Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients

2015 ◽  
Vol 56 (7) ◽  
pp. 845-851 ◽  
Author(s):  
Damiano Paolicelli ◽  
Vita Direnzo ◽  
Alessia Manni ◽  
Mariangela D'Onghia ◽  
Carla Tortorella ◽  
...  
Author(s):  
Guerrieri S. ◽  
Lazzarin S. ◽  
Zanetta C. ◽  
Nozzolillo A. ◽  
Filippi M. ◽  
...  

Abstract Background Recent observations suggest a lack of humoral response after SARS-CoV-2 vaccination in multiple sclerosis (MS) patients treated with fingolimod or ocrelizumab Objectives To assess serological response to SARS-CoV-2 vaccination in MS patients receiving these disease-modifying treatments (DMTs) in a real-life setting. Methods Retrospective clinical data collection from MS patients followed at San Raffaele Hospital MS Centre (Milan, Italy). All patients treated with fingolimod or ocrelizumab who had received a complete anti-COVID-19 vaccination course, with no clinical history suggestive of previous SARS-CoV-2 infection and with an available post-vaccination serological assay obtained at least 14 days after vaccination completion were considered for the study. Results We collected data from 32 MS patients, 16 treated with fingolimod and 16 receiving ocrelizumab. Among the fingolimod group 10 patients (62.5%) had a positive serological response after vaccination and among ocrelizumab-treated patients a positive serological test was found in six cases (37.5%). No relation between serological response and clinical features (i.e., treatment duration, time between vaccination and last treatment dose, and white blood cells count) was identified. Conclusions Our initial real-life experience suggests a variable antibody production in MS patients receiving these DMTs. At present, there are no sufficient data to do not recommend anti-SARS-CoV-2 vaccine in these patients.


2021 ◽  
Vol 46 ◽  
pp. e021212
Author(s):  
Vanessa Marcon de Oliveira ◽  
Cinthia Caldas Rios ◽  
Vanessa Terezinha Gubert ◽  
Cristiane Munaretto Ferreira ◽  
Erica Freire de Vasconcelos-Pereira ◽  
...  

Introduction: Treatment for multiple sclerosis should focus on relapse prevention and treatment, as well as symptom and disease progression control, which require the use of multiple medications. Objective: To evaluate the association of polypharmacy and related clinical, epidemiological factors in multiple sclerosis patient cohorts. Methods: It was conducted a prospective study of multiple sclerosis patients that held a prescription of disease-modifying drugs between January and December 2017. The medications were analyzed and classified as either long-term or as-needed medications for therapeutic objective and prescription status purposes. Results: During 2017, 124 patients were attended, 106 were eligible for the study, and 81 agreed to participate. The average age was 40.95±11.69 years. The disease duration varied between 6 months and 30 years, with a median of 7 years. More than half of the multiple sclerosis patients suffered from comorbidities (54.32%), and 76.54% were categorized as polypharmacy. The comparison of polypharmacy between the groups yielded significant differences for comorbidities and employment status and regarding age between patients with polypharmacy and patients without polypharmacy of long-term medications. Conclusion: The age of the patient and the presence of comorbidities are important factors related to polypharmacy.


2021 ◽  
pp. 1-6
Author(s):  
Cihat Uzunköprü ◽  
Yesim Beckmann ◽  
Sabiha Türe

<b><i>Introduction:</i></b> The primary aim of the present study was to evaluate the long-term efficacy of fingolimod in patients with multiple sclerosis (MS); secondary aims were to describe the safety of fingolimod with the evaluation of treatment satisfaction and impact on the quality of life in real life. <b><i>Methods:</i></b> We collected clinical, demographical, neuroradiological, and treatment data, including pre- and posttreatment status health-related quality of life from 286 MS patients consecutively treated with fingolimod. Clinical assessment was based on the Expanded Disability Status Scale (EDSS), and quality of life assessment was performed with MS-related quality of life inventory (MSQOLI). The data were recorded at baseline and every 6 months for 2 years. <b><i>Results:</i></b> One hundred and fourteen males and 172 females were enrolled. The annualized relapse rate and EDSS showed a statistically significant reduction during the observation period (<i>p</i> &#x3c; 0.001). The patients also demonstrated substantial improvements in magnetic resonance imaging (MRI) outcomes (<i>p</i> &#x3c; 0.001). Health-related quality of life scores improved significantly between baseline and 24-month visit (<i>p</i> &#x3c; 0.001). No serious adverse events occurred. <b><i>Conclusion:</i></b> In our cohort, fingolimod treatment was associated with reduced relapse, MRI activity, and improved EDSS and MSQOLI scores. Additionally, fingolimod has been able to maintain its effectiveness over a considerable long period of treatment.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lisa-Marie Ohle ◽  
David Ellenberger ◽  
Peter Flachenecker ◽  
Tim Friede ◽  
Judith Haas ◽  
...  

AbstractIn 2001, the German Multiple Sclerosis Society, facing lack of data, founded the German MS Registry (GMSR) as a long-term data repository for MS healthcare research. By the establishment of a network of participating neurological centres of different healthcare sectors across Germany, GMSR provides observational real-world data on long-term disease progression, sociodemographic factors, treatment and the healthcare status of people with MS. This paper aims to illustrate the framework of the GMSR. Structure, design and data quality processes as well as collaborations of the GMSR are presented. The registry’s dataset, status and results are discussed. As of 08 January 2021, 187 centres from different healthcare sectors participate in the GMSR. Following its infrastructure and dataset specification upgrades in 2014, more than 196,000 visits have been recorded relating to more than 33,000 persons with MS (PwMS). The GMSR enables monitoring of PwMS in Germany, supports scientific research projects, and collaborates with national and international MS data repositories and initiatives. With its recent pharmacovigilance extension, it aligns with EMA recommendations and helps to ensure early detection of therapy-related safety signals.


2020 ◽  
Vol 11 ◽  
Author(s):  
Justin M. Honce ◽  
Kavita V. Nair ◽  
Brian D. Hoyt ◽  
Rebecca A. Seale ◽  
Stefan Sillau ◽  
...  

Author(s):  
L.F. Kastrukoff ◽  
D.R. McLean ◽  
T.A. McPherson

SUMMARY:Multiple sclerosis patients treated with antithymocyte globulin (ATG) were re-evaluated after five years. No long term benefit was found. Notably, the group of patients with an elevated gamma globulin to total protein ration in their C.S.F. and who did particularly well after treatment with ATG also failed to show any long term benefit. Few long term detrimental effects of ATG immunosuppression were identified. The implications of the results are discussed as they relate to the use of immunosuppression in multiple sclerosis.


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