Analysis to retreatment with monoclonal antibodies in chronic/episodic migraine: Real world data. / [Artículo traducido] Análisis del retratamiento con anticuerpos monoclonales en la migraña crónica/episódica: datos en vida real.

OBJECTIVE: To analyze the response to retreatment in patients with chronic/episodic migraine who discontinued therapy with erenumab/fremanezumab after one year of treatment. METHODS: Observational, retrospective, single-center, multidisciplinary study in patients with chronic/episodic migraine who received therapy with erenumab/fremanezumab for at least one year and discontinued it after achieving an adequate response (optimization). The evaluation of the response after retreatment included the following variables: migraine days per month, MIDAS and HIT-6 scales at the beginning of retreatment and 3 months later. The response was evaluated in different subgroups (episodic/chronic, erenumab/fremanezumab and time until retreatment). RESULTS: 48 patients were included. 70.8% (n=34) required retreatment with mAb, with a median of 3.9 (2.9-6.4) months until reintroduction. Clinical response after retreatment was achieved in 67.6% (n=23) of patients. No statistically significant differences were found in the analyzed subgroups. CONCLUSION: Interruption of treatment with erenumab/fremanezumab for chronic/episodic migraine produces a clinical worsening of the disease requiring retreatment in most cases, approximately after 4 months. Two out of three patients respond positively after restarting monoclonal therapy. This response does not appear to be related to the type of migraine, the specific monoclonal antibody prescribed, or the time to retreatment.

Prevalencia de anticuerpos neutralizantes frente al SARS-CoV-2 inducidos tras 2 dosis de vacuna BNT162b2 (Pfizer–BioNTech) en trabajadores sanitarios / Prevalence of neutralizing antibodies against SARS-CoV-2 using a rapid serological test in health workers of a Spanish Department of Health in Alicante (Spain) before the booster dose of the vaccine

Fundamento: Estudiar la prevalencia de anticuerpos neutralizantes en el personal sanitario y de apoyo tras la administración de la segunda dosis de vacuna BNT162b2 (Pfizer–BioNTech). Material y métodos: En diciembre 2021 llevamos a cabo un estudio en el Departamento de Salud de Orihuela, Alicante (España), formado por 1.500 trabajadores. En los participantes del estudio, recogimos variables demográficas y realizamos un test «point-of-care» (POC) de inmunocromatografía para medir la presencia de anticuerpos neutralizantes (OJABIO® SARS-CoV-2 Neutralizing Antibody Detection Kit, fabricado por Wenzhou OJA Biotechnology Co., Ltd.- Wenzhou, Zhejiang, China) antes de la administración de la tercera dosis de vacuna. Resultados: Obtuvimos información completa de 964 (64%) trabajadores, siendo 290 varones y 674 mujeres. La edad media fue de 45,8 años (mín: 18, máx: 68) y el tiempo desde la última dosis (TUD) de vacuna fue 40,5 semanas (mín: 1,71; máx: 47,71). Un total de 131 (13,5%) habían padecido infección por SARS-CoV-2 confirmada mediante RT-PCR. La proporción de sujetos con presencia de anticuerpos neutralizantes fue de 38,5%. En el análisis multivariable el TUD de vacuna (razón de probabilidades ajustada [ORa] semana: 1,07; IC 95%: 1,04; 1,09) y la infección previa por SARS-CoV-2 (ORa: 3,7; IC 95%: 2,39; 5,63) mostraron asociación estadísticamente significativa con la presencia de anticuerpos neutralizantes. Conclusiones: El TUD de vacuna y la infección previa por SARS-CoV-2 determinaron la presencia de anticuerpos neutralizantes en 38,5% del personal sanitario y personal de apoyo.(AU)

Aim: To study the prevalence of neutralizing antibodies in healthcare workers and healthcare support personnel after the administration of the second dose of the BNT162b2 vaccine (Pfizer-BioNTech). Materials and methods: In December 2021, we undertook a study in the Health Department in Orihuela, Alicante (Spain), which consists of 1500 workers. We collected demographic variables about the study participants, and we performed a «point-of-care» immunochromatography test to measure the presence of neutralizing antibodies (OJABIO® SARS-CoV-2 Neutralizing Antibody Detection Kit, manufactured by Wenzhou OJA Biotechnology Co., Ltd. Wenzhou, Zhejiang, China) before the administration of the third dose of the vaccine. Results: We obtained complete information about 964 (64%) workers, which consisted of 290 men and 674 women. The average age was 45,8 years (min. 18, max. 68) and the average time since the last dose of the vaccine was 40,5 weeks (min. 1,71, max. 47,71). A total of 131 participants (13,5%) had suffered infection by SARS-CoV-2 confirmed using RT-PCR. The proportion of participants who showed presence of neutralizing antibodies was 38,5%. In the multivariable analysis, the time since the last dose of the vaccine (aOR week: 1,07; 95%CI: 1,04; 1,09) and previous infection by SARS-CoV-2 (aOR: 3,7; 95CI: 2,39; 5,63) showed a statistically significant association with the presence of neutralizing antibodies. Conclusions: The time since the administration of the last dose of the vaccine and the previous infection by SARS-CoV-2 determined the presence of neutralizing antibodies in 38,5% of the healthcare workers and support workers.(AU)

Respiratory syncytial virus: A new era / Virus respiratorio sincitial: un nuevo tiempo

