Real-world Safety and Efficacy of Risankizumab in Psoriatic Patients: A Multicenter, Retrospective, and Not-interventional Study.

BACKGROUND AND OBJECTIVE: Risankizumab - a humanized monoclonal antibody that targets the p19 subunit of IL-23 - has been recently approved to treat moderate-to-severe plaque psoriasis. Real-world data based on a representative pool of patients are currently lacking. OBJECTIVE: To assess the mid- and long-term safety and efficacy profile of risankizumab in patients with moderate-to-severe psoriasis in the routine clinical practice. METHODS: This was a retrospective and multicenter study of consecutive psoriatic patients on risankizumab from April 2020 through November 2022. The primary endpoint was the number of patients who achieved a 100% improvement in their Psoriasis Area and Severity Index (PASI) (PASI100) on week 52. RESULTS: A total of 510 patients, 198 (38.8%) women and 312 (61.2%) men were included in the study. The mean age was 51.7±14.4 years. A total of 227 (44.5%) study participants were obese (body mass index [BMI] >30kg/m2). The mean baseline PASI score was 11.4±7.2, and the rate of patients who achieved PASI100 on week 52, 67.0%. Throughout the study follow-up, 21%, 50.0%, 59.0%, and 66% of the patients achieved PASI100 on weeks 4, 16, 24, and 40, respectively. The number of patients who achieved a PASI ≤2 was greater in the group with a BMI ≤30kg/m2 on weeks 4 (P=.04), 16 (P=.001), and 52 (P=.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (P=.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (P=.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment. CONCLUSIONS: Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.

Efectos secundarios oculares de las terapias oncológicas. Revisión / Ocular side effects of oncological therapies: Review

Con el avance de la terapia contra el cáncer en los últimos años, ha aumentado el conocimiento de los mecanismos involucrados en esta enfermedad, lo que ha supuesto un aumento de la calidad de vida y de la supervivencia de los pacientes con afecciones tumorales anteriormente consideradas incurables o refractarias al tratamiento. El número de fármacos utilizados ha sufrido un aumento exponencial, y a pesar de que la toxicidad implícita es menor que la de la terapia antineoplásica convencional, conllevan la aparición de nuevos efectos adversos asociados, que el oftalmólogo debe reconocer y manejar.(AU)

With the advance of cancer therapy in recent years, the knowledge of the mechanisms involved in this disease has increased, which has meant an increase in the quality of life and survival of patients with tumor pathologies previously considered incurable or refractory to treatment. The number of drugs used has increased exponentially in number, and although the implicit toxicity is lower than that of conventional antineoplastic therapy, they lead to the appearance of new associated adverse effects that the ophthalmologist must recognize and manage.(AU)

Ocular side effects of oncological therapies: Review.

With the advance of cancer therapy in recent years, the knowledge of the mechanisms involved in this disease has increased, which has meant an increase in the quality of life and survival of patients with tumor pathologies previously considered incurable or refractory to treatment. The number of drugs used has increased exponentially in number, and although the implicit toxicity is lower than that of conventional antineoplastic therapy, they lead to the appearance of new associated adverse effects that the ophthalmologist must recognize and manage.

Actualización en prevención de VRS: Nirsevimab vs vacunación en embarazadas (RSVpreF) / Update on RSV prevention: Nirsevimab vs vaccination in pregnant women (RSVpreF)

El anticuerpo monoclonal Nirsevimab fue el primero que se implantó para la prevención de infección por virus respiratorio sincitial (VRS) de todos los lactantes en sus primeros meses de vida. Recientemente se ha aprobado el uso de una vacuna en la embarazada (RSVpreF) con distinta forma de inmunización pero el mismo objetivo en el lactante. De este modo, surge la necesidad de valorar una nueva estrategia de inmunización. Desarrollo. Nirsevimab demostró en ensayos clínicos buenos datos de eficacia clínica y de seguridad. Tras su inclusión en la temporada epidémica 2023-2024, la cobertura en España ha sido muy alta y los resultados preliminares parecen mantener la tendencia de los ensayos. Queda pendiente una valoración adecuada de su eficiencia. RSVpreF tiene resultados similares pero, de momento, solo en ensayos y, aunque podría tener alguna ventaja inmunológica, se desconoce si se traduciría en eficacia real. Aún así, esta nueva vacuna respaldada por organismos sanitarios y científicos sería una alternativa segura y eficaz. Por otro lado, incluso con la implementación en el calendario vacunal de RSVpreF, Nirsevimab va a continuar siendo clave en la protección de ciertos lactantes. Conclusión. La aprobación de la vacuna en la embarazada RSVpreF añade una segunda herramienta inmunológica frente a la infección por VRS en lactantes. RSVpreF y Nirsevimab pueden desarrollar un papel complementario en la prevención de estas infecciones.(AU)

