Efficacy and safety in relapsing multiple sclerosis (RMS)

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Relapse Reductions vs Rebif

Risk of Disability Progression

Suppression of T1 Gd+ Lesions

T2 Lesion Endpoint

OCREVUS reduced relapses by half vs Rebif 8

Superior relapse rate reductions vs Rebif at year 2 of pivotal studies.

RELATIVE REDUCTIONS IN ANNUALIZED RELAPSE RATE
Reductions in annualized relapse rate in OPERA 1 & 2 vs Rebif

The efficacy and safety of OCREVUS in RMS were studied vs Rebif in 2 double-blind, double-dummy trials evaluating over 1600 patients for 2 years.

Robust relapse rate reductions were demonstrated in the controlled period 8

Relapses were defined as new or worsening neurologic symptoms that were attributable to multiple sclerosis, persisted for over 24 hours, were immediately preceded by a stable or improving neurological state for at least 30 days, and were accompanied by objective neurological worsening as defined in the study protocols. 1

PROPORTION OF RELAPSE-FREE PATIENTS

Important Safety Information

Contraindications

OCREVUS is contraindicated in patients with active hepatitis B virus infection and in patients with a history of life-threatening infusion reaction to OCREVUS.

OCREVUS patients achieved significant reductions in risk of disability progression vs Rebif in the controlled period 1

OCREVUS reduced the risk of disability progression confirmed at 2 timepoints over 2 years in both pooled and individual trials.

Proportions of patients with 3-month and 6-month confirmed disability progression in the controlled period

Confirmed 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 or 6 months over the treatment period.

Time to onset of 6-month confirmed disability progression during the controlled and OLE periods 8

OCREVUS significantly reduced T1 Gd+ lesions vs Rebif in the controlled period 9

Superior reductions in mean number of T1 Gd+ lesions per MRI over 2 years; T1 Gd+ lesions are thought to represent acute inflammation.

Relative reductions in mean number of T1 Gd+ lesions in OPERA I and II

Near-complete suppression of T1 Gd+ lesions in controlled trials at 2 years 9*†

*The precise mechanism by which OCREVUS exerts its therapeutic effects in MS is unknown
Number of T1 Gd+ lesions at each timepoint (either Week 24, 48, or 96) for all patients in the treatment group divided by the total number of brain MRI scans at this timepoint. 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 timepoints. 1

Controlled and OLE data include the ITT population; clinical cutoff date: February 17, 2017. Controlled data adjusted by baseline T1 Gd+ lesion (present or not), baseline EDSS (<4.0 vs. ≥4.0), and geographical region (US vs ROW); OLE data are unadjusted.

Gd+=gadolinium-enhancing; ITT=intent-to-treat.

Superior relative reductions in new or enlarging T2 lesions vs Rebif in the controlled period 9

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 hyperintense T2 lesions with OCREVUS vs Rebif

Significant reductions in new or enlarging T2 lesions over 2 years in controlled trials 9*

*Number of new or enlarging T2 lesions relative to preceding scan for all patients in the treatment group at each timepoint (either Week 24, 48, or 96), divided by the total number of brain MRI scans at that timepoint. Brain MRIs were performed at baseline and at Weeks 24, 48, and 96. Relative reductions in T2 lesions were observed at each of these timepoints. 1

Controlled and OLE data include the ITT population; clinical cutoff date: February 17, 2017. Controlled data adjusted by baseline T2 lesion count, baseline EDSS (<4.0 vs ≥4.0), and geographical region (US vs ROW); open-label data are unadjusted.

Safety profile in OPERA I and II

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

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