Respiratory syncytial virus (RSV) is a major public health problem that has undergone significant changes in recent years. First of all, it has become easier to diagnose with highly reliable and rapidly available confirmatory tests. This has led to a better understanding of its epidemiology and RSV has gone from being a disease of the pediatric age group, severe only in infants and immunosuppressed children, to being a common disease in people of all ages, particularly important in patients of advanced age or with immunosuppressive diseases. Recent therapeutic and prophylactic advances, both with long-lasting monoclonal antibodies and vaccines, are another reason for satisfaction. For these reasons, the COVID and Emerging Pathogens Committee of the Illustrious Official College of Physicians of Madrid (ICOMEM) has considered it pertinent to review this subject in the light of new knowledge and new resources for dealing with this infection. We have formulated a series of questions that we believe will be of interest not only to members of the College but also to any non-expert in this subject, with a particular focus on the situation of RSV infection in Spain. (AU)

El Virus Respiratorio Sincitial (VRS), es un problema de salud pública de primera magnitud que en años recientes ha experimentado cambios muy importantes. En primer lugar, se ha producido una mayor facilidad diagnóstica con pruebas confirmatorias altamente fiables y rápidamente disponibles. Esto ha permitido conocer mejor su epidemiología y VRS ha pasado de ser una enfermedad de la edad pediátrica, grave sólo en lactantes y niños inmunodeprimidos, a ser una enfermedad común en personas de toda edad, particularmente importante en pacientes de edades avanzadas o con enfermedades que inmunodeprimen. Los avances terapéuticos y profilácticos, recientes, tanto con anticuerpos monoclonales de larga duración como con vacunas, constituyen otro motivo de satisfacción. Por estos motivos, el Comité de COVID y de patógenos emergentes del Ilustre Colegio Oficial de Médicos de Madrid (ICOMEM) ha considerado pertinente revisar este tema, a la luz de los nuevos conocimientos y de los nuevos recursos para afrontar esta infección. Hemos formulado una serie de preguntas que creemos de interés no sólo para los colegiados si no para cualquier persona no experta en este tema, con una vista particular en la situación de la infección por VRS en España. (AU)

Nefropatía membranosa: genética, antígenos y anticuerpos

La nefropatía membranosa es un trastorno renal caracterizado por el engrosamiento de la membrana basal glomerular, que causa el síndrome nefrótico. Puede deberse a diversas afecciones subyacentes que provocan daños en las unidades de filtración de los riñones, conocidas como nefronas, produciendo proteinuria masiva, hipoalbuminemia, edema e hiperlipidemia. Entre el 30 y el 40% de los casos de síndrome nefrótico en adultos se deben a una nefropatía membranosa. En las últimas décadas se ha avanzado en el descubrimiento de antígenos, anticuerpos y genes implicados en la fisiopatología de la enfermedad y se ha propuesto un nuevo sistema de clasificación. La presencia de complejos antígeno-anticuerpo junto con factores genéticos puede influir en la susceptibilidad a dicha desregulación inmunológica, y establece nueva información en un lo que se conocía entre las etiologías de causas primarias y secundarias.La comprensión de los antígenos implicados en la nefropatía membranosa es un área de investigación activa, y es posible que se identifiquen antígenos adicionales a medida que nuestro conocimiento de la enfermedad siga evolucionando. Este artículo resume algunos conceptos y hallazgos recientes sobre este tema. (provisto por Infomedic International)

Membranous nephropathy is a kidney disorder characterized by thickening of the glomerular basement membrane, that causes nephrotic syndrome. It can be caused by various underlying conditions that result in damage to the filtering units of the kidneys, known as nephrons, producing massive proteinuria, hypoalbuminemia, edema and hyperlipidemia.  Between 30 to 40% of cases of nephrotic syndrome in adults are due to membranous nephropathy. In recent decades, progress has been made with the discovery of antigens, antibodies and genes involved in the pathophysiology of the disease and a new classification system has been proposed. The presence of antigen-antibody complexes together with genetic factors may influence the susceptibility to such immune dysregulation, and states new information in a what was known between the etiologies of primary and secondary causes. The understanding of the antigens involved in membranous nephropathy is an area of active research, and additional antigens may be identified as our knowledge of the disease continues to evolve. This article summarizes some concepts and recent findings made on this topic. (provided by Infomedic International)

Estudio tecnofarmacéutico de los Anticuerpos Conjugados a Fármacos comercializados en España / Technopharmaceutical study of antibodies drug conjugated marketed in Spain