Introduction: Nirsevimab was the first monoclonal antibody to be implemented in order to prevent respiratory syncytial virus (RSV) infection in all infants in their first months of life. The use of a vaccine in pregnant women (RSVpreF) using a different way of immunization but still sharing the same objective in infants has recently been approved. Thus, there is a necessity to evaluate a new immunization strategy. Development. Nirsevimab showed good clinical efficacy and safety data in medical trials. After its inclusion in the 2023-2024 epidemic season, coverage in Spain has been very high and preliminary results seem to maintain the trend shown in the trials. An adequate assessment of its efficiency is still pending. RSVpreF has similar results but, for now, only in trials and although it could have some immunological advantages, it is unknown if it would result in actual efficacy. Even so, this new vaccine, supported by health and scientific organizations, would provide a safe and effective alternative. Nonetheless, even with the implementation in the RSVpreF vaccine schedule, Nirsevimab will continue to be a key factor in the protection of certain infants. Conclusion. The approval of the RSVpreF vaccine in pregnant women adds a second immunological tool against RSV infections in infants. RSVpreF and Nirsevimab may play a complementary role in the prevention of these infections.(AU)

Recomendaciones de consenso para el tratamiento de la prevención de la migraña / Consensus recommendations for the treatment of migraine prevention

Objetivo los objetivos son conocer la opinión de neurólogos y farmacéuticos hospitalarios sobre aquellos aspectos aún en el debate respecto al papel de los anticuerpos monoclonales anti-CGRP en el tratamiento preventivo de la migraña. Identificar aquellas controversias aún existentes. Proponer recomendaciones consensuadas de mejora asistencial. Y promover el acceso de los clínicos y los pacientes a estos nuevos tratamientos en la prevención de la migraña con fármacos biológicos, a fin de mejorar la atención y seguimiento del paciente. Métodos se identificaron y valoraron recomendaciones para la utilización de fármacos biológicos en la prevención de la migraña a través de la metodología de consenso Delphi, proponiendo 88 aseveraciones agrupadas en 3 temas: un módulo de clínica que trata sobre el manejo de los tratamientos biológicos en la migraña, un módulo de pacientes que trata sobre las estrategias de educación al paciente y mejora de la adhesión y un módulo de coordinación que incluye las aseveraciones relacionadas con las estrategias para mejorar el trabajo conjunto entre los 2 colectivos. Se empleó la escala ordinal de Likert de 9 puntos para puntuar dichas recomendaciones y, posteriormente, los datos se analizaron estadísticamente a través de diferentes métricas. Resultados tras las 2 rondas de consulta, se alcanzó consenso en el acuerdo en 71 aseveraciones (80,7%) y consenso en el desacuerdo en una de ellas (1,1%), quedando como indeterminadas 16 aseveraciones (18,2%) de las 88 debatidas. Conclusiones el alto grado de consenso indica que la opinión de neurólogos y farmacéuticos hospitalarios sobre el papel de los anticuerpos monoclonales anti-CGRP en el tratamiento de la migraña es muy similar y permite identificar aquellas controversias aún existentes, para mejorar la atención y seguimiento del paciente con migraña. (AU)

Objective The objectives are to know the opinion of neurologists and hospital pharmacists on those aspects still under debate regarding the role of anti-CGRP monoclonal antibodies in the preventive treatment of migraine. To identify those controversies that still exist. To propose agreed recommendations for improvement of care. And to promote access of clinicians and patients to these new treatments in the prevention of migraine with biological drugs, in order to improve patient care and follow-up. Methodology Recommendations for the use of biological drugs in the prevention of migraine were identified and evaluated through the Delphi consensus methodology, proposing 88 statements grouped into three themes: a clinical module that deals with the management of biological treatments in migraine; a patient module that discusses patient education and adherence improvement strategies; and a coordination module that includes statements related to strategies to improve joint work between the two groups. The 9-point Likert ordinal scale was used to score these recommendations and, subsequently, the data was statistically analyzed through different metrics. Results After both rounds of voting, consensus was reached in agreement on 71 of the 88 statements (80.7%), leaving one statement (1.1%) with consensus in disagreement and 16 remaining as indeterminate (18.2%). Conclusions The high degree of consensus indicates that the opinion of neurologists and hospital pharmacists on the role of anti-CGRP monoclonal antibodies in the treatment of migraine is very similar and allows identifying those controversies that still exist, to improve the care and follow-up of patients with migraine. (AU)

Nirsevimab para la prevención de la enfermedad por virus respiratorio sincitial en niños. Posicionamiento de la Sociedad Española de Infectología Pediátrica / Nirsevimab for the prevention of respiratory syncytial virus disease in children: Statement of the Spanish Society of Paediatric Infectious Disease (SEIP)

Introducción: Recientemente se ha aprobado en Europa y en España el uso de nirsevimab, un anticuerpo monoclonal (AcM) para la prevención de la enfermedad por virus respiratorio sincitial (VRS). Objetivos: Facilitar unas recomendaciones para la administración de nirsevimab para la prevención de la enfermedad por VRS. Métodos: Para la elaboración de estas recomendaciones, se decidió realizar una revisión crítica de la literatura, utilizando la metodología Delphi y la metodología GRADE. Se definió un grupo de expertos. Se realizaron tres rondas para definir las preguntas, manifestarse a favor o en contra, graduar la recomendación, y definir el acuerdo o el desacuerdo con las conclusiones. Resultados: En la población general de recién nacidos, se recomienda administrar rutinariamente nirsevimab para reducir la enfermedad y la hospitalización por bronquiolitis y enfermedad de vías bajas por VRS. Se recomienda administrar nirsevimab a todos los lactantes que nazcan en la estación de alta incidencia de VRS y aquellos que cuando esta comience, tengan menos de seis meses de edad. En los pacientes prematuros de 29 a 35 semanas de edad gestacional, en los lactantes con cardiopatía hemodinámicamente significativa y lactantes con enfermedad pulmonar crónica se recomienda rutinariamente administrar nirsevimab para reducir la enfermedad y la hospitalización por bronquiolitis y enfermedad de vías bajas por VRS. En los pacientes con indicación actual de palivizumab, se recomienda sustituir palivizumab por nirsevimab para reducir la carga de enfermedad de bronquiolitis. Conclusiones: Se recomienda administrar rutinariamente nirsevimab a todos los recién nacidos menores de seis meses nacidos en la estación de VRS o que tengan menos de seis meses cuando entran en la estación invernal, para reducir la carga de enfermedad y la hospitalización por bronquiolitis. (AU)

