OCREVUS significantly reduced the risk of disability progression vs placebo (median treatment duration over 3 years) 3,18

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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.

OCREVUS treatment resulted in a significant difference in the mean change in T2 lesion volume compared to placebo 3

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

All endpoints were studied from baseline to Week 120. 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 (ocrelizumab)-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.

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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.

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.

Malignancies

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

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PPMS=primary progressive multiple sclerosis.