Abstract: Long-Term Predictors of Clinical Outcomes in Patients with Multiple Sclerosis in the Phase 3 Freedoms, Freedoms II and Transforms Studies (2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

DX20
Long-Term Predictors of Clinical Outcomes in Patients with Multiple Sclerosis in the Phase 3 Freedoms, Freedoms II and Transforms Studies

Thursday, May 31, 2018

Exhibit Hall A (Nashville Music City Center)

Till Sprenger, MD , Department of Neurology, DKD HELIOS Klinik, Wiesbaden, Germany

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

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

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

Daniela Piani Meier, PhD , Novartis Pharma AG, Basel, Switzerland

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

Diego Silva, MD, PhD , Novartis Pharma AG, Basel, Switzerland

Frederik Barkhof, MD, PhD , Institutes of Neurology and Healthcare Engineering, University College London, London, United Kingdom

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

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Background: Previous studies suggest that treatment and disease histories of patients with multiple sclerosis (MS) can be used to predict long-term clinical outcomes.

Objectives: To assess the ability of patient variables at Baseline and during the first year of the FREEDOMS, FREEDOMS II and TRANSFORMS trials and their extensions to predict long-term clinical outcomes in patients with MS.

Methods:

This was a post hoc analysis of data from the subgroups of patients who received fingolimod 0.5 mg in the pooled 24-month FREEDOMS/FREEDOMS II trials (N=649), the 12-month TRANSFORMS trial (N=342) and their extensions. Unadjusted logistic regression assessed which patient or disease characteristics at Baseline, or from Baseline to Month (M)12, predicted six clinical outcomes (relapses, Expanded Disability Status Scale [EDSS] score ≥6, 3M-confirmed disability progression [3M-CDP], 6M-CDP, relapses and 3M-CDP, and relapses and 6M-CDP) during M12–M48. Parameters included sex, age, Baseline EDSS, relapses (M0–M12), EDSS change (M0–M12), and magnetic resonance imaging measurements. Significant predictors from the univariate analyses were included in multiple-logistic regression analyses.

Results:

Multiple-regression analyses identified relapses (M0–M12) and EDSS score (Baseline and M0–M12) as the most consistent predictors of worsening clinical outcomes during M12–M48. In the FREEDOMS/FREEDOMS II studies, relapses (M0–M12) were predictive of (odds ratio [95% confidence interval]): relapses (3.227 [1.756–5.931], p=0.0002), relapses and 3M-CDP (2.606 [1.418–4.791], p=0.0020) and relapses and 6M-CDP (2.350 [1.287–1.291], p=0.0054). In TRANSFORMS, relapses (M0–M12) were only predictive of relapses (1.745 [1.054–2.889], p=0.0306). EDSS change (M0–M12) was predictive of EDSS ≥6 (3.217 [1.77–5.837], p=0.0001) in TRANSFORMS.

Conclusions:

In the FREEDOMS and TRANSFORMS trials, relapses (M0–M12) and EDSS score (Baseline and M0–M12) were consistently predictive of long-term clinical outcomes, including relapses, 3M-CDP and 6M-CDP, in patients receiving fingolimod 0.5 mg.

DX20 Long-Term Predictors of Clinical Outcomes in Patients with Multiple Sclerosis in the Phase 3 Freedoms, Freedoms II and Transforms Studies

DX20
Long-Term Predictors of Clinical Outcomes in Patients with Multiple Sclerosis in the Phase 3 Freedoms, Freedoms II and Transforms Studies