111 results on '"Meca Lallana, V."'
Search Results
2. Documento de consenso de la Sociedad Española de Neurología sobre el tratamiento de la esclerosis múltiple y manejo holístico del paciente 2023
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Meca-Lallana, J.E., Martínez Yélamos, S., Eichau, S., Llaneza, M.A., Martín Martínez, J., Peña Martínez, J., Meca Lallana, V., Alonso Torres, A.M., Moral Torres, E., Río, J., Calles, C., Ares Luque, A., Ramió-Torrentà, L., Marzo Sola, M.E., Prieto, J.M., Martínez Ginés, M.L., Arroyo, R., Otano Martínez, M.Á., Brieva Ruiz, L., Gómez Gutiérrez, M., Rodríguez-Antigüedad Zarranz, A., Sánchez-Seco, V.G., Costa-Frossard, L., Hernández Pérez, M.Á., Landete Pascual, L., González Platas, M., and Oreja-Guevara, C. more...
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- 2024
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Catalog
3. Cost-Analysis of Subcutaneous vs Intravenous Administration of Natalizumab Based on Patient Care Pathway in Multiple Sclerosis in Spain
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Alonso Torres, A. M., Arévalo Bernabé, A. G., Becerril Ríos, N., Hellín Gil, M. F., Martínez Sesmero, J. M., Meca Lallana, V., Ramió-Torrentà, Ll., Rodríguez-Antigüedad, A., Gómez Maldonado, L., Triana Junco, I., Gómez-Barrera, M., Espinoza Cámac, N., and Oyagüez, I. more...
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- 2023
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4. Real-life safety and effectiveness outcomes of teriflunomide in patients with relapsing–remitting multiple sclerosis: The TERICAM study
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Martínez-Ginés, M.L., García-Domínguez, J.M., Cuello, J.P., Meca-Lallana, V., Aguirre, C., Costa-Frossard, L., Monreal, E., Sainz de la Maza, S., Salgado-Cámara, P., Labiano-Fontcuberta, A., Fernández-Cabredo, L., Aladro-Benito, Y., Canelo, L.B., Valle, O.Sánchez-del, Blasco, M.R., Sabin-Muñoz, J., Caminero-Rodríguez, A.B., Gracia-Gil, J., Fernandez-Diaz, E., Mendoza-Rodríguez, A., Gómez-Moreno, M., Orviz-García, A., Moreno-Torres, I., Casanova-Peño, L.I., and Lozano-Ros, A. more...
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- 2023
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5. Experience with tocilizumab in patients with neuromyelitis optica spectrum disorders
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Carreón Guarnizo, E., Hernández Clares, R., Castillo Triviño, T., Meca Lallana, V., Arocas Casañ, V., Iniesta Martínez, F., Olascoaga Urtaza, J., and Meca Lallana, J.E.
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- 2022
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6. Experiencia con tocilizumab en pacientes con espectro de la neuromielitis óptica
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Carreón Guarnizo, E., Hernández Clares, R., Castillo Triviño, T., Meca Lallana, V., Arocas Casañ, V., Iniesta Martínez, F., Olascoaga Urtaza, J., and Meca Lallana, J.E.
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- 2022
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7. Information-Seeking Strategies of People with Multiple Sclerosis in Spain: The INFOSEEK-MS Study
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Higueras Y, Salas E, Meca-Lallana V, Carrascal Rueda P, Rodríguez De la Fuente O, Cabello-Moruno R, Maurino J, and Ruiz Díaz MÁ
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multiple sclerosis ,information sources ,internet ,quality of life ,healthcare professionals. ,Medicine (General) ,R5-920 - Abstract
Yolanda Higueras,1 Elisa Salas,2 Virginia Meca-Lallana,3 Pedro Carrascal Rueda,4 Ofir Rodríguez De la Fuente,5 Rosana Cabello-Moruno,2 Jorge Maurino,2 Miguel Ángel Ruiz Díaz6 1Department of Neurology, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; 2Medical Department, Roche Pharma, Madrid, Spain; 3Department of Neurology, Hospital Universitario La Princesa, Madrid, Spain; 4Esclerosis Múltiple España, Madrid, Spain; 5Department of Neurology, Hospital Universitario Puerta de Hierro, Madrid, Spain; 6Universidad Autónoma de Madrid, Madrid, SpainCorrespondence: Elisa SalasMedical Department, Roche Pharma, Calle Ribera del Loira, 50, Madrid, 28042, SpainTel +34 913248173Email elisa.salas@roche.comPurpose: Patients with multiple sclerosis (MS) are increasingly demanding access to reliable information regarding their disease. The objective of the INFOSEEK-MS study was to assess what are the strategies people with MS use when searching for information on their disease, including sources, frequency, reliability, and preferred content.Patients and Methods: A non-interventional, cross-sectional study was conducted. Patients with a diagnosis of MS according to the 2010 McDonald criteria were included. The InfoSeek questionnaire was used to assess patients’ strategies when seeking information about the disease. Clinical characteristics and other variables, including disability, quality of life, fatigue, cognition, anxiety and depression, were analysed using the Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale (MSIS-29), 5-item Modified Fatigue Scale (MFIS-5), Symbol Digit Modalities Test (SDMT), and Hospital Anxiety and Depression Scale (HADS), respectively.Results: Three hundred and two patients were studied (mean age: 42.3 ± 10 years, 64% female, mean disease duration: 9.6 ± 7.0 years, 90% with relapsing-remitting MS, and mean EDSS score: 2.6 ± 1.9). The internet (either via mobile or computer) is a frequently reported source of information. Lifestyle-related information (67.2%), research and emerging treatments (63.6%), symptom control (49.7%), sharing experiences with other patients (46.4%), and disease prognosis (46.4%) were the most searched topics. Neurologists and nurses were the most trusted source of information. Younger patients and higher SDMT scores were associated with all search resources (M = 37.7 and M = 49.97, respectively). The frequency of searches was related to the number of relapses (R2 = 0.07), EDSS (R2 = 0.14), MSIS-29 physical and psychological components (R2 = 0.132) and inversely with depression (R2 = 0.132).Conclusion: Although healthcare professionals are considered the most reliable source of information for people with MS, searching for information on the Internet is very frequent. An individualized information strategy considering the different factors involved is needed.Keywords: multiple sclerosis, information sources, internet, quality of life, healthcare professionals more...
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- 2022
8. Perception of Stigma in Patients with Neuromyelitis Optica Spectrum Disorder
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Meca-Lallana JE, Prefasi D, Pérez-Miralles F, Forero L, Sepúlveda M, Calles C, Martínez-Ginés ML, González-Suárez I, Boyero S, Romero-Pinel L, Sempere ÁP, Meca-Lallana V, Querol L, Costa-Frossard L, de Castro-Trapiello H, Canal N, and Maurino J more...
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neuromyelitis optica spectrum disorder ,stigma ,quality of life ,depression ,patient-reported outcomes ,Medicine (General) ,R5-920 - Abstract
Jose E Meca-Lallana,1 Daniel Prefasi,2 Francisco Pérez-Miralles,3 Lucía Forero,4 María Sepúlveda,5 Carmen Calles,6 María L Martínez-Ginés,7 Inés González-Suárez,8 Sabas Boyero,9 Lucía Romero-Pinel,10 Ángel P Sempere,11 Virginia Meca-Lallana,12 Luis Querol,13 Lucienne Costa-Frossard,14 Hugo de Castro-Trapiello,2 Neus Canal,15 Jorge Maurino2 1Clinical Neuroimmunology Unit and Multiple Sclerosis CSUR. Department of Neurology. Hospital Universitario “Virgen de la Arrixaca”, IMIB-Arrixaca, Murcia, Spain; 2Medical Department, Roche Farma, Madrid, Spain; 3Unit of Neuroimmunology, Department of Neurology, Hospital Universitari i Politècnic La Fe, Valencia, Spain; 4Department of Neurology, Hospital Universitario Puerta del Mar, Cádiz, Spain; 5Department of Neurology, Hospital Clínic i Provincial de Barcelona, Barcelona, Spain; 6Department of Neurology, Hospital Universitari Son Espases, Palma de Mallorca, Spain; 7Department of Neurology, Hospital Universitario Gregorio Marañón, Madrid, Spain; 8Department of Neurology, Hospital Universitario Álvaro Cunqueiro, Vigo, Spain; 9Department of Neurology, Hospital Universitario Cruces, Bilbao, Spain; 10Department of Neurology, Hospital Universitari de Bellvitge, Barcelona, Spain; 11Department of Neurology, Hospital General Universitario de Alicante, Alicante, Spain; 12Department of Neurology, Hospital Universitario La Princesa, Madrid, Spain; 13Department of Neurology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 14Department of Neurology, Hospital Universitario Ramón y Cajal, Madrid, Spain; 15Department of Statistics, IQVIA, Barcelona, SpainCorrespondence: Jorge MaurinoRoche Farma, Ribera Del Loira, 50, Madrid, 28042, SpainTel +34 913 24 81 00Email jorge.maurino@roche.comBackground: Perception of stigma was associated with low self-esteem, psychological problems, and decreased health-seeking behavior among patients with different neurological disorders. The purpose of this study was to assess stigmatization and its impact in patients with neuromyelitis optica spectrum disorder (NMOSD).Methods: A non-interventional study was conducted at thirteen neuroimmunology clinics in Spain. Patients with a diagnosis of NMOSD (2015 Wingerchuk criteria) were included. The 8-item Stigma Scale for Chronic Illness (SSCI-8), the Expanded Disability Status Scale (EDSS), the 29-item Multiple Sclerosis Impact Scale (MSIS-29), the Beck Depression Inventory-Fast Screen (BDI-FS), the MOS Pain Effects Scale (MOS-PES) and the Fatigue Impact Scale for Daily Use (D-FIS) were used to assess the perception of stigma, disability, quality of life, mood, pain, and fatigue, respectively. Associations between outcome measures were analyzed using Spearman’s rank correlation.Results: Seventy-one patients were studied (mean age: 47.4 years ± 14.9, 81.7% female, mean time since disease onset: 9.9 years ± 8.1). The median EDSS score was 3.0 (interquartile range 1.5, 4.5). Stigma prevalence was 61.4% (n=43). Thirty-one patients (43.6%) had depression. The SSCI-8 score showed a significant correlation with both physical (rho=0.576, p< 0.0001) and psychological (rho=0.608, p< 0.0001) MSIS-29 scales scores, EDSS score (rho=0.349, p=0.0033), BDI-FS score (rho= 0.613, p< 0.0001), MOS-PES score (rho= 0.457, p< 0.0001), and D-FIS score (rho=0.556, p< 0.0001).Conclusion: Stigma is a common phenomenon affecting over 6 out of 10 patients with NMOSD. Understanding stigma may be useful to develop educational strategies improving NMOSD knowledge.Keywords: neuromyelitis optica spectrum disorder, stigma, quality of life, depression, patient-reported outcomes more...
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- 2021
9. 20839. EVALUACIÓN A MEDIO PLAZO DE EVOLUCIÓN EN PACIENTES NEDA CON NEUROFILAMENTOS SÉRICOS COMO FACTOR PRONÓSTICO
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Meca Lallana, V., Domínguez Gallego, M., Aguirre, C., del Río Muñoz, B., and Villar, M.
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- 2024
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10. 20415. USO DE SIPONIMOD EN PACIENTES CON ESCLEROSIS MÚLTIPLE SECUNDARIA PROGRESIVA EN PRÁCTICA CLÍNICA. ESTUDIO RESYZE
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Díaz Sánchez, M., Gómez-Estévez, I., Aguado García, L., Martín Martínez, J., Gómez Gutiérrez, M., Gascón Giménez, F., Agüera Morales, E., Meca Lallana, V., Barrero Hernández, F., González Quintanilla, V., Romero Pinel, L., Delgado Gil, V., Durán Ferreras, E., Blasco Quílez, R., Meca Lallana, J., Landete Pascual, L., Aladro-Benito, Y., Boyero Durán, S., Gracia Gil, J., Caminero Rodríguez, A., Cano Orgaz, A., Eichau Madueno, S., Querol Pascual, M., Otano Martínez, M., Alonso Torres, A., Calles Hernández, C., López Real, A., Ares Luque, A., Lorenzo González, J., Gómez Vicente, L., and Oreja Guevara, C. more...
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- 2024
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11. 20634. CRIPTOCOCOSIS PULMONAR ASOCIADA AL TRATAMIENTO CON FINGOLIMOD EN UN PACIENTE CON EM: INFORME DE UN CASO CLÍNICO Y REVISIÓN DE LA LITERATURA
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Domínguez Gallego, M., Aguirre Hernández, C., Pérez, J., Sáez, C., and Meca Lallana, V.