Introducción: el tratamiento del cáncer supone uno de los grandes desafíos a los que se enfrenta la sociedad cien-tífica actual. En esta lucha sanitaria, se desarrollan los anticuerpos conjugados a fármacos, capaces de lograr la muerte celular mediante el transporte y liberación de compuestos citotóxicos selectivamente sobre células tumorales. Se componen de un anticuerpo monoclonal (de naturaleza proteica) unido a un fármaco citotóxico (de carácter lipófilo) mediante un enlazador. Las formulaciones se han de diseñar para mantener dicha unión durante su almacenamiento y administración. Objetivo: identificar los medicamentos comercializados en España cuyo principio activo es un anticuerpo conjugado a fármaco, estudiando diferentes aspectos tecnofarmacéuticos, en especial los componentes de sus formulaciones. Método: dado que este tipo de medicamento pertenece al grupo ATC L01F, han sido identificados a través del bus-cador de la Agencia Española de Medicamentos y Productos Sanitarios. La consulta de sus fichas técnicas, artículos de revisión e investigación relacionados con el tema así como el Handbook of Pharmaceuticals Excipients, ha permitido realizar el estudio tecnofarmacéutico. Resultados: se han analizado distintos aspectos tecnofarmacéuticos: forma farmacéutica, vía de administración, conservación y, en especial, sus formulaciones. Se ha estudiado en profundidad la naturaleza del principio activo y los requisitos de las formulaciones en base a sus características. Conclusiones: los ocho anticuerpos conjugados a fármacos aprobados en España se presentan en forma de polvo liofilizado en vial que se deben almacenar entre 2-8 ºC. Para su administración, se reconstituyen obteniéndose inicialmente un concentrado, que posteriormente se diluye y administra en forma de perfusión intravenosa o goteo. Su formulación tipo incluye un lioprotector, un antiagregante, un regulador del pH y eventualmente antioxidantes o reductores de la viscosidad. (AU)

Introduction: cancer treatment is one of the great challenges facing today’s scientific society. In this health fight, drug-conjugated antibodies (ADCs) are being developed, drugs capable of causing cell death by transporting and releasing cytotoxic compounds into tumor cells. They are composed of a monoclonal antibody (of protein nature) linked to a cytotoxic drug (of lipophilic character) through a linker. Formulations must be designed to maintain this binding during storage and administration.Objective: identify the medicines marketed in Spain whose active ingredient is an antibody-drug conjugate, studying techno pharmaceutical aspects, especially the components of their formulations. Method: since this type of drugs belongs to the ATC group L01F, they have been identified through the search engine of the Spanish Agency of Medicines and Health Products. The search for their technical sheets, along with articles of review and research related to the topic, as well as the Handbook of Pharmaceuticals Excipients, has enabled the execution of the techno pharmaceutical study.the formulation of the tested conjugates to drugs marketed in Spain belonging to the ATC L01F group corresponding to “monoclonal antibodies and tested conjugated to drugs” identified through the search engine of the Spanish Agency of Medicines and Health Products has been studied. Results: different aspects of this group of drugs have been analyzed, such as the pharmaceutical form, the route of administration, conservation and especially the techno pharmaceutical formulation. The nature of the active ingredient and the requirements of the formulations based on their characteristics have been studied in depth. Conclusions: the eight antibody-drug conjugates approved in Spain are presented in the form of lyophilized powder in a vial and should be stored between 2-8 ºC... (AU)

External validation of the 2017 ACR/EULAR classification criteria for inflammatory myopathies in a Mexican cohort: Role of autoantibodies in the diagnosis and classification of patients with inflammatory myopathies.

OBJECTIVE: This retrospective study aimed to perform the first external validation of the ACR/EULAR classification criteria for inflammatory myopathy (IIM) in a Mexican dynamic cohort where the patients were evaluated with clinical and laboratory values. As secondary objectives, we presented the clinical characteristics of the patients and included antibodies other than anti Jo1 to evaluate their impact on our population. METHODOLOGY: This study included 70 patients with IIM and 70 patients with differential diagnoses of IIM, according to the absolute score of the classification criteria. We obtained sensitivity and specificity in the modality without biopsy, and as an exploratory analysis, we added other antibodies from the myositis extended panel. We analyzed the area under the curve (AUC) of three models: score without antibodies, with anti Jo1 and with any antibody. RESULTS: The ACR/EULAR criteria showed increased specificity and at least similar sensitivity to that of the original cohort (85% sensitivity and 92% specificity), with a cohort point of >55%. When we classified patients into definite, probable, possible, and no IIM categories, by adding the extended myopathy panel, 6 of the 10 patients initially classified as "no IIM" changed their classification to "Probable IIM" and 4 to "Definite IIM"; of the 16 patients classified as "probable IIM," 15 changed their classification to "Definite IIM." CONCLUSION: Considering the limitations of this study, we concluded that the 2017 EULAR/ACR criteria for IIM classification are sensitive and specific for classifying patients with IIM in the Mexican population. Additionally, the addition of antibodies other than anti-Jo1 may improve performance in certain populations.

Analysis of retreatment with monoclonal antibodies in chronic/episodic migraine: Real world data.

OBJECTIVE: To analyze the response to retreatment in patients with chronic/episodic migraine who discontinued therapy with erenumab/fremanezumab after 1 year of treatment. METHODS: Observational, retrospective, single-center, multidisciplinary study in patients with chronic/episodic migraine who received therapy with erenumab/fremanezumab for at least 1 year and discontinued it after achieving an adequate response (optimization). The evaluation of the response after retreatment included the following variables: DMM, MIDAS, and HIT-6 scales at the beginning of retreatment and 3 months later. The response was evaluated in different subgroups (episodic/chronic, erenumab/fremanezumab, and time until retreatment). RESULTS: 48 patients were included. 70.8% (n=34) required retreatment with mAb, with a median of 3.9 (2.9-6.4) months until reintroduction. Clinical response after retreatment was achieved in 67.6% (n=23) of patients. No statistically significant differences were found in the analyzed subgroups. CONCLUSION: Interruption of treatment with erenumab/fremanezumab for chronic/episodic migraine produces a clinical worsening of the disease requiring retreatment in most cases, approximately after 4 months. Two out of three patients respond positively after restarting monoclonal therapy. This response does not appear to be related to the type of migraine, the specific monoclonal antibody prescribed, or the time to retreatment.

