Humoral Response to SARS-COV-2 Vaccination in Patients with Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder: A Real-World Study.

INTRODUCTION: The risk of SARS-CoV-2 infection or severe coronavirus disease 2019 (COVID-19) has been shown to increase in patients with multiple sclerosis (MS). Vaccination is recommended in this patient population, and the effect of disease-modifying treatments (DMTs) on response to vaccination should be considered. METHODS: This prospective, observational, cross-sectional study investigated humoral response after COVID-19 vaccination as well as possible predictors for response in patients with MS and other neuroinflammatory diseases who received DMTs in routine clinical practice in Spain. Responses were compared versus those seen in healthy controls. RESULTS: After vaccination against COVID-19, most patients with MS developed an immune response comparable to that of healthy individuals. However, approximately half of patients receiving a sphingosine-1-phosphate modulator (SP1-M, fingolimod or siponimod) or a B-cell-depleting agent (aCD20, ocrelizumab or rituximab) did not develop protective antibodies, although patients receiving other DMTs had humoral immune responses comparable to healthy controls. Lymphocyte count was not associated with reduced humoral response in patients receiving an SP1-M or aCD20, whereas, in patients receiving an aCD20 or SP1-M, older age was associated with lower anti-SARS-CoV-2 spike protein immunoglobulin G antibody levels. CONCLUSIONS: Treatment with aCD20 or SP1-M therapies appears to be associated with a lower humoral response to vaccines against SARS-CoV-2. Vaccination prior to initiation of these DMTs should be recommended whenever possible.

Treatment with natalizumab during pregnancy in multiple sclerosis: The experience of implementing a clinical practice protocol (NAP-30).

BACKGROUND: Pregnancy planning in women with highly active multiple sclerosis (HAMS) who need a high-efficacy disease-modifying therapy (heDMT) currently requires a careful risk-benefit evaluation. This includes minimizing fetal drug toxicity and preventing MS reactivation. We describe our experience with natalizumab in women with HAMS and unplanned pregnancy by implementing a clinical practice protocol (NAP-30) designed to maintain the effectiveness of natalizumab during pregnancy, reduce fetal exposure and prevent complications. METHODS: This was an observational retrospective study including women with HAMS on active treatment with natalizumab who became unexpectedly pregnant in the period 2018-2021 and continued this treatment during pregnancy according to the NAP-30 protocol. MS clinical and radiological variables were analyzed before and during pregnancy and in the postpartum period, along with maternal and fetal toxicity during pregnancy and safety findings in newborns. We also describe the NAP-30 protocol, which includes the use of a bridging dose to adjust and maintain natalizumab infusions every 6 weeks during pregnancy up to week 30 and scheduled delivery at week 40. RESULTS: Six women (one in her first gestation) with a median age of 31.5 years at the onset of pregnancy (min-max: 24-37 years) were included. All were negative for anti-John Cunningham virus (JCV) antibodies and were on treatment with intravenous natalizumab 300 mg every 4 weeks. At the time of conception, three patients had received 12, 17 and 53 infusions of natalizumab, respectively, while for the remaining three patients natalizumab was their first DMT (two patients had received 6 infusions and one patient had received 3 infusions of natalizumab). All six patients received 6 doses of natalizumab during pregnancy according to the NAP-30 protocol. After delivery, all six patients restarted natalizumab every 4 weeks (median: 3 days; range: 2-4 days). No patients had relapses during pregnancy or at 6 months postpartum, nor did they develop any general health or laboratory abnormalities. The MRI scan performed at 4-6 months postpartum showed no new T2 lesions or gadolinium-enhancing lesions. No miscarriages or threatened miscarriages were reported. One of the patients underwent elective preterm delivery at week 35 after mild-to-moderate anemia was detected by fetal Doppler scan. The newborn had low birth weight (2080 g) and mild anemia, which resolved within two months with oral iron supplementation. The other infants were born with normal birth weight and showed no blood count abnormalities. After a median follow-up of 10 months, all six babies showed normal development with no complications detected. CONCLUSIONS: Based on our experience, the implementation of the NAP-30 protocol in women with HAMS and unplanned pregnancy undergoing treatment with natalizumab allows the continuation of natalizumab during pregnancy, with a very favorable clinical and radiological effectiveness and maternal-fetal safety profile during pregnancy and postpartum. Both in pregnancy with HAMS and in general, and particularly for successful implementation of the NAP-30 protocol, obstetric support and monitoring is essential for adequate pregnancy management.

Prevention of rebound effect after natalizumab withdrawal in multiple sclerosis. Study of two high-dose methylprednisolone schedules.