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- 2024
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12. 20252. ESTUDIO MULTICÉNTRICO SOBRE LA INCIDENCIA, PRESENTACIÓN CLÍNICA Y FACTORES DE RIESGO DE LA NEUROTOXICIDAD ASOCIADA A LA TERAPIA CON CÉLULAS CART ANTI-CD19 EN ESPAÑA: WORK IN PROGRESS
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Cabrera Maqueda, J., Fonseca, E., Guerra, V., Alba-Isasi, T., Martínez-Cibrián, N., Ortiz-Maldonado, V., Serra Smith, C., Gómez Costas, D., García Domínguez, J., Fernández Bullido, Y., Gómez Llobell, M., Hernández Chamorro, F., Hernández Ramos, F., Palomino García, A., Alañá García, M., González García, A., López Corral, L., Velilla, G., Herrero San Martín, A., Pérez Rangel, D., García-Bellido Ruíz, S., Sánchez Pina, J., García Gil-Perotin, S., Cabello, J., Bataller Alberola, L., Sanz, J., Velasco, R., Castillo, T., Arruti, M., Zeberio, I., Mendibil, B., Chico García, J., Sainz de la Maza, S., Corral, Í., Chinea-Rodríguez, A., Cabezudo García, P., Serrano Castro, P., Díaz Aizpun, C., Isidro Muñoz, M., Massot Cladera, M., Barceló Artigues, M., Torres, G., Aguilar-Amat Prior, M., Gómez Prieto, P., de la Cruz-Benito, B., Cacabelos, P., Martínez Coego, C., Bao Pérez, L., González Suárez, I., Sequeiros, S., Vázquez Álvarez, J., García Molina, E., Hernández Clares, R., Español, I., Domínguez-Gallego, M., Aguirre Hernández, C., Meca Lallana, V., Alba Alcántara, L., Subín Muñoz, J., Esain, Í., Navarro Matilla, B., Martín-Aguilar, L., Querol, L., Carolina Caballero, A., Briones, J., Izquierdo, C., Torrent, A., Gállego, J., Delgado, J., Martínez-Hernández, E., and Blanco, Y. more...
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- 2024
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13. 20835. OZANIMOD EN PACIENTES NAÏVE CON ESCLEROSIS MÚLTIPLE REMITENTE RECURRENTE LEVE-MODERADA: CARACTERÍSTICAS DE LA ENFERMEDAD EN EL ESTUDIO APPREZIATE
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Costa-Frossard França, L., Brieva, L., Muñoz Fernández, C., Martín Martínez, J., Romero Villarrubia, A., Kuprinski, J., García Estévez, D., Prieto González, J., Carmona, O., Blasco Quílez, M., Garcés Redondo, M., Calles Hernández, M., Candeliere Merlicco, A., Eichau Madueño, S., Barbero, D., López Muñoz, P., Meca Lallana, V., Álvarez Bravo, G., Ramo Tello, C., Puertas, I., Pérez, X., Villanova Larena, D., and Villar Guimerans, L. more...
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- 2024
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14. 20841. IMPACTO DE UN PROGRAMA DE REHABILITACIÓN VIRTUAL EN LA SATISFACCIÓN DE PACIENTES CON ESCLEROSIS MÚLTIPLE (ESTUDIO REHABVR)
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Meca Lallana, V., Aguirre, C., del Río Muñoz, B., Spottorno, P., Medrano, N., Mauriño, J., García Delgado, L., and Vázquez Doce, A.
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- 2024
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15. 20403. NIVELES SÉRICOS DE NEUROFILAMENTOS DE CADENA LIGERA COMO FACTOR PREDICTOR DE RESPUESTA EN UNA COHORTE MULTICÉNTRICA DE PACIENTES CON ESCLEROSIS MÚLTIPLE TRATADOS CON OCRELIZUMAB
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Rodríguez Jorge, F., Fernández Velasco, J., Villarubia Migallón, N., Gracia Gil, J., Fernández Díaz, E., Bau Vila, L., Martínez Yélamos, S., Díaz Pérez, C., Meca Lallana, V., Sainz de la Maza Cantero, S., Pacheco Cortegana, E., Monreal Laguillo, E., Borrega, L., Chico García, J., López Real, A., Sainz Amo, R., Barrero, F., Martínez Ginés, M., de la Fuente, S., Moreno, I., Caminero, A., Castellanos, F., Ayuso, L., Abreu, R., Meca, J., Quiroga, A., Ramió, L., Masjuan, J., Costa-Frossard, L., and Villar Guimerans, L. more...
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- 2024
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16. 20914. NEUMONÍA ORGANIZADA SECUNDARIA A INFECCIÓN POR SARS-COV-2 EN PACIENTES CON ESCLEROSIS MÚLTIPLE TRATADOS CON OCRELIZUMAB: REPORTE DE UNA SERIE DE CASOS
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Somovilla García-Vaquero, A., Domínguez Gallego, M., Aguirre Hernández, C., Sanabria Gago, C., Sánchez-Rodríguez, C., del Río, B., Vivancos, J., and Meca-Lallana, V.
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- 2024
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17. Expert-Agreed Practical Recommendations on the Use of Cladribine
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Meca-Lallana V, García Domínguez JM, López Ruiz R, Martín-Martínez J, Arés Luque A, Hernández Pérez MA, Prieto González JM, Landete Pascual L, and Sastre-Garriga J
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Consensus ,Expert opinion ,Relapsing multiple sclerosis ,Cladribine ,Disease-modifying drugs ,Treatment response - Abstract
Cladribine is a disease-modifying selective immune reconstitution oral therapy for adult patients with highly active relapsing multiple sclerosis (RMS). It was approved in the USA in 2019 and in Europe in 2017, thus there are still gaps in existing guidelines for using cladribine tablets in clinical practice. Nine experts with extensive experience in managing patients with multiple sclerosis in Spain identified some of the unanswered questions related to the real-life use of cladribine tablets. They reviewed the available clinical trial data and real-world evidence, including their own experiences of using cladribine, over the course of three virtual meetings held between November 2020 and January 2021. This article gathers their practical recommendations to aid treatment decision-making and optimise the use of cladribine tablets in patients with RMS. The consensus recommendations cover the following areas: candidate patient profiles, switching strategies (to and from cladribine), managing response to cladribine and safety considerations. more...
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- 2022
18. Brain region volumes and their relationship with disability progression and cognitive function in primary progressive multiple sclerosis
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Perez-Miralles F, Prefasi D, Garcia-Merino A, Ara J, Izquierdo G, Meca-Lallana V, Gascon-Gimenez F, Martinez-Gines M, Ramio-Torrenta L, Costa-Frossard L, Fernandez O, Moreno-Garcia S, Maurino J, Carreres-Polo J, and Casanova B more...
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disability progression ,primary progressive multiple sclerosis ,magnetic resonance imaging ,brain volume ,cognitive function - Abstract
Background and purpose Evidence on regional changes resulting from neurodegenerative processes underlying primary progressive multiple sclerosis (PPMS) is still limited. We assessed brain region volumes and their relationship with disability progression and cognitive function in PPMS patients. Methods This was an MRI analysis of 43 patients from the prospective Understanding Primary Progressive Multiple Sclerosis (UPPMS) cohort study. MRI scans were performed within 3 months before enrollment and at month 12. Results Gray matter volume of declive and white matter volumes adjacent to left straight gyrus, right calcarine sulcus, and right inferior occipital gyrus significantly decreased from baseline to month 12. Baseline white matter volumes adjacent to right amygdala and left cuneus significantly differed between patients with and without disability progression, as well as baseline gray matter volumes of left cuneus, right parahippocampal gyrus, right insula, left superior frontal gyrus, declive, right inferior temporal gyrus, right superior temporal gyrus (pole), and right calcarine sulcus. Baseline gray matter volumes of right cuneus and right superior temporal gyrus positively correlated with 12-month Selective Reminding Test and Word List Generation performance, respectively. Gray matter changes in right superior semilunar lobe and white matter adjacent to left declive and right cerebellar tonsil also positively correlated with Word List Generation scores, while white matter change in left inferior semilunar lobe positively correlated with Symbol Digit Modalities Test performance after 12 months. Conclusions White and gray matter volumes of specific brain regions could predict disability progression and cognitive performance of PPMS patients after one year. more...
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- 2021
19. Deciphering Multiple Sclerosis Progression
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Meca-Lallana V, Berenguer-Ruiz L, Carreres-Polo J, Eichau-Madueno S, Ferrer-Lozano J, Forero L, Higueras Y, Lara N, Vidal-Jordana A, and Perez-Miralles F
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progressive multiple sclerosis ,neurodegeneration ,neurofilament ,multiple sclerosis ,MRI - Abstract
Multiple sclerosis (MS) is primarily an inflammatory and degenerative disease of the central nervous system, triggered by unknown environmental factors in patients with predisposing genetic risk profiles. The prevention of neurological disability is one of the essential goals to be achieved in a patient with MS. However, the pathogenic mechanisms driving the progressive phase of the disease remain unknown. It was described that the pathophysiological mechanisms associated with disease progression are present from disease onset. In daily practice, there is a lack of clinical, radiological, or biological markers that favor an early detection of the disease's progression. Different definitions of disability progression were used in clinical trials. According to the most descriptive, progression was defined as a minimum increase in the Expanded Disability Status Scale (EDSS) of 1.5, 1.0, or 0.5 from a baseline level of 0, 1.0-5.0, and 5.5, respectively. Nevertheless, the EDSS is not the most sensitive scale to assess progression, and there is no consensus regarding any specific diagnostic criteria for disability progression. This review document discusses the current pathophysiological concepts associated with MS progression, the different measurement strategies, the biomarkers associated with disability progression, and the available pharmacologic therapeutic approaches. more...
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- 2021
20. Short-term data on disease activity, cognition, mood, stigma and employment outcomes in a cohort of patients with primary progressive multiple sclerosis (UPPMS study)
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Perez-Miralles F, Prefasi D, Garcia-Merino A, Ara J, Izquierdo G, Meca-Lallana V, Gascon-Gimenez F, Martinez-Gines M, Ramio-Torrenta L, Costa-Frossard L, Fernandez O, Moreno-Garcia S, Medrano N, Maurino J, and Casanova B more...
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Disability progression, Disease activity, Primary progressive multiple sclerosis - Abstract
BACKGROUND: Primary progressive multiple sclerosis (PPMS) has long been defined by progressive disability accrual in the absence of initial relapses. However, its underlying neurodegenerative process seems to be accompanied by central nervous system inflammation. A new classification defined multiple sclerosis courses according to clinical/radiological activity and progression. We provide further insight into PPMS activity according to this classification and other daily living aspects. METHODS: This was a multicentre, prospective, cohort study including 55 adult patients with PPMS according to 2010 McDonald criteria, within ten years from neurologic symptom onset and not receiving disease-modifying therapies during the past six months, who were followed up for 12 months. The primary study endpoint was the percentage of patients with active disease based on clinical relapses and/or magnetic resonance activity. Disability progression, cognitive function, physical/psychological impact, depression symptoms, stigma and employment were secondary endpoints. RESULTS: Eleven (25.6%) patients exhibited multiple sclerosis activity throughout the 12-month study follow-up. Fourteen showed non-active multiple sclerosis without progression, 11 non-active multiple sclerosis with progression, 6 active multiple sclerosis without progression and 4 active multiple sclerosis with progression; one patient with disease activity was not assessable for progression. Cognitive function scores remained unchanged or increased, disease physical impact was maintained and disease psychological impact significantly decreased. The proportion of patients with depression symptoms or stigma remained without significant changes as well as employment outcomes. CONCLUSION: This study shows that one-fourth of PPMS patients may exhibit disease activity over one year, with disability progression in approximately one-third but without worsening of cognitive function, disease impact, depression, stigma or employment outcomes. more...
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- 2021
21. Four-year safety and effectiveness data from patients with multiple sclerosis treated with fingolimod: The Spanish GILENYA registry
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Meca-Lallana, J. E., Oreja-Guevara, C., Munoz, D., Olascoaga, J., Pato, A., Ramio-Torrenta, L., Meca-Lallana, V., Hernandez, M. A., Marzo, M. E., Alvarez- Cermeno, J. C., Rodriguez-Antigueedad, A., Montalban, X., Fernandez, O., Meca-Lallana, J. E., Oreja-Guevara, C., Munoz, D., Olascoaga, J., Pato, A., Ramio-Torrenta, L., Meca-Lallana, V., Hernandez, M. A., Marzo, M. E., Alvarez- Cermeno, J. C., Rodriguez-Antigueedad, A., Montalban, X., and Fernandez, O. more...