Introduction: Nirsevimab, a monoclonal antibody for the prevention of disease caused by respiratory syncytial virus (RSV), has recently been approved for use in Europe and Spain. Objectives: To provide recommendations for the administration of nirsevimab for prevention of RSV disease. Methods: The approach chosen to develop these recommendations involved a critical review of the literature and the use of the Delphi and GRADE methods. An expert group was formed. The group engaged in three rounds to define the questions, express support or opposition, grade recommendations and establish the agreement or disagreement with the conclusions. Results: In the general neonatal population, routine administration of nirsevimab is recommended to reduce the frequency of illness and hospitalisation for bronchiolitis and RSV lower respiratory tract infection. Nirsevimab is recommended for all infants born in high-incidence RSV season and infants aged less than 6 months at the season onset. In infants born preterm between 29 and 35 weeks of gestation, with haemodynamically significant heart disease or with chronic lung disease, routine administration of nirsevimab is recommended to reduce the incidence of disease and hospitalisation due to bronchiolitis and RSV lower respiratory tract infection. In patients in whom palivizumab is currently indicated, its substitution by nirsevimab is recommended to reduce the burden of bronchiolitis. Conclusions: Routine administration of nirsevimab to all infants aged less than 6 months born during the RSV season or aged less than 6 months at the start of the winter season is recommended to reduce the burden of disease and the frequency of hospitalization due to bronchiolitis. (AU)

Nirsevimab for the prevention of respiratory syncytial virus disease in children. Statement of the Spanish Society of Paediatric Infectious Disease (SEIP).

INTRODUCTION: Nirsevimab, a monoclonal antibody for the prevention of disease caused by respiratory syncytial virus (RSV), has recently been approved for use in Europe and Spain. OBJECTIVES: To provide recommendations for the administration of nirsevimab for prevention of RSV disease. METHODS: The approach chosen to develop these recommendations involved a critical review of the literature and the use of the Delphi and GRADE methods. An expert group was formed. The group engaged in three rounds to define the questions, express support or opposition, grade recommendations and establish the agreement or disagreement with the conclusions. RESULTS: In the general neonatal population, routine administration of nirsevimab is recommended to reduce the frequency of illness and hospitalisation for bronchiolitis and RSV lower respiratory tract infection. Nirsevimab is recommended for all infants born in high-incidence RSV season and infants aged less than 6 months at the season onset. In infants born preterm between 29 and 35 weeks of gestation, with haemodynamically significant heart disease or with chronic lung disease, routine administration of nirsevimab is recommended to reduce the incidence of disease and hospitalisation due to bronchiolitis and RSV lower respiratory tract infection. In patients in whom palivizumab is currently indicated, its substitution by nirsevimab is recommended to reduce the burden of bronchiolitis. CONCLUSIONS: Routine administration of nirsevimab to all infants aged less than 6 months born during the RSV season or aged less than 6 months at the start of the winter season is recommended to reduce the burden of disease and the frequency of hospitalization due to bronchiolitis.

[Translated article] Consensus recommendations on the preventive treatment of migraine.

OBJECTIVE: The objectives are to know the opinion of neurologists and hospital pharmacists on those aspects still under debate regarding the role of anti-Calcitonin Gene-related Peptide monoclonal antibodies in the preventive treatment of migraine. To identify those controversies that still exist. To propose agreed recommendations for improvement of care. And to promote access of clinicians and patients to these new treatments in the prevention of migraine with biological drugs, in order to improve patient care and follow-up. METHODOLOGY: Recommendations for the use of biological drugs in the prevention of migraine were identified and evaluated through the Delphi consensus methodology, proposing 88 statements grouped into 3 themes: a clinical module that deals with the management of biological treatments in migraine; a patient module that discusses patient education and adherence improvement strategies; and a coordination module that includes statements related to strategies to improve joint work between the two groups. The 9-point Likert ordinal scale was used to score these recommendations and, subsequently, the data was statistically analysed through different metrics. RESULTS: After both rounds of voting, consensus was reached in agreement on 71 of the 88 statements (80.7%), leaving 1 statement (1.1%) with consensus in disagreement and 16 remaining as indeterminate (18.2%). CONCLUSIONS: The high degree of consensus indicates that the opinion of neurologists and hospital pharmacists on the role of anti-Calcitonin Gene-related Peptide monoclonal antibodies in the preventive treatment of migraine is very similar and allows identifying those controversies that still exist, to improve the care and follow-up of patients with migraine.

Consensus recommendations for the treatment of migraine prevention. / Recomendaciones de consenso para el tratamiento de la prevención de la migraña.

