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Superior relapse reductions vs Rebif 2,3,5,11

OCREVUS REDUCED RELAPSES BY NEARLY HALF VS REBIF AT YEAR 2 OF THE CONTROLLED PERIOD

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.

ANNUALIZED RELAPSE RATES OBSERVED IN THE OLE WERE CONSISTENT WITH THOSE OBSERVED IN THE CONTROLLED PERIOD

Conclusions regarding the treatment effect of OCREVUS (ocrelizumab) cannot be drawn on the basis of OLE data.

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.

Measurements performed at intermediate timepoints were not prespecified in the statistical testing hierarchy and reflect numerical trends only.

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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.

Proven to slow disability progression vs Rebif 2,3,5

OCREVUS CONSISTENTLY DELAYED DISABILITY PROGRESSION CONFIRMED BY 2 DISABILITY ENDPOINTS OVER 2 YEARS

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 CONTROLLED AND OLE PERIODS

Conclusions regarding the treatment effect of OCREVUS (ocrelizumab) cannot be drawn on the basis of OLE data.

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Infusion Reactions

OCREVUS can cause infusion reactions, which can include pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis.

Near-complete suppression of T1 Gd+ lesions vs Rebif 2,3,5,12,13*

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 OBSERVED IN THE OLE WERE CONSISTENT WITH THE CONTROLLED PERIOD

Conclusions regarding the treatment effect of OCREVUS (ocrelizumab) cannot be drawn on the basis of OLE data.

*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 intermediate timepoints. The measurements performed at these intermediate timepoints were not prespecified in the statistical testing hierarchy and reflect numerical trends only.

Controlled and OLE data include the ITT population; clinical cutoff date: February 5, 2018. Controlled data adjusted by baseline T1 Gd+ lesions (present or not) and baseline T2 lesion count, baseline EDSS (<4.0 vs ≥4.0), and geographical region (US vs ROW); OLE data are unadjusted.

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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.

Superior reductions in T2 lesion activity vs Rebif 3,5,12,13

SIGNIFICANT RELATIVE REDUCTIONS 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 AND ENLARGING T2 LESIONS OBSERVED IN THE OLE WERE CONSISTENT WITH THE CONTROLLED PERIOD

Conclusions regarding the treatment effect of OCREVUS (ocrelizumab) cannot be drawn on the basis of OLE data.

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 intermediate timepoints. Measurements performed at these intermediate timepoints were not prespecified in the statistical testing hierarchy and reflect numerical trends only.

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Malignancies

An increased risk of malignancy, including breast cancer, may exist with OCREVUS.

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EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing; ITT=intent-to-treat; OLE=open-label extension; RMS=relapsing multiple sclerosis; ROW=rest of world.