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.

Regresión logística / Logistic regression

La regresión logística es un grupo de técnicas estadísticas que tienen como objetivo comprobar hipótesis o relaciones causales entre una variable dependiente categórica y otras variables independientes que pueden ser categóricas y cuantitativas. Mediante este modelo pretendemos estudiar la probabilidad de que ocurra el evento estudiado en función de unas variables que suponemos que son relevantes o influyentes. En este método es necesario detectar las variables modificadoras de efecto y las de confusión. Sus parámetros se estiman con el método de la máxima verosimilitud a través de un proceso con sucesivas iteraciones (AU)

Logistic regression is a group of statistical techniques that aim to test hypotheses or causal relationships between a categorical dependent variable and other independent variables that can be categorical and quantitative. Through this model we intend to study the probability that the event studied will occur based on some variables that we assume are relevant or influential. In this method it is necessary to detect effect modifier and confounding variables. Its parameters are estimated with the maximum likelihood method through a process with successive iterations (AU)

[Logistic regression]. / Regresión logística.

Logistic regression is a group of statistical techniques that aim to test hypotheses or causal relationships between a categorical dependent variable and other independent variables that can be categorical and quantitative. Through this model we intend to study the probability that the event studied will occur based on some variables that we assume are relevant or influential. In this method it is necessary to detect effect modifier and confounding variables. Its parameters are estimated with the maximum likelihood method through a process with successive iterations.

Metastasis Models: Thermodynamics and Complexity.

The thermodynamic formalism of nonequilibrium systems together with the theory of complex systems and systems biology offer an appropriate theoretical framework to explain the complexity observed at the macroscopic level in physiological phenomena. In turn, they allow the establishment of an appropriate conceptual and operational framework to address the study of phenomena such as the emergence and evolution of cancer.This chapter is organized as follows: In Subheading 1, an integrated vision of these disciplines is offered for the characterization of the emergence and evolution of cancer, seen as a nonlinear dynamic system, temporally and spatially self-organized out of thermodynamic equilibrium. The development of the various mathematical models and different techniques and approaches used in the characterization of cancer metastasis is presented in Subheading 2. Subheading 3 is devoted to the time course of cancer metastasis, with particular emphasis on the epithelial-mesenchymal transition (EMT henceforth) as well as chronotherapeutic treatments. In Subheading 4, models of the spatial evolution of cancer metastasis are presented. Finally, in Subheading 5, some conclusions and remarks are presented.

Nanocomposites from spent coffee grounds and iron/zinc oxide: green synthesis, characterization, and application in textile wastewater treatment.

This study reports on a novel composite of bimetallic FeO/ZnO nanoparticles supported by spent coffee grounds (SCGs). The leaves of eucalyptus (Eucalyptus globulus Labill) and trumpet (Cuphea aequipetala Cav), with their high antioxidant content, serve as bio-reductant agents for the green synthesis of nanoparticles. It was characterized using Fourier transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), energy dispersive X-ray spectroscopy (EDS), X-ray diffraction (XRD), and transmission electron microscopy (TEM). Stable nanoparticles were produced with different diameters of 5-30 nm, and they were applied as catalysts in Fenton-like processes. Box-Behnken experimental design (BBD) was used to determine the optimal removal efficiency with three factors and was used in the degradation of textile dyes from wastewater. The nanocomposite displayed a high decolorization ratio (88%) of indigo carmine in the presence of H2O2 combined. This resulted in a reduction in chemical oxygen demand (COD) of 56% at 120 min of contact time at an initial pH of 3.0 and a 0.5 g/L of catalyst dose, a H2O2 concentration of 8.8 mM/L, an initial dye concentration of 100 mg/L, and a temperature of 25 °C.

Continuous flow operation of solar photo-Fenton fused with NaOCl as a novel tertiary treatment.

A novel strategy based on solar photo-Fenton mediated by ferric nitrilotriacetate (Fe3+-NTA) combined with NaOCl in continuous flow mode for wastewater reclamation has been studied. Escherichia coli (E. coli) inactivation attained ≥ 5 log10-units, meeting the most restrictive EU 2020/741 target (10 CFU/100 mL), and 75% of organic microcontaminant total load was removed. As a remarkable finding, trihalomethanes (THMs) concentration was insignificant, complying by far with the Italian legislation limit. To attain these results, first the effect of liquid depth on E. coli inactivation and imidacloprid (IMD) removal from spiked municipal effluents was evaluated in continuous flow pilot-scale raceway pond reactors at 60-min hydraulic residence time with low reagent concentrations (0.10 mM Fe3+-NTA, 0.73 mM H2O2 and 0.13 mM NaOCl). Disinfection was due to the bactericidal effect of chlorine. In contrast, liquid depth notably influenced microcontaminant removal, highlighting that operation at 10-cm liquid depth allows achieving treatment capacities higher than at 5 cm (16.50 vs 28.20 mg IMD/m2∙day). Next, the monitoring of THMs was carried out to evaluate the generation and degradation of disinfection by-products, along with the removal of actual microcontaminants. These promising results draw attention to the treatment potential and open the way for its commercial application.