OBJECTIVE: The objectives are to know the opinion of neurologists and hospital pharmacists on those aspects still under debate regarding the role of anti-CGRP monoclonal antibodies in the preventive treatment of migraine. To identify those controversies that still exist. To propose agreed recommendations for improvement of care. And to promote access of clinicians and patients to these new treatments in the prevention of migraine with biological drugs, in order to improve patient care and follow-up. METHODOLOGY: Recommendations for the use of biological drugs in the prevention of migraine were identified and evaluated through the Delphi consensus methodology, proposing 88 statements grouped into three themes: a clinical module that deals with the management of biological treatments in migraine; a patient module that discusses patient education and adherence improvement strategies; and a coordination module that includes statements related to strategies to improve joint work between the two groups. The 9-point Likert ordinal scale was used to score these recommendations and, subsequently, the data was statistically analyzed through different metrics. RESULTS: After both rounds of voting, consensus was reached in agreement on 71 of the 88 statements (80.7%), leaving one statement (1.1%) with consensus in disagreement and 16 remaining as indeterminate (18.2%). CONCLUSIONS: The high degree of consensus indicates that the opinion of neurologists and hospital pharmacists on the role of anti-CGRP monoclonal antibodies in the treatment of migraine is very similar and allows identifying those controversies that still exist, to improve the care and follow-up of patients with migraine.

Consenso multidisciplinar español sobre las características de los pacientes con asma grave en tratamiento con biológicos susceptibles de pasar a tratamiento domiciliario / Spanish multidisciplinary consensus on the characteristics of severe asthma patients on biologic treatment who are candidates for at-home administration

Antecedentes y objetivo Es bien sabido que las terapias biológicas reducen las exacerbaciones y mejoran el tratamiento del asma grave no controlada. La administración domiciliaria de biológicos ha aumentado durante la pandemia de COVID-19, pero aún no se han identificado las características de los pacientes con asma grave no controlada que pueden beneficiarse de la administración domiciliaria de terapia biológica. Materiales y métodos Este proyecto se basa en la metodología Delphi, diseñada para alcanzar un consenso entre expertos a través de un comité científico multidisciplinar que aborda las siguientes cuestiones: características clínicas, adherencia al tratamiento, capacidad de administración del paciente o cuidador, autocuidado del paciente, relación con el profesional sanitario, preferencias del paciente y acceso al hospital. Resultados Ciento treinta y un profesionales sanitarios (neumólogos, alergólogos, enfermeros y farmacéuticos hospitalarios) cumplimentaron las dos rondas de consenso del cuestionario Delphi. Se identificaron 14 ítems como características prioritarias, siendo los cinco primeros: 1. El paciente sigue las indicaciones/recomendaciones del equipo sanitario para controlar su enfermedad. 2. El paciente es capaz de detectar cualquier deterioro de su enfermedad y de identificar los factores desencadenantes de las exacerbaciones. 3. El paciente recibe tratamiento biológico y tiene una enfermedad estable sin riesgo vital. 4. El paciente se responsabiliza de su autocuidado y 5. el paciente tiene obligaciones laborales/educativas que le impiden acudir al hospital con regularidad (AU)

Background and objective Biologic therapies are known to reduce exacerbations and improve severe uncontrolled asthma management. The at-home administration of biologics has increased during the COVID-19 pandemic, but the characteristics of severe uncontrolled asthma patients who may benefit from at-home administration of biologic therapy have yet to be identified. Materials and methods This project is based on the Delphi method, designed to reach an expert consensus through a multidisciplinary scientific committee addressing the following questions: clinical characteristics, treatment adherence, patient or caregiver administration ability, patient self-care, relationship with the healthcare professional, patient preference, and access to the hospital. Results One hundred and thirty-one healthcare professionals (pulmonologists, allergists, nurses, and hospital pharmacists) completed two Delphi consensus questionnaires. Fourteen items were identified as priority characteristics, the first five being: 1. The patient follows the healthcare team's indications/recommendations to control their disease, 2. The patient is capable of detecting any deterioration in their disease and of identifying exacerbation triggers, 3. The patient receives biologic therapy and has stable disease with no vital risk, 4. The patient takes responsibility for their self-care, 5. The patient has occupational/educational obligations that prevent them from going to the hospital regularly. Conclusions Disease stability and control plus the ability to identify exacerbation triggers are the most important characteristics when opting for at-home administration for a patient with severe uncontrolled asthma on biologic therapy. These recommendations could be applicable in clinical practice (AU)

Spanish multidisciplinary consensus on the characteristics of severe asthma patients on biologic treatment who are candidates for at-home administration.

BACKGROUND AND OBJECTIVE: Biologic therapies are known to reduce exacerbations and improve severe uncontrolled asthma management. The at-home administration of biologics has increased during the COVID-19 pandemic, but the characteristics of severe uncontrolled asthma patients who may benefit from at-home administration of biologic therapy have yet to be identified. MATERIALS AND METHODS: This project is based on the Delphi method, designed to reach an expert consensus through a multidisciplinary scientific committee addressing the following questions: clinical characteristics, treatment adherence, patient or caregiver administration ability, patient self-care, relationship with the healthcare professional, patient preference, and access to the hospital. RESULTS: One hundred and thirty-one healthcare professionals (pulmonologists, allergists, nurses, and hospital pharmacists) completed two Delphi consensus questionnaires. Fourteen items were identified as priority characteristics, the first five being: 1. The patient follows the healthcare team's indications/recommendations to control their disease, 2. The patient is capable of detecting any deterioration in their disease and of identifying exacerbation triggers, 3. The patient receives biologic therapy and has stable disease with no vital risk, 4. The patient takes responsibility for their self-care, 5. The patient has occupational/educational obligations that prevent them from going to the hospital regularly. CONCLUSION: Disease stability and control plus the ability to identify exacerbation triggers are the most important characteristics when opting for at-home administration for a patient with severe uncontrolled asthma on biologic therapy. These recommendations could be applicable in clinical practice.

