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1.
Neurologia (Engl Ed) ; 37(8): 615-630, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-36195374

RESUMEN

INTRODUCTION: Alemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis. OBJECTIVE: A consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain. DEVELOPMENT: A group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug's efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group. CONCLUSION: The present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice.


Asunto(s)
Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Alemtuzumab/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Humanos , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , España
2.
Neurologia (Engl Ed) ; 37(3): 178-183, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35465911

RESUMEN

INTRODUCTION: Neuromyelitis optica spectrum disorders (NMOSD) are immune-mediated inflammatory disorders of the central nervous system involving astrocytes, B lymphocytes, anti-aquaporin 4, and such inflammatory mediators as interleukin-6. Several immunosuppressants are used in their treatment. Tocilizumab, an interleukin-6 receptor antagonist, may be a treatment option. METHOD: We performed an observational, retrospective study analysing parameters of effectiveness (annualised relapse rate, disability, and radiological progression) and safety of tocilizumab in patients with NMOSD in whom previous immunosuppressant treatment had failed. We aimed to evaluate the effectiveness and safety of tocilizumab in clinical practice in patients with NMOSD not responding to other immunosuppressants. RESULTS: Five patients with NMOSD were analysed. Sixty percent of patients were women; mean age at diagnosis was 50±5.3 years and mean progression time was 4.5±3.6 years. Previously administered immunosuppressants were rituximab (in all 5), cyclophosphamide (2), and azathioprine (1). Mean time of exposure to tocilizumab was 2.3±1 years. Mean annualised relapse rate was 1.8±1.3 in the year prior to the introduction of tocilizumab and 0.2±0.4 the year after (P<.05), representing a reduction of 88.9%. CONCLUSIONS: In our experience, tocilizumab is safe and effective in patients with NMOSD showing no response to other immunosuppressants.


Asunto(s)
Neuromielitis Óptica , Anticuerpos Monoclonales Humanizados , Femenino , Humanos , Inmunosupresores/uso terapéutico , Masculino , Neuromielitis Óptica/tratamiento farmacológico , Recurrencia , Estudios Retrospectivos
3.
Neurologia (Engl Ed) ; 37(8): 615-630, 2022 10.
Artículo en Inglés, Español | MEDLINE | ID: mdl-31987648

RESUMEN

INTRODUCTION: Alemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis. OBJECTIVE: A consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain. DEVELOPMENT: A group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug's efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group. CONCLUSION: The present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice.

4.
Neurologia (Engl Ed) ; 2019 Mar 27.
Artículo en Inglés, Español | MEDLINE | ID: mdl-30928236

RESUMEN

INTRODUCTION: Neuromyelitis optica spectrum disorders (NMOSD) are immune-mediated inflammatory disorders of the central nervous system involving astrocytes, B lymphocytes, anti-aquaporin 4, and such inflammatory mediators as interleukin-6. Several immunosuppressants are used in their treatment. Tocilizumab, an interleukin-6 receptor antagonist, may be a treatment option. METHOD: We performed an observational, retrospective study analysing parameters of effectiveness (annualised relapse rate, disability, and radiological progression) and safety of tocilizumab in patients with NMOSD in whom previous immunosuppressant treatment had failed. We aimed to evaluate the effectiveness and safety of tocilizumab in clinical practice in patients with NMOSD not responding to other immunosuppressants. RESULTS: Five patients with NMOSD were analysed. Sixty percent of patients were women; mean age at diagnosis was 50±5.3 years and mean progression time was 4.5±3.6 years. Previously administered immunosuppressants were rituximab (in all 5), cyclophosphamide (2), and azathioprine (1). Mean time of exposure to tocilizumab was 2.3±1 years. Mean annualised relapse rate was 1.8±1.3 in the year prior to the introduction of tocilizumab and 0.2±0.4 the year after (P <.05), representing a reduction of 88.9%. CONCLUSIONS: In our experience, tocilizumab is safe and effective in patients with NMOSD showing no response to other immunosuppressants.

5.
Mult Scler Relat Disord ; 28: 50-56, 2019 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-30553169

RESUMEN

OBJECTIVE: Although cognitive impairment (CI) is common in multiple sclerosis (MS), it is difficult to suspect in patients with low disability and there is a lack of brief and effective CI screening tools with a define cut-off point to be used during routine clinic visits. This study aims to validate the Electronic Screening Cognitive Impairment in Multiple Sclerosis (SCI-MS) test for CI among MS patients. METHODS: Cross-sectional, observational study that included adult patients, diagnosed with MS, Expanded Disability Status Scale (EDSS) score ≤6.5, without relapses within the last 2 months and no depression symptoms. The SCI-MS test consists of two modules: questionnaire (SCI-MS-Q) and pictogram matching tool (SCI-MS-P) measured for score and time. At inclusion, patients completed the Beck Depression Inventory (BDI-II test), the Brief Repeatable Battery of Neuropsychological Test (BRB-N) and the SCI-MS. The SCI-MS feasibility, test-retest reliability and predictive validity were assessed. RESULTS: A total of 194 patients (59.3% female) were included: mean (SD) age of 42 (9) years, mean time since diagnosis of 10 (7) years, 89.7% relapsing-remitting MS, and median (Q1-Q3) EDSS of 2.0 (1.0-3.5). According to BRB-N, 26.8% of patients had CI. Internal consistency was high (Cronbach alpha: 0.97). The intra-class correlation coefficient was 0.88 for the SCI-MS-Q, 0.09 for the SCI-MS-P score and 0.48 for the SCI-MS-P time, corresponding to AUC of the ROC curves of 0.571, 0.574 and 0.714, respectively. For a clinically significant cut-off point of ≥60 seconds, the reached CI sensitivity of SCI-MS-P time was 0.75 and the specificity 0.51. CONCLUSION: SCI-MS showed good psychometric properties. SCI-MS-P time of pictogram completion had an acceptable diagnostic accuracy of CI in MS patients with low disability. SCI-MS-P time of pictogram completion tool is an easy and quick score that can help neurologists to early identify CI in MS patients that should be further assessed to confirm CI diagnosis and to describe its characteristics and mainly affected domains.


Asunto(s)
Disfunción Cognitiva/diagnóstico , Disfunción Cognitiva/etiología , Diagnóstico por Computador , Esclerosis Múltiple/psicología , Pruebas Neuropsicológicas , Adulto , Estudios Transversales , Diagnóstico por Computador/métodos , Estudios de Factibilidad , Femenino , Humanos , Masculino , Esclerosis Múltiple/complicaciones , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/terapia , Psicometría , Reproducibilidad de los Resultados , Sensibilidad y Especificidad
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