Demonstrated efficacy and safety in relapsing multiple sclerosis (RMS)
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Superior relapse reductions vs Rebif
OCREVUS significantly reduced the rate of relapse vs Rebif consistently across both identical trials over 2 years.
Relative Reductions in Annualized Relapse Rate
Relapses were defined as new or worsening neurologic symptoms that met the following criteria: were attributable to multiple sclerosis only in the absence of fever or infection; persisted for over 24 hours; were immediately preceded by a stable or improving neurologic state for at least 30 days; and were accompanied by objective neurologic worsening consistent with an increase of at least half a step on the Expanded Disability Status Scale (EDSS), 2 points in one EDSS functional system score, or 1 point in each of two or more EDSS functional system scores (pyramidal, ambulation, cerebellar, brainstem, sensory, or visual). 1
PROPORTION OF RELAPSE-FREE PATIENTS
Important Safety Information
OCREVUS is contraindicated in patients with active hepatitis B virus infection and in patients with a history of life-threatening infusion reaction to OCREVUS.
Reduced the risk of disability progression
OCREVUS demonstrated superior reductions in risk of disability progression confirmed at 3 months vs Rebif over 2 years.
Reduction In Risk Of 3-Month Confirmed Disability Progression
Prespecified, pooled analysis across two 2-year pivotal trials; proportions represent Kaplan-Meier estimates at Week 96.
Disability progression was defined as patients with EDSS ≤5.5 who experienced an EDSS increase of ≥1.0. For patients with EDSS >5.5, progression was an EDSS increase of ≥0.5. Disability progression was categorized as confirmed if it was present at 3 months over the 2-year treatment period. 1
- The prespecified population for analysis of confirmed disability progression was the pooled population from OPERA I and II. Risk reductions in confirmed disability progression were shown in the individual OPERA studies 1
- OCREVUS significantly increased the proportion of patients with disability improvement, confirmed at 3 months in OPERA I and II (20.7% OCREVUS vs 15.6% Rebif, p=0.02); confirmed disability improvement was defined as a reduction from the baseline EDSS score of at least 1.0 point (or 0.5 points if the baseline EDSS score was >5.5) that was sustained for at least 3 months in patients with a baseline EDSS score of at least 2.0 1
Near-complete suppression of T1 Gd+ lesions*
Superior reductions in mean number of T1 Gd+ lesions per MRI over 2 years; T1 Gd+ lesions are thought to represent acute inflammation.
Mean Number Of T1 GD+ Lesions Per MRI
Brain MRIs were performed at baseline and at Weeks 24, 48, and 96. Relative reductions vs Rebif in T1 Gd+ lesions were observed at each of these time points. 1
*The precise mechanism by which OCREVUS exerts its therapeutic effects in MS is unknown.
Superiority of T2 lesion endpoint
Significant relative reduction in mean number of new or enlarging T2 lesions per MRI over 2 years; T2 lesions are thought to represent cumulative disease burden.
Mean Number Of New Or Enlarging T2 Hyperintense Lesions per MRI
Brain MRIs were performed at baseline and at Weeks 24, 48, and 96. Relative reductions vs Rebif in T2 lesions were observed at each of these time points. 1
Safety profile in OPERA I and II
Learn more about OCREVUS safety information, including infusion-related reactions (IRRs).