Preliminary Comparison of Baseline Cognition and Correlations with PROs of FTY Versus GA in MS Patients in a Longitudinal Observational Study
Objectives: Compare baseline cognitive characteristics and describe correlations between Neuro-QoL scales and cognitive tests in a cohort of stable relapsing multiple sclerosis (MS) patients on fingolimod (FTY) or glatiramer acetate (GA) enrolled in a prospective 2-year study examining brain volume, cognition and patient reported outcomes (PROs).
Methods: Relapsing MS patients aged 18-60 years on FTY or GA for >2 years were identified and will be followed for 2 years with a baseline and subsequent annual visits including MRI, cognitive testing, and the NeuroQoL. In this analysis, baseline performance was compared on measures of attention/processing speed, executive function, and memory on the following tests: Paced Auditory Serial Addition Test (PASAT), Symbol Digital Modalities Test (SDMT), Verbal Fluency (VF), California Verbal Learning Test-II (CVLT-II), Brief Visuospatial Memory Test-Revised (BVMT-R). An analysis of baseline cognitive characteristics by treatment arm, and correlations between Neuro-QoL scales and cognitive tests for all currently enrolled patients is presented.
Results: For this analysis, 45/60 planned FTY and 25/60 planned GA patients had completed a baseline visit. No group differences were found for demographic or disease characteristics (disease duration, EDSS, or normalized brain volume). Similarly, no group differences were found on the cognitive measures (all p>0.05). For all patients, PASAT, SDMT, and VF correlated with NeuroQoL general cognition and executive function scales (all p<0.05). Correlations between CVLT-II and BVMT-R and the NeuroQoL general cognition scale approached significance (p=0.06). The NeuroQoL fatigue scale was negatively correlated with VF (p=0.01).
Conclusions: Preliminary analysis suggests that stable long-term users of FTY and GA are comparable on measures of cognition. Performance on all objective cognitive measures was correlated with subjective self-report of cognitive concerns. This comparison will help determine whether future differences over the 2 year study period can be attributed to type of therapy or other group differences.