Ocrelizumab dose selection for treatment of pediatric relapsing-remitting multiple sclerosis: results of the OPERETTA I study.

ABSTRACT:

Background

The presented study identified the appropriate ocrelizumab dosing regimen for patients with pediatric-onset multiple sclerosis (POMS).

Methods

Patients with POMS aged 10-17 years were enrolled into cohort 1 (body weight [BW] < 40 kg, ocrelizumab 300 mg) and cohort 2 (BW ≥ 40 kg, ocrelizumab 600 mg) during a 24-week dose-exploration period (DEP), followed by an optional ocrelizumab (given every 24 weeks) extension period.

Primary endpoints

pharmacokinetics, pharmacodynamics (CD19⁺ B-cell count); secondary endpoint: safety; exploratory endpoints: MRI activity, protocol-defined relapses, Expanded Disability Status Scale (EDSS) score change.

Results

A total of 23 patients (cohort 1: n = 6, age 10-12 years, BW 27.0-39.0 kg; cohort 2: n = 17, ag

SUBMITTER: Mar S 

PROVIDER: S-EPMC11735518 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature