Is disease activity prior to fingolimod initiation predictive of response? Fingolimod as a "common" first line treatment.

Abstract Background In countries where fingolimod is available as first-line therapy without restrictions, we have an opportunity to observe long-term efficacy profile of this drug in treatment-naive patients according to their initial disease activity. Methods We retrospectively analysed the data of RRMS patients treated with FTY, focusing on 2 groups: 17 highly active patients (HA) defined as follows: ≥  2 relapses in the year before treatment initiation and either ≥ 1 Gd-enhancing T1 lesion or a significant increase in T2 lesion load from a baseline MRI; and 37 “not highly active” (NHA). We reviewed treatment efficacy (defined as NEDA-3), reasons for discontinuation and treatment tolerance in both groups. Results Mean follow-up duration was 48.2 months, SD 18.4. Fingolimod efficiently reduced relapses (NHA 90.3% reduction, P  0.001), and new Gd enhancing lesions (NHA 85.4% reduction, P = 0.019, HA 92.3%, P = 0.043). The proportion of patients reaching NEDA-3 status was higher in the NHA group (NHA: 80% at 2 years and 66% at 4 years, HA: 58% at 2 years and 38% at 4 years, P = 0.042). Fingolimod was discontinued in 20 cases, mainly because of lack of efficacy (n = 15). Conclusions FTY is efficient in reducing relapses and new Gd enhancing lesions in both HA and NHA patients although the probability of achieving NEDA-3 over time is higher in early-treated treatment-naive NHA patients.