RESUMEN
With the advent of new disease-modifying drugs, the treatment of multiple sclerosis is becoming increasingly complex. Using consensus statements is therefore advisable. The present consensus statement, which was drawn up by the Spanish Society of Neurology's study group for demyelinating diseases, updates previous consensus statements on the disease. The present study lists the medications currently approved for multiple sclerosis and their official indications, and analyses such treatment-related aspects as activity, early treatment, maintenance, follow-up, treatment failure, changes in medication, and special therapeutic situations. This consensus statement includes treatment recommendations for a wide range of demyelinating diseases, from isolated demyelinating syndromes to the different forms of multiple sclerosis, as well as recommendations for initial therapy and changes in drug medication, and additional comments on induction and combined therapy and practical aspects of the use of these drugs.
Asunto(s)
Consenso , Esclerosis Múltiple/tratamiento farmacológico , Neurología , Sociedades Médicas , HumanosRESUMEN
The last consensus statement of the Spanish Society of Neurology's Demyelinating Diseases Study Group on the treatment of multiple sclerosis (MS) was issued in 2016. Although many of the positions taken remain valid, there have been significant changes in the management and treatment of MS, both due to the approval of new drugs with different action mechanisms and due to the evolution of previously fixed concepts. This has enabled new approaches to specific situations such as pregnancy and vaccination, and the inclusion of new variables in clinical decision-making, such as the early use of high-efficacy disease-modifying therapies (DMT), consideration of the patient's perspective, and the use of such novel technologies as remote monitoring. In the light of these changes, this updated consensus statement, developed according to the Delphi method, seeks to reflect the new paradigm in the management of patients with MS, based on the available scientific evidence and the clinical expertise of the participants. The most significant recommendations are that immunomodulatory DMT be started in patients with radiologically isolated syndrome with persistent radiological activity, that patient perspectives be considered, and that the term "lines of therapy" no longer be used in the classification of DMTs (> 90% consensus). Following diagnosis of MS, the first DMT should be selected according to the presence/absence of factors of poor prognosis (whether epidemiological, clinical, radiological, or biomarkers) for the occurrence of new relapses or progression of disability; high-efficacy DMTs may be considered from disease onset.
Asunto(s)
Esclerosis Múltiple , Neurología , Humanos , Esclerosis Múltiple/tratamiento farmacológico , Sociedades , ConsensoRESUMEN
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 , EspañaRESUMEN
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.
RESUMEN
El último documento de consenso del Grupo de Estudio de Enfermedades Desmielinizantes de la Sociedad Española de Neurología sobre el tratamiento de la esclerosis múltiple (EM) data del año 2016. Aunque muchas consideraciones continúan todavía vigentes, desde entonces se han producido cambios significativos en el manejo y tratamiento de esta enfermedad, motivados no solo por la aprobación de nuevos fármacos con diferentes mecanismos de acción, sino también por la evolución de conceptos otrora consolidados. Esto ha permitido abordar situaciones especiales como el embarazo y la vacunación desde otra perspectiva, e incluir nuevas variables en la toma de decisiones en práctica clínica, como plantear tratamiento modificador de la enfermedad (TME) de alta eficacia en fases tempranas, considerar la perspectiva del paciente y utilizar nuevas tecnologías como monitorización remota. Estos cambios han motivado la presente actualización del consenso mediante metodología Delphi, con el objetivo de reflejar el nuevo paradigma de manejo del paciente con EM basándose en la evidencia científica y la experiencia clínica de los participantes. Entre las principales conclusiones destacan como recomendaciones: iniciar TME inmunomodulador en el síndrome radiológico aislado con actividad radiológica persistente, evaluar la perspectiva del paciente y abandonar la terminología «líneas de tratamiento» en la clasificación de los TME (consenso mayor del 90%). Tras el diagnóstico de EM la elección del primer TME debería considerar la presencia/ausencia de factores de mal pronóstico (epidemiológicos, clínicos, radiológicos y biomarcadores) para la aparición de nuevos brotes o progresión de discapacidad, pudiendo plantear desde el inicio TME de alta eficacia. (AU)
The last consensus statement of the Spanish Society of Neurology's Demyelinating Diseases Study Group on the treatment of multiple sclerosis (MS) was issued in 2016. Although many of the positions taken remain valid, there have been significant changes in the management and treatment of MS, both due to the approval of new drugs with different action mechanisms and due to the evolution of previously fixed concepts. This has enabled new approaches to specific situations such as pregnancy and vaccination, and the inclusion of new variables in clinical decision-making, such as the early use of high-efficacy disease-modifying therapies (DMT), consideration of the patient's perspective, and the use of such novel technologies as remote monitoring. In the light of these changes, this updated consensus statement, developed according to the Delphi method, seeks to reflect the new paradigm in the management of patients with MS, based on the available scientific evidence and the clinical expertise of the participants. The most significant recommendations are that immunomodulatory DMT be started in patients with radiologically isolated syndrome with persistent radiological activity, that patient perspectives be considered, and that the term lines of therapy no longer be used in the classification of DMTs (> 90% consensus). Following diagnosis of MS, the first DMT should be selected according to the presence/absence of factors of poor prognosis (whether epidemiological, clinical, radiological, or biomarkers) for the occurrence of new relapses or progression of disability; high-efficacy DMTs may be considered from disease onset. (AU)