Protocolo del proyecto de investigación: efectividad y seguridad de galcanezumab en pacientes con migraña. Resultados en práctica clínica habitual / Research project protocol: effectiveness and safety of galcanezumab in patients with migraine. Results in habitual clinical practice

Objetivo: Evaluar la efectividad de galcanezumab en práctica real mediante la reducción en el número de migrañas al mes y la reducción en la puntuación del cuestionario de calidad de vida especifico de migraña HIT-6, utilizando una variable combinada. Los objetivos secundarios son, establecer correlación entre la disminución en el número de migrañas al mes y el resultado obtenido en el cuestionario HIT-6, evaluar la efectividad de galcanezumab en migraña crónica y migraña episódica, en pacientes con y sin abuso de medicación y en combinación con otros tratamientos preventivos y evaluar la mejoría en la percepción de los pacientes respecto a la intensidad del dolor. Material y método: Estudio observacional, prospectivo y multidisciplinar, en un hospital de tercer nivel, en pacientes diagnosticados de migraña que inicien tratamiento con galcanezumab en el periodo de un año. Se incluirán todos los pacientes mayores de edad, con 8 o más días de migraña al mes y tres o más fracasos de tratamientos previos durante al menos 3 meses, siendo uno de estos tratamientos toxina botulínica en el caso de migraña crónica y que hayan recibido al menos una dosis de galcanezumab, según criterios de financiación. Los pacientes deben presentar capacidad funcional para completar correctamente el diario de migrañas y el cuestionario HIT-6. La variable principal es la efectividad del tratamiento medida como el porcentaje de pacientes con reducción de al menos el 30% en el número de migrañas al mes 3 desde el inicio del tratamiento o reducción de al menos 5 puntos en el cuestionario HIT-6 durante los 3 primeros meses de tratamiento respecto al valor basal. La recogida de variables se realizará mediante la historia clínica informatizada y un diario de migrañas. El paciente indicará los días de administración, el número de días de migrañas y su intensidad, y el número de días de consumo de tratamiento sintomático. ... (AU)

Goals: The main objective of the study is to evaluate the effectiveness of galcanezumab in real practice according to the reduction in the number of migraines per month and the reduction in the score of the HIT-6 an specific quality of life questionnaire for migraine, using a combined variable. The secondary objectives of the study are to establish a correlation between the decrease in the number of migraines per month and the result obtained in the HIT-6 questionnaire, to evaluate the different behavior regarding the effectiveness of galcanezumab in chronic migraine and episodic migraine in patients with and without medication abuse and in combination with other preventive treatments and finally, to evaluate the improvement in the perception of the patients according to the intensity of the pain. Method: Observational, prospective and multidisciplinary study in patients diagnosed with migraine in a third line hospital who started treatment with galcanezumab within one year period. All elderly patients diagnosed with migraine will be included, with 8 or more days of migraine per month and three or more failures of previous treatments for at least 3 months, one of these being botulinum toxin in chronic migraine cases and that have received at least one dose of galcanezumab, based on funding criteria. Patients must present functional capacity to correctly complete the migraine diary and the specific HIT-6 migraine quality of life questionnaire. The main variable of the study is the effectiveness of the treatment measured as the percentage of patients with a reduction of at least 30% in the number of migraines at month 3 from the start of treatment or a reduction of at least 5 points in the HIT-6 questionnaire during the first 3 months of treatment compared to baseline. The collection of variables will be carried out through the computerized clinical history and a migraine diary, where the patient will indicate the day of administration of all 6 ... (AU)

Tratamientos y bioterapias para COVID-19 / Therapeutics and biotherapies for covid-19

INTRODUCCIÓN: Un nuevo brote de coronavirus surgió en 2019 en Wuhan, China, causando conmoción en el sistema sanitario de todo el mundo; el Comité Internacional de Taxonomía de Virus lo denominó SARS-CoV-2, agente causante de la enfermedad COVID-19.El espectro de gravedad de la enfermedad es muy amplio: la mayoría de los pacientes no presentan gravedad, pero otros pueden desarrollar neumonías, y la insuficiencia respiratoria aguda es la causa más frecuente de mortalidad. Objetivo: analizar y desarrollar las distintas alternativas terapéuticas aportadas por la Biotecnología para tratar los síntomas de aquellos pacientes con COVID-19. Metodología: se realizó una revisión de la bibliografía disponible, a partir de enero de 2020 en PubMed, acerca de los tratamientos que se encuentran aún en ensayos clínicos y aquellos que cuentan con aprobación bajo uso de emergencia para la enfermedad COVID-19. También se realizaron búsquedas a través de Google y Google Académico para publicaciones de organismos de Salud en referencia a políticas de salud establecidas para la terapéutica durante dicha pandemia. Resultados: este trabajo aborda las nuevas alternativas terapéuticas para COVID-19 derivadas de la Biotecnología, que se encuentran tanto en uso como en etapas de ensayos clínicos comprendidos dentro del segmento de los biofármacos y las bioterapias. Se incluye un breve resumen del estatus regulatorio de entidades de salud, el mecanismo de acción de dichas terapias y características generales de cada uno. Se incluyen novedosas bioterapias que se empezaron a implementar para afrontar la pandemia. Conclusiones: la pandemia de coronavirus está poniendo a prueba el sistema sanitario internacional, para brindar soluciones tanto desde el diagnóstico y prevención como para el tratamiento de la población a fin de disminuir la mortalidad. Esto incluyó, obviamente también, al área de la Biotecnología aplicada a la salud, que ha aportado en los tres aspectos mencionados; el presente trabajo se centra en las respuestas de tipo terapéutico que ha brindado y que están comercializadas o en fases clínicas. (AU)

