Is disease activity prior to fingolimod initiation predictive of response? Fingolimod as a “common” first line treatment - 24/02/21

Doi : 10.1016/j.neurol.2020.11.009

V. Pantazou ^a,^b, R. Du Pasquier ^a,^b, C. Pot ^a,^b, G. Le Goff ^a, M. Théaudin ^a,⁎
^a Division of Neurology, Department of Clinical Neurosciences, Lausanne University Hospital and University of Lausanne, Rue du Bugnon 46, 1011 Lausanne, Switzerland
^b Laboratories of Neuroimmunology, Neuroscience Research Center , Lausanne University, Epalinges, Switzerland

^⁎Corresponding author at: Division of Neurology, Department of Clinical Neurosciences, Lausanne University Hospital and University of Lausanne, Rue du Bugnon 46, 1011 Lausanne, Switzerland.Division of Neurology, Department of Clinical Neurosciences, Lausanne University Hospital and University of LausanneRue du Bugnon 46Lausanne1011Switzerland

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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, HA 84.9%, 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.

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Keywords : Multiple Sclerosis, Disease Modifying Treatment, Fingolimod, Highly Active, Treatment Naive, First Line Treatment

Abbreviations : EDSS, DMT, FTY, HA, NEDA, NHA, RCT, RRMS