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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 01; 32(1):75-84.CD

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.

Links

Publisher Full Text
ncbi.nlm.nih.gov
dx.doi.org
PMC Free PDF

Authors+Show Affiliations

Weinstock-Guttman B
State University of New York at Buffalo, Jacobs Multiple Sclerosis Center for Treatment and Research, Jacobs Pediatric Multiple Sclerosis Center of Excellence, New York State Multiple Sclerosis Consortium, Buffalo, NY, USA. bw8@buffalo.edu.
Medin J
Novartis Pharma AG, Basel, Switzerland.
Khan N
IQVIA, Basel, Switzerland.
Korn JR
IQVIA, Burlington, MA, USA.
Lathi E
The Elliot Lewis Center for Multiple Sclerosis Care, Boston, MA, USA.
Silversteen J
Christiana Care Multiple Sclerosis Center, Newark, DE, USA.
Calkwood J
Minneapolis Clinic of Neurology, Golden Valley, MN, USA.
Silva D
Novartis Pharma AG, Basel, Switzerland.
Zivadinov R
Department of Neurology, Buffalo Neuroimaging Analysis Center, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York at Buffalo, Buffalo, NY, USA. Translational Imaging Center at Clinical Translational Science Institute, University at Buffalo, State University of New York at Buffalo, Buffalo, NY, USA.
MS-MRIUS Study Group
No affiliation info available

MeSH

AdultCohort StudiesDisease ProgressionFemaleFingolimod HydrochlorideFollow-Up StudiesHumansImmunosuppressive AgentsLongitudinal StudiesMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingRetrospective StudiesTreatment OutcomeYoung Adult

Pub Type(s)

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

Language

eng

PubMed ID

29270772

Citation

Weinstock-Guttman, Bianca, et al. "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, vol. 32, no. 1, 2018, pp. 75-84.
Weinstock-Guttman B, Medin J, Khan N, et al. 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;32(1):75-84.
Weinstock-Guttman, B., Medin, J., Khan, N., Korn, J. R., Lathi, E., Silversteen, J., Calkwood, J., Silva, D., & Zivadinov, R. (2018). 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, 32(1), 75-84. https://doi.org/10.1007/s40263-017-0482-4
Weinstock-Guttman B, et al. 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;32(1):75-84. PubMed PMID: 29270772.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Weinstock-Guttman,Bianca, AU - Medin,Jennie, AU - Khan,Nasreen, AU - Korn,Jonathan R, AU - Lathi,Ellen, AU - Silversteen,Jason, AU - Calkwood,Jonathan, AU - Silva,Diego, AU - Zivadinov,Robert, AU - ,, PY - 2017/12/23/pubmed PY - 2019/3/1/medline PY - 2017/12/23/entrez SP - 75 EP - 84 JF - CNS drugs JO - CNS Drugs VL - 32 IS - 1 N2 - 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. SN - 1179-1934 UR - https://www.unboundmedicine.com/medline/citation/29270772/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_ L2 - https://dx.doi.org/10.1007/s40263-017-0482-4 DB - PRIME DP - Unbound Medicine ER -