Análisis de supervivencia / Survival analysis

El análisis de supervivencia es un método estadístico que valora el tiempo entre un evento inicial (inclusión del sujeto en el estudio) y uno final, que sucede cuando este presenta una característica definida con anterioridad (evento). Su objetivo es estimar, teniendo en cuenta la variable tiempo, la probabilidad de que ocurra un suceso determinado. Tiene la particularidad de aceptar tiempos incompletos de participación y asumir que todos los factores implicados en el estudio son homogéneos. Existen varios métodos para calcular la probabilidad de supervivencia; los más utilizados son los de Kaplan-Meier y el actuarial (AU)

Survival analysis is a statistical method that assesses the time between an initial event (inclusion of the subject in the study) and a final event, which occurs when the subject presents a previously defined characteristic. Its objective is to estimate, taking into account the time variable, the probability of a certain event occurring. It has the particularity of accepting incomplete participation times and assuming that all the factors involved in the study are homogeneous. There are several methods to calculate the probability of survival, the most used are the Kaplan-Meier and the actuarial (AU)

Continuous solar photo-Fenton for wastewater reclamation in operational environment at demonstration scale.

For the first time, a continuous flow solar photo-Fenton demonstration plant has been assessed for wastewater reclamation according to the EU 2020/741 regulation. The treated water qualities achieved under two operating strategies (acidic and neutral pH) in a 100-m2 raceway pond reactor were explored in terms of liquid depth, iron source, reagent concentrations, and hydraulic residence time over three consecutive days of operation. The results obtained at acidic pH showed removal percentages of contaminants of emerging concern (CECs) > 75% and water quality classes B, C and D according to EU regulation at both assessed operating conditions, with treatment capacities up to 1.92 m3 m-2 d-1. At neutral pH with ferric nitrilotriacetate (Fe3+-NTA), 50% of CEC removal and only water quality class D were achieved with the most oxidizing condition assessed, giving a treatment capacity of 0.80 m3 m-2 d-1. The treatment capacities obtained in this work, which have never been achieved with solar water treatments, demonstrate the potential of this technology for commercial-scale application.

Farmacovigilancia de las vacunas frente a la COVID-19 en farmacias comunitarias. Resultados tras la segunda dosis y comparación entre ambas / Pharmacovigilance of vaccines against COVID-19 in community pharmacies. Results after the second dose and comparison between both

Objetivos: detección y seguimiento de sospechas de reacciones adversas (RA) en farmacias comunitarias tras la segunda dosis de vacunas frente a la COVID-19. Comparación entre dosis.Material y métodos: diseño: estudio observacional prospectivo.Sujetos: vacunados frente a la COVID-19, mayores de edad, que consintieron participar.Variables: número y porcentaje de participantes con RA. Su número, tipo y frecuencia. Repercusión en su vida diaria. Relaciones entre variables.Aprobado por CEIm-G.Resultados: 693 participantes con la 2ª dosis, 63,6 % mujeres. Edad media 56,8 años. 312 (45,0 %) vacunados, 49,4 % de mujeres y 37,3 % de hombres (p<0,0001), refirieron al menos una RA: 43,9 % con Comirnaty®, 37,7 % con Vaxzevria®, 63,0 % con Spikevax®.Se registraron 972 RA, 75,2 % en mujeres y 24,8 % en hombres (p<0,0001). Media 1,4/vacunado (máximo 11). Las más prevalentes: dolor en punto de inyección 197 (28,4 %), cansancio/fatiga 141 (20,3 %), mialgia 112 (16,2 %), cefalea 95 (13,7 %), fiebre 84 (12,1 %).51 encuestados con RA necesitaron ayuda profesional: 10 del médico, 6 en urgencias, 3 en hospital (1 derivado), 33 en la farmacia. A 70 (15,1 %) les impidió su actividad diaria. Se comunicaron RA de 201 vacunados.Los vacunados con RA y su número fueron menos tras la administración de la 2ª dosis (p<0,05).Relación inversa (p<0,05) entre “edad” y “número de vacunados con RA”, “necesidad de atención profesional” e “impidió la actividad diaria”.Conclusiones: el número de vacunados con RA y su número fue alto también con la segunda dosis, aunque menor que tras la primera. Mujer y menor edad son predictores de riesgo de sufrir RA tras la vacunación frente a COVID-19.(AU)

Magnetic resonance in patients with cardiovascular devices. SEC-GT CRMTC/SEC-Heart Rhythm Association/SERAM/SEICAT consensus document.

