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  1. Home
  3. Defining Activity-based Subgroups In Multiple Sclerosis: A Review And Framework Proposal.
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  3. Defining Activity-based Subgroups In Multiple Sclerosis: A Review And Framework Proposal.

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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

View abstract on PubMed

Summary
This summary is machine-generated.

Inconsistent definitions for multiple sclerosis (MS) activity subgroups hinder treatment access. This study proposes a standardized framework for

Keywords:
clinical trialsevidence synthesismultiple sclerosisrelapsing–remittingreview

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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.