Original Research ARTICLE
Prospective assessment of no evidence of disease activity-4 status in early disease stages of multiple sclerosis in routine clinical practice
- 1University of Chile, Chile
- 2Universidad de Santiago de Chile, Chile
- 3King's College London, United Kingdom
Background: In relapsing-remitting multiple sclerosis, no evidence of disease activity-3 (NEDA-3) is defined as no relapses, no disability progression and no MRI activity. NEDA-4 status is defined as meeting all NEDA-3 criteria plus having an annualized brain volume loss (a-BVL) of ≤ 0.4%. Prospective real-world studies presenting data on NEDA-4 are scarce. Objective: To determine the proportion of patients failing to meet one or more NEDA-4 criteria and the contribution of each component to this failure. Methods: Forty-eight patients were followed for 12 months. Structural image evaluation, using normalization, of atrophy was used to assess a-BVL. Results: The patients had a mean age of 33.0 years (range 18-57), disease duration of 1.7 years (0.4-4) and Expanded Disability Status Scale score of 1.3 (0-4); 71% were women. All patients were on first-line disease-modifying therapies. During follow-up, 21% of the patients had at least one relapse, 21% had disability progression, 8% had new T2 lesions, and 10% had gadolinium-enhanced lesions. Fifty-eight percent (28/48) achieved NEDA-3 status. a-BVL of >0.4% was observed in 52% (25/48). Only 29% (14/48) achieved NEDA-4 status. Conclusion: a-BVL is a good marker to detect subclinical disease activity. We propose a-BVL as a fourth parameter to continue investigating for guiding clinical practice in relapsing-remitting multiple sclerosis.
Keywords: relapsing/remitting, quantitative MRI, Outcome measurement, Multiple Sclerosis, Atrophy
Received: 08 Feb 2019;
Accepted: 08 Jul 2019.
Edited by:Achim Gass, Universitätsmedizin Mannheim (UMM), Germany
Reviewed by:Scott Kolbe, Monash University, Australia
Marcello Moccia, Institute of Neurology, Faculty of Brain Sciences, University College London, United Kingdom
Copyright: © 2019 Guevara, Garrido, Martinez, Farías, Orellana, Soruco, ALARCON, Diaz, Silva-Rosas, Kempton and de Grazia. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dr. Carlos Guevara, University of Chile, Santiago, Chile, firstname.lastname@example.org