External validation of the 2017 ACR/EULAR classification criteria for inflammatory myopathies in a Mexican cohort: Role of autoantibodies in the diagnosis and classification of patients with inflammatory myopathies / Validación externa de los criterios de clasificación de la ACR/EULAR de 2017 para miopatías inflamatorias en una cohorte mexicana. Papel de los anticuerpos en el diagnóstico y la clasificación de pacientes con miopatías inflamatorias

Objective: This retrospective study aimed to perform the first external validation of the ACR/EULAR classification criteria for inflammatory myopathy (IIM) in a Mexican dynamic cohort where the patients were evaluated with clinical and laboratory values. As secondary objectives, we presented the clinical characteristics of the patients and included antibodies other than anti Jo1 to evaluate their impact on our population. Methodology: This study included 70 patients with IIM and 70 patients with differential diagnoses of IIM, according to the absolute score of the classification criteria. We obtained sensitivity and specificity in the modality without biopsy, and as an exploratory analysis, we added other antibodies from the myositis extended panel. We analyzed the area under the curve (AUC) of three models: score without antibodies, with anti Jo1 and with any antibody. Results: The ACR/EULAR criteria showed increased specificity and at least similar sensitivity to that of the original cohort (85% sensitivity and 92% specificity), with a cohort point of >55%. When we classified patients into definite, probable, possible, and no IIM categories, by adding the extended myopathy panel, 6 of the 10 patients initially classified as “no IIM” changed their classification to “Probable IIM” and 4 to “Definite IIM”; of the 16 patients classified as “probable IIM,” 15 changed their classification to “Definite IIM.” Conclusion: Considering the limitations of this study, we concluded that the 2017 EULAR/ACR criteria for IIM classification are sensitive and specific for classifying patients with IIM in the Mexican population. Additionally, the addition of antibodies other than anti-Jo1 may improve performance in certain populations.(AU)

Objetivo: Este estudio retrospectivo tuvo como objetivo realizar la primera validación externa de los criterios de clasificación ACR/EULAR para miopatía inflamatoria (MII) en una cohorte dinámica de pacientes mexicanos que fueron evaluados en consulta y con muestras de laboratorio. Como objetivos secundarios presentamos las características clínicas de los pacientes e incluimos anticuerpos distintos al anti-Jo1 para evaluar su impacto en nuestra población. Metodología: Este estudio incluyó a 70 pacientes con MII y 70 pacientes con diagnóstico diferencial de MII, según la puntuación absoluta de los criterios de clasificación. Obtuvimos la sensibilidad y la especificidad en la modalidad sin biopsia, y como análisis exploratorio añadimos otros anticuerpos del panel extendido de miositis. Analizamos el área bajo la curva (AUC) de tres modelos: puntuación sin anticuerpos, con anti-Jo1 y con cualquier otro anticuerpo. Resultados: Los criterios ACR/EULAR mostraron una mayor especificidad y una sensibilidad, al menos similar a la de la cohorte original (85% de sensibilidad y 92% de especificidad), con un punto de cohorte de >55%. Cuando clasificamos a los pacientes en las categorías de definitiva, probable, posible y sin MII, al agregar el panel ampliado de miopatía, 6 de los 10 pacientes clasificados inicialmente como «Sin MII» cambiaron su clasificación a «Probable MII» y 4 a «MII Definitiva»; de los 16 pacientes clasificados como «Probable MII», 15 cambiaron su clasificación a «MII Definitiva». Conclusión: Considerando las limitaciones de este estudio, concluimos que los criterios de 2017 de la EULAR/ACR para la clasificación de la MII son sensibles y específicos para clasificar a los pacientes con MII en la población mexicana. Además, la adición de anticuerpos que no sean anti-Jo1 puede mejorar la estadificación en ciertas poblaciones.(AU)

Prevalence of neutralizing antibodies against SARS-CoV-2 using a rapid serological test in health workers of a Spanish Department of Health in Alicante (Spain) before the booster dose of the vaccine.

AIM: To study the prevalence of neutralizing antibodies in healthcare workers and healthcare support personnel after the administration of the second dose of the BNT162b2 vaccine (Pfizer-BioNTech). MATERIALS AND METHODS: In December 2021, we undertook a study in the Health Department in Orihuela, Alicante (Spain), which consists of 1500 workers. We collected demographic variables about the study participants, and we performed a "point-of-care" immunochromatography test to measure the presence of neutralizing antibodies (OJABIO® SARS-CoV-2 Neutralizing Antibody Detection Kit, manufactured by Wenzhou OJA Biotechnology Co., Ltd. Wenzhou, Zhejiang, China) before the administration of the third dose of the vaccine. RESULTS: We obtained complete information about 964 (64%) workers, which consisted of 290 men and 674 women. The average age was 45,8 years (min. 18, max. 68) and the average time since the last dose of the vaccine was 40,5 weeks (min. 1,71, max. 47,71). A total of 131 participants (13,5%) had suffered infection by SARS-CoV-2 confirmed using RT-PCR. The proportion of participants who showed presence of neutralizing antibodies was 38,5%. In the multivariable analysis, the time since the last dose of the vaccine (aOR week: 1,07; 95%CI: 1,04; 1,09) and previous infection by SARS-CoV-2 (aOR: 3,7; 95CI: 2,39; 5,63) showed a statistically significant association with the presence of neutralizing antibodies. CONCLUSIONS: The time since the administration of the last dose of the vaccine and the previous infection by SARS-CoV-2 determined the presence of neutralizing antibodies in 38,5% of the healthcare workers and support workers.