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- 2021
22. Spanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study
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Barrero F, Mallada-Frechin J, Martínez-Ginés ML, Marzo ME, Meca-Lallana V, Izquierdo G, Ara JR, Oreja-Guevara C, Meca-Lallana J, Forero L, Sánchez-Vera I, and Moreno MJ
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Purpose The objective of this study was to characterize the demographic and clinical profile of RRMS patients receiving fingolimod in Spain, and to evaluate drug effectiveness and safety in clinical practice. Methods This observational, retrospective, multicentre, nationwide study was performed at 56 Spanish hospitals and involved 804 RRMS patients who received oral fingolimod (0.5 mg) since November 2011, with a minimum follow-up of 12 months. Results The mean annualized relapse rate (ARR) in the year before fingolimod was 1.08 and the median EDSS was 3; patients were exposed to fingolimod for 2.2 years as average; regarding magnetic resonance imaging (MRI) activity, more than half of the patients had > 20 lesions at baseline. Patients were previously treated with first-line injectable DMTs (60.3%), or natalizumab (31.3%), and 8.3% were naive patients. Overall, the ARR significantly decreased to 0.28, 0.22 and 0.17 (74.1%, 79.7% and 83.5% of relative reduction, respectively) after 12, 24 and 36 months of treatment, P more...
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- 2020
23. Effectiveness of Fingolimod versus Natalizumab as Second-Line Therapy for Relapsing-Remitting Multiple Sclerosis in Spain: Second-Line GATE Study
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Meca-Lallana J, Ayuso T, Martinez-Yelamos S, Duran C, Martin Y, Navarro N, Sempere A, Alvarez-Cermeno J, Pascual J, Meca-Lallana V, Sevilla R, and Ricart J
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body regions ,Multiple sclerosis ,Natalizumab ,parasitic diseases ,Second-line treatment ,Effectiveness ,Fingolimod ,human activities - Abstract
Background: There is a lack of head-to-head studies comparing the efficacy of fingolimod (FIN) and natalizumab (NTZ) as second-line therapy for relapsing-remitting multiple sclerosis (RRMS). Methods: Multicenter, observational study, in which, information of 388 patients randomly selected and treated with FIN or NTZ in routine clinical practice was retrospectively collected with the main objective of comparing the annualized relapse rate (ARR) over the first year, after FIN or NTZ treatment initiation. Results: Mean ARR during the first year of treatment was 0.28 in FIN group and 0.12 in NTZ group (p = 0.0064); nevertheless, the difference between groups lost statistical significance when the propensity score analysis was performed. Time to disability -progression was similar in both treatment groups (12.3 +/- 6.7 months in FIN, and 12.8 +/- 0.1 months in NTZ; p = 0.4654). Treatment persistence after the first year of treatment was higher in patients treated with FIN (95%) than in those treated with NTZ (84%; p = 0.0014). Conclusions: After 12 months of treatment, both FIN and NTZ reduced the ARR, but ARR percent reduction was significantly higher with NTZ. Treatment persistence was higher in patients receiving FIN. more...
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- 2020
24. PND22 Discover Study, First Analysis Specific for Secondary Progressive Multiple Sclerosis Burden and Cost in Spain: Interim Analysis Results
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Oreja-Guevara, C., primary, Río Izquierdo, J., additional, Ara Callizo, J.R., additional, Hernández-Pérez, M.A., additional, Gracia Gil, J., additional, Pilo de la Fuente, B., additional, Ramió-Torrentà, L., additional, Alonso Torres, A.M., additional, Eichau, S., additional, Martínez Yélamos, S., additional, Casanova Estruch, B., additional, Gascón Giménez, F., additional, Aguado Valcárcel, M.L., additional, Martínez Ginés, M.L., additional, López de Silanes, C., additional, El Berdei Montero, Y., additional, López Real, A.M., additional, Martínez Rodríguez, J.E., additional, González Quintanilla, V., additional, Labiano Fontcuberta, A., additional, Costa-Frossard França, L., additional, Garcés Redondo, M., additional, García Merino, J.A., additional, Castellanos Pinedo, F., additional, Meca-Lallana, V., additional, Muñoz Fernández, C., additional, Castillo Triviño, T., additional, Rodríguez, A., additional, Peña Martínez, J., additional, Prieto González, J.M., additional, Solar Sánchez, D.M., additional, Agüera Morales, E., additional, Molina, M.I., additional, Herrera Varo, N., additional, Aguirre Vazquez, M., additional, and Meca-Lallana, J., additional more...
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- 2020
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25. Trial of fingolimod versus interferon beta-1a in pediatric multiple sclerosis
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Chitnis, T, Arnold, Dl, Banwell, B, Brück, W, Ghezzi, A, Giovannoni, G, Greenberg, B, Krupp, L, Rostásy, K, Tardieu, M, Waubant, E, Wolinsky, Js, Bar-Or, A, Stites, T, Chen, Y, Putzki, N, Merschhemke, M, Gärtner, Collaborators (85): Kornberg A, J, Bajer-Kornek, B, Likhachev, S, Pereira Gomes Neto, A, Diniz, D, Paz, J, Alvarenga, R, Bojinova-Tchamova, V, Mah, J, Venkateswaran, S, Hafner, K, Gross-Paju, K, Brochet, B, Cheuret, E, Rivier, F, Deiva, K, Milh, M, Blaschek, A, Trollmann, R, Korinthenberg, R, Luecke, T, Ziemssen, T, Pozzilli, C, Patti, F, Comi, G, Marfia, G, Grimaldi, L, Trojano, M, Zaffaroni, M, Capra, R, Brescia Morra, V, Rozentals, G, Laurynaitiene, J, Vaiciene-Magistris, N, Castro Farfan, F, Quinones, S, Steinborn, B, Ujma-Czapska, B, Stasiolek, M, Jasinski, M, Craiu, D, Boyko, A, Kairbekova, E, Khabirov, F, Kuzenkova, L, Malkova, N, Nikolic, D, Jancic, J, Gebauer-Bukurov, K, Payerova, J, Gascon Jiménez, F, Izquierdo Ayuso, G, Mendibe Bilbao, M, Hintzen, R, Fernandez Sanchez VE, Meca Lallana, V, Montalban Gairin, X, Nordborg, K, Anlar, B, Yalcinkaya, C, Gucuyener, K, Terzi, M, Ozakbas, S, Yilmaz, U, Makedonska, I, Prokopenko, K, Tantsura, L, Moskovko, S, Kobys, T, Muratova, T, Nehrych, T, Prykhodko, T, Hemingway, C, Wassmer, E, Shetty, J, Desai, J, Waldman, A, Chinea Martinez, A, Ness, J, Rammohan, K, Lloyd, M, Williams, M, Ayala, R, Davis, R, Bhise, V, Brigham & Women’s Hospital [Boston] (BWH), Harvard Medical School [Boston] (HMS), McConnell Brain Imaging Centre (MNI), Montreal Neurological Institute and Hospital, McGill University = Université McGill [Montréal, Canada]-McGill University = Université McGill [Montréal, Canada], University of Pennsylvania [Philadelphia], Immunologie antivirale systémique et cérébrale, Université Paris-Sud - Paris 11 (UP11)-IFR93-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier) more...
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0301 basic medicine ,[SDV]Life Sciences [q-bio] ,Administration, Oral ,administration ,oral ,adolescent ,brain ,child ,female ,fingolimod hydrochloride ,headache ,humans ,immunologic factors ,infection ,injections ,intramuscular ,interferon-beta ,leukopenia ,magnetic resonance imaging ,male ,multiple sclerosis ,relapsing-remitting ,secondary prevention ,medicine (all) ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,Interferon ,law ,Medicine ,Secondary prevention ,General Medicine ,Fingolimod ,3. Good health ,Settore MED/26 - Neurologia ,medicine.drug ,medicine.medical_specialty ,Infections ,Injections, Intramuscular ,Adolescent ,Brain ,Child ,Female ,Fingolimod Hydrochloride ,Headache ,Humans ,Immunologic Factors ,Infection ,Interferon-beta ,Leukopenia ,Magnetic Resonance Imaging ,Male ,Multiple Sclerosis, Relapsing-Remitting ,Secondary Prevention ,03 medical and health sciences ,Internal medicine ,business.industry ,Multiple sclerosis ,Interferon beta-1a ,medicine.disease ,Clinical trial ,030104 developmental biology ,Multicenter study ,business ,030217 neurology & neurosurgery - Abstract
International audience; BACKGROUND: Treatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared fingolimod with interferon beta-1a in this population. METHODS: In this phase 3 trial, we randomly assigned patients 10 to 17 years of age with relapsing multiple sclerosis in a 1:1 ratio to receive oral fingolimod at a dose of 0.5 mg per day (0.25 mg per day for patients with a body weight of more...
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- 2018
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26. PND135 - FATIGUE IN MULTIPLE SCLEROSIS: ASSESSING THE PSYCHOMETRIC PROPERTIES OF THE MFIS-5 QUESTIONNAIRE
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Ballesteros, J, primary, Meca-Lallana, V., additional, Brañas, M, additional, Higueras, Y, additional, Candeliere-Merlicco, A., additional, Carrascal, P, additional, Rodríguez-De la Fuente, O, additional, Salas, E, additional, Amoros, C, additional, and Maurino, J, additional more...
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- 2018
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27. Patients’ Information Sources and Needs in Multiple Sclerosis: the Infoseek-MS Questionnaire
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Meca-Lallana, V, primary, Branas, M, additional, Higueras, Y, additional, Carrascal, P, additional, Rodriguez, O, additional, Salas, E, additional, Amoros, C, additional, Maurino, J, additional, and Ruiz, MA, additional more...
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- 2017
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28. Effects of diazoxide in multiple sclerosis: A randomized, double-blind phase 2 clinical trial
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Villoslada P, Rovira A, Montalban X, Arroyo R, Paul F, Meca-Lallana V, Ramo C, Fernandez O, Saiz A, Garcia-Merino A, Ramió-Torrentà L, Casanova B, Oreja-Guevara C, Muñoz D, Martinez-Rodriguez JE, Lensch E, Prieto JM, Meuth SG, Nuñez X, Campás C, Pugliese M, and NeuroAdvan study more...
- Abstract
OBJECTIVE: The aim of this study was to test the safety of diazoxide and to search for signs of efficacy in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: In this multicenter, randomized, placebo-controlled, double-blind trial (treatment allocation was concealed), 102 patients with RRMS were randomized to receive a daily oral dose of diazoxide (0.3 and 4 mg/d) or placebo for 24 weeks (NCT01428726). The primary endpoint was the cumulative number of new T1 gadolinium-enhancing lesions per patient, recorded every 4 weeks from week 4 to week 24. Secondary endpoints included brain MRI variables such as the number of new/enlarging T2 lesions and the percentage brain volume change (PBVC); clinical variables such as the percentage of relapse-free patients, relapse rate, and change in the Expanded Disability Status Scale score; and safety and tolerability. RESULTS: Diazoxide was well-tolerated and it produced no serious adverse events other than 1 case of Hashimoto disease. At the 2 doses tested, diazoxide did not improve the primary endpoint or the MRI and clinical variables related to the presence of new lesions or relapses. Patients treated with diazoxide showed reduced PBVC compared with the placebo group, although such changes could be confounded by the higher disease activity of the treated group and the vascular effects of diazoxide. CONCLUSION: At the doses tested, oral diazoxide did not decrease the appearance of new lesions evident by MRI. The effects in slowing the progression of brain atrophy require further validation. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with RRMS, diazoxide (0.3 and 4 mg/d) does not significantly change the number of new MRI T1 gadolinium-enhancing lesions. more...
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- 2015
29. DI-049 Duration of natalizumab maintenance in patients with multiple sclerosis
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Lopez-Matencio, JM Serra, primary, Meca-Lallana, V, additional, Herraiz, E Ramirez, additional, Magaña, M Riesgo, additional, and Baladron, A Morell, additional
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- 2016
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30. PND138 - INFORMATION SEARCHING PREFERENCES IN PEOPLE WITH MULTIPLE SCLEROSIS: THE INFOSEEK STUDY
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Higueras, Y, Meca-Lallana, V., Brañas, M, Carrascal, P, Rodríguez-De la Fuente, O, Salas, E, Maurino, J, and Ruiz, M.A.
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- 2018
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31. PND50 - Patients’ Information Sources and Needs in Multiple Sclerosis: the Infoseek-MS Questionnaire
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Meca-Lallana, V, Branas, M, Higueras, Y, Carrascal, P, Rodriguez, O, Salas, E, Amoros, C, Maurino, J, and Ruiz, MA
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- 2017
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32. Cost-Analysis of Subcutaneous vs Intravenous Administration of Natalizumab Based on Patient Care Pathway in Multiple Sclerosis in Spain
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A. M. Alonso Torres, A. G. Arévalo Bernabé, N. Becerril Ríos, M. F. Hellín Gil, J. M. Martínez Sesmero, V. Meca Lallana, Ll. Ramió-Torrentà, A. Rodríguez-Antigüedad, L. Gómez Maldonado, I. Triana Junco, M. Gómez-Barrera, N. Espinoza Cámac, I. Oyagüez, Institut Català de la Salut, [Alonso Torres AM] Neurology Department, Hospital Universitario de Málaga, Málaga, Spain. [Arévalo Bernabé AG] Servei de Farmàcia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Becerril Ríos N] Specialised Nurse, Hospital Virgen Macarena, Sevilla, Spain. [Hellín Gil MF] Specialised Nurse, Hospital Virgen Arrixaca, Murcia, Spain. [Martínez Sesmero JM] Pharmacy Department, Hospital Clínico San Carlos, Madrid, Spain. [Meca Lallana V] Neurology Department, Hospital Universitario La Princesa, Madrid, Spain, and Vall d'Hebron Barcelona Hospital Campus more...
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Pharmacology ,Assistència sanitària - Cost ,Anticossos monoclonals - Ús terapèutic ,Health Care Economics and Organizations::Economics::Costs and Cost Analysis [HEALTH CARE] ,Health Policy ,Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES] ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Injeccions hipodèrmiques ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized [CHEMICALS AND DRUGS] ,terapéutica::farmacoterapia::vías de administración de medicamentos::inyecciones::inyecciones subcutáneas [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,economía y organizaciones para la atención de la salud::economía::costes y análisis de costes [ATENCIÓN DE SALUD] ,enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES] ,Pharmacology (medical) ,Therapeutics::Drug Therapy::Drug Administration Routes::Injections::Injections, Subcutaneous [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados [COMPUESTOS QUÍMICOS Y DROGAS] ,Esclerosi múltiple - Tractament - Abstract
Análisis de costes; Administración subcutánea; Esclerosis múltiple Anàlisi de costos; Administració subcutània; Esclerosi múltiple Cost-analysis; Subcutaneous administration; Multiple sclerosis Introduction A subcutaneous (SC) formulation of natalizumab has been recently authorised for multiple sclerosis patients. This study aimed to assess the implications of the new SC formulation, and to compare the annual treatment costs of SC versus intravenous (IV) natalizumab therapy from both the Spanish healthcare system (direct health cost) and the patient (indirect cost) perspectives. Methods A patient care pathway map and a cost-minimisation analysis were developed to estimate SC and IV natalizumab annual costs over a 2-year time horizon. Considering the patient care pathway and according to natalizumab experience (IV) or estimation (SC), a national expert panel involving neurologists, pharmacists, and nurses provided information/data regarding resource consumption for drug and patient preparation, administration, and documentation. One hour of observation was applied to the first six (SC) or 12 (IV) doses, and 5 min for successive doses. The Day hospital (infusion suite) facilities at a reference hospital were considered for IV administrations and the first six SC injections. For successive SC injections, either a reference hospital or regional hospital in a consulting room was considered. Productivity time associated with travel (56 min to reference hospital, 24 min to regional hospital) and waiting time pre- and post-treatment (SC 15 min, IV 25 min) were assessed for patients and caregivers (accompanying 20% of SC and 35% of IV administrations). National salaries for healthcare professionals were used for cost estimation (€, year 2021). Results At years 1 and 2, total time and cost savings (excluding drug acquisition cost) per patient, driven by saving on administration and patient and caregiver productivity for SC at a reference hospital versus IV at a reference hospital, were 116 h (a reduction of 54.6%) and €3682.82 (a reduction of 66.2%). In the case of natalizumab SC at a regional hospital, the total time and cost saving were 129 h (a reduction of 60.6%) and €3883.47 (a reduction of 69.8%). Conclusions Besides the potential benefits of convenient administration and improving work–life balance, as suggested by the expert panel, natalizumab SC was associated with cost savings for the healthcare system by avoiding drug preparation, reducing administration time, and freeing up infusion suite capacity. Additional cost savings could be derived with regional hospital administration of natalizumab SC by reducing productivity loss. more...
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- 2023
33. Expert-Agreed Practical Recommendations on the Use of Cladribine
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Virginia Meca-Lallana, José M. García Domínguez, Rocío López Ruiz, Jesús Martín-Martínez, Adrián Arés Luque, Miguel A. Hernández Pérez, José M. Prieto González, Lamberto Landete Pascual, Jaume Sastre-Garriga, Institut Català de la Salut, [Meca-Lallana V] Multiple Sclerosis Unit, Department of Neurology, Hospital Universitario 'La Princesa', Madrid, Spain. [García Domínguez JM] Demyelinating Diseases Unit, Hospital Gregorio Marañón, Madrid, Spain. [López Ruiz R] Multiple Sclerosis Unit, Hospital Universitario Virgen Macarena, Seville, Spain. [Martín-Martínez J] Department of Neurology, Hospital Universitario Miguel Servet, Saragossa, Spain. [Arés Luque A] Neurology Department, Complejo Asistencial Universitario de León, León, Spain. [Hernández Pérez MA] Hospital Universitario Ntra. Sra de Candelaria, Santa Cruz de Tenerife, Spain. [Sastre-Garriga J] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus more...
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Consensus ,Presa de decisions ,Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES] ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,conducta y mecanismos de la conducta::psicología social::procesos de grupo::consenso [PSIQUIATRÍA Y PSICOLOGÍA] ,Treatment response ,Neurology ,Expert opinion ,enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES] ,Relapsing multiple sclerosis ,Avaluació de resultats (Assistència sanitària) ,Cladribine ,Disease-modifying drugs ,Neurology (clinical) ,Esclerosi múltiple - Tractament - Abstract
Cladribine; Disease-modifying drugs; Relapsing multiple sclerosis Cladribina; Medicaments modificadors de malalties; Esclerosi múltiple recurrent Cladribina; Medicamentos modificadores de enfermedades; Esclerosis múltiple recurrente Cladribine is a disease-modifying selective immune reconstitution oral therapy for adult patients with highly active relapsing multiple sclerosis (RMS). It was approved in the USA in 2019 and in Europe in 2017, thus there are still gaps in existing guidelines for using cladribine tablets in clinical practice. Nine experts with extensive experience in managing patients with multiple sclerosis in Spain identified some of the unanswered questions related to the real-life use of cladribine tablets. They reviewed the available clinical trial data and real-world evidence, including their own experiences of using cladribine, over the course of three virtual meetings held between November 2020 and January 2021. This article gathers their practical recommendations to aid treatment decision-making and optimise the use of cladribine tablets in patients with RMS. The consensus recommendations cover the following areas: candidate patient profiles, switching strategies (to and from cladribine), managing response to cladribine and safety considerations. The publication of this article, as well as journal’s Rapid Service Fee, was funded by Merck, S.L.U., Mollet del Valles, Spain, an affiliate of Merck KGaA. more...
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- 2022
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34. Cognitive impairment in multiple sclerosis: diagnosis and monitoring
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Angela Vidal-Jordana, Ricardo C Ginestal-López, Virginia Meca-Lallana, Francisco Pérez-Miralles, Joan Carreres-Polo, Francisco Gascón-Giménez, Nieves Téllez-Lara, Yolanda Higueras, Jesús Romero-Imbroda, Sara Eichau-Madueño, Institut Català de la Salut, [Meca-Lallana V] Unidad de Enfermedades Desmielinizantes, Servicio de Neurología, Hospital Universitario de La Princesa, Madrid, Spain. [Gascón-Giménez F] Unidad de Esclerosis Múltiple, Servicio de Neurología, Hospital Clínico Universitario, Valencia, Spain. [Ginestal-López RC] Servicio de Neurología, Hospital Clínico San Carlos, Madrid, Spain. [Higueras Y] Instituto de Investigación Sanitaria del Gregorio Marañón, Hospital Gregorio Marañón, Madrid, Spain. [Téllez-Lara N] Servicio de Neurología, Hospital Clínico Universitario, Valladolid, Spain. [Carreres-Polo J] Servicio de Radiología, Hospital Universitari i Politècnic La Fe de Valencia, Valencia, Spain. [Vidal-Jordana Á] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus more...
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Esclerosi múltiple - Complicacions ,medicine.medical_specialty ,Neurology ,Otros calificadores::/diagnóstico [Otros calificadores] ,Dermatology ,Cognitive dysfunction, Multiple sclerosis, Neurophysiological monitoring, Neuropsychological tests ,Multiple sclerosis ,Otros calificadores::Otros calificadores::/complicaciones [Otros calificadores] ,Physical medicine and rehabilitation ,Quality of life (healthcare) ,Cognitive dysfunction ,Multidisciplinary approach ,Neuropsychology ,Other subheadings::/diagnosis [Other subheadings] ,Medicine ,Humans ,Neuropsychological assessment ,Cognitive rehabilitation therapy ,Tests neuropsicològics ,Cognitive evaluation theory ,medicine.diagnostic_test ,business.industry ,Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES] ,Cognition ,General Medicine ,Psychiatry and Mental health ,Neuropsychological tests ,Mental Disorders::Neurocognitive Disorders::Cognition Disorders::Cognitive Dysfunction [PSYCHIATRY AND PSYCHOLOGY] ,enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES] ,Quality of Life ,Original Article ,Neurology (clinical) ,Neurophysiological monitoring ,business ,Trastorns de la cognició - Diagnòstic ,trastornos mentales::trastornos neurocognitivos::trastornos cognitivos::disfunción cognitiva [PSIQUIATRÍA Y PSICOLOGÍA] ,Other subheadings::Other subheadings::/complications [Other subheadings] - Abstract
Introduction Cognitive impairment (CI) has a prevalence of 45–70% in people with multiple sclerosis (MS), producing a negative impact on their quality of life, personal life, and work. Early detection of CI has become an important aspect to be considered for an adequate follow-up, to optimize social adaptation and to implement specific cognitive rehabilitation strategies. The aim of this work is to propose a suitable cognitive evaluation of patients with MS based on available and efficient tools for diagnosis and monitoring purposes well supported by literature review and clinical experience. Methods A multidisciplinary panel of professionals from the field of neurology, neuropsychology, and neuroimaging performed a literature review of the topic of cognitive impairment assessment. This was combined and completed with their clinical experience to produce a set of recommendations. Results Some limitations to cognitive evaluation are described: shortage of time and resources during the neurology consultation, scarceness or absence of specialized professionals’ availability, importance of tests adaptation, and doubts about its use to define therapeutic efficiency. We recommend a baseline and annual screening evaluation, and we suggest a baseline and periodic neuropsychological assessment. The latter ought to change to a recommendation with the presence of either positive screening test, or subjective to cognitive complaints, screening-test results and patient or family report mismatch, or in specific social/work situations. Conclusions Cognitive evaluation should be performed on all patients diagnosed with MS and throughout follow-up. It is necessary to support the creation of multidisciplinary MS teams to optimize the evaluation and follow-up of MS patients. more...
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- 2021
35. Brain region volumes and their relationship with disability progression and cognitive function in primary progressive multiple sclerosis
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Guillermo Izquierdo, Jorge Maurino, Lluís Ramió-Torrentà, Bonaventura Casanova, Daniel Prefasi, Jose R. Ara, Francisco Pérez-Miralles, Lucienne Costa-Frossard, Oscar Fernandez, Virginia Meca-Lallana, Antonio García-Merino, María L Martínez-Ginés, Sara Moreno-García, Francisco Gascón-Giménez, Joan Carreres-Polo, Institut Català de la Salut, [Pérez-Miralles FC] Neuroimmunology Unit, Department of Neurology, Hospital Universitari i Politècnic La Fe, Valencia, Spain. [Prefasi D] Department of Medical, Roche Farma S.A, Madrid, Spain. [García-Merino A] Department of Neurology, Hospital Universitario Puerta de Hierro, Majadahonda, Spain. [Ara JR] Department of Neurology, Hospital Universitario Miguel Servet, Zaragoza, Spain.[Izquierdo G] Department of Neurology, Hospital Universitario Virgen Macarena, Seville, Spain. [Meca-Lallana V] Department of Neurology, Hospital Universitario La Princesa, Madrid, Spain. [Ramió-Torrentà L] Unitat de Neuroimmunologia i Esclerosi Múltiple, Departament de Neurologia, Hospital Universitari de Girona Dr. Josep Trueta, Institut Català de la Salut (ICS), Girona, Spain. Institut d’Assistència Sanitària, Salt, Spain. Institut d’Investigació Biomèdica de Girona (IDIBGI), Salt, Spain. Departament de Ciències Mèdiques, Facultat de Medicina, Universitat de Girona, Girona, Spain, and Hospital Universitari de Girona Dr Josep Trueta more...
