Hopelessness in Patients with Early-Stage Relapsing-Remitting Multiple Sclerosis.

Background: Hopelessness is a risk factor for depression and suicide. There is little information on this phenomenon among patients with relapsing-remitting multiple sclerosis (RRMS), one of the most common causes of disability and loss of autonomy in young adults. The aim of this study was to assess state hopelessness and its associated factors in early-stage RRMS. Methods: A multicenter, non-interventional study was conducted. Adult patients with a diagnosis of RRMS, a disease duration ≤ 3 years, and an Expanded Disability Status Scale (EDSS) score of 0-5.5 were included. The State-Trait Hopelessness Scale (STHS) was used to measure patients´ hopelessness. A battery of patient-reported and clinician-rated measurements was used to assess clinical status. A multivariate logistic regression analysis was conducted to determine the association between patients' characteristics and state hopelessness. Results: A total of 189 patients were included. Mean age (standard deviation-SD) was 36.1 (9.4) years and 71.4% were female. Median disease duration (interquartile range-IQR) was 1.4 (0.7, 2.1) years. Symptom severity and disability were low with a median EDSS (IQR) score of 1.0 (0, 2.0). A proportion of 65.6% (n=124) of patients reported moderate-to-severe hopelessness. Hopelessness was associated with older age (p=0.035), depressive symptoms (p=<0.001), a threatening illness perception (p=0.001), and psychological and cognitive barriers to workplace performance (p=0.029) in the multivariate analysis after adjustment for confounders. Conclusion: Hopelessness was a common phenomenon in early-stage RRMS, even in a population with low physical disability. Identifying factors associated with hopelessness may be critical for implementing preventive strategies helping patients to adapt to the new situation and cope with the disease in the long term.

Effectiveness and Safety of Teriflunomide in Relapsing-Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study.

INTRODUCTION: Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing-remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. METHODS: This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. RESULTS: A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14-0.21) from the baseline of 0.42 (95% CI 0.38-0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12-24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. CONCLUSION: Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression.

Effectiveness of Dimethyl Fumarate in Real-World Clinical Practice and Strategy to Minimize Adverse Effects and Use of Healthcare Resources.

BACKGROUND: Dimethyl fumarate (DMF) has shown efficacy in reducing relapse rates in patients with multiple sclerosis (MS). However, associated adverse effects (AE) such as gastrointestinal (GI) AE, flushing and lymphopenia are the main cause of treatment discontinuation. The aim of this study was to evaluate the effectiveness of DMF, and to assess strategies to reduce treatment discontinuation rates in routine clinical practice. PATIENTS AND METHODS: Ninety patients started DMF treatment between August 2015 and February 2020. Prior to DMF therapy, patients received written information regarding treatment and the management of AE, along with medical prescriptions. Clinical and analytical data were collected at clinical visits performed at least 6-monthly, and disease progression was evaluated by brain magnetic resonance imaging (MRI). RESULTS: Prior to DMF, 78.7% of patients had an annualized relapse rate (ARR) of 1.07 (range: 1-3) and median Expanded Disability Status Scale (EDSS) score of 1.0 (range: 0-2). At final follow-up, ARR and median EDSS scores were significantly reduced to 0.09 (range: 0-2; p< 0.001) and 0 (range: 0-1.625; p< 0.001), respectively. Just over one quarter of patients with brain MRI (26.8% of 71 patients) showed improvement in disease activity based on MRI evaluation. Lymphopenia was associated with previous treatment lines (p=0.042) and longer disease duration (p=0.032). A total of twelve patients abandoned DMF treatment, mainly due to lymphopenia (7.9%), but none did it because of GI AE or flushing. CONCLUSION: In our series, DMF showed high clinical and radiological efficacy. Providing patients with complete information prior to treatment on the management of associated AE helps them to better understand what to expect, improves tolerance and reduces clinical and telephone consultations, which may help to reduce the use and cost of healthcare resources.

Clinical response and tolerability of fampridine in clinical practice.

