Assessing 'No Evidence of Disease Activity' Status in Patients with Relapsing-Remitting Multiple Sclerosis Receiving Fingolimod in Routine Clinical Practice: A Retrospective Analysis of the Multiple Sclerosis Clinical and Magnetic Resonance Imaging Outcomes in the USA (MS-MRIUS) Study

CNS Drugs. 2018 Jan;32(1):75-84. doi: 10.1007/s40263-017-0482-4.


Background: 'No evidence of disease activity' (NEDA), a composite measure of clinical and magnetic resonance imaging outcomes, provides a comprehensive assessment of disease activity, but is not extensively reported in clinical practice. NEDA-3 is defined as patients with no new/enlarged T2 or gadolinium-enhancing lesions, no relapses, and no disability progression (according to Expanded Disability Status Scale scores). NEDA-4 comprises the components of NEDA-3 and a fourth criterion of ≤ 0.4% annualized brain volume loss.

Objective: The objective of this study was to assess NEDA status among patients with relapsing-remitting multiple sclerosis receiving fingolimod in clinical practice.

Methods: Clinical and magnetic resonance imaging data were retrospectively collected from 590 patients who initiated fingolimod at 33 multiple sclerosis centers in the USA. Patients were required to have a magnetic resonance imaging scan in the 6 months before or 1 month after fingolimod initiation (index period) and in the 9-24 months after fingolimod initiation (post-index period). Magnetic resonance imaging data were systematically quantified at a centralized reading facility. The proportions of patients with NEDA-3 or NEDA-4 status during fingolimod treatment were assessed.

Results: During the follow-up period (median: 16 months), data to assess NEDA-3 and NEDA-4 were available for 586 and 325 patients, respectively. In the post-index period, 58.7% of patients achieved NEDA-3 status (no relapses, 85.2%; no new/enlarged T2/gadolinium-enhancing lesions, 76.3%; no disability progression, 87.9%) and 37.2% achieved NEDA-4 status (no relapses, 86.5%; no new/enlarged T2/gadolinium-enhancing lesions, 78.8%; no disability progression, 91.1%; brain volume loss ≤ 0.4, 58.2%).

Conclusion: Among patients receiving fingolimod, over half achieved NEDA-3 status and over one-third achieved NEDA-4 status.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cohort Studies
  • Disease Progression
  • Female
  • Fingolimod Hydrochloride / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Longitudinal Studies
  • Magnetic Resonance Imaging / methods*
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / diagnostic imaging
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / physiopathology
  • Retrospective Studies
  • Treatment Outcome
  • Young Adult


  • Immunosuppressive Agents
  • Fingolimod Hydrochloride