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primary progressive multiple sclerosis ,Esclerosi múltiple ,enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple crónica progresiva [ENFERMEDADES] ,brain volume ,Audiology ,Esclerosi múltiple -- Tractament ,Cohort Studies ,Behavioral Neuroscience ,0302 clinical medicine ,Cognition ,fenómenos psicológicos::procesos mentales::cognición [PSIQUIATRÍA Y PSICOLOGÍA] ,magnetic resonance imaging ,Prospective Studies ,Gray Matter ,Cervell ,Original Research ,medicine.diagnostic_test ,05 social sciences ,Psychological Phenomena::Mental Processes::Cognition [PSYCHIATRY AND PSYCHOLOGY] ,Brain ,brain volume, cognitive function, disability progression, magnetic resonance imaging, primary progressive multiple sclerosis ,Multiple Sclerosis, Chronic Progressive ,Magnetic Resonance Imaging ,Straight gyrus ,medicine.anatomical_structure ,disability progression ,Brain size ,medicine.medical_specialty ,Multiple Sclerosis ,050105 experimental psychology ,lcsh:RC321-571 ,White matter ,03 medical and health sciences ,Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Tomography::Magnetic Resonance Imaging [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Chronic Progressive [DISEASES] ,medicine ,Humans ,0501 psychology and cognitive sciences ,diagnóstico::técnicas y procedimientos diagnósticos::diagnóstico por imagen::tomografía::imagen por resonancia magnética [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Effects of sleep deprivation on cognitive performance ,lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry ,cognitive function ,business.industry ,Magnetic resonance imaging ,Lobe ,Cerebellar tonsil ,Imatgeria per ressonància magnètica ,business ,030217 neurology & neurosurgery ,Multiple sclerosis -- Treatment - Abstract
Background and purpose Evidence on regional changes resulting from neurodegenerative processes underlying primary progressive multiple sclerosis (PPMS) is still limited. We assessed brain region volumes and their relationship with disability progression and cognitive function in PPMS patients. Methods This was an MRI analysis of 43 patients from the prospective Understanding Primary Progressive Multiple Sclerosis (UPPMS) cohort study. MRI scans were performed within 3 months before enrollment and at month 12. Results Gray matter volume of declive and white matter volumes adjacent to left straight gyrus, right calcarine sulcus, and right inferior occipital gyrus significantly decreased from baseline to month 12. Baseline white matter volumes adjacent to right amygdala and left cuneus significantly differed between patients with and without disability progression, as well as baseline gray matter volumes of left cuneus, right parahippocampal gyrus, right insula, left superior frontal gyrus, declive, right inferior temporal gyrus, right superior temporal gyrus (pole), and right calcarine sulcus. Baseline gray matter volumes of right cuneus and right superior temporal gyrus positively correlated with 12‐month Selective Reminding Test and Word List Generation performance, respectively. Gray matter changes in right superior semilunar lobe and white matter adjacent to left declive and right cerebellar tonsil also positively correlated with Word List Generation scores, while white matter change in left inferior semilunar lobe positively correlated with Symbol Digit Modalities Test performance after 12 months. Conclusions White and gray matter volumes of specific brain regions could predict disability progression and cognitive performance of PPMS patients after one year., The data described in the present manuscript provide a detailed description of region volume changes exhibited by primary progressive multiple sclerosis patients over one year, including decreases in gray matter declive and white matter adjacent to left straight gyrus, right calcarine sulcus, and right inferior occipital gyrus. In addition, baseline volumes of white matter adjacent to right amygdala and left cuneus could also predict 1‐year disability progression in patients with primary progressive multiple sclerosis, as well as baseline grey matter volumes of left cuneus, right parahippocampal gyrus, right insula, left superior frontal gyrus, declive, right inferior temporal gyrus, right superior temporal gyrus (pole), and right calcarine sulcus. Furthermore, baseline volumes of certain regions such as grey matter of right cuneus and right superior temporal gyrus could also predict cognitive performance after one year, as well as volume changes in grey matter of right superior semilunar lobe and white matter of left inferior semilunar lobe and adjacent to left declive and right cerebellar tonsil were correlates of cognitive performance. more...
- Published
- 2021
36. Deciphering Multiple Sclerosis Progression
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Virginia Meca-Lallana, Leticia Berenguer-Ruiz, Joan Carreres-Polo, Sara Eichau-Madueño, Jaime Ferrer-Lozano, Lucía Forero, Yolanda Higueras, Nieves Téllez Lara, Angela Vidal-Jordana, Francisco Carlos Pérez-Miralles, Institut Català de la Salut, [Meca-Lallana V] Multiple Sclerosis Unit, Neurology Department, Fundación de Investigación Biomédica, Hospital Universitario de la Princesa, Madrid, Spain. [Berenguer-Ruiz L] Neurology Department, Hospital Marina Baixa, Alicante, Spain. [Carreres-Polo J] Neuroradiology Section, Radiology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain. [Eichau-Madueño S] Multiple Sclerosis CSUR Unit, Neurology Department, Hospital Universitario Virgen Macarena, Seville, Spain. [Ferrer-Lozano J] Department of Pathology, Hospital Universitari i Politècnic La Fe, Valencia, Spain. [Forero L] Neurology Department, Hospital Puerta del Mar, Cádiz, Spain. [Vidal-Jordana A] Servei de Neurologia/Neuroimmunologia, Centre d'Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus more...
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Oncology ,medicine.medical_specialty ,Other subheadings::Other subheadings::/physiopathology [Other subheadings] ,Otros calificadores::Otros calificadores::/fisiopatología [Otros calificadores] ,Esclerosi múltiple - Propensió ,Genetic Phenomena::Genotype::Genetic Predisposition to Disease [PHENOMENA AND PROCESSES] ,Review ,Disease ,neurofilament ,Esclerosi múltiple - Fisiologia patològica ,multiple sclerosis ,lcsh:RC346-429 ,Sistema nerviós - Degeneració ,03 medical and health sciences ,0302 clinical medicine ,Degenerative disease ,Internal medicine ,medicine ,In patient ,030212 general & internal medicine ,enfermedades del sistema nervioso::enfermedades neurodegenerativas [ENFERMEDADES] ,lcsh:Neurology. Diseases of the nervous system ,fenómenos genéticos::genotipo::predisposición genética a la enfermedad [FENÓMENOS Y PROCESOS] ,Expanded Disability Status Scale ,business.industry ,Multiple sclerosis ,Neurodegeneration ,Disease progression ,neurodegeneration ,Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES] ,medicine.disease ,Clinical trial ,progressive multiple sclerosis ,Neurology ,Nervous System Diseases::Neurodegenerative Diseases [DISEASES] ,enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES] ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,MRI - Abstract
Esclerosi múltiple; Neurodegeneració Esclerosis múltiple; Neurodegeneración Multiple sclerosis; Nneurodegeneration Multiple sclerosis (MS) is primarily an inflammatory and degenerative disease of the central nervous system, triggered by unknown environmental factors in patients with predisposing genetic risk profiles. The prevention of neurological disability is one of the essential goals to be achieved in a patient with MS. However, the pathogenic mechanisms driving the progressive phase of the disease remain unknown. It was described that the pathophysiological mechanisms associated with disease progression are present from disease onset. In daily practice, there is a lack of clinical, radiological, or biological markers that favor an early detection of the disease's progression. Different definitions of disability progression were used in clinical trials. According to the most descriptive, progression was defined as a minimum increase in the Expanded Disability Status Scale (EDSS) of 1.5, 1.0, or 0.5 from a baseline level of 0, 1.0–5.0, and 5.5, respectively. Nevertheless, the EDSS is not the most sensitive scale to assess progression, and there is no consensus regarding any specific diagnostic criteria for disability progression. This review document discusses the current pathophysiological concepts associated with MS progression, the different measurement strategies, the biomarkers associated with disability progression, and the available pharmacologic therapeutic approaches. more...
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- 2021
37. Observational study of gadolinium-enhancing lesions in MRI in patients with multiple sclerosis from the Spanish Mediterranean coast: Seasonal variability and relationship with climatic factors.
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Romero Del Rincón C, Claramonte-Clausell B, Aguirre C, Domiguez-Gallego M, Meca-Lallana V, and Belenguer Benavides A
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- Humans, Female, Male, Adult, Retrospective Studies, Spain epidemiology, Middle Aged, Climate, Brain diagnostic imaging, Brain pathology, Multiple Sclerosis diagnostic imaging, Multiple Sclerosis epidemiology, Multiple Sclerosis pathology, Contrast Media, Magnetic Resonance Imaging, Seasons, Gadolinium, Multiple Sclerosis, Relapsing-Remitting diagnostic imaging, Multiple Sclerosis, Relapsing-Remitting epidemiology
- Abstract
Introduction: Environmental factors appear to play an important role in the development and course of Multiple Sclerosis (MS). Seasonal variability in disease activity has been described and it is postulated that it may vary according to geographical area. The aim of this study is to analyse the monthly distribution of activity observed on Magnetic Resonance Imaging (MRI) and to look for a possible relationship with climate in patients with relapsing remitting MS., Material and Methods: Retrospective observational study, carried out in the population of one hospital on the Spanish Mediterranean coast. A total of 238 MRI scans of 51 patients were evaluated. Climatological data were obtained from the Spanish State Meteorological Agency from 2012 to 2016. Activity was defined as contrast-enhancing lesions., Results: The distribution of gadolinium-enhancing lesions was found to be non-uniform across months (p = 0.008). Visual inspection suggests higher activity in July and August. Regarding weather, tropical nights (defined as days with a minimum temperature above 20 °C) were associated with increased risk of MRI activity (OR = 1.06, p = 0.001)., Conclusion: These findings suggest a non-uniform monthly distribution of gadolinium-enhancing lesions and an association between warmer nights and increased MRI activity, pointing to a potential impact of environmental factors on multiple sclerosis activity in neuroimaging., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.) more...
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- 2024
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38. Biomarkers of response to ocrelizumab in relapsing-remitting multiple sclerosis.
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Rodríguez-Jorge F, Fernández-Velasco JI, Villarrubia N, Gracia-Gil J, Fernández E, Meca-Lallana V, Díaz-Pérez C, Sainz de la Maza S, Pacheco EM, Quiroga A, Ramió-Torrentà L, Martínez-Yélamos S, Bau L, Monreal E, López-Real A, Rodero-Romero A, Borrega L, Díaz S, Eguía P, Espiño M, Chico-García JL, Barrero FJ, Martínez-Ginés ML, García-Domínguez JM, De la Fuente S, Moreno I, Sainz-Amo R, Mañé-Martínez MA, Caminero A, Castellanos F, Gómez López A, Labiano-Fontcuberta A, Ayuso L, Abreu R, Hernández MÁ, Meca-Lallana J, Martín-Aguilar L, Muriel García A, Masjuan J, Costa-Frossard L, and Villar LM more...
