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

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

Bianca Weinstock-Guttman  1 , Jennie Medin  2 , Nasreen Khan  3 , Jonathan R Korn  4 , Ellen Lathi  5 , Jason Silversteen  6 , Jonathan Calkwood  7 , Diego Silva  2 , Robert Zivadinov  8   9 ; MS-MRIUS Study Group
Affiliations
Multicenter Study

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

Bianca Weinstock-Guttman et al. CNS Drugs. 2018 Jan.

Abstract

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.

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Conflict of interest statement

Funding

This study was funded by Novartis Pharma AG. Oxford PharmaGenesis received funding from Novartis Pharma AG for medical writing support. IQVIA received funding from Novartis Pharma AG. The open access fee was covered by Novartis Pharma AG

Conflict of interest

Bianca Weinstock-Guttman has received honoraria as a speaker and consultant for Biogen, EMD Serono, Sanofi Genzyme, Novartis, Teva Pharmaceuticals, and Genentech. She has received research funds from Biogen, EMD Serono, Sanofi Genzyme, Novartis, and Teva Pharmaceuticals. Jennie Medin and Diego Silva are paid employees of Novartis Pharma AG, Basel, Switzerland. Nasreen Khan is a paid consultant for IQVIA, Basel, Switzerland. Jonathan R. Korn was a paid employee of IQVIA (previously QuintilesIMS), Burlington, MA, USA at the time of this study. Ellen Lathi has received honoraria as a speaker and consultant for Acorda, Biogen, Genzyme, Novartis, Teva Pharmaceuticals, and Genentech. Jason Silversteen has no conflicts of interest to report. Jonathan Calkwood has performed advisory, consultancy, and speaker activities for Acorda, Biogen, EMD Serono, Genzyme, Novartis, Roche, and Teva; and has received grant/research support from Biogen, Celgene, Genzyme, Novartis, and Roche. Robert Zivadinov has received personal compensation from EMD Serono, Celgene, Claret Medical, Novartis, and Sanofi Genzyme for speaking and consultancy. He has received financial support for research activities from Claret Medical, IMS Health, InteKrin-Coherus, Novartis, Sanofi Genzyme, and Teva Pharmaceuticals.

Informed consent

For this type of study, formal consent is not required.

Figures

Fig. 1
Fig. 1
Attrition of the study sample, by reason. aTo be eligible for analysis, magnetic resonance imaging (MRI) scans were required to have been performed on 1.5 Tesla or 3 Tesla scanners, within the allowed window, and to have quality information available. BNAC Buffalo Neuroimaging Analysis Center, NEDA no evidence of disease activity
Fig. 2
Fig. 2
Proportion of patients achieving the individual components of no evidence of disease activity (NEDA)-3 and overall NEDA-3 status in the post-index period (n = 586). aPatients for whom gadolinium-enhancing (Gd+) lesions were not assessed in the post-index period were assumed to have no Gd+ lesions if they had no new/enlarged T2 lesions
Fig. 3
Fig. 3
Proportion of patients achieving the individual components of no evidence of disease activity (NEDA)-4 and overall NEDA-4 status in the post-index period (n = 325). aPatients for whom gadolinium-enhancing (Gd+) lesions were not assessed in the post-index period were assumed to have no Gd+ lesions if they had no new/enlarged T2 lesions. BVL brain volume loss
See this image and copyright information in PMC

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