Farmacocinética de eculizumab en pacientes adultos y pediátricos con síndrome hemolítico urémico atípico y glomerulopatía C3 / Pharmacokinetics of eculizumab in adult and pediatric patients with atypical hemolytic uremic syndrome and C3 glomerulopathy

Objetivo analizar y describir las concentraciones de eculizumab y el bloqueo del complemento en los pacientes con síndrome hemolítico urémico atípico (SHUa) y glomerulopatía C3, y definir un margen terapéutico donde se alcance una alta probabilidad de conseguir eficacia terapéutica. Métodos estudio observacional, ambispectivo y multicéntrico que incluyó pacientes adultos y pediátricos diagnosticados de SHUa y glomerulopatía C3 desde septiembre de 2020 hasta octubre de 2022 en 5 hospitales de España. Eculizumab se administró a las dosis recomendadas por la ficha técnica. Se determinaron las concentraciones pre y posdosis de eculizumab, así como del bloqueo de la vía clásica del complemento (CH50). Se recogieron variables sociodemográficas, analíticas y clínicas, y se calcularon los parámetros farmacocinéticos. Para establecer el punto de corte de las concentraciones de eculizumab que predecían el bloqueo del complemento se realizó un análisis de curvas ROC (Receiver Operating Characteristic). Se utilizó el test de Kruskal-Wallis para contrastar las diferencias en distintos parámetros según las concentraciones de eculizumab. Resultados se incluyeron 25 pacientes, 19 adultos (76,0%) y 6 pediátricos (24,0%), con edades medianas de 43,4 (RIC 35,7-48,8) y 10,1 (RIC 9,6-11,3) años, respectivamente. De ellos, 22 (88,0%) pacientes fueron diagnosticados con SHUa y 3 (12,0%) con glomerulopatía C3. Se determinaron un total de 111 concentraciones de eculizumab. Las concentraciones predosis y posdosis medias detectadas durante la fase de mantenimiento fueron 243,8 (SD 240,6) μg/ml y 747,4 (SD 444,3) μg/ml, respectivamente (AU)

Objective The objective of the study was to analyze and describe the concentrations of eculizumab and the complement blockade in patients with atypical hemolytic uremic syndrome (aHUS) and C3 glomerulopathy, and to define a therapeutic margin where there is a high probability of achieving therapeutic efficacy. Methods Observational, ambispective and multicenter study that included adult and pediatric patients diagnosed with aHUS and C3 glomerulopathy from September 2020 to October 2022 in five hospitals in Spain. Eculizumab was administered at the doses recommended by the data sheet according to the European Medicines Agency (EMA). Pre-dose and post-dose concentrations of eculizumab were determined, as well as blockade of the classical complement pathway (CH50). Sociodemographic and clinical data were collected, and pharmacokinetic parameters were calculated. To establish the cut-off point for eculizumab concentrations that predicted complement blockade, Receiver Operating Characteristic (ROC) curve analysis was performed. Lastly, the Kruskal-Wallis test was used to contrast the differences in different parameters according to eculizumab concentrations. Results Twenty-five patients were included, 19 adults (76.0%) and 6 pediatrics (24.0%), with median ages of 43.4 (IQR 35.7-48.8) and 10.1 (IQR 9.6-11.3) years, respectively. Of these, 22 (88.0%) patients were diagnosed with aHUS and 3 (12.0%) with C3 glomerulopathy. A total of 111 eculizumab concentrations were determined (AU)

Anti-parietal cell antibodies as a potential biomarker for interstitial lung disease associated with primary Sjögren's syndrome / Anticuerpos contra las células parietales como biomarcadores potenciales de enfermedad pulmonar intersticial relacionada con el síndrome de Sjögren primario

Background ILD is a common manifestation in pSS and is associated with an increased risk of death. APCA are strongly expressed by hyperplastic alveolar epithelial cells in the fibrotic lung and are associated with an accelerated decline in lung function in IPF. In the present study, we aimed to evaluate the clinical utility of APCA in ILD patients with pSS. Methods Clinical, laboratory, PFTs and imaging data from pSS patients were reviewed, and the ESSDAI was utilized to evaluate disease activity. HRCT semiquantitative scoring was conducted. We compared the clinical characteristics of pSS patients with and without ILD and carried out logistic regression analysis of risk factors for ILD in pSS. Results A total of 74 patients with pSS and 40 HCs were included in the study. ILD was more commonly observed in the APCA-positive group than in the APCA-negative group. The quantitative levels of APCA were positively correlated with the imaging score. Multivariate analysis found that the long disease duration, elevated APCA and elevated KL-6 level were independent risk factors for ILD in pSS patients. The area under ROC curve for APCA was 0.6618, and the threshold concentration was 153.82ng/ml (sensitivity 45.24%, specificity 87.50%). Conclusion APCA level is an independent risk factor and might be a potential biomarker for ILD in patients with pSS (AU)

