New data says Ocrevus is effective and safe

April 26, 2018
New Ocrevus (ocrelizumab) data showcase the efficacy of Ocrevus in relapsing multiple sclerosis through several measures of underlying disease activity and disability progression, MRI, cognitive function, and spinal fluid biomarkers of inflammation and neurodegeneration. New safety data remain consistent with Ocrevus’ favorable benefit-risk profile in both relapsing and primary progressive multiple sclerosis.

After four years of continuous treatment, the benefits of Ocrevus in reducing underlying disease activity in RMS were sustained, as shown in a platform presentation measuring brain MRI activity through the randomized and open-label extension periods of the Phase III studies. Patients who stayed on Ocrevus maintained low numbers of T1 gadolinium-enhancing lesions and new/enlarging T2 lesions through year two of the open-label extension phase. Patients who switched from Rebif (interferon beta-1a) to Ocrevus at the start of the open-label extension period had a near-complete silencing of T1 gadolinium-enhancing lesions per scan within two years. Patients saw an 85 percent decrease in new/enlarging T2 lesions at year one and a 97 percent decrease in new/enlarging T2 lesions per scan at year two.

A second four-year analysis showed people who stayed on Ocrevus through year two of the open-label extension period sustained low annualized relapse rates and 24-week confirmed disability progression. Those who switched from interferon beta-1a to Ocrevus experienced a significant decline in annualized relapse rate by year one that was maintained through year two.

New cognitive performance data showed Ocrevus reduced the risk cognitive decline by 38 percent at week 12 and then by 39 percent at week 24 in people with RMS, compared to interferon beta-1a.

In a separate presentation of pooled OPERA I and OPERA II data, people with RMS at increased risk of progressive disease and treated with Ocrevus experienced a significant improvement in cognitive function compared with those taking interferon beta-1a through 96 weeks.

Ocrevus was also shown at 12 and 24 weeks to reduce the presence of nerve damage and inflammation biomarkers in spinal fluid, including median concentration of neurofilament light chain and median number of CD19+ B cells, respectively. This interim analysis in RMS patients from the new, Phase III Ocrelizumab Biomarker Outcome Evaluation study adds to the field’s body of evidence around key MS biomarkers, which may be used in future research to more rapidly measure new disease activity and how patients are responding to different therapies.

New safety data representing 3,778 RMS and PPMS patients and 9,474 patient years of exposure to Ocrevus, across all Ocrevus clinical trials, remain consistent with the medicine’s favorable benefit-risk profile. As of April 2018, over 40,000 people have been treated globally with Ocrevus.

The data were presented at the 70th American Academy of Neurology Annual Meeting.

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