Proven in primary progressive multiple sclerosis (PPMS)

Proven clinical efficacy in PPMS

OCREVUS significantly reduced the risk of disability progression vs placebo (median treatment duration over 3 years).

3-month Confirmed Disability Progression
Reduction in risk of 3-month confirmed disability progression vs placebo.
20% worsening of timed 25-foot walk, confirmed at 3 months
20% worsening of timed 25-foot walk, confirmed at 3 months vs placebo.

Important Safety Information

Infections

A higher proportion of OCREVUS-treated patients experienced infections compared to patients taking REBIF or placebo. In RMS trials, 58% of OCREVUS-treated patients experienced one or more infections compared to 52% of REBIF-treated patients. In the PPMS trial, 70% of OCREVUS-treated patients experienced one or more infections compared to 68% of patients on placebo. OCREVUS increased the risk for upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes-related infections. OCREVUS was not associated with an increased risk of serious infections in MS patients. Delay OCREVUS administration in patients with an active infection until the infection is resolved.

MRI endpoint in PPMS

OCREVUS treatment resulted in a significant difference in the mean change in T2 lesion volume compared to placebo.

Mean change in volume of T2 lesions (cm3)
Mean change in volume of T2 lesions (cubic centimeters) with OCREVUS vs placebo

All endpoints were studied from baseline to Week 120. 3 Neurological evaluations were performed every 12 weeks and at every infusion cycle. Brain MRIs were performed at baseline and at Weeks 24, 48, and 120+. 

In exploratory subgroup analyses of ORATORIO, the proportion of female patients with disability progression confirmed at 12 weeks after onset was similar in OCREVUS-treated patients and placebo-treated patients (approximately 36% in each group). In male patients, the proportion of patients with disability progression confirmed at 12 weeks after onset was approximately 30% in OCREVUS-treated patients and 43% in placebo-treated patients. Clinical and MRI endpoints that generally favored OCREVUS numerically in the overall population, and that showed similar trends in both male and female patients, included annualized relapse rate, change in T2 lesion volume, and number of new or enlarging T2 lesions. ORATORIO was not powered to detect differences in these subgroups. 

Safety profile in ORATORIO

Learn more about OCREVUS safety information, including infusion-related reactions (IRRs).

Want to learn more about OCREVUS?

Sign up to speak with an OCREVUS clinical specialist.