BACKGROUND: Natalizumab (NTZ) is a disease-modifying treatment (DMT) in multiple sclerosis (MS) whose discontinuation can produce a "rebound effect", consisting of severe clinical deterioration and/or evidence of disease reactivation on magnetic resonance imaging (MRI). OBJECTIVE: To analyze the efficacy of two treatment schedules with intravenous methylprednisolone (IVMP) administered during the washout period of natalizumab (i.e., before starting another DMT) in preventing the rebound phenomenon. METHODS: Five-year retrospective study of NTZ withdrawals after at least 24 uninterrupted doses. Two IVMP schedules were tested. In schedule 1 (3-month washout), 1, 2, and 3 g of IVMP were administered on the first, second, and third month respectively. In schedule 2 (2-month washout), 1 and 2 g of IVMP were administered on the first and second month respectively. A new DMT was started 10 days after the end of each schedule. Rebound was defined as at least one clinical relapse plus rebound activity on MRI (>5 gadolinium-enhanced lesions and a number of new/T2-enhanced and/or gadolinium-enhanced lesions greater than before initiation of NTZ) during washout or at 6 months after new DMT initiation (6M-DMT). Clinical and MRI evaluations were performed at 3, 6, 12, and 24 months after initiation of the new DMT. RESULTS: Fifty patients (68% women) were included, with a mean (SD) age of 37.76 (10.88) years and pre-NTZ annualized relapse rate (ARR) of 1.78 (1.04). During NTZ therapy, mean Expanded Disability Status Scale (EDSS) score was 3.7 (1.73) and ARR was 0.23 (0.39). The ARR (mean of both schedules) was 0.1 (0.71) during washout and 0.32 (0.84) at 6M-DMT. Rebound was observed in 10% of cases (n = 5), with no significant clinical or radiological differences (p>0.05) between the two IVMP schedules. Rebound was observed in younger patients and was associated with new MRI lesions and higher ARR at 3M-DMT and 6M-DMT respectively, with no difference in EDSS after 2 years of follow-up. Neither the ARR before NTZ initiation nor the choice of new DMT after NTZ discontinuation was associated with development of rebound effect. CONCLUSIONS: Both IVMP schedules were well tolerated during NTZ washout and rebound was observed in only 10% of cases. In our experience, administration of IVMP during NTZ washout could reduce the possibility of a rebound effect.

Timectomía en miastenia grave timomatosa y no timomatosa: análisis de una cohorte de 46 pacientes / Thymectomy in thymomatous and non-thymomatous myasthenia gravis: analysis of a cohort of 46 patients

INTRODUCCIÓN: En la actualidad, los factores predictores de remisión de la enfermedad en la miastenia grave tras una timectomía no están claramente establecidos. OBJETIVO: Analizar la evolución clínica de los pacientes tras esta intervención y abordar los posibles determinantes pronósticos. PACIENTES Y MÉTODOS: Se analizaron retrospectivamente los registros de pacientes con miastenia grave timectomizados en nuestro centro entre 2006 y 2016. Se utilizó la escala Miasthenya Gravis Foundation of America-Post Intervention Status agrupando las categorías «remisión completa estable», «remisión farmacológica», «manifestaciones mínimas» y «mejoría» como «buen resultado clínico», y las categorías «sin cambios», «empeoramiento», «exacerbación» y «muerte», como «mal resultado clínico». RESULTADOS: Se analizaron 46 timectomías de pacientes con miastenia grave, un 71,7% mujeres. La mediana de edad era de 37 años y el 10,9% asociaba enfermedades autoinmunes. El timoma (23,9%) fue más frecuentes en los varones (54,5% frente a 18,8%) y a mayor edad (53 ± 20 frente a 33 ± 24 años). Un año después de la timectomía, el 28,2% se encontraba en el grupo de mal resultado clínico, y un 54,3%, en el de buen resultado clínico. En el análisis univariante, el timoma se asoció a peor resultado clínico al año de la intervención. Tras diez años de seguimiento, 32 pacientes (78%) alcanzaron un buen resultado clínico, un 9,8% en remisión completa estable, y el timoma no se correlacionó como factor de mal pronóstico. CONCLUSIÓN: La timectomía se considera un tratamiento efectivo, pero sin beneficio inmediato. La presencia de timoma podría determinar una respuesta clínica inicial peor tras la realización de una timectomía en pacientes con miastenia grave

