Holistic, Long-Term Management of People with Relapsing Multiple Sclerosis with Cladribine Tablets: Expert Opinion from France

Abstract

Cladribine tablets (CladT) has been available for therapeutic use in France since March 2021 for the management of highly active relapsing multiple sclerosis (RMS). This high-efficacy disease-modifying therapy (DMT) acts as an immune reconstitution therapy. In contrast to most high-efficacy DMTs, which act via continuous immunosuppression, two short courses of oral treatment with CladT at the beginning of years 1 and 2 of treatment provide long-term control of MS disease activity in responders to treatment, without the need for any further pharmacological treatment for several years. Although the labelling for CladT does not provide guidance beyond the initial treatment courses, real-world data on the therapeutic use of CladT from registries of previous clinical trial participants and patients treated in routine practice indicate that MS disease activity is controlled for a period of years beyond this time for a substantial proportion of patients. Moreover, this clinical experience has provided useful information on how to initiate and manage treatment with CladT. In this article we, a group of expert neurologists from France, provide recommendations on the initiation of CladT in DMT-naïve patients, how to switch from existing DMTs to CladT for patients with continuing MS disease activity, how to manage patients during the first 2 years of treatment and finally, how to manage patients with or without MS disease activity in years 3, 4 and beyond after initiating treatment with CladT. We believe that optimisation of the use of CladT beyond its initial courses of treatment will maximise the benefits of this treatment, especially early in the course of MS when suppression of focal inflammation in the CNS is a clinical priority to limit MS disease progression.

Keywords: Cladribine tablets; Disease-modifying therapy; Holistic management; Multiple sclerosis.

Fig. 1

Overview of cladribine tablet posology for relapsing multiple sclerosis patients. ^aCladribine tablets is given as two treatment courses 1 year apart [7]. Inset shows details of one treatment course: blue arrows show treatment days at the beginning of month 1 and month 2 (5 treatment days are shown for each month, but in practice this could be 4 or 5 days, depending on body weight). ^bEuropean Summary of Product Characteristics (SmPC). Compiled from information presented in the European SmPC for cladribine tablets [7] and aadapted here from reference [8] under the Creative Commons Attribution-Non Commercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0)

Fig. 2

Overview of the expert opinion on the management of patients treated with cladribine tablets at time of initiation according to patient profile regarding prior DMT and follow-up recommendation during 1st year of treatment. *Expert opinion based on real-world evidence and clinical practice that may differ from recommendations in the European Summary of Product Characteristics [7]. DMF dimethyl fumarate, IFN interferon, IRT immune reconstitution therapy, M1, M6, etc., refers to months, MRI magnetic resonance imaging, N/A not applicable, S1P sphingosine-1-phosphate inhibitor(s)

Fig. 3

Overview of expert opinion on patient management after taking a full dose of cladribine tablets, year 1 and beyond. DMT disease-modifying treatment, M6, M12, etc., refers to months, MRI magnetic resonance imaging