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Defining Activity-Based Subgroups in Multiple Sclerosis: A Review and Framework Proposal
Catalina Lopez Manzano1, Claire M Rice2,3, Emma Tallantyre4
1Bristol Technology Assessment Group (TAG), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
European Journal of Neurology
|June 10, 2026
Summary
Inconsistent definitions for multiple sclerosis (MS) activity subgroups hinder treatment access. This study proposes a standardized framework for
Area of Science:
- Neurology
- Clinical Trials
- Health Technology Assessment
Background:
- Multiple sclerosis (MS) is stratified into activity-based subgroups to guide treatment and health technology assessments (HTAs).
- Current terminology and criteria for 'active', 'highly active', and 'rapidly evolving severe' (RES) MS disease lack consistency across clinical trials and regulatory guidance.
- This inconsistency creates ambiguity in clinical practice and limits patient access to treatments.
Purpose of the Study:
- To review definitions of activity-based MS subgroups within NICE technology appraisals (TAs) and their supporting randomized controlled trials (RCTs).
- To propose a preliminary framework for standardized terminology to address current inconsistencies.
Main Methods:
- Systematic review of NICE TAs for disease-modifying therapies in MS and the RCTs cited within them.
- Extraction and comparative analysis of definitions for MS activity subgroups based on relapse history, MRI findings, and treatment status.
- Classification of definitions to identify consensus and areas of controversy.
Main Results:
- Significant variation in definitions was observed, particularly for 'highly active' relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).
- While NICE TAs showed some consistency for 'active' and 'RES' RRMS, definitions within RCTs were heterogeneous.
- A simplified framework with three overlapping subgroups for relapsing MS (RMS) was proposed: active RRMS/RRMS, highly active RRMS (HARRMS), and rapidly evolving severe RRMS (RES-RRMS).
Conclusions:
- Standardized definitions are crucial for improving evidence synthesis, regulatory clarity, and equitable patient access to MS therapies.
- A formal consensus process is recommended to solidify the proposed framework for future research, HTAs, and clinical pathways.
- Implementing standardized terminology will enhance the reliability of MS disease stratification and treatment decision-making.