Magnetic resonance has become a first-line imaging modality in various clinical scenarios. The number of patients with different cardiovascular devices, including cardiac implantable electronic devices, has increased exponentially. Although there have been reports of risks associated with exposure to magnetic resonance in these patients, the clinical evidence now supports the safety of performing these studies under specific conditions and following recommendations to minimize possible risks. This document was written by the Working Group on Cardiac Magnetic Resonance Imaging and Cardiac Computed Tomography of the Spanish Society of Cardiology (SEC-GT CRMTC), the Heart Rhythm Association of the Spanish Society of Cardiology (SEC-Heart Rhythm Association), the Spanish Society of Medical Radiology (SERAM), and the Spanish Society of Cardiothoracic Imaging (SEICAT). The document reviews the clinical evidence available in this field and establishes a series of recommendations so that patients with cardiovascular devices can safely access this diagnostic tool.

[Survival analysis]. / Análisis de supervivencia.

Survival analysis is a statistical method that assesses the time between an initial event (inclusion of the subject in the study) and a final event, which occurs when the subject presents a previously defined characteristic. Its objective is to estimate, taking into account the time variable, the probability of a certain event occurring. It has the particularity of accepting incomplete participation times and assuming that all the factors involved in the study are homogeneous. There are several methods to calculate the probability of survival, the most used are the Kaplan-Meier and the actuarial.

General Purpose Transistor Characterized as Dosimetry Sensor of Proton Beams.

A commercial pMOS transistor (MOSFET), 3N163 from Vishay (USA), has been characterized as a low-energy proton beam dosimeter. The top of the samples' housing has been removed to guarantee that protons reached the sensitive area, that is, the silicon die. Irradiations took place at the National Accelerator Centre (Seville, Spain). During irradiations, the transistors were biased to improve the sensitivity, and the silicon temperature was monitored activating the parasitic diode of the MOSFET. Bias voltages of 0, 1, 5, and 10 V were applied to four sets of three transistors, obtaining an averaged sensitivity that was linearly dependent on this voltage. In addition, the short-fading effect was studied, and the uncertainty of this effect was obtained. The bias voltage that provided an acceptable sensitivity, (11.4 ± 0.9) mV/Gy, minimizing the uncertainty due to the fading effect (-0.09 ± 0.11) Gy was 1 V for a total absorbed dose of 40 Gy. Therefore, this off-the-shelf electronic device presents promising characteristics as a dosimeter sensor for proton beams.

Coeficiente de correlación intraclase / Intraclass correlation coefficient

El coeficiente de correlación intraclase permite medir la concordancia general entre dos o más mediciones que implican variables de carácter cuantitativo, obtenidas estas con diferentes instrumentos de medida o evaluadores. Se basa en un modelo de análisis de varianza con medidas repetidas. Su uso solo es posible si existe normalidad de las distribuciones de las variables, igualdad de varianzas e independencia entre los errores producidos por los observadores (AU)

The intraclass correlation coefficient makes it possible to measure the general concordance between two or more measurements that involve variables of a quantitative nature, obtained with different measuring instruments or evaluators. It is based on an analysis of variance model with repeated measures. Its use is only possible if there is normality of the distributions of the variables, equality of variances and independence between the errors produced by the observers (AU)

La curva ROC / ROC curve

La curva ROC es una herramienta estadística que se utiliza para evaluar la capacidad discriminativa de una prueba diagnóstica dicotómica. Se trata de curvas en las que se presenta la sensibilidad en función de los falsos positivos (complementario de la especificidad) para distintos puntos de corte. Son útiles para elegir el punto de corte más adecuado de una prueba, conocer el rendimiento global de esta y comparar la capacidad discriminativa de 2 o más pruebas diagnósticas. (AU)

The ROC curve is a statistical tool used to evaluate the discriminative capacity of a dichotomous diagnostic test. These are curves in which sensitivity is presented as a function of false positives (complementary to specificity) for different cut-off points. They are useful for choosing the most appropriate cut-off point for a test, knowing its overall performance and comparing the discriminative capacity of 2 or more diagnostic tests. (AU)

[Impact of COVID-19 lockdown on patients with idiopathic intracranial hypertension in Spain]. / Impacto del confinamiento por COVID-19 en pacientes con hipertensión intracraneal idiopática en España.

