- OCREVUS subcutaneous maintains a consistent benefit-risk profile for up to two years.
- Fenebrutinib Phase II data shows near-complete suppression of disease activity at 96 weeks.
- OCREVUS reduces disability progression by 30% in advanced PPMS patients over 2.75 years.
- OCREVUS exposure during pregnancy or breastfeeding does not increase adverse infant outcomes.
OCREVUS Data Highlights
Roche presented new data on OCREVUS at the ECTRIMS 2025 Congress, showing its consistent benefit-risk profile over two years. The Phase III OCARINA II study confirmed that OCREVUS subcutaneous injection maintains similar efficacy to the intravenous form, with significant suppression of relapses, brain lesion activity, and disability progression.
Advanced PPMS Findings
The ORATORIO-HAND study expanded on previous research by including older patients and those with advanced disability. OCREVUS demonstrated a 30% reduction in the risk of 12-week confirmed disability progression in advanced PPMS patients over a median of 2.75 years, with a 55% reduction in patients with baseline MRI lesion activity.
Infant Outcomes
An analysis of over 5,000 pregnancies from the ocrelizumab registry showed that in-utero exposure to OCREVUS does not increase adverse pregnancy or infant outcomes. Most infants exposed to OCREVUS during pregnancy or breastfeeding exhibited meaningful antibody responses to vaccines, indicating effective immune function.
Fenebrutinib Efficacy
Fenebrutinib's two-year Phase II data revealed near-complete suppression of disease activity in relapsing multiple sclerosis patients. The open-label extension study showed a low annualized relapse rate and no disability progression, with MRI scans detecting no new active inflammation markers. Neurofilament light chain levels decreased to healthy ranges, supporting fenebrutinib's potential in MS treatment.