INTRODUCTION: A new coronavirus outbreak emerged in 2019 in Wuhan, China, causing a shock to the healthcare system around the world; the International Committee on Taxonomy of Viruses named it SARS-CoV- 2, the infectious agent of the COVID-19 disease. The spectrum of severity of the disease is very wide, most patients are not serious, but others can develop pneumonia, with acute respiratory failure being the most frequent cause of mortality. Objective: to analyze and develop the different therapeutic alternatives provided by Biotechnology dedicated to Health, to treat the symptoms of those COVID-19 patients who require it, and thus reduce mortality.Methodology: a review of the available literature from January 2020 in PubMed of the treatments that are still in clinical trials and those that have been approved under emergency use for the disease COVID-19 was performed. Searches were also carried out through Google and Google Scholar for publications of Health organizations in reference to health policies established for therapeutics during the mentioned pandemic. Results: this work addresses the new therapeutic alternatives derived from Biotechnology, which are both in use and in stages of clinical trials, to treat patients who developed COVID-19 included within the segment of biopharmaceuticals and biotherapies. A brief summary of the regulatory status of health entities, the mechanism of action of said therapies and general characteristics of each one is included. Innovative biotherapies that began to be implemented to face the pandemic are included. Conclusions: The coronavirus pandemic has driven the international health system to the test, to provide solutions both from the diagnosis, prevention and treatment of the population to reduce the mortality of patients. This obviously also included the area of Biotechnology applied to health, which has contributed in the three aspects mentioned. The present work focuses on the therapeutic responses that it has provided and that are commercialized or in clinical phases. (AU)

Fracaso de un anticuerpo monoclonal anti-CGRP en el tratamiento de la migraña. ¿Tiene sentido probar otro? / Failure of an anti-CGRP monoclonal antibody in the treatment of migraine. Is it worthwhile trying another one?

Introducción: La migraña es una enfermedad neurológica altamente prevalente y la búsqueda de un tratamiento eficaz que mejore la calidad de vida del paciente es fundamental. En 2018 se aprobaron en España los anticuerpos monoclonales anti-CGRP como tratamiento preventivo, y han demostrado eficacia al reducir el número de crisis de migraña al mes frente a placebo. Pacientes y métodos: Estudio descriptivo y retrospectivo de 14 pacientes con migraña episódica de alta frecuencia y crónica, en seguimiento en nuestra unidad de cefaleas, en los que se ha realizado el cambio de un monoclonal anti-CGRP por ineficacia. Se han recogido datos epidemiológicos y variables relacionadas con la respuesta a ambos fármacos, como los días de cefalea al mes y los días de migraña al mes, además de escalas validadas de calidad de vida (Migraine Disability Assessment Scale y Headache Impact Test-6). Resultados: El 50% de los pacientes son varones, con una mediana de edad de 46,5, y el 92% estaba diagnosticado de migraña crónica. Se realizó un seguimiento de entre seis y 12 meses tras el cambio de tratamiento en el 91,6%, y se observó mejoría significativa en el 33% de los pacientes. Además, en el 50% se objetivó respuesta inicial tras tres dosis con el primer monoclonal. Conclusiones: En nuestra serie, el 66% de los pacientes que no respondieron a un primer fármaco respondió inicialmente al cambio, y esta mejoría se mantuvo en el 36%. Se precisan estudios más amplios para aclarar esta diferencia de respuesta a los distintos anticuerpos monoclonales anti-CGRP.(AU)

Introduction: Migraine is a highly prevalent neurological disease and the search for an effective treatment to improve the patient’s quality of life is essential. In 2018, anti-CGRP monoclonal antibodies were approved in Spain as a preventive treatment, and have proved to be effective in reducing the number of migraine crisis per month compared to placebo. Patients and methods: We conducted a descriptive and retrospective study of 14 patients suffering from high-frequency or chronic episodic migraine, under follow-up in our headache unit, in whom an anti-CGRP monoclonal was changed due to its ineffectiveness. Epidemiological data and variables related to the response to both drugs were collected, such as headache days per month and migraine days per month, as well as validated quality of life scales (Migraine Disability Assessment Scale and Headache Impact Test-6). Results: 50% of patients were males, with a median age of 46.5 years and 92% were diagnosed with chronic migraine. A follow-up of 6 to 12 months after the change of treatment was performed in 91.6% and significant improvement was observed in 33% of the patients. In addition, 50% had an initial response after three doses of the first monoclonal drug. Conclusions: In our series, 66% of patients who did not respond to a first drug responded initially to the switch and this improvement was maintained in 36% of them. Larger studies are needed to clarify this difference in response to different anti-CGRP monoclonal antibodies.(AU)

Linfomas no Hodgkin indolentes y terapia anti-CD20: una revisión de la literatura / Indolent non-Hodgkin's lymphomas and anti-CD20 therapy: a literature review

Introducción: Los linfomas no Hodgkin indolentes se destacan por el reto que suponen desde el punto de vista terapéutico. La introducción de la terapia con rituximab, un anticuerpo monoclonal que se une al antígeno CD20 de la membrana de los linfocitos B, revolucionó los tratamientos hasta ese momento y abrió el camino para el desarrollo de otros anticuerpos monoclonales anti-CD20. Objetivo: Describir las características generales de los linfomas no Hodgkin indolentes y de los anticuerpos monoclonales anti-CD20, así como el rol de la terapia anti-CD20 en dichas enfermedades. Métodos: Se realizó una revisión de la literatura publicada en los últimos 20 años, disponible en los repositorios: Scielo, Scopus, Pubmed/Medline, ScienceDirect y Mediagraphic. Se emplearon para elaborar este manuscrito 35 documentos, de ellos 80 por ciento correspondieron a los últimos 5 años. Conclusiones: La sólida evidencia científica, acumulada durante las últimas dos décadas, respalda el uso clínico de los anticuerpos monoclonales anti-CD20 en el tratamiento de los linfomas no Hodgkin indolentes. El uso efectivo de estos fármacos como agentes únicos o combinados con quimioterapia demuestran su versatilidad terapéutica(AU)

Introduction: Indolent non-Hodgkin's lymphomas are notable for the challenge they pose from a therapeutic point of view. The introduction of rituximab, a monoclonal antibody that binds to the CD20 antigen of the B-lymphocyte membrane, revolutionized treatments up to that time and opened the way for the development of other anti-CD20 monoclonal antibodies. Objective: To describe the general characteristics of indolent non-Hodgkin's lymphomas and anti-CD20 monoclonal antibodies, as well as the role of anti-CD20 therapy in these diseases. Methods: A review of the literature published in the last 20 years, available in the repositories: Scielo, Scopus, Pubmed/Medline, Science Direct and Mediagraphic, was performed. Thirty-five papers were used to prepare this manuscript, 80 percent of which corresponded to the last 5 years. Conclusions: Strong scientific evidence, accumulated over the last two decades, supports the clinical use of anti-CD20 monoclonal antibodies in the treatment of indolent non-Hodgkin's lymphomas. The effective use of these drugs as single agents or in combination with chemotherapy demonstrates their therapeutic versatility(AU)

Eventos adversos del nimotuzumab en pacientes con tumor cerebral primario / Adverse events to the nimotuzumab in patients with primary cerebral tumor

Introducción: El nimotuzumab es un anticuerpo monoclonal empleado en el tratamiento de pacientes con tumor cerebral. Dada su novedad se justifica la realización de estudios de farmacovigilancia que avalen su seguridad. Objetivo: Caracterizar los eventos adversos relacionados con este medicamento en la práctica médica habitual. Métodos: Se realizó un estudio descriptivo y transversal de 41 pacientes con tumor cerebral primario tratados con nimotuzumab en el Departamento de Ensayos Clínicos del Hospital Provincial Docente Saturnino Lora Torres de Santiago de Cuba, desde mayo de 2017 hasta abril de 2019. Resultados: En la serie se identificaron 31 eventos adversos, de los cuales 17 eran conocidos y 14 desconocidos. Predominaron la cefalea (80,5 %), la debilidad en miembros inferiores (48,8 %) y la fosfatasa alcalina elevada (41,5 %). Cabe destacar que el total de los efectos no deseados se consideraron ligeros, según su intensidad; reversibles, según sus resultados y sin cambios, según la actitud respecto al medicamento. Conclusiones: Las características de los eventos adversos encontrados se asemejan a las descritas en otros estudios que también avalan la seguridad del fármaco.

Introduction: The nimotuzumab is a monoclonal antibody used in the treatment of patients with cerebral tumor. The realization of pharmaco surveillance studies that guaranteed its security is justified given its new features. Objective: To characterize the adverse events related to this medicine in the habitual medical practice. Methods: A descriptive and cross-sectional study of 41 patients with primary cerebral tumor treated with nimotuzumab in the Clinical Trial Department of Saturnino Lora Torres Teaching Provincial Hospital was carried out in Santiago de Cuba, from May, 2017 to April, 2019. Results: In the series 31 adverse events were identified, of which 17 were known and 14 were unknown. There was a prevalence of the headache (80.5 %), weakness in lower members (48.8 %) and the high alcaline phosphatase (41.5 %). It is necessary to highlight that all the non wanted effects were considered light according to the intensity; reversible, according to the results and without changes, according to the attitude regarding the medicine. Conclusions: The characteristics of the adverse events that were found resemble to those described in other studies that also guarantee the security of the drug.

