Abstract: Short- and Long-Term Predictors of Relapse or Disability Worsening in Patients with Multiple Sclerosis in the Phase 3 FREEDOMS and FREEDOMS II Studies (2017 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

DX55
Short- and Long-Term Predictors of Relapse or Disability Worsening in Patients with Multiple Sclerosis in the Phase 3 FREEDOMS and FREEDOMS II Studies

Thursday, May 25, 2017

B2 (New Orleans Convention Center)

Aaron Boster, MD , OhioHealth Neurological Physicians, Columbus, OH

Pavle Repovic, MD, PhD , Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, WA

Shannon Ritter, MS , Novartis Pharmaceuticals Corporation, East Hanover, NJ

Davorka Tomic, PhD , Novartis Pharma AG, Basel, Switzerland

Xiangyi Meng, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ

Daniela P Meier, MD , Novartis Pharma AG, Basel, Switzerland

Fernanda Boulos, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ

Frederik Barkhof, MD, PhD , Department of Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, Netherlands

Till Sprenger, MD , Medical Image Analysis Center and Department of Neurology, University Hospital Basel, Basel, Switzerland

PDF

Background: There is evidence that long-term clinical outcomes in patients with multiple sclerosis may be predicted by treatment and disease histories.

Objectives: To assess which parameters at baseline and during year 1 of the 2-year FREEDOMS and FREEDOMS II studies predict relapse or 6-month confirmed disability progression (6MCDP) in the short term and long term during the trials and their extensions.

Methods: This post hoc analysis used data from the fingolimod and placebo groups pooled from the phase 3 FREEDOMS and FREEDOMS II studies. On entering the extension phases, patients had their treatment switched from placebo to fingolimod. Unadjusted logistic regression assessed which patient or disease parameters from baseline to month (M) 12 predicted outcomes (relapses or 6MCDP, measured using the Expanded Disability Status Scale [EDSS]) during M12–24 and M12‒48.

Results: In total, 2355 patients were randomized in FREEDOMS and FREEDOMS II (M12–24, n=1971; M12–48, n=1162). During M0‒12, predictors of relapses in the short and long terms included the combination of magnetic resonance imaging (MRI) lesion activity (at least one gadolinium-enhancing lesion or at least two new T2 lesions) and at least one confirmed relapse (M12–24: odds ratio [OR] 3.399, 95% confidence interval [CI] 2.523–4.579, p<0.0001; M12–48: OR 3.468, 95% CI 2.370–5.073, p<0.0001), and the number of confirmed relapses (M12–24: OR 2.475, 95% CI 2.073–2.954, p<0.0001; M12–48: OR 3.215, 95% CI 2.485–4.159, p<0.0001). Predictors of 6MCDP during M12–48 included baseline EDSS score (OR 1.306, 95% CI 1.157–1.473, p<0.0001), disease duration (OR 1.053, 95% CI 1.026–1.081, p=0.0001) and age (OR 1.04, 95% CI 1.02–1.06, p<0.0001).

Conclusions: During year 1 of the FREEDOMS trials, at least one confirmed relapse, the number of confirmed relapses and MRI lesion activity predicted further relapses in the short and long terms. Baseline EDSS score, disease duration and age predicted disability worsening. These results suggest that early high-efficacy therapy may help to prevent permanent disability.

DX55 Short- and Long-Term Predictors of Relapse or Disability Worsening in Patients with Multiple Sclerosis in the Phase 3 FREEDOMS and FREEDOMS II Studies

DX55
Short- and Long-Term Predictors of Relapse or Disability Worsening in Patients with Multiple Sclerosis in the Phase 3 FREEDOMS and FREEDOMS II Studies