Ocrelizumab (another MAB – Mono Clonal Antibody)

                                                                  

Ocrelizumab is an intravenous infusion treatment that has been developed by Hoffmann-La Roche. Top-line results have been announced from a phase 3 clinical trial looking at the use of ocrelizumab in primary progressive MS and phase 3 clinical trials for relapsing MS were announced as complete in June 2015.

Current phase of trial: Under review by US Food and Drug Administration (FDA)

Type of MS: primary progressive, relapsing remitting, and secondary progressive MS with relapses.

Ocrelizumab works by targeting immune cells known as B-lymphocytes. This helps to supress the immune responseand reduce the damage to myelin that occurs in MS.

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Ocrelizumab is taken as an intravenous infusion every 6 months.

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Two phase 3 trials (OPERA I and OPERA II) were completed in June 2015 and Roche reported positive outcomes for the effectiveness of ocrelizumab as a treatment for relapsing remitting MS against interferon beta-1a (also known as Rebif). The trials involved over 1,600 people and after two years, the study is reported to show that ocrelizumab reduced the annual relapse rate by 46% in OPERA 1, 47% in OPERA II and the progression of clinical disability by 40%, as measured by the Expanded Disability Status Scale (EDSS). Additionally, the study has been reported to show that ocrelizumab reduced the number of lesions in the brain, as measured by MRI scans by 94%.

Roche have also reported at a conference in April 2016 that around 50% of people taking ocrelizumab saw no evidence of disease activity (NEDA) in both OPERA I and OPERA II, this was compared to 25-30% of people taking interferon-beta-1a. NEDA is defined as no relapses, no confirmed disability progression as measured by EDSS, and no new or enlarging lesions.

A phase 3 trial (ORATORIO) began in 2011 to test ocrelizumab against placebo in 732 people with primary progressive MS. This involved two infusions 14 days apart in each treatment cycle.

Top-line results announced by Roche at a conference in April 2016 show treatment with ocrelizumab led to a reduction in the progression of clinical disability by 25% compared to placebo. This reduction was sustained for at least 24 weeks and was measured by the Expanded Disability Status Scale (EDSS). Roche also reported that ocrelizumab reduced the rate of brain atrophy (shrinkage) by 17.5%.

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