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The prognostic utility of no evidence of disease activity (neda)
  1. Grace Lu1,
  2. Heidi Beadnall1,
  3. Chenyu Wang1,
  4. Todd Hardy1,
  5. Joshua Barton1,
  6. Michael Barnett1
  1. 1St Vincents Hospital, Sydney, NSW, Australia
  2. 2Brain and Mind Research Institute, University of Sydney, Sydney, NSW, Australia
  3. 3Sydney Neuroimaging Analysis Centre, Sydney, NSW, Australia

Abstract

Objectives To investigate NEDA-3 and NEDA-4 status over one year in a group of heterogeneously treated patients with relapsing-remitting multiple sclerosis (MS). To investigate the prognostic utility of NEDA-3 status at 3 months for NEDA-3 at 12 months.

Methods Sixty-nine patients with relapsing-remitting MS were recruited from the MS Clinic, Brain and Mind Centre, Sydney. Patients underwent clinical assessments, including an Expanded Disability Scale Status (EDSS), and MRI at baseline, 3 and 12 months. NEDA-3 was defined as; i) the absence of clinical relapses, ii) no 3 month confirmed disability progression, and iii) no new/enlarging T2 lesions or gadolinium-enhancing lesions. NEDA-4, determined at 12 months was defined as NEDA-3 plus the inclusion of a fourth measure, iv) no annualised brain atrophy of >0.4%.

Results Of the participants, 84.1% were female, mean (SD) age was 37.1 (9.1) years, mean EDSS score 1.9 (1.4), average disease duration 7.6 (7.1) years and all patients were on disease-modifying therapy (DMT). At 3 months, 47.83% of the cohort had NEDA-3. Between 3 and 12 months, 36.23% had NEDA-3. Between 0 and 12 months, 23.19% had NEDA-3% and 13.04% achieved NEDA-4 status. The positive predictive value of NEDA-3 status at 3 months for 12 months was 39% (95%CI 23 to 58). Negative predictive value was 67% (95%CI 49 to 81), sensitivity 52% (95%CI 31 to 72) and specificity 55% (95%CI 39 to 70).

Conclusions NEDA-3 was achieved more frequently than NEDA-4, suggesting significant disease progression in a proportion of patients despite the absence of traditional clinical and MRI metrics of disease activity. In this heterogeneous cohort, NEDA-3 at 3 months was not useful in predicting those who would maintain NEDA-3 at 12 months, emphasising the need for regular clinical and radiological assessment in MS. In this real-world patient cohort, disease progression occurred despite DMT in most patients, emphasising the need for improved treatment escalation paradigms in MS.

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