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- Humans, Female, Male, Adult, Prospective Studies, Glial Fibrillary Acidic Protein blood, Middle Aged, Immunologic Factors therapeutic use, Treatment Outcome, Disease Progression, Multiple Sclerosis, Relapsing-Remitting drug therapy, Multiple Sclerosis, Relapsing-Remitting blood, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Biomarkers blood, Neurofilament Proteins blood
- Abstract
Objective: To ascertain the changes of serum neurofilament light chain (sNfL) and glial fibrillary acidic protein (sGFAP) values in relapsing-remitting multiple sclerosis (RRMS) patients treated with ocrelizumab and their association with treatment response., Methods: Multicenter prospective study including 115 RRMS patients initiating ocrelizumab treatment between February 2020 and March 2022 followed during a year. Serum samples were collected at baseline and every 3 months to measure sNfL and sGFAP levels using single-molecule array (SIMOA) technology. Based on age and body mass index, sNfL values were standardized using z-score. NEDA (non-evidence of disease activity)-3 status was defined for patients free of disease activity after a year of follow-up. Inflammation (INFL) was considered when new relapses occurred during follow-up or new MRI lesions were found at 1-year exploration. PIRA (progression independent of relapse activity) was defined as disability progression occurring in the absence of relapses or new MRI activity., Results: After a year on ocrelizumab, 85 patients (73.9%) achieved NEDA-3. Thirty patients did not achieve NEDA: 20 (17.4%) because of INFL and 10 (8.7%) because of PIRA. Of INFL patients, 6 (30.0%) had relapses, and 17 (85.0%) had at least one new MRI lesion at the 12-month examination. At baseline, INFL patients had higher sNfL (p = 0.0003) and sGFAP (p = 0.03) than the NEDA-3 group. PIRA patients mostly exhibited low sNfL and heterogeneous sGFAP levels. After a year, NEDA-3 and INFL patients showed similar decreases in sNfL (p < 0.0001) and sGFAP (p < 0.0001 for NEDA-3 and p = 0.001 for INFL ones). However, the decrease occurred earlier in NEDA-3 patients. Accordingly, sNfL > 1.5 z-score 3 months after ocrelizumab initiation indicated a higher risk of inflammation (OR = 13.6; p < 0.0001). Decrease in sGFAP values occurred later in both groups, with significant reductions observed at 12 months for INFL and 6 and 12 months for NEDA-3. No significant changes in sNfL or sGFAP were observed in PIRA patients., Conclusion: Ocrelizumab induced normalization of sNfL and sGFAP in the majority of NEDA-3 and inflammatory patients but did not cause changes in the PIRA group. Our data suggest that normalization of sNfL and sGFAP is associated with the lack of inflammatory-associated disease progression but it may not affect non-inflammatory PIRA., Competing Interests: FR-J received research grants and travel support for speaking engagements from Janssen, Biogen, Novartis, Roche, Sanofi-Genzyme, Bristol-Myers-Squibb and Merck. JG-G received research support, compensation for participating on advisory boards, lecture fees, and/or travel support from Almirall, Bayer, Biogen, Genzyme‐Sanofi, Novartis, Roche, and Teva. EF received research support, compensation for participating on advisory boards, speaking fees, and/or funding for travel from Almirall, Bayer, Biogen, Genzyme‐Sanofi, Merck, Novartis, and Roche. VM-L received consulting and speaking fees from Almirall, Biogen, Genzyme, Janssen, Merck, Novartis, Roche, Terumo, Sanofi, Teva, and Bristol Myers Squibb. CD-P received funding for training and scientific meetings from Sanofi, Merck, Novartis and Roche. SS received research grants, travel support or honoraria for speaking engagements from Almirall, Biogen, Bristol Myers Squibb, Janssen, Merck, Novartis, Roche, Sanofi-Genzyme, and Teva. AQ is funded by a grant from the Fundación Francisco Soria y Melguizo and has received funding from Merck, Novartis, and Horizon Therapeutics to attend conferences. LR-T received compensation for consulting services and speaking fees from Biogen, Novartis, Bayer, Merck, Sanofi, Genzyme, Roche, Bristol-Myers-Squibb, TEVA, and Horizon. SM-Y received honoraria for participating on advisory boards and for collaborations as consultant and scientific communications and also received research support as well as funding for travel and congress expenses from Roche, Biogen Idec, Novartis, TEVA, Merck, Genzyme, Sanofi, Bayer, Almirall, and Bristol Myers Squibb. EM received research grants, travel support, or honoraria for speaking engagements from Almirall, Merck, Roche, Sanofi, Bristol Myers Squibbb, Biogen, Janssen, and Novartis. AL-R received speaker and consultation fees from Biogen, Janssen, Novartis, Roche and Sanofi, and congress travel support from Roche. LBo received research grants and travel support from Merck, Roche, Novartis, Sanofi, Horizon and Bristol Myer Squibb. JC-G received speaker fees, travel support, and/or served on advisory boards by Biogen, Sanofi, Bayer, Janssen, BMS, and Bial. FB received compensation for consulting services and speaking honoraria from Almirall, Biogen, Bristol Myer Squibb, Genzyme, Johnson & Johnson, Merck, Novartis, Roche, Sanofi, Teva. MM-G received compensation for consulting services and speaking fees from Merck, Biogen, Novartis, Sanofi-Genzyme, Almirall, BMS, Janssen, Roche, Horizon, and Viatris. JG-D received honoraria as speaker, advisor and researcher from Almirall, Bristol Myers Squibb, Biogen, Janssen, Merck, Novartis, Roche, Teva, and Sanofi. MM-M received research support, funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries Ltd., Sanofi-Aventis, Merck Serono, Novartis, Bayer Schering Pharma, Bristol Myers Squibb and Roche. JM-L received honoraria as a consultant, lecturer in meetings and has participated in clinical trials and other research projects promoted by Alexion, Almirall, Biogen, Bristol-Meyers-Squibb, Horizon, Johnson & Johnson, Merck, Neuraxpharm, Novartis, Roche, Sandoz, Sanofi and UCB. LC-F received speaker fees, travel support, and/or served on advisory boards by Biogen, Sanofi, Merck, Bayer, Novartis, Roche, Teva, Celgene, Ipsen, Biopas, Almirall. LV received research grants and personal fees from Merck, Roche, Sanofi, Bristol Myers Squibb, Biogen, and Novartis. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Rodríguez-Jorge, Fernández-Velasco, Villarrubia, Gracia-Gil, Fernández, Meca-Lallana, Díaz-Pérez, Sainz de la Maza, Pacheco, Quiroga, Ramió-Torrentà, Martínez-Yélamos, Bau, Monreal, López-Real, Rodero-Romero, Borrega, Díaz, Eguía, Espiño, Chico-García, Barrero, Martínez-Ginés, García-Domínguez, De la Fuente, Moreno, Sainz-Amo, Mañé-Martínez, Caminero, Castellanos, Gómez López, Labiano-Fontcuberta, Ayuso, Abreu, Hernández, Meca-Lallana, Martín-Aguilar, Muriel García, Masjuan, Costa-Frossard and Villar.) more...
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- 2024
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39. Real-World Experience with Diroximel Fumarate in Patients with Multiple Sclerosis: A Prospective Multicenter Study.
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Aguirre C, Alonso-Torres A, Agüera E, García-Domínguez JM, Montero-Escribano P, González-Quintanilla V, Costa-Frossard L, Oreja-Guevara C, Reyes-Garrido V, Caminero-Rodríguez AB, Riancho J, Sánchez O, Forero L, Pérez-Parra F, Ares-Luque A, Téllez N, Arzalluz-Luque J, Iglesias F, Casado-Ruiz V, Castellano-Vicente AJ, Borrega L, Galán V, de Antonio LAR, Romero C, García-Rodríguez R, Cano-Orgaz AT, Sánchez-Menoyo JL, Pérez-Ruiz D, Gutiérrez-Martin F, Hernández-Echevarría L, and Meca-Lallana V more...
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- Humans, Female, Male, Adult, Prospective Studies, Middle Aged, Treatment Outcome, Immunosuppressive Agents therapeutic use, Immunosuppressive Agents adverse effects, Immunosuppressive Agents administration & dosage, Registries, Multiple Sclerosis drug therapy, Dimethyl Fumarate therapeutic use, Dimethyl Fumarate adverse effects
- Abstract
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., Competing Interests: Declarations Funding Writing and editorial assistance was provided by Content Ed Net (Madrid, Spain) with funding from Biogen. Conflict of interest C.A. has received lecture honoraria, consultancy fees, and travel expenses from Biogen, Bristol Mayers Squibb, Merck, Novartis, Sanofi-Genzyme and Roche. A.A.T. has received fees as a speaker, consultant or travel support from Biogen, Almirall, Merck, Roche, Sanofi, Sandoz and Janssen. E.A. has no disclosures for financial affiliation, financial support nor grants moneys and has disclosure for speaker honorarium from Novartis, Merck and Biogen. JM.G.D. has received compensation as a consultant, researcher, or speaker from Biogen, Sanofi, Roche, Zenas Biopharma, Almirall, Novartis, Merck, Bristol-Myers-Squidd, and Johnson & Johnson. PM-E has received speaker and consultation fees from Allergan, Almirall, Biogen Idec, Merck, Merz, Novartis and Sanofi-Genzyme. V.G.Q has no conflict of interest related to this work. L.C.F. has received lecture honoraria, consultancy fees, clinical research funding, and travel expenses from Almirall, Amgen, AstraZeneca, Biogen, Bristol Mayers Squibb, Janssen, Merck, Neuraxpharma, Novartis, Sanofi-Genzyme, Roche. C.O.G. has received speaker and consultation fees from Alexion, Biogen Idec, BMS, Horizon, Janssen, Merck, Novartis, Roche, Sanofi-Genzyme and Teva. V.R.G. has received fees as a speaker, consultant or travel support from Almirall, Merck, Alexion, Roche and Sanofi. AB.C.R. has received honoraria as speaker/meeting moderator/courses/symposium organized by Almirall Prodesfarma S.A, Biogen Idec Inc, Bristol-Myers-Squibb, Janssen Pharmaceutical; Merck-Serono, Mylan, Novartis Pharmaceutical, Roche, Sanofi-Genzyme, Teva Pharmaceuticals; and for congress assistance from Biogen Idec Inc, Bial, Merck-Serono, Novartis Pharmaceutical, Roche, Sanofi-Genzyme, Teva Pharmaceuticals. J.R. has received speaking/consulting fees and/or travel funding from Merck, Sanofi-Genzyme, Roche, Biogen, Novartis, BMS, Jannsen and Teva. O.S. has received fees from Almirall, Biogen, Novartis, Merck, Sanofi, Alter, Bial, Teva, Neuraxfarma, Esteve, Pfizer, Roche and UCB. L.F. has no conflict of interest related to this work. F.P.P has no conflict of interest related to this work. A.A.R. has received fees as a speaker and advisor, and funding for attendance at congresses and other medical meetings, from Bayer, Biogen, Bristol, Janssen, Merck, Novartis, Roche, Sanofi and Teva. J.A.L. received consultant fees from Merck. F.I. has received speaker honoraria and travel reimbursement from Biogen, Merck, Novartis, Roche Spain, and Genzyme-Sanofi. V.C.R has no conflict of interest related to this work. AJ.C.V. has no conflict of interest related to this work. L.B. has no conflict of interest related to this work. V.G. has received speaker fees from Merck, Roche, Biogen, Novartis and Sanofi. L.A.R.A. declares to have received travel aid and financial compensation for talks from BMS and Novartis. R.G.R received payments from Biogen for participating in training conferences. AT.C.O. has received payments from Biogen for participating in training conferences for other professionals. JL.S.M. accepted travel compensation from Novartis, Merck and Biogen, speaking honoraria from Biogen, Novartis, Sanofi, Merck, Almirall, Bayer and Teva and has participated in clinical trials by Biogen, Sanofi, Merck and Roche. D.P.R. has received honoraria as a speaker, funding to attend courses and conferences, and consultancies and research grants from Merck, Biogen, Novartis, Sanofi, Teva, Roche and Almirall. F.G.M has received speaker honoraria and travel reimbursement from Biogen, Merck, Novartis, Roche Spain, and Genzyme-Sanofi. L.H.E. has received speaker and consultation fees from Biogen, Merck, Novartis, Roche and Sanofi. Ethics approval The research protocol received approval from the independent ethics committee at the Hospital Universitario de La Princesa (10 November 2022, acta CEIM 5723). Consent to participate This investigation adhered to the principles of the Helsinki Declaration and complied with the EU General Data Protection Regulation (GDPR). All personal identifiers were excluded from the findings. Consent for publication Not applicable. Data availability statement Data are available from the corresponding author upon reasonable request. Author contributions CAH and VML made substantial contributions to the conception and design of the work, interpretation of data and drafting the manuscript. All authors contributed to the acquisition of data and revised the manuscript and approved the version to be published. Code availability Not applicable., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.) more...
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- 2024
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40. Beyond lines of treatment: embracing early high-efficacy disease-modifying treatments for multiple sclerosis management.
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Oreja-Guevara C, Martínez-Yélamos S, Eichau S, Llaneza MÁ, Martín-Martínez J, Peña-Martínez J, Meca-Lallana V, Alonso-Torres AM, Moral-Torres E, Río J, Calles C, Ares-Luque A, Ramió-Torrentà L, Marzo-Sola ME, Prieto JM, Martínez-Ginés ML, Arroyo R, Otano-Martínez MÁ, Brieva-Ruiz L, Gómez-Gutiérrez M, Rodríguez-Antigüedad A, Galán Sánchez-Seco V, Costa-Frossard L, Hernández-Pérez MÁ, Landete-Pascual L, González-Platas M, and Meca-Lallana JE more...
- Abstract
Recent advances in multiple sclerosis (MS) management have shifted perspectives on treatment strategies, advocating for the early initiation of high-efficacy disease-modifying therapies (heDMTs). This perspective review discusses the rationale, benefits, and challenges associated with early heDMT initiation, reflecting on the obsolescence of the traditional "first-line" and "second-line" treatment classifications. The article emerges from the last update of the consensus document of the Spanish Society of Neurology on the treatment of MS. During its development, there was a recognized need to further discuss the concept of treatment lines and the early use of heDMTs. Evidence from randomized controlled trials and real-world studies suggests that early heDMT initiation leads to improved clinical outcomes, including reduced relapse rates, slowed disease progression, and decreased radiological activity, especially in younger patients or those in early disease stages. Despite the historical belief that heDMTs involve more risks and adverse events compared to moderate-efficacy DMTs (meDMTs), some studies have reported comparable safety profiles between early heDMTs and meDMTs, though long-term safety data are still lacking. The review also addresses the need for a personalized approach based on patient characteristics, prognostic factors, and preferences, explores the importance of therapeutic inertia, and highlights the evolving landscape of international and national guidelines that increasingly advocate for early intensive treatment approaches. The article also addresses the challenges of ensuring access to these therapies and the importance of further research to establish long-term safety and effectiveness of DMTs in MS., (© The Author(s), 2024.) more...
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- 2024
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41. Does serum neurofilament light chain measurement influence therapeutic decisions in multiple sclerosis?
