use of Ocrevus resulted in a higher proportion of patients who achieved No Evidence of Disease Activity (NEDA) by 76% vs. interferon beta-1a over 2 years (P<0.0001).
Pooled analysis data from the Phase 3 relapsing multiple sclerosis (RMS) open-label extension (OLE) studies found that patients who switched from interferon beta-1a to Ocrevus had lower relapse rates (unadjusted annualized relapse rate 0.102 post-switch) and MRI brain lesions (0.01 mean number of T1 gadolinium-enhancing, 0.37 new or enlarging T2 lesions post-switch). Patients who originally started treatment with Ocrevus demonstrated a lasting benefit after 3 years.
Findings from the Phase 3, randomized, double-blind, global multi-center ORATORIO study showed a higher increase in fatigue among primary progressive multiple sclerosis (PPMS) patients with confirmed disability progression (CDP) (P=0.0003), demonstrating the need for preventing disease progression in these patients. After treatment with Ocrevus, those who did not experience disability progression reported a significant decrease in fatigue vs. treatment with placebo (P=0.0337).
Across the OLE studies involving 2,200 patients with RMS and PPMS, the safety profile of Ocrevus proved consistent as seen during the controlled treatment periods.
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