Efectividad del tocilizumab intravenoso en la práctica clínica usual de una cohorte de pacientes costarricenses con artritis reumatoide / Effectiveness of intravenous tocilizumab in routine clinical practice in a cohort of Costa Rican patients with rheumatoid arthritis

Objetivo: Determinar la efectividad y la incidencia de eventos adversos graves del tocilizumab (TCZ) en una cohorte de pacientes costarricenses con artritis reumatoide (AR). Pacientes y métodos: Se realizó un análisis retrospectivo de 45 pacientes con AR, refractarios al uso previo de fármacos modificadores de la enfermedad reumática (FAME), que utilizaron TCZ a una dosis inicial de 4mg/kg intravenoso (IV) cada 4 semanas en asociación con metotrexato o leflunomida. La medida de efectividad fue la incidencia de remisión clínica, determinada cada 3 meses y definida por un puntaje de actividad de la enfermedad en 28 articulaciones con velocidad de sedimentación globular (DAS28-VSG) menor de 2,6. La seguridad del fármaco se evaluó mediante la tasa de incidencia de eventos adversos severos. Se realizó un modelo de regresión logística uni- y multivariado para determinar las variables asociadas con la probabilidad de remisión a los 3 meses de iniciado el tratamiento. Resultados: A los 3 meses de tratamiento un total de 22 pacientes (48,9%; intervalo de Confianza [IC] del 95%: 34,3-63,5%) alcanzaron remisión, en tanto que a los 12 meses de terapia con TCZ el valor aumentó a 34 pacientes (75%; IC 95%: 62,3-87,6%). Un total de 18 pacientes (40%; IC 95%: 25,7-54,3%) requirieron aumento de dosis del TCZ de 4 a 8mg/kg ante la ausencia de remisión. La tasa de incidencia de eventos adversos severos fue de 0,98 por 100 pacientes/año, correspondiendo todos ellos a cuadros infecciosos que resolvieron sin ningún desenlace fatal. Solo el DAS28-VSG inicial se asoció de forma independiente con la probabilidad de remisión a los 3 meses. Conclusiones: El uso de TCZ IV a una dosis inicial de 4mg/kg en pacientes costarricenses con AR es efectivo y seguro en la práctica clínica.(AU)

Objective: To determine the effectiveness and the incidence of severe adverse events in a cohort of Costa Rican patients with Rheumatoid Arthritis (RA) treated with intravenous (IV) tocilizumab (TCZ). Patients and methods: A retrospective analysis was carried out in 45 patients that were unresponsive to disease-modifying antirheumatic drugs (DMARDs). The study included patients who received IV TCZ every 4 weeks (4mg/kg) along with methotrexate or leflunomide. Effectiveness was measured through the incidence of clinical remission according to a disease activity score - erythrocyte sedimentation rate (DAS28-ESR) less than 2.6. Safety was assessed by the incidence rate of serious adverse events. An univariate and multivariate logistic regression analysis was performed to assess the association of potential variables with the probability of achieving remission during the first 3 months of TCZ therapy. Results: During the 3rd month of TCZ therapy, a total of 22 patients (48.9%; 95% Confidence Interval (CI) 34.3-63.5%) achieved remission. The cumulative incidence of patients with remission at month 12 was 75.0% (n=34) (95% CI: 62.3-87.6%). A total of 18 patients (40%; 95% CI: 25.7-54.3%) were switched to a 8mg/kg dose due to the absence of remission. The incidence rate of serious adverse events was .98 per 100 patients/year, all of them due to infectious diseases with no fatal events reported. Only basal DAS28-ESR was associated with the probability of achieving remission at month 3. Conclusions: IV TCZ (4mg/kg) is an effective and safe treatment for RA patients in a clinical setting in Costa Rica.(AU)

Effectiveness of intravenous tocilizumab in routine clinical practice in a cohort of Costa Rican patients with rheumatoid arthritis. / Efectividad del tocilizumab intravenoso en la práctica clínica usual de una cohorte de pacientes costarricenses con artritis reumatoide.

OBJECTIVE: To determine the effectiveness and the incidence of severe adverse events in a cohort of Costa Rican patients with Rheumatoid Arthritis (RA) treated with intravenous (IV) tocilizumab (TCZ). PATIENTS AND METHODS: A retrospective analysis was carried out in 45 patients that were unresponsive to disease-modifying antirheumatic drugs (DMARDs). The study included patients who received IV TCZ every 4 weeks (4mg/kg) along with methotrexate or leflunomide. Effectiveness was measured through the incidence of clinical remission according to a disease activity score - erythrocyte sedimentation rate (DAS28-ESR) less than 2.6. Safety was assessed by the incidence rate of serious adverse events. An univariate and multivariate logistic regression analysis was performed to assess the association of potential variables with the probability of achieving remission during the first 3 months of TCZ therapy. RESULTS: During the 3rd month of TCZ therapy, a total of 22 patients (48.9%; 95% Confidence Interval (CI) 34.3-63.5%) achieved remission. The cumulative incidence of patients with remission at month 12 was 75.0% (n=34) (95% CI: 62.3-87.6%). A total of 18 patients (40%; 95% CI: 25.7-54.3%) were switched to a 8mg/kg dose due to the absence of remission. The incidence rate of serious adverse events was .98 per 100 patients/year, all of them due to infectious diseases with no fatal events reported. Only basal DAS28-ESR was associated with the probability of achieving remission at month 3. CONCLUSIONS: IV TCZ (4mg/kg) is an effective and safe treatment for RA patients in a clinical setting in Costa Rica.