The Place of Immune Reconstitution Therapy in the Management of Relapsing Multiple Sclerosis in France: An Expert Consensus.

The treatment strategy in relapsing multiple sclerosis (RMS) is a complex decision requiring individualization of treatment sequences to maximize clinical outcomes. Current local and international guidelines do not provide specific recommendation on the use of immune reconstitution therapy (IRT) as alternative to continuous immunosuppression in the management of RMS. The objective of the program was to provide consensus-based expert opinion on the optimal use of IRT in the management of RMS. A Delphi method was performed from May 2022 to July 2022. Nineteen clinical assertions were developed by a scientific committee and sent to 14 French clinical experts in MS alongside published literature. Two consecutive reproducible anonymous votes were conducted. Consensus on recommendations was achieved when more than 75% of the respondents agreed or disagreed with the clinical assertions. After the second round, consensus was achieved amongst 16 out of 19 propositions: 13 clinical assertions had a 100% consensus, 3 clinical assertions a consensus above 75% and 3 without consensus. Expert-agreed consensus is provided on topics related to the benefit of the early use of IRT from immunological and clinical perspectives, profiles of patients who may benefit most from the IRT strategy (e.g. patients with family planning, patient preference and lifestyle requirements). These French expert consensuses provide up-to-date relevant guidance on the use of IRT in clinical practice. The current program reflects status of knowledge in 2022 and should be updated in timely manner when further clinical data in IRT become available.

An analysis of first-line disease-modifying therapies in patients with relapsing-remitting multiple sclerosis using the French nationwide health claims database from 2014-2017.

BACKGROUND: Little is known about the use of first-line treatments for relapsing-remitting multiple sclerosis (RRMS), whether oral (teriflunomide and dimethyl fumarate) or injectable (interferons/glatiramer acetate [GA]) in France. We conducted an observational study to determine patient profile, persistence and compliance to first-line disease-modifying treatments (DMT), and factors related to discontinuation in naïve patients with RRMS. METHODS: This is a retrospective study using the French Nationwide Health Data System (SNDS) which collects outpatient and hospitalization data for the entire population. Naïve patients aged 18 and older, starting first-line DMT between September 1,2014 and August 31,2016, were identified and followed-up until the end of 2017. Treatment persistence identified by the first and last dispensation dates, death, DMT discontinuation ≥6 months, compliance measured by the Medication Possession Ratio (MPR), and number of relapses were estimated. RESULTS: During the inclusion period, 10,240 patients starting a first-line DMT for RRMS (mainly oral) were identified. Patients treated with teriflunomide were older, more often men with reduced relapses in the year prior to treatment initiation compared to those treated with dimethyl fumarate. Treatment compliance with teriflunomide was 81% [95% CI 80-82] at 6 months and 60% at 24 months [95% CI 58-62] compared to 79% [95% CI 78-80] at 6 months, 55% [95% CI 53-56] at 24 months with dimethyl fumarate versus 74% [95% CI 73-76] at 6 months and 39 % [95% CI 37-41] at 24 months with interferons/GA. After patient profile's adjustment, the risk of discontinuing first-line DMT was higher with interferons/GA and dimethyl fumarate than teriflunomide (HR=1.74, p <0.0001 and HR=1.12, p <0.0001; respectively). Although compliance was good with all treatments, it was significantly better with oral therapies compared to injectables. Probability to relapse at least once in the year after treatment initiation is lower for patients starting oral treatments than those treated with injectables, even after adjusting for patient profile. CONCLUSION: This real-world study demonstrated better compliance and persistence to oral therapies in naïve patients initiating first-line DMT for RRMS in France. Within oral therapies, persistence to teriflunomide was higher compared to dimethyl fumarate, with no difference observed in treatment compliance or risk on relapses' occurrence after patient profile's adjustment.

Anxiety and Coping Strategy Changes in Multiple Sclerosis Patients Initiating Fingolimod: The GRACE Prospective Study.

The objective of this prospective study was to assess the changes in anxiety levels, and their relationship with coping strategies over the first four months of fingolimod treatment in patients with relapsing remitting multiple sclerosis (RRMS). Data were collected at the inclusion visit (Visit 1) and 4 months later (Visit 2). We used the Hospital Anxiety and Depression Scale (HADS) to assess the level of anxiety and the Coping Inventory for Stressful Situations scale to assess the coping strategies used when engaged with stressful situations. The HADS anxiety scores were compared between Visits 1 and 2, according to the preferred coping strategy. At Visit 1, half of the 198 patients included were considered to be anxious (doubtful or in a certain way). The same proportion preferentially used an avoidance-oriented strategy and one-third preferentially used an emotion-oriented strategy. The mean HADS anxiety score decreased significantly (p = 0.001) at Visit 2 (8.1 ± 4.0) compared to Visit 1 (8.8 ± 4.3), particularly in the group of patients who used an emotion-oriented strategy (p = 0.002). In conclusion, the initiation of fingolimod in patients with RRMS is followed by a decrease of anxiety levels which vary according to the coping strategy used.