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Saposnik G, Monreal E, Medrano N, García-Domínguez JM, Querol L, Meca-Lallana JE, Landete L, Salas E, Meca-Lallana V, García-Arcelay E, Agüera-Morales E, Martínez-Yélamos S, Gómez-Ballesteros R, Maurino J, Villar LM, and Caminero AB more...
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- Humans, Female, Male, Cross-Sectional Studies, Adult, Middle Aged, Biomarkers blood, Multiple Sclerosis, Relapsing-Remitting blood, Multiple Sclerosis, Relapsing-Remitting therapy, Multiple Sclerosis, Relapsing-Remitting drug therapy, Neurofilament Proteins blood, Clinical Decision-Making, Multiple Sclerosis blood, Multiple Sclerosis therapy, Multiple Sclerosis diagnosis, Neurologists
- Abstract
Background: The assessment of serum neurofilament light chain (sNfL) concentration in multiple sclerosis (MS) is a useful tool for predicting clinical outcomes and assessing treatment response. However, its use in clinical practice is still limited. We aimed to assess how measurement of sNfL influences neurologists' treatment decisions in MS., Methods: We conducted a cross-sectional, web-based study in collaboration with the Spanish Society of Neurology. Neurologists involved in MS care were presented with different simulated case scenarios of patients experiencing either their first demyelinating MS event or a relapsing-remitting MS. The primary outcome was therapeutic inertia (TI), defined as the absence of treatment initiation or intensification despite elevated sNfL levels. Nine cases were included to estimate the TI score (range 0-9, where higher values represented a higher degree of TI)., Results: A total of 116 participants were studied. Mean age (standard deviation-SD) was 41.9 (10.1) years, 53.4 % male. Seventy-eight (67.2 %) were neurologists fully dedicated to the care of demyelinating disorders. Mean (SD) TI score was 3.65 (1.01). Overall, 92.2 % of participants (n = 107) presented TI in at least 2/9 case scenarios. The lack of full dedication to MS care (p = 0.014), preference for taking risks (p = 0.008), and low willingness to adopt evidence-based innovations (p = 0.009) were associated with higher TI scores in the multivariate analysis after adjustment for confounders., Conclusion: TI was a common phenomenon among neurologists managing MS patients when faced with the decision to initiate or escalate treatment based on elevated sNfL levels. Identifying factors associated with this phenomenon may help optimize treatment decisions in MS care., Competing Interests: Declaration of competing interest Gustavo Saposnik received consulting fees from Roche Farma Spain and is supported by the University of Toronto Scientific Merit award. He also receives a modest stipend from the World Stroke Organization as the Editor in Chief of the World Stroke Academy. Enric Monreal reported receiving research grants, travel support, or honoraria for speaking engagements from Almirall, Merck, Roche, Sanofi, Bristol Myers Squibbb, Biogen, Janssen, and Novartis. Jose M García-Domínguez received honoraria as speaker, advisor and researcher from Almirall, Bristol Myers Squibb, Biogen, Janssen, Merck, Novartis, Roche, Teva, and Sanofi. Jose E Meca-Lallana received honoraria as a consultant, chairman and lecturer in meetings and participated in clinical trials and other research projects promoted by Alexion, Biogen, Bristol Myers Squibb, Janssen, Merck, Novartis, Roche, and Sanofi. Lamberto Landete received honoraria for participating in advisory boards and scientific and educational activities from Almirall, Bayer, Biogen, Bristol Myers Squibb, Sanofi, Merck, Novartis, UCB, Roche, and Teva. Virginia Meca-Lallana received consulting and speaking fees from Almirall, Biogen, Genzyme, Janssen, Merck, Novartis, Roche, Terumo, Sanofi, Teva, and Bristol Myers Squibb. Luis Querol received speaker honoraria from Merck, Sanofi, Roche, Biogen, Grifols and CSL Behring; provided expert testimony for Grifols, Johnson & Johnson, Annexon Pharmaceuticals, Sanofi, Novartis, Takeda, and CSL-Behring; and received research funds from Roche, UCB, and Grifols. Eduardo Agüera received speaking honoraria from Roche, Novartis, Merck, Sanofi, and Biogen. Sergio Martínez-Yélamos received honoraria for participating on advisory boards and for collaborations as consultant and scientific communications; they also received research support as well as funding for travel and congress expenses from Roche, Biogen Idec, Novartis, TEVA, Merck, Genzyme, Sanofi, Bayer, Almirall, and Bristol Myers Squibb. Luisa M Villar reported receiving research grants and personal fees from Merck, Roche, Sanofi, Bristol Myers Squibb, Biogen, and Novartis. Ana B Caminero received courses and honoraria for her participation as speaker/meeting moderator/symposia organizer from Alter, Almirall, Bayer, Bial, Biogen, Bristol Myers Squibb, Lilly, Merck, Mylan, Novartis, Roche, Sanofi-Genzyme, Teva, and UCB; and support to attend scientific meetings from Biogen, Bial, Merck-Serono, Novartis, Roche, Sanofi, and Teva. Rocío Gómez-Ballesteros, Elisa Salas, Nicolas Medrano, Elena García-Arcelay, and Jorge Maurino are employees of Roche Farma Spain., (Copyright © 2024 Elsevier B.V. All rights reserved.) more...
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- 2024
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42. Clinical characteristics and impact on patient-reported outcomes and quality of life of people with ambulatory secondary progressive multiple sclerosis: DISCOVER study.
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Oreja-Guevara C, Meca-Lallana JE, Díaz-Díaz J, Ara JR, Hernández Pérez MÁ, Gracia Gil J, Alonso Torres AM, Pilo de la Fuente B, Ramió-Torrentà L, Eichau Madueño S, Gascón-Giménez F, Casanova B, Martínez-Yélamos S, Aguado Valcárcel M, Martínez Ginés ML, El Berdei Montero Y, López Real AM, González-Quintanilla V, De Torres L, Martínez-Rodríguez JE, Costa-Frossard L, Garcés Redondo M, Labiano Fontcuberta A, Castellanos-Pinedo F, García Merino JA, Muñoz Fernández C, Castillo-Triviño T, Meca-Lallana V, Peña Martínez J, Rodríguez-Antigüedad A, Prieto González JM, Agüera Morales E, Pérez Molina I, Solar Sánchez DM, Herrera Varo N, Romero Sevilla R, Gómez Vicente L, and Río J more...
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- Humans, Female, Male, Middle Aged, Cross-Sectional Studies, Adult, Retrospective Studies, Spain, Quality of Life, Patient Reported Outcome Measures, Multiple Sclerosis, Chronic Progressive physiopathology, Multiple Sclerosis, Chronic Progressive economics, Multiple Sclerosis, Chronic Progressive psychology
- Abstract
Background: People with secondary progressive multiple sclerosis (pwSPMS) experience increasing disability, which impacts negatively on their health-related quality of life (HRQoL). Our aims were to assess the impact of secondary progressive multiple sclerosis (SPMS) on functional status and HRQoL and describe the clinical profile in this population., Methods: DISCOVER is an observational, cross-sectional, multicenter study with retrospective data collection in real-world clinical practice in Spain. Sociodemographic and clinical variables, functional and cognitive scales, patient-reported outcomes (PROs), and direct healthcare, and non-healthcare and indirect costs were collected., Results: A total of 297 evaluable pwSPMS with a EDSS score between 3-6.5 participated: 62.3 % were female and 18.9 % had active SPMS. At the study visit, 77 % of them presented an Expanded Disability Scale Score (EDSS) of 6-6.5. Nearly 40 % did not receive any disease-modifying treatment. Regarding the working situation, 61.6 % were inactive due to disability. PROs: 99.3 % showed mobility impairment in EuroQoL-5 Dimensions-5 Levels, and about 60 % reported physical impact on the Multiple Sclerosis Impact Scale-29. Fatigue was present in 76.1 %, and almost 40 % reported anxiety or depression. The Symbol Digit Modalities Test was used to assess cognitive impairment; 80 % of the patients were below the mean score. Participants who presented relapses two years before and had high EDSS scores had a more negative impact on HRQoL. PwSPMS with a negative impact on HRQoL presented a higher cost burden, primarily due to indirect costs., Conclusions: PwSPMS experience a negative impact on their HRQoL, with a high physical impact, fatigue, cognitive impairment, and a high burden of indirect costs., Competing Interests: Declaration of competing interest None, (Copyright © 2024. Published by Elsevier B.V.) more...
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- 2024
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43. [XVI Post-ECTRIMS Meeting: review of the new developments presented at the 2023 ECTRIMS Congress (II)].
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Fernández O, Montalbán X, Agüera E, Aladro Y, Alonso A, Arroyo R, Brieva L, Calles C, Costa-Frossard L, Eichau S, García-Domínguez JM, Hernández MA, Landete L, Llaneza M, Llufriu S, Meca-Lallana JE, Meca-Lallana V, Moral E, Prieto JM, Ramió-Torrentà L, Téllez N, Romero-Pinel L, Vilaseca A, and Rodríguez-Antigüedad A more...
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- Aged, Female, Humans, Male, Congresses as Topic, Multiple Sclerosis therapy
- Abstract
The XVI Post-ECTRIMS meeting was held in Seville on 20 and 21 October 2023, where expert neurologists in multiple sclerosis (MS) summarised the main new developments presented at the ECTRIMS 2023 congress, which took place in Milan from 11 to 13 October. The aim of this article is to summarise the content presented at the Post-ECTRIMS Meeting, in an article in two parts. This second part covers the health of women and elderly MS patients, new trends in the treatment of cognitive impairment, focusing particularly on meditation, neuroeducation and cognitive rehabilitation, and introduces the concept of fatigability, which has been used to a limited extent in MS. The key role of digitalization and artificial intelligence in the theoretically near future is subject to debate, along with the potential these technologies can offer. The most recent research on the various treatment algorithms and their efficacy and safety in the management of the disease is reviewed. Finally, the most relevant data for cladribine and evobrutinib are presented, as well as future therapeutic strategies currently being investigated. more...
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- 2024
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44. Defining a standard set of health outcomes for patients with relapsing-remitting multiple sclerosis.
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Llaneza González M, Carrascal Rueda P, Delgado Sánchez O, Borges Guerra M, Rodríguez Antigüedad A, Morell Baladrón A, Becerril Ríos N, Rovira À, Meca Lallana V, Benedito-Palos L, Comellas M, Vilanova D, Echeto A, Pérez X, and Oreja-Guevara C more...
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- Humans, Quality of Life, Outcome Assessment, Health Care, Multiple Sclerosis, Relapsing-Remitting diagnosis, Multiple Sclerosis, Relapsing-Remitting therapy, Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
- Abstract
Background: Standardizing health outcomes is challenging in clinical management, but it also holds the potential for creating a healthcare system that is both more effective and efficient. The aim of the present study is to define a standardized set of health outcomes for managing Relapsing-Remitting Multiple Sclerosis (RRMS)., Methods: The project was led and coordinated by a multidisciplinary scientific committee (SC), which included a literature review, a patient-focused group, three nominal group meetings, and two SC meetings., Results: 36 outcome variables were included in the standard set: 24 clinical (including weight, smoking habit, comorbidities, disability, mobility, diagnosis of secondary progressive multiple sclerosis, relapsed-related variables, radiological variables, cognitive status and disease-related symptoms), nine treatment-related (pharmacological and non-pharmacological information), and 3 related to the impact of RRMS on the patient's life (quality of life, pregnancy desire, work-related difficulties). In addition, experts also agreed to collect 10 case-mix variables that may affect but cannot be controlled as part of the management of the condition: 4 sociodemographic (age, sex, race, and employment status) and 6 clinical (height, date of diagnosis and first episode, serological status, early symptoms, and number of relapses pre-diagnosis)., Conclusion: The information provided through the present standard set of outcome variables can improve the management of RRMS and promote patient-centred quality care., Competing Interests: Declaration of competing interest MLG has received fees from the following pharmaceutical companies for his participation in advisory groups, talks, workshops, seminars, conferences, studies or clinical trials: Bayer, Biogen, Teva, Novartis, Sanofi-Genzyme, Almirall, Roche, Bristol Myers Squibb, Merk and Janssen. PCR has served as a speaker for several pharmaceutical companies. ODS reports fees as a study investigator with Pfizer and Bristol Myers Squibb. MB declares relationships with Bristol Myers Squibb, Roche and Biogen. ARA has participated in scientific consultancies and has been a speaker at scientific meetings organized by Merk, Biogen, Novartis, Sanofi, Teva and Bristol Myers Squibb. AMB has no conflicts of interest to disclose. NBR declares relationships with Roche, Merck, Biogen, Sanofi, Janssen and Bristol Myers Squibb. AR serves on scientific advisory boards for Bristol Myers Squibb, Novartis, Sanofi-Genzyme, Synthetic MR, Tensor Medical, Roche, Biogen, and OLEA Medical and has received speaker honoraria from Bayer, Sanofi-Genzyme, Merck-Serono, Teva Pharmaceutical Industries Ltd, Novartis, Roche, Bristol Myers Squibb, and Biogen. AR is also a member of the editorial boards of Neurology and Neuroradiology and the executive committee of MAGNIMS. VML has not declared conflicts of interest. LBP and MC are employees of Outcomes 10, an independent research entity that has received fees from Bristol Myers Squibb for conducting this research. DV and AE are employees and may be shareholders of Bristol Myers Squibb. CO-G has received speaker and consultation fees from Alexion, Biogen Idec, Bristol Myers Squibb, Janssen, Merck, Novartis, Roche, Sanofi-Genzyme and Teva., (Copyright © 2024. Published by Elsevier B.V.) more...
