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.

Is the use of secukinumab after anti-TNF therapy greater than expected for the risk of developing inflammatory bowel disease?

OBJECTIVE: In this study, our objective was to present real-life data on the incidence of inflammatory bowel disease (IBD) among patients receiving secukinumab treatment. METHODS: The study consisted of 209 patients who had prior exposure to anti-tumor necrosis factor (TNF) or were biologically naive. Patients with a pre-existing history of IBD were excluded from the study. RESULTS: Of the 209 patients in the study, 176 (84.3%) had ankylosing spondylitis, while 33 (15.7%) had psoriatic arthritis. 112 (53.6%) patients had prior exposure to at least one anti-TNF treatment before initiating secukinumab. IBD developed in 10 (4.8%) of the 209 patients. The incidence of IBD among patients who initiated secukinumab as their first biologic agent was 1%. For patients who had previously received any anti-TNF treatment and subsequently transitioned to secukinumab, the incidence of IBD was 8% (p=0.018, odds ratio (OR): 8.38, 95% CI: 1.04-67.45). A mean of 3.67 months (±4.3) after anti-TNF use, whereas IBD symptoms developed in the biologically naive patient after 15 months. CONCLUSION: Our study observed IBD incidence in 4.8% of patients using secukinumab. Patients who initiated secukinumab after previous anti-TNF treatment exhibited a significantly higher rate and risk of developing IBD. The onset of IBD occurred earlier in these patients (mean 3.67 months), whereas a single case of IBD showed a longer duration (15 months). Further studies with larger patient numbers are warranted to provide a more comprehensive understanding of our findings.

Is the use of secukinumab after anti-TNF therapy greater than expected for the risk of developing inflammatory bowel disease? / El uso de secukinumab tras la terapia anti-TNF es mayor de lo esperado por el riesgo de desarrollar enfermedad inflamatoria intestinal?

Objective: In this study, our objective was to present real-life data on the incidence of inflammatory bowel disease (IBD) among patients receiving secukinumab treatment. Methods: The study consisted of 209 patients who had prior exposure to anti-tumor necrosis factor (TNF) or were biologically naive. Patients with a pre-existing history of IBD were excluded from the study. Results: Of the 209 patients in the study, 176 (84.3%) had ankylosing spondylitis, while 33 (15.7%) had psoriatic arthritis. 112 (53.6%) patients had prior exposure to at least one anti-TNF treatment before initiating secukinumab. IBD developed in 10 (4.8%) of the 209 patients. The incidence of IBD among patients who initiated secukinumab as their first biologic agent was 1%. For patients who had previously received any anti-TNF treatment and subsequently transitioned to secukinumab, the incidence of IBD was 8% (p=0.018, odds ratio (OR): 8.38, 95% CI: 1.04–67.45). A mean of 3.67 months (±4.3) after anti-TNF use, whereas IBD symptoms developed in the biologically naive patient after 15 months. Conclusion: Our study observed IBD incidence in 4.8% of patients using secukinumab. Patients who initiated secukinumab after previous anti-TNF treatment exhibited a significantly higher rate and risk of developing IBD. The onset of IBD occurred earlier in these patients (mean 3.67 months), whereas a single case of IBD showed a longer duration (15 months). Further studies with larger patient numbers are warranted to provide a more comprehensive understanding of our findings.(AU)

Objetivo: En este estudio, nuestro objetivo fue presentar datos de la vida real sobre la incidencia de la enfermedad inflamatoria intestinal (EII) entre los pacientes que reciben tratamiento con secukinumab. Métodos: El estudio consistió en 209 pacientes que habían tenido una exposición previa al factor de necrosis antitumoral (TNF) o eran biológicamente naive. Los pacientes con antecedentes preexistentes de EII fueron excluidos del estudio. Resultados: De los 209 pacientes del estudio, 176 (84,3%) tenían espondilitis anquilosante, mientras que 33 (15,7%) tenían artritis psoriásica. 112 (53,6%) pacientes tenían exposición previa a al menos un tratamiento anti-TNF antes de iniciar secukinumab. La EII se desarrolló en 10 (4,8%) de los 209 pacientes. La incidencia de EII entre los pacientes que iniciaron secukinumab como primer agente biológico fue del 1%. Para los pacientes que habían recibido previamente algún tratamiento anti-TNF y posteriormente hicieron la transición a secukinumab, la incidencia de EII fue del 8% (p=0,018, odds ratio (OR): 8,38, IC del 95%: 1,04-67,45). Una media de 3,67 meses (±4,3) después del uso de anti-TNF, mientras que los síntomas de la EII se desarrollaron en el paciente biológicamente naive después de 15 meses. Conclusión: Nuestro estudio observó una incidencia de EII en el 4,8% de los pacientes que usaban secukinumab. Los pacientes que iniciaron secukinumab después de un tratamiento anti-TNF previo mostraron una tasa y un riesgo significativamente mayores de desarrollar EII. El inicio de la EII ocurrió antes en estos pacientes (media de 3,67 meses), mientras que un solo caso de EII mostró una duración más prolongada (15 meses). Se justifican más estudios con un mayor número de pacientes para proporcionar una comprensión más completa de nuestros hallazgos.(AU)

