Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study.

ABSTRACT:

Objective

To assess dose-response effects of the anti-CD20 monoclonal antibody ofatumumab on efficacy and safety outcomes in a phase 2b double-blind study of relapsing forms of multiple sclerosis (RMS).

Methods

Patients (n = 232) were randomized to ofatumumab 3, 30, or 60 mg every 12 weeks, ofatumumab 60 mg every 4 weeks, or placebo for a 24-week treatment period, with a primary endpoint of cumulative number of new gadolinium-enhancing lesions (per brain MRI) at week 12. Relapses and safety/tolerability were assessed, and CD19+ peripheral blood B-lymphocyte counts measured. Safety monitoring continued weeks 24 to 48 with subsequent individualized follow-up evaluating B-cell repletion.

Results

The cumulative number of new lesions was reduced by 65% for all ofatumumab d

SUBMITTER: Bar-Or A 

PROVIDER: S-EPMC5957306 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature