ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial.

ABSTRACT:

Introduction

Ocrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). The safety profile and patient preference for conventional versus shorter ocrelizumab infusions were investigated in the ENSEMBLE PLUS study.

Methods

ENSEMBLE PLUS was a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810), comparing outcomes in patients with early-stage relapsing-remitting MS receiving ocrelizumab 600 mg over the approved 3.5-h (conventional) versus 2-h (shorter) infusion. The primary endpoint was the proportion of patients with infusion-related reactions (IRRs) following the first randomized dose (RD); the secondary endpoint included IRR frequency at subsequent RDs.

Results

At first RD, the number of patients

SUBMITTER: Hartung HP 

PROVIDER: S-EPMC11233283 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature