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BACKGROUND: Current literature and a real-world study suggest that diroximel fumarate (DRF) is safer than dimethyl fumarate (DMF) in the treatment of multiple sclerosis (MS). However, no real-world study to date has significantly addressed the efficacy of this treatment. OBJECTIVES: This study aims to elucidate the safety, tolerability, and efficacy of DRF in a real-world setting, utilizing data from a Spanish national registry of patients commencing DRF therapy post-market introduction. METHODS: In this multicenter, prospective observational study, data were collected from MS patients who initiated DRF treatment. The study monitored demographic and clinical characteristics, safety outcomes (including adverse events, reasons for discontinuation, and lymphocyte counts), and efficacy outcomes (radiological and clinical activity). RESULTS: A total of 195 MS patients across 26 neurological departments were included, predominantly female (79.5%), with a mean age of 42.17 years, and a mean duration of treatment with DRF of 6.3 months. Most patients (70.3%) reported no adverse events, while gastrointestinal issues and flushing were the most common adverse events observed. The majority of patients (84.6%) continued with DRF treatment, with tolerability issues being the primary reason for discontinuation. Efficacy analysis showed low relapse rates post-DRF initiation, with most patients exhibiting stable or improved Expanded Disability Status Scale scores and radiological assessments demonstrating minimal activity. CONCLUSION: This comprehensive analysis provides valuable insights into the real-world application of DRF, confirming its safety and tolerability while offering preliminary evidence of its efficacy in managing MS.
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BACKGROUND AND PURPOSE: Limited information is available on incidence and outcomes of COVID-19 in patients with multiple sclerosis (MS). This study investigated the risks of SARS-CoV-2 infection and COVID-19-related outcomes in patients with MS, and compared these with the general population. METHODS: A regional registry was created to collect data on incidence, hospitalization rates, intensive care unit admission, and death in patients with MS and COVID-19. National government outcomes and seroprevalence data were used for comparison. The study was conducted at 14 specialist MS treatment centers in Madrid, Spain, between February and May 2020. RESULTS: Two-hundred nineteen patients were included in the registry, 51 of whom were hospitalized with COVID-19. The mean age ± standard deviation was 45.3 ± 12.4 years, and the mean duration of MS was 11.9 ± 8.9 years. The infection incidence rate was lower in patients with MS than the general population (adjusted incidence rate ratio = 0.78, 95% confidence interval [CI] = 0.70-0.80), but hospitalization rates were higher (relative risk = 5.03, 95% CI = 3.76-6.62). Disease severity was generally low, with only one admission to an intensive care unit and five deaths. Males with MS had higher incidence rates and risk of hospitalization than females. No association was found between the use of any disease-modifying treatment and hospitalization risk. CONCLUSIONS: Patients with MS do not appear to have greater risks of SARS-CoV-2 infection or severe COVID-19 outcomes compared with the general population. The decision to start or continue disease-modifying treatment should be based on a careful risk-benefit assessment.
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COVID-19 , Esclerose Múltipla , Feminino , Hospitalização , Humanos , Masculino , Esclerose Múltipla/epidemiologia , SARS-CoV-2 , Estudos SoroepidemiológicosRESUMO
INTRODUCTION: The medical report is a legal, written document issued by the physician, exposing the clinical history and the diagnostic and therapeutic protocols applied to the patient. AIM: To evaluate the patient knowledge about the medical report and its usefulness. PATIENTS AND METHODS: We included consecutive first-visit patients attended in four general neurology offices. The descriptive analysis included: demographic data (age, sex, level of studies), degree of knowledge on the referring doctor (name, specialty, reason for referral), medical history (medical antecedents, treatment, dosage, reasons for its intake, reasons for not providing it) and the medical report (applications, reasons for not providing it and awarded usefulness). These data were compared between different sanitary areas and cultural levels. RESULTS: We included 378 patients (average age: 49.1 ± 20.6 years-old; 62.2% women; 40.2% with primary studies; 23.3% with secondary studies). 41.5% did not know the name of the referring doctor, 5.5% his specialty and 2.6% the reason for referral. 3.7% did not know their medical antecedents, 20.4% did not provide the treatment (49.3% did not know it was necessary), 4.8% did not know why they took it and 27.6% the dosage. 14.3% did not provide the medical report and 18.0% applied it (61.7% for bureaucratic reasons and 28.0% for information). Only 18.0% knew that the medical report included the medical information of the patient. CONCLUSION: The patient does not know the usefulness and importance of the medical report, despite being a legal document exposing the medical information of the patient disease.