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  1. E Silber1,
  2. X Montalban2,
  3. F Barkhof3,
  4. B Khatri4,
  5. HP Hartung5,
  6. S Ritter6,
  7. D Piani Meier7,
  8. D Tomic7,
  9. L Kappos8
  1. 1King's College Hospital, London, UK
  2. 2Vall d'Hebron University Hospital, Barcelona, Spain
  3. 3VU University Medical Center, Amsterdam, Netherlands
  4. 4Center for Neurological Disorders at WFHC, Milwaukee, USA
  5. 5Department of Neurology, Heinrich Heine University, Düsseldorf, Germany
  6. 6Novartis Pharmaceuticals Corporation, East Hanover, USA.
  7. 7Novartis Pharma AG, Basel, Switzerland
  8. 8University Hospital Basel, Basel, Switzerland


Introduction To compare effects of fingolimod vs. interferon beta-1a (IFN) in achieving no evidence of disease activity (NEDA-4) in patients with relapsing-remitting multiple sclerosis (RRMS) in the TRANSFORMS study. Adding Brain Volume Loss (BVL) to NEDA results in a more comprehensive and balanced measure of focal and diffuse damage.

Methods In this post-hoc analysis, we used data from the fingolimod 0.5 mg daily (n=431) and IFN 30 µg weekly (n=435) groups. NEDA-4 was defined as absence of confirmed relapses, new/enlarging T2 lesions, 6-month confirmed disability progression (CDP) and BVL (annual percent brain volume change [PBVC] of >−0.4%). 3-month CDP and additional PBVC cut-offs representing mean BVL rates in healthy adults (0.2%), MS patients (0.6%), or accelerated BVL (1.2%) were also tested. Odds ratios (OR) were calculated for differences between fingolimod- and IFN-treated groups.

Results Significantly more fingolimod (n=425) than IFN-treated patients (n=418) achieved NEDA-4 status: 27.9% vs. 16.7% (OR:1.93; 95% CI: 1.36–2.73; p=0.0002). Results were similar for other PBVC cut-offs: (>–0.2%): 20.2% vs 11.5%; 1.94; 1.30–2.90, p=0.0011; (>–0.6%): 34.6% vs 20.4%; 2.06; 1.49–2.86, p<0.0001; (>–1.2%): 40.8% vs 26.4%; 1.92; 1.42–2.60; p<0.0001.

Conclusion Fingolimod-treated patients had twice the odds of achieving NEDA-4 status over 1 year as patients treated with IFN.

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