INTRODUCTION: The nationwide lockdown implemented in Spain in March 2020 in response to the 2019 coronavirus disease pandemic (COVID-19) could have had an effect on the clinical situation, disease management and access to care in patients with idiopathic intracranial hypertension. PATIENTS AND METHODS: A cross-sectional observational study was conducted by means of an online survey. The frequency and impact of headache, visual symptoms, dizziness, cognitive symptoms, diplopia, anxiety and depression on patients' quality of life were recorded. Disease treatment and delays experienced in accessing care were recorded. Participants were grouped according to the time elapsed since diagnosis. RESULTS: A total of 112 patients participated in the study (103 women). The average time since disease onset was 6.25 years. Headache, anxiety and depression were responsible for considerable impact in the period prior to lockdown. The impact of headache was not aggravated during lockdown, but anxiety and depression did become significantly worse. Recently diagnosed participants reported higher rates of anxiety, depression, dizziness and diplopia; chronically diagnosed participants reported a higher frequency of cognitive symptoms. CONCLUSIONS: The clinical situation of the participants deteriorated during lockdown, although the differences were smaller than previously thought. This was probably because the baseline situation was more severe than expected. Further studies are needed to clarify the medium and long-term impact of the COVID-19 pandemic on patients with idiopathic intracranial hypertension.

TITLE: Impacto del confinamiento por COVID-19 en pacientes con hipertensión intracraneal idiopática en España.Introducción. El confinamiento nacional instaurado en España en marzo de 2020 como respuesta a la pandemia por la enfermedad por coronavirus 2019 (COVID-19) pudo tener un efecto en la situación clínica, el manejo de la enfermedad y el acceso a la atención médica en pacientes con hipertensión intracraneal idiopática. Pacientes y métodos. Se realizó un estudio observacional transversal por medio de una encuesta en línea. Se registraron la frecuencia y el impacto en la calidad de vida de la cefalea, los síntomas visuales, el mareo, los síntomas cognitivos, la diplopía, la ansiedad y la depresión. Se registró el tratamiento de la enfermedad y los retrasos experimentados en el acceso a la atención médica. Se agrupó a los participantes según el tiempo de evolución desde el diagnóstico. Resultados. Participaron 112 pacientes (103 mujeres). El tiempo medio de evolución de la enfermedad fue 6,25 años. La cefalea, la ansiedad y la depresión fueron responsables de un impacto considerable en el período previo al confinamiento. El impacto de la cefalea no empeoró durante el confinamiento, pero la ansiedad y la depresión empeoraron significativamente. Los participantes diagnosticados recientemente comunicaron mayores tasas de ansiedad, depresión, mareo y diplopía; los de evolución crónica, mayor frecuencia de síntomas cognitivos. Conclusiones. La situación clínica de los participantes se deterioró durante el confinamiento, aunque las diferencias fueron menores de lo que se pensaba. Esto se debió, probablemente, a que la situación basal era más grave de lo esperado. Son necesarios más estudios para aclarar el impacto a medio y largo plazo de la pandemia por COVID-19 en pacientes con hipertensión intracraneal idiopática.

Impacto del confinamiento por COVID-19 en pacientes con hipertensión intracraneal idiopática en España / Impact of COVID-19 lockdown on patients with idiopathic intracranial hypertension in Spain

Introducción: El confinamiento nacional instaurado en España en marzo de 2020 como respuesta a la pandemia por la enfermedad por coronavirus 2019 (COVID-19) pudo tener un efecto en la situación clínica, el manejo de la enfermedad y el acceso a la atención médica en pacientes con hipertensión intracraneal idiopática. Pacientes y métodos: Se realizó un estudio observacional transversal por medio de una encuesta en línea. Se registraron la frecuencia y el impacto en la calidad de vida de la cefalea, los síntomas visuales, el mareo, los síntomas cognitivos, la diplopía, la ansiedad y la depresión. Se registró el tratamiento de la enfermedad y los retrasos experimentados en el acceso a la atención médica. Se agrupó a los participantes según el tiempo de evolución desde el diagnóstico. Resultados: Participaron 112 pacientes (103 mujeres). El tiempo medio de evolución de la enfermedad fue 6,25 años. La cefalea, la ansiedad y la depresión fueron responsables de un impacto considerable en el período previo al confinamiento. El impacto de la cefalea no empeoró durante el confinamiento, pero la ansiedad y la depresión empeoraron significativamente. Los participantes diagnosticados recientemente comunicaron mayores tasas de ansiedad, depresión, mareo y diplopía; los de evolución crónica, mayor frecuencia de síntomas cognitivos. Conclusiones: La situación clínica de los participantes se deterioró durante el confinamiento, aunque las diferencias fueron menores de lo que se pensaba. Esto se debió, probablemente, a que la situación basal era más grave de lo esperado. Son necesarios más estudios para aclarar el impacto a medio y largo plazo de la pandemia por COVID-19 en pacientes con hipertensión intracraneal idiopática.(AU)

