OCREVUS (ocrelizumab), immunosuppressant

Moderate clinical benefit in early-stage primary progressive multiple sclerosis (PP-MS) in terms of disease duration and degree of disability, associated with imaging data characteristic of inflammatory activity, but no demonstrated clinical advantage in the therapeutic strategy

• OCREVUS has been granted marketing authorisation for the treatment of early-stage PP-MS in terms of duration of disease and degree of disability, associated with imaging data characteristic of inflammatory activity.

• A single study, conducted on a stringently selected population (age <55 years), detected a modest gain versus placebo, whose clinical relevance was not guaranteed: after 120 weeks of treatment, the proportion of patients with disability progression confirmed at least 12 weeks later was 34.0% in the placebo group and 30.2% in the ocrelizumab group, i.e. an absolute difference of less than 4%.

• OCREVUS failed to improve the quality of life of the patients in the study.

• A number of major uncertainties remain concerning the long-term safety of OCREVUS-induced lymphodepletion in this disease that progresses over numerous years.

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