INTRODUCTION: Factors predicting remission after thymectomy for myasthenia gravis are not well known. AIM: To analyze the clinical evolution of the patients after this intervention and discuss about predictors of response. PATIENTS AND METHODS: We retrospectively reviewed all clinical data of thymectomies in myasthenia gravis patients performed at our hospital between 2006 from 2016. Using the MGFA-PIS classification, «complete stable remission», «pharmacologic remission», «minimal manifestations» and «improved» were defined as «good clinical outcome», and «unchanged», «worse», «exacerbation» or «died», as «poor clinical outcome». RESULTS: In 46 consecutive thymectomies for myasthenia gravis, women comprised 71.7%. Median age was 37 years and 10.9% had concomitant autoimmune disorders associated. Thymoma (23.96%) was more frequent in older patients (53 ± 20 vs 33 ± 24 years) and men (54.5% vs 18.8%). A year after thymectomy, 28.2% of patients were in poor clinical outcome group and 54.3% had good clinical outcome. On univariate analysis, thymomatous myasthenia was associated with poor clinical outcome a year after surgical intervention. After ten years of follow-up, 9.8% reached complete stable remission, a total of 32 patients (78%) had a favourable outcome and thymoma was not correlated. CONCLUSION. Thymectomy is considered an effective treatment for myasthenia gravis but the benefit is not immediate. The presence of thymoma may determine a worse initial clinical response following thymectomy in patients with myasthenia gravis

[Identification of the factors conditioning times and indicators of quality in the intrahospital care of acute stroke]. / Identificación de los factores condicionantes de tiempos e indicadores de calidad en la atención intrahospitalaria al ictus agudo.

INTRODUCTION: Stroke is a serious but potentially reversible entity. Reducing the time of care in the acute phase is essential to limit morbidity and mortality. The evaluation of the performances in stroke care is essential because it allows identify opportunities for improvement. AIM: To understand and analyze the determinants of the delay in the time of hospital care for the subsequent implementation of a cycle of improvement. PATIENTS AND METHODS: Retrospective study of patients with acute ischemic stroke treated with intravenous thrombolysis (IVT) and/or intra-arterial mechanical thrombectomy (IAMT) in a tertiary hospital between 2009-2014. In-hospital times, quality indicators and associated factors were analyzed. RESULTS: 337 patients with acute ischemic stroke were treated with IVT (66.2%) and/or IAMT (54.1%). In-hospital times (95% confidence interval): door-to-needle time, 75.88 min (71.67-80.16 min); door-to-imaging, 43.27 min (40.17-46.37 min), imaging-to-needle, 38.01 min (34.08-41.93 min); IVT-IAMT time, 127.44 min (108.7-146.18 min); door-to-groin puncture, 155.22 min (140.03-170.40 min). 36.6% treated in less than 60 min, neuroimaging in less than 25 min in 19.9% and IVT-IAMT time in less than 90 minutes in 28.8%. Age, onset-to-door time, non-ambulance transport and the learning period were identified as determinants. CONCLUSIONS: Knowledge of the current situation of the times and quality indicators and their determinants are essential to provide the motivation to start an initiative to improve the quality of care in patients with acute stroke.

TITLE: Identificacion de los factores condicionantes de tiempos e indicadores de calidad en la atencion intrahospitalaria al ictus agudo.Introduccion. El ictus es una entidad grave, pero potencialmente reversible. La reduccion del tiempo de atencion en el momento agudo es fundamental para limitar la morbimortalidad. La evaluacion de las actuaciones en la atencion al ictus es esencial, porque permite identificar oportunidades de mejora. Objetivo. Conocer y analizar los factores condicionantes de la demora en los tiempos de atencion intrahospitalaria para la posterior implementacion de un ciclo de mejora. Pacientes y metodos. Estudio retrospectivo de pacientes con ictus isquemico agudo tratados con trombolisis intravenosa (TLIV) y/o trombectomia intraarterial mecanica (TIAM) en un hospital terciario entre 2009-2014. Se analizaron los tiempos intrahospitalarios, los indicadores de calidad y sus factores condicionantes. Resultados. Un total de 337 pacientes fueron tratados con TLIV (66,2%) y/o TIAM (54,1%). Tiempos medios de actuacion (intervalo de confianza al 95%): puerta-TLIV, 75,88 min (71,67-80,16 min); puerta-TC, 43,27 min (40,17-46,37 min); TC-TLIV, 38,01 min (34,08-41,93 min); TLIV-TIAM, 127,44 min (108,7-146,18 min); puerta-TIAM, 155,22 min (140,03-170,4 min). El 36,6% fue tratado en menos de 60 min, la neuroimagen se realizo en menos de 25 min en un 19,9% y el tiempo TLIV-TIAM fue menor de 90 min en un 28,8%. La edad, el tiempo inicio-puerta, la procedencia de otro hospital y el periodo de aprendizaje se identificaron como factores condicionantes. Conclusiones. El conocimiento de la situacion actual de los tiempos e indicadores intrahospitalarios y sus factores condicionantes son el punto de partida y proporcionan la motivacion necesaria para impulsar una iniciativa para la mejora de la calidad asistencial en el paciente con ictus agudo.