Introduction: The nationwide lockdown implemented in Spain in March 2020 in response to the 2019 coronavirus disease pandemic (COVID-19) could have had an effect on the clinical situation, disease management and access to care in patients with idiopathic intracranial hypertension. Patients and methods: A cross-sectional observational study was conducted by means of an online survey. The frequency and impact of headache, visual symptoms, dizziness, cognitive symptoms, diplopia, anxiety and depression on patients’ quality of life were recorded. Disease treatment and delays experienced in accessing care were recorded. Participants were grouped according to the time elapsed since diagnosis. Results: A total of 112 patients participated in the study (103 women). The average time since disease onset was 6.25 years. Headache, anxiety and depression were responsible for considerable impact in the period prior to lockdown. The impact of headache was not aggravated during lockdown, but anxiety and depression did become significantly worse. Recently diagnosed participants reported higher rates of anxiety, depression, dizziness and diplopia; chronically diagnosed participants reported a higher frequency of cognitive symptoms. Conclusions: The clinical situation of the participants deteriorated during lockdown, although the differences were smaller than previously thought. This was probably because the baseline situation was more severe than expected. Further studies are needed to clarify the medium and long-term impact of the COVID-19 pandemic on patients with idiopathic intracranial hypertension.(AU)

Farmacovigilancia de las vacunas frente a COVID-19 en farmacias comunitarias. Resultados tras la primera dosis / Pharmacovigilance of vaccines against COVID-19 in community pharmacies. Results with the first dose

Objetivos: detección, notificación y seguimiento de sospechas de reacciones adversas (RA) tras la administración de la primera dosis de la vacuna frente a la COVID-19 en usuarios de las farmacias comunitarias y su repercusión sobre la salud y vida diaria. Métodos: diseño: observacional prospectivo. Sujetos: personas vacunadas frente a la COVID-19, mayores de edad, que firmaron el consentimiento informado. Variables: número y porcentaje de participantes que presentaban al menos una RA. Número, tipo y frecuencia de posible reactividad. Repercusión en su vida diaria. El estudio fue aprobado por el CEIm-G (Exp. 2021-007).Resultados: colaboraron 10 farmacias de Pontevedra y 2 de Ourense. 781 casos, 488 (62,5 %) mujeres. Edad 56,8 (DE=17,9) años. 389 (49,8 %) en grupo de riesgo.495 (63,4 %) vacunados, 321 mujeres (65,8 %) y 174 (59,4 %) hombres refirieron al menos una RA: 236 (53,0 %) frente a Comirnaty®, 157 (82,6 %) a Vaxzevria®, 69 (66,3 %) a Spikevax® y 33 (80,5) a Janssen®.Se registraron 1.367 RA, 1,8 por persona vacunada. Las más prevalentes (el % es sobre el total de pacientes): dolor en punto de inyección 375 (48,0 %), cansancio/fatiga 170 (21,8 %), escalofríos 118 (15,1 %), cefalea 117 (15,0 %), dolor muscular 112 (14,3 %) y fiebre 98 (12,5 %). De los 495 encuestados con RA, necesitaron ayuda profesional 77 (15,6 %): del médico de familia 30 (39,0 %), 9 (11,7 %) en servicio de urgencias, 1 (1,3 %) en hospital y 37 (48,1 %) en la farmacia. A 118 (15,1 %) les impidió desarrollar su actividad diaria.Se comunicaron las RA que refirieron 264 vacunados (53,3 %).Conclusiones: el número de vacunados que manifestaron haber sufrido RA fue alto. Dolor en el punto de inyección fue la RA más prevalente. La mitad fueron atendidos en la farmacia. Aunque fueron en general leves, afectaron notablemente a su vida diaria. (AU)

[Intraclass correlation coefficient]. / Coeficiente de correlación intraclase.

The intraclass correlation coefficient makes it possible to measure the general concordance between two or more measurements that involve variables of a quantitative nature, obtained with different measuring instruments or evaluators. It is based on an analysis of variance model with repeated measures. Its use is only possible if there is normality of the distributions of the variables, equality of variances and independence between the errors produced by the observers.