OCREVUS (ocrelizumab), immunosuppressant
Reason for request
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.
Clinical Benefit
Moderate |
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Clinical Added Value
no clinical added value |
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Therapeutic use
- |
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