Long-Term Effectiveness, Safety and Tolerability of Fingolimod in Patients with Multiple Sclerosis in Real-World Treatment Settings in France: The VIRGILE Study.

INTRODUCTION: It is important to confirm the effectiveness and tolerability of disease-modifying treatments for relapsing-remitting multiple sclerosis (RRMS) in real-world treatment settings. This prospective observational cohort study (VIRGILE) was performed at the request of the French health authorities. The primary objective was to evaluate the effectiveness of fingolimod 0.5 mg in reducing the annualised relapse rate (ARR) in patients with RRMS. METHODS: Participating neurologists enrolled all adult patients with RRMS starting fingolimod treatment between 2014 and 2016, who were followed for 3 years. Follow-up consultations took place at the investigator's discretion. The primary outcome measure was the change in ARR at month 24 after fingolimod initiation. Relapses and adverse events were documented at each consultation; disability assessment (EDSS) and magnetic resonance imagery were performed at the investigator's discretion. RESULTS: Of 1055 eligible patients, 633 patients were assessable at month 36; 405 (64.0%) were treated continuously with fingolimod for 3 years. The ARR decreased from 0.92 ± 0.92 at inclusion to 0.31 ± 0.51 at month 24, a significant reduction of 0.58 [95% CI - 0.51 to - 0.65] relapses/year (p < 0.001). Since starting fingolimod, 461 patients (60.9%) remained relapse-free at month 24 and 366 patients (55.5%) at month 36. In multivariate analysis, no previous disease-modifying treatment, number of relapses in the previous year and lower EDSS score at inclusion were associated with a greater on-treatment reduction in ARR. The mean EDSS score remained stable over the course of the study. Sixty-one out of 289 (21.1%) patients presented new radiological signs of disease activity. Treatment-related serious adverse events were lymphopenia (N = 21), bradycardia (N = 19), elevated transaminases (N = 9) and macular oedema (N = 9). CONCLUSIONS: The effectiveness and tolerability of fingolimod in everyday clinical practice are consistent with findings of previous phase III studies. Our study highlights the utility of fingolimod for the long-term management of patients with multiple sclerosis.

[Teaching intramuscular self-injection in patients with multiple sclerosis reaching interferon beta-1a: evaluation of a descriptive multicenter program]. / Evaluation d'un programme d'éducation à l'auto-injection chez des patients atteints de sclérose en plaques rémittente débutant un traitement par interféron bêta-1a intramusculaire. Etude descriptive, multicentrique, non randomisée.

INTRODUCTION: In France, self-administration is less common for intramuscular (IM) than parenteral injections, because of the widespread availability of home visits by nurses, who can give these IM injections. An easy, personalized training program was set up to help French patients who wanted to be self-sufficient regarding their injections. METHODS: This noncomparative, open-label, multicenter study enrolled patients aged 18-75 years, diagnosed with relapsing-remitting multiple sclerosis (MS), with at least 2 relapses during the previous 3 years, no evidence of progression between relapses, and treated with IM interferon beta-1a. The main objective was to assess the proportion of patients able, according to their treating neurologist, to perform the IM injections on their own at the end of an 8-week training program led by nurses. RESULTS: The study included 440 patients (74% women, mean age=38.7+/-9.8 years) at 98 MS centers. At the end of the study, 87% were assessed as "able" to self-inject, and 86.6% of this group could do so by the second injection. Patients' satisfaction regarding the training program was high (89.4+/-13.4 mm at week 4. 89.5+/-12.1 mm at week 8 on a visual analog scale rated from 0 to 100 mm), as was their satisfaction regarding the injection (82.7+/-21.2 mm at week 4 and 84.2+/-20.0 mm at week 8). The correlation between the nurses' and neurologists' evaluations of the patients' ability to self-inject was high, exceeding>90%. CONCLUSION: This large-scale study demonstrated the feasibility of IM self-injection of interferon beta-1a in patients who want to administer their own injections.

Familial cluster headache: a series of 186 index patients.

OBJECTIVE: To investigate the familial occurrence of cluster headache in a series of French patients fulfilling the International Headache Society diagnosis criteria. METHODS: One hundred eighty-six index patients and 624 first-degree relatives were surveyed. RESULTS: A positive family history of cluster headache was found in 20 index patients (10.75%) with 22 affected first-degree relatives (3.4%). In multiplex families 6 of the 68 second-degree relatives that were contacted had cluster headache. CONCLUSION: No precise mode of inheritance could be drawn from the observed repartition of cases within multiplex families.