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- 2024
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45. Real-World Retrospective Analysis of Alemtuzumab Outcomes in Relapsing-Remitting Multiple Sclerosis: The LEMCAM Study.
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Costa-Frossard França L, Meca Lallana V, Labiano-Fontcuberta A, Blasco R, Monreal E, Martínez Ginés ML, Aguirre C, Sabin Muñoz J, Sainz de la Maza S, Cuello JP, Díaz-Pérez C, Chico García JL, Lozano Ros A, Rodríguez Jorge F, Martínez Martínez S, and García Domínguez JM more...
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- Adult, Humans, Alemtuzumab adverse effects, Retrospective Studies, Recurrence, Multiple Sclerosis, Relapsing-Remitting drug therapy, Multiple Sclerosis drug therapy
- Abstract
Background: Alemtuzumab is a high-efficacy treatment approved for relapsing-remitting multiple sclerosis (RRMS). Although clinical trials and observational studies are consistent in showing its efficacy and manageable safety profile, further studies under clinical practice conditions are needed to further support its clinical use., Objective: The aim of this observational retrospective study was to evaluate the effectiveness and safety of alemtuzumab to add to the current real-world evidence on the drug., Methods: A cohort of 115 adult patients with RRMS treated with alemtuzumab between 2014 and 2020 was retrospectively followed up in five centers in Spain. Analysis included annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW), 6-month confirmed disability improvement (CDI), radiological activity, no evidence of disease activity (NEDA-3), and safety signals. Given the different follow-up periods among participants, ARR was calculated using the person-years method. CDI was defined as a ≥ 1.0-point decrease in Expanded Disability Status Scale (EDSS) score assessed in patients with a baseline EDSS score ≥ 2.0 confirmed 6 months apart. CDW was defined as a ≥ 1.0-point increase in EDSS score assessed in patients with a baseline EDSS score ≥ 1.0 (≥ 1.5 if baseline EDSS = 0), confirmed 6 months apart., Results: ARR decreased from 1.9 (95% confidence interval 1.60-2.33) in the year prior to alemtuzumab initiation to 0.28 (0.17-0.37) after 1 year of treatment (87% reduction), and to 0.22 (0.13-0.35) after the second year. Over the entire follow-up period, ARR was 0.24 (0.18-0.30). At year 1, 75% of patients showed no signs of magnetic resonance imaging (MRI) activity and 70% at year 5. One percent of patients experienced 6-month CDW at year 1, 2.6% at year 2, 7.4% at year 3, and no patients over years 4 and 5. A total of 7.7% of patients achieved 6-month CDI in year 1, 3.6% in year 2, and maintained it at years 3 and 4. Most patients achieved annual NEDA-3: year 1, 72%; year 2, 79%; year 3, 80%; year 4, 89%; year 5, 75%. Infusion-related reactions were observed in 95% of patients and infections in 74%. Thyroid disorders occurred in 30% of patients, and only three patients developed immune thrombocytopenia. No cases of progressive multifocal leukoencephalopathy were reported., Conclusions: This study shows that alemtuzumab reduced the relapse rate and disability worsening in real-world clinical practice, with many patients achieving and sustaining NEDA-3 over time. The safety profile of alemtuzumab was consistent with previous findings, and no new or unexpected safety signals were observed. As this was an observational and retrospective study, the main limitation of not having all variables comprehensively available for all patients should be considered when interpreting results., (© 2024. The Author(s).) more...
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- 2024
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46. Analysis of humoral and cellular immunity after SARS-CoV-2 vaccination in patients with multiple sclerosis treated with immunomodulatory drugs.
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Meca-Lallana V, Esparcia-Pinedo L, Aguirre C, Díaz-Pérez C, Gutierrez-Cobos A, Sobrado M, Carabajal E, Río BD, Ropero N, Villagrasa R, Vivancos J, Sanchez-Madrid F, and Alfranca A
- Abstract
We analyzed immune response to SARS-CoV-2 vaccination by measuring specific IgG titers and T-cell reactivity to different SARS-CoV-2 peptides in multiple sclerosis patients taking different disease-modifying treatments. Of the 88 patients included, 72 developed any kind of immune response after vaccination. Although DMTs such as fingolimod and anti-CD20+ treatments prevented patients from developing a robust humoral response to the vaccine, most of them were still able to develop a cellular response, which could be crucial for long-term immunity. It is probably advisable that all MS patients take additional/booster doses to increase their humoral and/or cellular immune response to SARS-CoV-2., Competing Interests: L.E-P., N.R., F.S-M, and A.A. declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Published by Elsevier Inc.) more...
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- 2023
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47. [15th Post-ECTRIMS Meeting: a review of the latest developments presented at the 2022 ECTRIMS Congress (Part II)].
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Fernández O, Montalban X, Agüera E, Aladro Y, Alonso A, Arroyo R, Brieva L, Calles C, Costa-Frossard L, Eichau S, García-Domínguez JM, Hernández MA, Landete L, Llaneza M, Llufriu S, Meca-Lallana JE, Meca-Lallana V, Mongay-Ochoa N, Moral E, Oreja-Guevara C, Ramió-Torrentà L, Téllez N, Romero-Pinel L, and Rodríguez-Antigüedad A more...
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- Pregnancy, Female, Humans, Aged, Forecasting, Multiple Sclerosis drug therapy, Hematopoietic Stem Cell Transplantation, Cognitive Dysfunction
- Abstract
Introduction: On 4 and 5 November 2022, Madrid hosted the 15th edition of the Post-ECTRIMS Meeting, where neurologists specialised in multiple sclerosis outlined the latest developments presented at the 2022 ECTRIMS Congress, held in Amsterdam from 26 to 28 October., Aim: To synthesise the content presented at the 15th edition of the Post-ECTRIMS Meeting, in an article broken down into two parts., Development: This second part describes the new developments in terms of therapeutic strategies for escalation and de-escalation of disease-modifying therapies (DMT), when and in whom to initiate or switch to highly effective DMT, the definition of therapeutic failure, the possibility of treating radiologically isolated syndrome and the future of personalised treatment and precision medicine. It also considers the efficacy and safety of autologous haematopoietic stem cell transplantation, different approaches in clinical trial design and outcome measures to assess DMT in progressive stages, challenges in the diagnosis and treatment of cognitive impairment, and treatment in special situations (pregnancy, comorbidity and the elderly). In addition, results from some of the latest studies with oral cladribine and evobrutinib presented at ECTRIMS 2022 are shown. more...
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- 2023
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48. Impact of Neuromyelitis Optica Spectrum Disorder on Quality of Life from the Patients' Perspective: An Observational Cross-Sectional Study.
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Meca-Lallana JE, Gómez-Ballesteros R, Pérez-Miralles F, Forero L, Sepúlveda M, Calles C, Martínez-Ginés ML, González-Suárez I, Boyero S, Romero-Pinel L, Sempere ÁP, Meca-Lallana V, Querol L, Costa-Frossard L, Prefasi D, and Maurino J more...
- Abstract
Introduction: Neuromyelitis optica spectrum disorder (NMOSD) is associated with a reduced health-related quality of life (HRQoL). The purpose of this study was to describe the impact of NMOSD on HRQoL from the patients' perspective and its relationship with other disease factors., Methods: An observational, cross-sectional study was conducted at 13 neuroimmunology clinics in Spain. Patients with NMOSD diagnosis (2015 Wingerchuk criteria) were included. The 29-item Multiple Sclerosis Impact Scale (MSIS-29) was used to assess the HRQoL. Different questionnaires were used to measure symptom severity, stigma, mood disorders, pain, fatigue, and difficulties in the workplace. Factors that impact HRQoL were identified by Spearman's correlation and multivariate linear regression analysis., Results: Seventy-one patients were included (mean age 47.4 ± 14.9 years, 80.3% female, mean time since disease onset 9.9 ± 8.1 years). The median Expanded Disability Status Scale score was 3.0 (1.5-4.5). The mean (± SD) physical and psychological MSIS-29 sub-scores were 41.9 ± 16.8 and 20.9 ± 8.3, respectively. Fatigue and body pain were the most prevalent symptoms. Depressive symptoms were found in 44.3% (n = 31) of patients. The physical MSIS-29 dimension showed the highest correlation with symptom severity (ρ = 0.85584, p < 0.0001), whereas the highest correlations for psychological MSIS-29 dimension were pain, MSIS-29 physical dimension, and depression (ρ = 0.76487, 0.72779, 0.71380; p < 0.0001, respectively). Pain was a predictor of both dimensions of MSIS-29., Conclusion: Fatigue, pain, and depressive symptoms are frequent problems among patients with NMOSD, impacting on their quality of life. Assessment of patient-oriented outcomes may be useful to achieve a holistic approach, allowing early specific interventions., (© 2022. The Author(s).) more...
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- 2022
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49. Disease modifying therapy switching in relapsing multiple sclerosis: A Delphi consensus of the demyelinating expert group of the Spanish society of neurology.
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Brieva L, Estruch BC, Merino JAG, Meca-Lallana V, Río J, Rodríguez-Antigüedad A, Agüera E, Ara JR, Luque AA, Garcia CA, Blanco Y, Castillo-Triviño T, Costa-Frossard L, González Platas M, Pascual LL, Llaneza-González M, Ginés MLM, Matías-Guiu J, Meca-Lallana JE, Bilbao MM, Sempere AP, Romero-Pinel L, Saiz A, and Moral E more...
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- Consensus, Delphi Technique, Humans, Multiple Sclerosis, Neurology
- Abstract
Background: The increase in available disease modifying therapies (DMTs) for multiple sclerosis has led to greater emphasis on improving treatment sequencing paradigms. This article summarises the opinions from a panel of 25 experts on treatment switching approaches in relapsing multiple sclerosis (RMS)., Methods: A modified Delphi consensus process was carried out to develop clinically relevant statements for aiding treatment decisions in patients with RMS between the 16
th January and the 9th October 2019. A sub-group of two experts (core group) carried out an extensive review of the literature and formulated 106 statements for the expert panel to evaluate., Results: From a total number of 106 statements that were submitted to the expert panel for critical evaluation, consensus (at least 80% of the panelists agreed) was reached on 99 of them. These statements cover treatment objectives, reasons for DMT switching, suboptimal response criteria, strategies for treatment change and washout periods., Conclusion: The agreed statements provide up-to-date guidance on DMT sequencing for optimal patient management., (Copyright © 2022. Published by Elsevier B.V.) more...- Published
- 2022
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50. Disability and Fatigue in Multiple Sclerosis: Can Rehabilitation Improve Them through a Structured Retraining Program?
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Arriaza MJ, Vazquez A, Hernández T, Varillas-Delgado D, and Meca-Lallana V
- Abstract
Functional rehabilitation programs in multiple sclerosis have demonstrated their efficacy in improving fatigue. The assessment of functional impairment, however, is more difficult. The purpose is to assess fatigue and disability as a first study measure and to verify their improvement after a specific functional rehabilitation program. An analytical, longitudinal, prospective, and experimental study was carried out with 51 patients aged 18-55 years, with an Expanded Disability Status Scale (EDSS) between 2 and 6.5 who were being followed up in outpatient clinics of the Rehabilitation Service of La Princesa Hospital. The fatigue and disability outcomes before and after a structured exercise training program were evaluated, with each subject acting as their own control. The variables were measured using the Modified Fatigue Impact Scale (MFIS), Barthel Index (BI), and Functional Independence Scale (FIM). Differences according to recurrent or progressive course of the disease are assessed. Improvement in the FIM scale was observed after the retraining program ( p = 0.016) and was maintained in the medium term ( p = 0.042). This improvement is not statistically significant in Barthel Index. Improvement in MFIS is observed after the program ( p < 0.001) and 4-6 months after the end. Both disease courses experience the same improvements with no statistically significant differences between them. The retraining program improves fatigue and multiple sclerosis-related functionality in the short and medium term. There are no differences according to disease course. Both experience the same positive changes with our intervention., Competing Interests: The authors have reported no potential conflicts of interest that exist with any companies/organizations whose products or services may be discussed in this article., (Copyright © 2022 María José Arriaza et al.) more...
- Published
- 2022
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