Identificación de los factores condicionantes de tiempos e indicadores de calidad en la atención intrahospitalaria al ictus agudo / Identification of the factors conditioning times and indicators of quality in the intrahospital care of acute stroke

Introducción. El ictus es una entidad grave, pero potencialmente reversible. La reducción del tiempo de atención en el momento agudo es fundamental para limitar la morbimortalidad. La evaluación de las actuaciones en la atención al ictus es esencial, porque permite identificar oportunidades de mejora. Objetivo. Conocer y analizar los factores condicionantes de la demora en los tiempos de atención intrahospitalaria para la posterior implementación de un ciclo de mejora. Pacientes y métodos. Estudio retrospectivo de pacientes con ictus isquémico agudo tratados con trombólisis intravenosa (TLIV) y/o trombectomía intraarterial mecánica (TIAM) en un hospital terciario entre 2009-2014. Se analizaron los tiempos intrahospitalarios, los indicadores de calidad y sus factores condicionantes. Resultados. Un total de 337 pacientes fueron tratados con TLIV (66,2%) y/o TIAM (54,1%). Tiempos medios de actuación (intervalo de confianza al 95%): puerta-TLIV, 75,88 min (71,67-80,16 min); puerta-TC, 43,27 min (40,17-46,37 min); TC-TLIV, 38,01 min (34,08-41,93 min); TLIV-TIAM, 127,44 min (108,7-146,18 min); puerta-TIAM, 155,22 min (140,03-170,4 min). El 36,6% fue tratado en menos de 60 min, la neuroimagen se realizó en menos de 25 min en un 19,9% y el tiempo TLIVTIAM fue menor de 90 min en un 28,8%. La edad, el tiempo inicio-puerta, la procedencia de otro hospital y el período de aprendizaje se identificaron como factores condicionantes. Conclusiones. El conocimiento de la situación actual de los tiempos e indicadores intrahospitalarios y sus factores condicionantes son el punto de partida y proporcionan la motivación necesaria para impulsar una iniciativa para la mejora de la calidad asistencial en el paciente con ictus agudo (AU)

Introduction. Stroke is a serious but potentially reversible entity. Reducing the time of care in the acute phase is essential to limit morbidity and mortality. The evaluation of the performances in stroke care is essential because it allows identify opportunities for improvement. Aim. To understand and analyze the determinants of the delay in the time of hospital care for the subsequent implementation of a cycle of improvement. Patients and methods. Retrospective study of patients with acute ischemic stroke treated with intravenous thrombolysis (IVT) and/or intra-arterial mechanical thrombectomy (IAMT) in a tertiary hospital between 2009-2014. In-hospital times, quality indicators and associated factors were analyzed. Results. 337 patients with acute ischemic stroke were treated with IVT (66.2%) and/or IAMT (54.1%). In-hospital times (95% confidence interval): door-to-needle time, 75.88 min (71.67-80.16 min); door-to-imaging, 43.27 min (40.17-46.37 min), imaging-to-needle, 38.01 min (34.08-41.93 min); IVT-IAMT time, 127.44 min (108.7-146.18 min); door-to-groin puncture, 155.22 min (140.03-170.40 min). 36.6% treated in less than 60 min, neuroimaging in less than 25 min in a 19.9% and IVT-IAMT time in less than 90 minutes in 28.8%. Age, onset-to-door time, non-ambulance transport and the learning period were identified as determinants. Conclusions. Knowledge of the current situation of the times and quality indicators and their determinants are essential to provide the motivation to start an initiative to improve the quality of care in patients with acute stroke (AU)

[Opercular syndrome caused by infarct in a single brain operculum in a patient with a history of cerebral infarction]. / Sindrome opercular producido por infarto en un solo operculo cerebral en un paciente con antecedente de infarto cerebeloso.

TITLE: Sindrome opercular producido por infarto en un solo operculo cerebral en un paciente con antecedente de infarto cerebeloso.

Guía de práctica clínica sobre prevención primaria y secundaria del ictus / Primary and secondary prevention of stroke: A guideline

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Guía para la prevención secundaria del ictus : recomendaciones y actividades a realizar

Guía que contiene información sobre lo que tiene que hacerse en el seguimiento de un paciente con Ictus y sobre lo que debe hacerse para el control, de los principales factores de riesgo cardiovascular.