Totaro R, Costantino G, Bellantonio P, Danni M, Carmine CD, Fantozzi R, Cerqua R, Fuiani A, Carrocci C, Mundi C, Ruggieri S, Marini C, Provinciali L and Carolei A
Objective: The aim of this study was to compare the efficacy of natalizumab and fingolimod in relapsing-remitting multiple sclerosis patients in real-world clinical setting.
Methods: We enrolled 391 patients starting either natalizumab or fingolimod for relapsing-remitting multiple sclerosis, referred to four multiple sclerosis centers between March 2007 and July 2013. Cumulative proportion of patients free from any disease activity, as defined by freedom from relapse, Expanded Disability Status Scale (EDSS) progression, new or newly enlarging T2 lesions, and gadolinium enhancing lesions at magnetic resonance imaging (MRI) was assessed at 12-month follow-up.
Results: Out of 391 patients, 197 were treated with natalizumab and 194 with fingolimod. The cumulative proportion of patients free from any disease activity was 72.0% in the natalizumab and 59.1% in the fingolimod group (P=0.014). This proportion was lower in fingolimod patients with prior natalizumab exposure compared to those without (51.7% vs. 61.8%; P=0.008). Moreover, the cumulative proportion of patients free from new MRI lesions was 87.5% in the natalizumab vs. 70.0% in the fingolimod group (P<0.001); the cumulative proportion of patients free from clinical relapse was 82.5% in the natalizumab vs. 81.3% in the fingolimod group (P=0.739); 93.5% of patients on natalizumab were free from EDSS progression compared to 89.6% of patients on fingolimod (P=0.186).
Conclusions: Results from 1-year follow-up of treatment suggest higher efficacy of natalizumab compared to fingolimod in terms of proportion of patients free from any disease activity.