Antecedentes La enfermedad pulmonar intersticial (EPI) es una manifestación común del síndrome de Sjögren primario (SSp) y está relacionada con un mayor riesgo de muerte. Los anticuerpos anticélulas parietales (AACP) están fuertemente expresados por células epiteliales alveolares proliferantes en los pulmones fibróticos y están relacionados con la disminución acelerada de la función pulmonar en la gibrosis pulmonar idiopática. En este estudio, pretendemos evaluar la aplicación clínica de la AACP en pacientes con EPI con SSp. Método Se revisaron los datos clínicos, de laboratorio, de función pulmonar e imágenes de los pacientes con SSp y se utilizó la ESSDAI para evaluar la actividad de la enfermedad en general. Se registraron 5 características principales de imagen pulmonar de la EPI y 2 radiólogos ciegos experimentados realizaron una puntuación semicuantitativa de HRCT de forma independiente. Comparamos las características clínicas de los pacientes con y sin EPI con SSp y realizamos un análisis de regresión logística de los factores de riesgo de EPI en SSp. Resultados Un total de 74 pacientes con SSp y 40 controles sanos fueron incluidos en el estudio. La EPI es más común en el grupo positivo de AACP que en el grupo negativo de APCA. El nivel cuantitativo de AACP, está positivamente relacionado con la puntuación de imagen. El análisis multifactorial encontró que la larga duración, el aumento de los niveles de AACP y el aumento de los niveles de KL-6 fueron factores de riesgo independientes para la EPI en pacientes con SSp. El área bajo la curva ROC de AACP es de 0,6618 y la concentración umbral fue de 153,82 ng/ml (sensibilidad 45,24% y especificidad 87,50%). Conclusiones Los niveles de AACP son un factor de riesgo independiente y pueden ser biomarcadores potenciales de EPI en pacientes con SSp (AU)

Percepción de la mujer con psoriasis en la planificación familiar: Estudio descriptivo, transversal y multicéntrico / Family Planning Concerns Among Women With Psoriasis: A Descriptive, Cross-Sectional, Multicenter Study

Antecedentes y objetivos La psoriasis afecta a un gran porcentaje de mujeres en edad fértil. Nuestro objetivo fue conocer las inquietudes de las mujeres con psoriasis en relación con la planificación familiar. Material y métodos Estudio observacional, descriptivo, transversal y multicéntrico realizado entre marzo del 2020 y octubre del 2021. Se recabaron datos sociodemográficos e inquietudes relacionadas con la planificación familiar de mujeres entre 18-45 años con psoriasis en placas y candidatas a recibir tratamiento sistémico. Resultados Se reclutaron 153 pacientes de 11 centros españoles (edad media: 35,4 ± 8 años, duración media de la enfermedad: 16,7 años); 38,4% de los casos tenían una enfermedad moderada/grave para los médicos, aunque la percepción de la actividad era significativamente superior para las pacientes. En una de cada tres mujeres, la enfermedad limitaba o retrasaba el deseo gestacional. Existía preocupación de que la enfermedad empeorara al tener que retirar o cambiar un fármaco o que los tratamientos perjudicaran al bebé. Alrededor de la mitad de las pacientes no había recibido información sobre planificación familiar en la consulta, especialmente aquellas mujeres sin embarazos previos. Las mujeres con tratamiento biológico (58,7%) tenían mejor situación clínica, mejor calidad de vida y menos alteraciones en la esfera sexual que las pacientes sin tratamiento biológico. Conclusiones Las pacientes con psoriasis tienen numerosas preocupaciones relacionadas con la planificación familiar. En algunos casos, estos miedos podrían llevar a retrasar y/o limitar el deseo gestacional. Sería necesario incrementar la información que se da a las pacientes y mejorar la formación de los dermatólogos en este tema (AU)

Background and objective A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population. Material and methods Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment. Results We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected. Conclusions Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information (AU)

[Translated article] Family Planning Concerns Among Women With Psoriasis: A Descriptive, Cross-Sectional, Multicenter Study / Percepción de la mujer con psoriasis en la planificación familiar: estudio descriptivo, transversal y multicéntrico

Background and objective A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population. Material and methods Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment. Results We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected. Conclusions Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information (AU)

Antecedentes y objetivos La psoriasis afecta a un gran porcentaje de mujeres en edad fértil. Nuestro objetivo fue conocer las inquietudes de las mujeres con psoriasis en relación con la planificación familiar. Material y métodos Estudio observacional, descriptivo, transversal y multicéntrico realizado entre marzo del 2020 y octubre del 2021. Se recabaron datos sociodemográficos e inquietudes relacionadas con la planificación familiar de mujeres entre 18-45 años con psoriasis en placas y candidatas a recibir tratamiento sistémico. Resultados Se reclutaron 153 pacientes de 11 centros españoles (edad media: 35,4 ± 8 años, duración media de la enfermedad: 16,7 años); 38,4% de los casos tenían una enfermedad moderada/grave para los médicos, aunque la percepción de la actividad era significativamente superior para las pacientes. En una de cada tres mujeres, la enfermedad limitaba o retrasaba el deseo gestacional. Existía preocupación de que la enfermedad empeorara al tener que retirar o cambiar un fármaco o que los tratamientos perjudicaran al bebé. Alrededor de la mitad de las pacientes no había recibido información sobre planificación familiar en la consulta, especialmente aquellas mujeres sin embarazos previos. Las mujeres con tratamiento biológico (58,7%) tenían mejor situación clínica, mejor calidad de vida y menos alteraciones en la esfera sexual que las pacientes sin tratamiento biológico. Conclusiones Las pacientes con psoriasis tienen numerosas preocupaciones relacionadas con la planificación familiar. En algunos casos, estos miedos podrían llevar a retrasar y/o limitar el deseo gestacional. Sería necesario incrementar la información que se da a las pacientes y mejorar la formación de los dermatólogos en este tema (AU)