BACKGROUND: Gait disorder is very prevalent in multiple sclerosis. After 15 years of disease progression, 50% of patients need assistive devices for walking. MATERIALS & METHODS: We performed a multicenter observational study, including multiple sclerosis patients with an Expanded Disability Status Scale score between 4.0 and 7.0, normal kidney function and no previous history of seizures. RESULTS: The study sample comprised 138 patients with average age of 50.3 years median Expanded Disability Status Scale of 6.0. After treatment, a significant reduction was observed in both the Timed 25-Foot Walk test (baseline, 20.3 s; 14 days, 13.2 s; p < 0.001; 3 months, 12.1 s; p < 0.001) and the 12-Item Multiple Sclerosis Walking Scale score (baseline, 82.3; 14 days, 59.4; p < 0.001; 3 months, 57.2; p < 0.001). Adverse events were recorded in 39.9% of patients.

[Clinical experience with lacosamide in Galicia: the GALACO study]. / Experiencia clinica con lacosamida en Galicia: estudio GALACO.

INTRODUCTION: Lacosamide is a sodium channel blocker antiepileptic drug authorized as an adjunctive therapy for focal seizures in adolescents and adults. AIM: To analyze the efficacy and safety of lacosamide in Galicia according to its use in daily clinical practice. PATIENTS AND METHODS: Retrospective observational study in patients who started treatment with lacosamide between January 2014 and June 2013 in 10 hospitals in Galicia, Spain. Its efficacy and safety at 3, 6 and 12 months after starting lacosamide was assessed. RESULTS: We included 184 patients with a mean age of 44.2 ± 17.4 years old; 56.5% (n = 104) were male; 173 patients constituted the efficacy population. Mean duration of epilepsy was 18.8 ± 15.5 years. Seizure frequency was 2.5 ± 1.6 episodes/month. After 12 months, 68.2% of patients (n = 118) had >= 50% improvement (responders) and among them, 54 (45.8% of responder patients) were seizure free. Twenty-three percent (n = 43) suffered from adverse events after 12 months, being dizziness (10.3%) and instability (3.3%) the most frequently reported. After the 12 month visit, 87.5% of patients (n = 161) continued treatment with lacosamide. CONCLUSIONS: Lacosamide provides a very good efficacy and safety profile for patients with focal refractory epilepsy. High percentage of responders may be related to a less refractory population compared to other daily clinical practice studies. It constitutes an attractive therapeutic option for the treatment of focal epilepsies.

TITLE: Experiencia clinica con lacosamida en Galicia: estudio GALACO.Introducción. La lacosamida es un fármaco antiepiléptico bloqueante de los canales de sodio, autorizado en adolescentes y adultos como tratamiento coadyuvante en crisis de inicio focal. Objetivo. Analizar los resultados de eficacia y seguridad de la lacosamida en Galicia en su uso de acuerdo con la práctica clínica habitual. Pacientes y métodos. Estudio retrospectivo observacional en pacientes que iniciaron tratamiento con lacosamida entre enero de 2013 y junio de 2014 en 10 hospitales de Galicia. Se evaluó su eficacia y seguridad a los 3, 6 y 12 meses del inicio del tratamiento. Resultados. Se incluyeron 184 pacientes con edad media de 44,2 ± 17,4 años; el 56,5% (n = 104) eran varones. Conforman la población de eficacia 173 pacientes. El tiempo medio de evolución de la epilepsia fue de 18,8 ± 15,5 años. La frecuencia de crisis era de 2,5 ± 1,6 episodios/mes. A los 12 meses, el 68,2% de los pacientes (n = 118) presentaba una mejoría igual o superior al 50% (pacientes respondedores) y, de ellos, 54 (el 45,8% de los respondedores) estaban libres de crisis. El 23,4% (n = 43) refirió efectos adversos a los 12 meses, principalmente mareos (10,3%) e inestabilidad (3,3%). Después de la visita de los 12 meses, continuaba con lacosamida el 87,5% de los pacientes (n = 161). Conclusiones. La lacosamida ofrece un perfil de eficacia y seguridad muy favorable para pacientes con epilepsia focal refractaria. El elevado porcentaje de respondedores podría atribuirse a una población de epilépticos menos refractarios que en otros estudios de práctica clínica. Constituye una opción terapéutica atractiva para el tratamiento de epilepsias de inicio focal.