Is Baseline MRI Predictive of Response to Fingolimod Treatment in Multiple Sclerosis? (P3.280)

OBJECTIVE: To assess the value of quantitative baseline MRI metrics as predictors of response to fingolimod treatment in MS. BACKGROUND: Baseline MRI may have value in predicting response to specific MS treatments. DESIGN/METHODS: We used data from the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital (CLIMB). We identified 54 patients who had brain MRI performed within 3 months of starting treatment with fingolimod (0.5 mg/day); the patients remained on fingolimod for at least 12 months. For each patient, we measured global cerebral brain parenchymal fraction (BPF), T2 lesion volume (T2LV), and T1 hypointense (“black holes”) lesion volume (T1BHLV), and the number of gadolinium-enhanced (Gd+) lesions. Patients with corticosteroid infusions within 30 days prior to MRI were excluded. The predictive effect of baseline MRI on treatment response between months 3-24 was evaluated. Treatment responders were defined as having no clinical relapses or new MRI lesions, and no increase in Expanded Disability Status Scale (EDSS) score between months 3-24. Non-responders were defined as having at least 1 relapse, MRI activity, or an EDSS increase of 1 from baseline, if baseline EDSS under 6, or 0.5 if baseline EDSS was 6 or higher. Logistic regression modeling assessed associations between baseline MRI and responder/non-responder outcome. RESULTS: Using univariate analysis, we found that individual T2LV, BPF, T1BHLV, and number of Gd+ lesions were not significantly associated with the probability of treatment response (p>0.5 for each predictor). Furthermore, when all MRI predictors were included in the model, MRI remained not significantly associated with responder status. CONCLUSIONS: Baseline MRI data on lesions and atrophy did not predict the response to fingolimod in this real world cohort. Further studies will examine a second MRI timepoint, as well effects of additional clinical and biomarkers in predicting a treatment response to fingolimod. STUDY SUPPORT: Novartis Disclosure: Dr. Diaz-Cruz has nothing to disclose. Dr. Healy has received research support from Merck Serono. Dr. Malik has nothing to disclose. Dr. Egorova has nothing to disclose. Dr. Polgar-Turcsanyi has nothing to disclose. Dr. Anderson has nothing to disclose. Dr. Tauhid has nothing to disclose. Dr. Kim has nothing to disclose. Dr. Bakshi has received personal compensation for activities with Biogen Idec, Novartis, Sanofi/Genzyme, and Teva Neuroscience as a consultant. Dr. Chitnis has received personal compensation for activities with Biogen Idec and Alexion. Dr. Chitnis has received research support from Merck Serono and Novartis.