Pharmacokinetics of eculizumab in adult and pediatric patients with atypical hemolytic uremic syndrome and C3 glomerulopathy. / Farmacocinética de eculizumab en pacientes adultos y pediátricos con síndrome hemolítico urémico atípico y glomerulopatía C3.

OBJECTIVE: The objective of the study was to analyze and describe the concentrations of eculizumab and the complement blockade in patients with atypical hemolytic uremic syndrome (aHUS) and C3 glomerulopathy, and to define a therapeutic margin where there is a high probability of achieving therapeutic efficacy. METHODS: Observational, ambispective and multicenter study that included adult and pediatric patients diagnosed with aHUS and C3 glomerulopathy from September 2020 to October 2022 in five hospitals in Spain. Eculizumab was administered at the doses recommended by the data sheet according to the European Medicines Agency (EMA). Pre-dose and post-dose concentrations of eculizumab were determined, as well as blockade of the classical complement pathway (CH50). Sociodemographic and clinical data were collected, and pharmacokinetic parameters were calculated. To establish the cut-off point for eculizumab concentrations that predicted complement blockade, Receiver Operating Characteristic (ROC) curve analysis was performed. Lastly, the Kruskal-Wallis test was used to contrast the differences in different parameters according to eculizumab concentrations. RESULTS: Twenty-five patients were included, 19 adults (76.0%) and 6 pediatrics (24.0%), with median ages of 43.4 (IQR 35.7-48.8) and 10.1 (IQR 9.6-11.3) years, respectively. Of these, 22 (88.0%) patients were diagnosed with aHUS and 3 (12.0%) with C3 glomerulopathy. A total of 111 eculizumab concentrations were determined. Mean pre-dose and post-dose concentration values detected during the maintenance phase were 243.8 (SD 240.6) µg/mL and 747.4 (SD 444.3) µg/mL, respectively. Increased complement blockade was observed at higher pre-dose concentrations (p=0.002) and decreased serum creatinine at both higher pre- and post-dose concentrations (p=0.001 and p=0.017, respectively). Using ROC curves, it was determined that a pre-dose concentration >149.0 µg/mL was optimal to achieve complement blockade, with an AUC of 0.87 (0.78-0.95). Finally, high inter-individual (48.9% CV) with low intra-individual variabilities (11.9% CV) in eculizumab clearance were observed. CONCLUSIONS: The present study reports supratherapeutic concentrations of eculizumab in patients with aHUS, and defines higher concentrations than those described in the data sheet to achieve blockade, thus encouraging the personalization of treatment with eculizumab.

[Translated article] Pharmacokinetics of eculizumab in adult and pediatric patients with atypical hemolytic uremic syndrome and C3 glomerulopathy.

OBJECTIVE: The objective of the study was to analyze and describe the concentrations of eculizumab and the complement blockade in patients with atypical hemolytic uremic syndrome (aHUS) and C3 glomerulopathy, and to define a therapeutic margin where there is a high probability of achieving therapeutic efficacy. METHODS: Observational, ambispective, and multicenter study that included adult and pediatric patients diagnosed with aHUS and C3 glomerulopathy from September 2020 to October 2022 in 5 hospitals in Spain. Eculizumab was administered at the doses recommended by the data sheet according to the European Medicines Agency (EMA). Pre- and post-dose concentrations of eculizumab were determined, as well as blockade of the classical complement pathway (CH50). Sociodemographic and clinical data were collected, and pharmacokinetic parameters were calculated. To establish the cut-off point for eculizumab concentrations that predicted complement blockade, Receiver Operating Characteristic (ROC) curve analysis was performed. Lastly, the Kruskal-Wallis test was used to contrast the differences in different parameters according to eculizumab concentrations. RESULTS: Twenty-five patients were included, 19 adults (76.0%) and 6 pediatrics (24.0%), with median ages of 43.4 (interquartile range (IQR) 35.7-48.8) and 10.1 (IQR 9.6-11.3) years, respectively. Of these, 22 (88.0%) patients were diagnosed with aHUS and 3 (12.0%) with C3 glomerulopathy. A total of 111 eculizumab concentrations were determined. Mean pre- and post-dose concentration values detected during the maintenance phase were 243.8 (SD 240.6) µg/mL and 747.4 (standard deviation (SD) 444.3) µg/mL, respectively. Increased complement blockade was observed at higher pre-dose concentrations (P = .002) and decreased serum creatinine at both higher pre- and post-dose concentrations (P = .001 and P = .017, respectively). Using ROC curves, it was determined that a pre-dose concentration >149.0 µg/mL was optimal to achieve complement blockade, with an AUC of 0.87 (0.78-0.95). Finally, high inter-individual (48.9% variation coefficient (CV)) with low intra-individual variabilities (11.9% CV) in eculizumab clearance were observed. CONCLUSIONS: The present study reports supratherapeutic concentrations of eculizumab in patients with aHUS, and defines higher concentrations than those described in the data sheet to achieve blockade, thus encouraging the personalization of treatment with eculizumab.