Asunto(s)
Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple/terapia , Neurología , EspañaRESUMEN
La incorporación de nuevos medicamentos para modificar el curso de la esclerosis múltiple y la complejidad de su uso plantea la conveniencia de utilizar consensos terapéuticos. El consenso actual ha sido elaborado por el grupo de enfermedades desmielinizantes de la Sociedad Española de Neurología y actualiza consensos previamente publicados. Se enumeran los medicamentos aprobados para la esclerosis múltiple con sus indicaciones oficiales. Se analizan aspectos relacionados con el tratamiento, como la presencia de actividad, la precocidad, el mantenimiento terapéutico, el seguimiento, el fallo terapéutico, los cambios de medicación y el tratamiento en situaciones especiales. Se elaboran indicaciones de tratamiento desde el síndrome desmielinizante aislado a las distintas formas de esclerosis múltiple detallando recomendaciones de tratamiento inicial, cambios de medicación, con consideraciones sobre terapia combinada e inducción y aspectos prácticos del uso de medicamentos
With the advent of new disease-modifying drugs, the treatment of multiple sclerosis is becoming increasingly complex. Using consensus statements is therefore advisable. The present consensus statement, which was drawn up by the Spanish Society of Neurology's study group for demyelinating diseases, updates previous consensus statements on the disease. The present study lists the medications currently approved for multiple sclerosis and their official indications, and analyses such treatment-related aspects as activity, early treatment, maintenance, follow-up, treatment failure, changes in medication, and special therapeutic situations. This consensus statement includes treatment recommendations for a wide range of demyelinating diseases, from isolated demyelinating syndromes to the different forms of multiple sclerosis, as well as recommendations for initial therapy and changes in drug medication, and additional comments on induction and combined therapy and practical aspects of the use of these drugs
Asunto(s)
Humanos , Masculino , Femenino , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple/epidemiología , Esclerosis Múltiple/prevención & control , Consenso , Sociedades Médicas/organización & administración , Sociedades Médicas/normas , Sistemas de Medicación/normas , Enfermedades Desmielinizantes/tratamiento farmacológico , Enfermedades Desmielinizantes/epidemiología , Terapia Combinada/métodos , Administración del Tratamiento Farmacológico/organización & administración , Administración del Tratamiento Farmacológico/normas , Cumplimiento de la Medicación , Resultado del TratamientoRESUMEN
Antecedentes y objetivos La encefalopatía posterior reversible es una entidad clínicoradiológica caracterizada por cefalea, obnubilación y ceguera cortical asociada a edema cerebral en neuroimagen, cuyas causas clásicas son: eclampsia, encefalopatía hipertensiva y agentes inmunosupresores. Métodos Mujer de 33 años afecta de lupus eritematoso sistémico traída a urgencias por cefalea, agitación y amaurosis. Resultados A su llegada PA: 205/139mmHg. No signos meningeos ni focalidad motora. Examen cardiopulmonar y ECG normales. Analítica anodina excepto proteinuria. RMN craneal: lesiones simétricas córticosubcorticales bioccipitales, hiperintensas en T2. Estos hallazgos sugerían lesiones tipo encefalopatía posterior reversible. Se administró labetalol i.v. como tratamiento de la emergencia hipertensiva con evolución favorable, consiguiéndose cifras de normotensión en días posteriores con valsartan y lercanidipino. La paciente quedó asintomática en 24h, RM craneal de control a las 2 semanas: normal. Se instauró tratamiento con prednisona y azatioprina orientando el episodio como complicación de su lupus eritematoso sistémico. Conclusiones La encefalopatía posterior reversible no es una condición excepcional en pacientes con lupus eritematoso sistémico. La clínica debe diferenciarse de un neurolupus y de posibles causas infecciosas en relación con la inmunosupresión. La evolución clínica y radiológica de este síndrome es generalmente rápidamente favorable (AU)
Background and objects: Posterior reversible encephalopathy syndrome (PRES) is aclinical-radiological entity characterized by headache, clouding of consciousness and cortical visual blindness associated to cerebral edema on the neuro image. Its classical causes are: eclampsia, hypertensive encephalopathy and immunosuppressant drugs. Method: A 33-year old woman suffering from systemic lupus (SLE) who was brought to the Emergency Department due to headache, agitation and blindness. Results: On her arrival, her blood pressure was 205/139 mmHg, with no meningeal ormotor signs. Cardiopulmonary and ECG examination normal. Blood tests were normal except for proteinuria. Brain MRI showed symmetric cortico-subcortical occipital lesions,T2 hyperintensity. These findings were suggestive of PRES. IV labetalol was administered for the hypertensive emergency with favorable course, achieving normal blood pressure levels in the following days with valsartan and lercanidipine. The patient remained asymptomatic at 24 h. The control MRI at 2 weeks was normal. Treatment was established with prednisone and azathioprine, considering the episode as a complication of the patients SLE. Conclusions: PRES is not a rare condition in patients with SLE. The symptoms should be differentiated from a neurolupus and possible infectious causes related to immunosupression. The clinical and radiological evolution of this syndrome is generally rapidly favorable (AU)