AUTHOR=Guevara Carlos , Garrido Cristian , Martinez Melissa , Farias Gonzalo A. , Orellana Patricia , Soruco Wendy , Alarcón Pablo , Diaz Violeta , Silva Carlos , Kempton Matthew J. , Barker Gareth , de Grazia José TITLE=Prospective Assessment of No Evidence of Disease Activity-4 Status in Early Disease Stages of Multiple Sclerosis in Routine Clinical Practice JOURNAL=Frontiers in Neurology VOLUME=10 YEAR=2019 URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.00788 DOI=10.3389/fneur.2019.00788 ISSN=1664-2295 ABSTRACT=

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 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. a-BVL is parameter to continue investigating for guiding clinical practice in relapsing-remitting multiple sclerosis.