Family Planning Concerns Among Women With Psoriasis: A Descriptive, Cross-Sectional, Multicenter Study. / Percepción de la mujer con psoriasis en la planificación familiar: Estudio descriptivo, transversal y multicéntrico.

BACKGROUND AND OBJECTIVE: A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population. MATERIAL AND METHODS: Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment. RESULTS: We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected. CONCLUSIONS: Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information.

Anti-parietal cell antibodies as a potential biomarker for interstitial lung disease associated with primary Sjögren's syndrome.

BACKGROUND: ILD is a common manifestation in pSS and is associated with an increased risk of death. APCA are strongly expressed by hyperplastic alveolar epithelial cells in the fibrotic lung and are associated with an accelerated decline in lung function in IPF. In the present study, we aimed to evaluate the clinical utility of APCA in ILD patients with pSS. METHODS: Clinical, laboratory, PFTs and imaging data from pSS patients were reviewed, and the ESSDAI was utilized to evaluate disease activity. HRCT semiquantitative scoring was conducted. We compared the clinical characteristics of pSS patients with and without ILD and carried out logistic regression analysis of risk factors for ILD in pSS. RESULTS: A total of 74 patients with pSS and 40 HCs were included in the study. ILD was more commonly observed in the APCA-positive group than in the APCA-negative group. The quantitative levels of APCA were positively correlated with the imaging score. Multivariate analysis found that the long disease duration, elevated APCA and elevated KL-6 level were independent risk factors for ILD in pSS patients. The area under ROC curve for APCA was 0.6618, and the threshold concentration was 153.82ng/ml (sensitivity 45.24%, specificity 87.50%). CONCLUSION: APCA level is an independent risk factor and might be a potential biomarker for ILD in patients with pSS.

Detection of plasma anti-lipopolysaccharide (LPS) antibodies against enterohemorrhagic Escherichia coli (EHEC) in asymptomatic kindergarten teachers from Buenos Aires province.

In Argentina, hemolytic uremic syndrome (HUS) caused by EHEC has the highest incidence in the world. EHEC infection has an endemo-epidemic behavior, causing 20-30% of acute bloody diarrhea syndrome in children under 5 years old. In the period 2016-2020, 272 new cases per year were notified to the National Health Surveillance System. Multiple factors are responsible for HUS incidence in Argentina including person-to-person transmission. In order to detect possible EHEC carriers, we carried out a preliminary study of the frequency of kindergarten teachers with anti-LPS antibodies against the most prevalent EHEC serotypes in Argentina. We analyzed 61 kindergarten teachers from 26 institutions from José C. Paz district, located in the suburban area of Buenos Aires province, Argentina. Fifty-one percent of the plasma samples had antibodies against O157, O145, O121 and O103 LPS: 6.4% of the positive samples had IgM isotype (n=2), 61.3% IgG isotype (n=19) and 32.3% IgM and IgG (n=10). Given that antibodies against LPS antigens are usually short-lived specific IgM detection may indicate a recent infection. In addition, the high percentage of positive samples may indicate a frequent exposure to EHEC strains in the cohort studied, as well as the existence of a large non-symptomatic population of adults carrying pathogenic strains that could contribute to the endemic behavior through person-to-person transmission. The improvement of continuous educational programs in kindergarten institutions could be a mandatory measure to reduce HUS cases not only in Argentina but also globally.

[Translated article] Family Planning Concerns Among Women With Psoriasis: A Descriptive, Cross-Sectional, Multicenter Study.

BACKGROUND AND OBJECTIVE: A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population. MATERIAL AND METHODS: Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment. RESULTS: We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected. CONCLUSIONS: Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information.

Anticuerpos monoclonales biespecíficos: Cuidados de enfermería a propósito de un caso / [Bispecific monoclonal antibodies: Nursing care regarding a case]

El cáncer sigue siendo una enfermedad de primera magnitud a nivel mundial y uno de los pilares para su supervivencia son los tratamientos antineoplásicos. En los últimos años se ha producido un gran avance habiendo descrito múltiples estrategias de desarrollo, para conseguir mayor actividad antitumoral y menor toxicidad. En este contexto cabe destacar el uso de los anticuerpos monoclonales, en concreto, en los anticuerpos monoclonales biespecíficos. Dada la complejidad de estos tipos de tratamientos y sus efectos secundarios, es necesaria la formación en cuidados de enfermería específicos, con profesionales que tengan los conocimientos necesarios para garantizar una vigilancia adecuada a estos pacientes. Es por ello que el objetivo principal de este estudio es generar un Plan de Cuidados de Enfermería a una paciente con diagnóstico de Linfoma B del alto grado, que ha recibido tratamiento con Epcoritamab en el Hospital Universitario de Canarias. Así, en este artículo se realizó una valoración de enfermería según los patrones funcionales de Marjory Gordon y se desarrolló un Plan de Cuidados Individualizado (PCI) centrado en los siguientes diagnósticos: náuseas, patrón respiratorio ineficaz, riesgo de shock y riesgo de confusión aguda. (AU)