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Clinical Review Report

15 Dec 2017

This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. [...] The objective of this systematic review is to examine the beneficial and harmful effects of ocrelizumab treatment for the suppression of relapses and disease progression in adult patients with relapsing forms of MS. [...] Key limitations of the OPERA-I and OPERA-II trials include the differential rates of withdrawal between the interferon beta-1a groups (17.3% and 23.4%) and the ocrelizumab groups (10.7% and 13.7%), the potential for unblinding due to the adverse event profiles for the two treatments (particularly those related to the administration of the study drugs), prior exposure to interferon products for a m [...] Infusion-related reactions were the most commonly reported adverse event in both of the pivotal trials and occurred at a greater frequency in the ocrelizumab groups than in the interferon beta-1a groups (34.3% versus 9.7% in the pooled analysis). [...] Nearly all of the infusion-related adverse events were mild or moderate in severity and the proportion of ocrelizumab-treated patients who experienced infusion-related reactions tended to decrease over the course of the trial.
health drugs cancer medicine pharmacology therapy magnetic resonance imaging clinical trial medline multiple sclerosis medical specialties adverse effect sd mri ms natalizumab daclizumab ocrelizumab interferon beta-1a alemtuzumab glatiramer acetate
Pages
118
Published in
Calgary, AB, CA

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