Related Experiment Video
Updated: Dec 25, 2025
A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability
Jerry S Wolinsky1, Natalie J Engmann, Jinglan Pei
1McGovern Medical School, The University of Texas Health Science Center at Houston, TX, USA.
Background:
Ocrelizumab, an anti-CD20 humanized monoclonal antibody, reduced disease progression in pivotal trials of patients with relapsing (OPERA I, OPERA II) and primary progressive (ORATORIO) multiple sclerosis (MS). These effects may be particularly important among patients with increased disability.
Objective:
In this post hoc exploratory analysis, we evaluated the efficacy of ocrelizumab on disability progression among a subgroup of patients with MS who had increased baseline disability levels (Expanded Disability Status Scale scores ≥4.0) in the pivotal trials.
Methods:
During the double-blind period, patients received ocrelizumab 600 mg intravenously every 24 weeks for 96 weeks in the OPERA trials (versus interferon β-1a 44 μg subcutaneously three times per week) and for 120 weeks in ORATORIO (versus placebo). Kaplan-Meier and Cox survival analyses were used to assess disability outcome measures.
Results:
Baseline demographic, disease, and treatment characteristics were generally comparable across treatment groups in patients with increased disability from the OPERA and ORATORIO trials. Ocrelizumab treatment numerically, and in some instances significantly, reduced confirmed disability progression versus the comparator in these patients.
Conclusions:
In patients with increased baseline disability, ocrelizumab reduced the risk of confirmed disability progression versus interferon β-1a in patients with relapsing-onset MS and versus placebo in patients with progression-onset MS.
Insights
Ocrelizumab significantly reduced disability progression in multiple sclerosis (MS) patients with higher baseline disability. This analysis confirms ocrelizumab
Area of Science:
- Neurology
- Immunology
- Clinical Trials
Background:
- Ocrelizumab, an anti-CD20 antibody, has shown efficacy in reducing disease progression in relapsing and primary progressive multiple sclerosis (MS).
- The benefits of ocrelizumab may be especially significant for patients experiencing greater disability at baseline.
Purpose of the Study:
- To evaluate the efficacy of ocrelizumab in slowing disability progression in a subgroup of MS patients with high baseline disability (Expanded Disability Status Scale scores ≥4.0).
- This post hoc analysis focused on pivotal trial data from OPERA I, OPERA II, and ORATORIO.
Main Methods:
- Patients received ocrelizumab 600 mg intravenously every 24 weeks during the double-blind period.
- Comparisons were made against interferon β-1a in the OPERA trials and placebo in the ORATORIO trial.
- Kaplan-Meier and Cox survival analyses were employed to assess disability outcomes.
Main Results:
- Demographic and disease characteristics were comparable between treatment groups in the high-disability subgroup.
- Ocrelizumab demonstrated a numerical and, in some cases, statistically significant reduction in confirmed disability progression compared to the respective comparators.
- These positive effects were observed in both relapsing and primary progressive forms of MS.
Conclusions:
- Ocrelizumab effectively reduced the risk of confirmed disability progression in multiple sclerosis patients with significant baseline disability.
- The findings support ocrelizumab's role in managing MS, particularly for individuals with advanced disease.
- Treatment benefits were confirmed against both interferon β-1a and placebo in relevant patient populations.
Related Concept Videos
01:27Chronic Obstructive Pulmonary Disease-IV: Assessement and Diagnostic Studies
Medical History
01:11Bioavailability Study Design: Single Versus Multiple Dose Studies
01:15Bioavailability Study Design: Healthy Subjects Versus Patients