Hand Anthropometry of Italian Elite Male Swimmers / Antropometría de la Mano en Nadadores Italianos Masculinos de Élite

SUMMARY: Hand size is part of the anthropometric parameters that are assessed in swimmers to select elite athletes, as certain anthropometric relationships involving hand measurements are significantly correlated with sports performance in various swimming disciplines. The authors present the results of the anthropometric study carried out on the hands of 15 elite male Italian swimmers from to the Italian national open water swimming team. All swimmers participated at least once in World Cup and Absolute Italian Championships, winning at least one medal in their sporting career. In particular, the sample includes a medallist at the World Championships, a winner of the World Cup ultra swim marathon circuit and medallists at the European Championships. The sample consisted of 15 elite male swimmers with a mean age of 28.93 years. The following anthropometric measurements were taken on each athlete: Stature; weight; seven dimensions on each hand: hand length; hand breadth metacarpal; palm length; middle finger length; index finger length; thumb distance; and the distance from the thumb root to first flexure line of the index finger - trigger length. The size of the hands is an important factor in the swimmer's propulsion and push as a larger hand allows for greater support in the water and consequently generates more resistance. The anthropometric characteristics of the hands of Italian swimmers are missing from the anthropometric data already reported in the literature and can be used to make comparisons with elite athletes from other nations. Furthermore, anthropometric measurements could be used as predictors to estimate the swimmers' chance of success.

El tamaño de la mano es uno de los parámetros antropométricos que se evalúan en los nadadores para seleccionar a los deportistas de élite. Los autores presentan los resultados de un estudio antropométrico realizado en las manos de 15 nadadores italianos masculinos de élite pertenecientes al equipo nacional de natación en aguas abiertas. Todos los nadadores participaron al menos una vez en Copas del Mundo y Campeonatos de Italia, ganando al menos una medalla en su carrera deportiva. En concreto, la muestra incluye un medallista en los Campeonatos del Mundo, un ganador de la Copa del Mundo del circuito de ultra maratón de natación y medallistas en los Campeonatos de Europa. La muestra consta de 15 nadadores masculinos de élite con una edad media de 28,93 años. Se tomaron las siguientes medidas antropométricas a cada atleta: estatura; peso; siete dimensiones en cada mano: longitud de la mano, anchura de la mano en el metacarpiano, longitud de la palma, longitud del primer, segundo y tercer dedo, distancia entre la raíz del primer dedo y la primera línea de flexión del segundo dedo. El tamaño de las manos es un factor importante para la propulsión y el empuje del nadador, ya que una mano más grande permite un mayor apoyo en el agua y, en consecuencia, genera más resistencia. Las características antropométricas de las manos de los nadadores italianos faltan en los datos antropométricos recolectados en la literatura y pueden utilizarse para hacer comparaciones con los atletas de élite de otras naciones. Además, las medidas antropométricas podrían utilizarse como predictores para estimar las posibilidades de éxito de los nadadores.

Profiles of posttraumatic stress disorder and negative world assumptions in treatment-seeking refugees.

Background: Refugees often suffer from trauma-related psychopathology, specifically posttraumatic stress disorder (PTSD). Negative world assumptions are strongly correlated with the development, course, and severity of PTSD.Objective: This study aimed to investigate whether there are distinct profiles of PTSD and negative world assumptions (NWA) and examine whether trauma load, torture, and gender differentially predict such symptom profiles.Method: In a sample of 225 treatment-seeking refugees who had resettled in the Netherlands, latent profile analysis was used to identify subgroups of patients sharing the same profile of PTSD and NWA symptoms. Predictors of profile membership were analyzed via multinomial logistic regression.Results: A three-profile solution yielded the best model fit: a low PTSD/low NWA profile (23.6%), a high PTSD/high NWA profile (41.8%), and a high PTSD/low NWA profile (34.7%). Participants who reported a higher trauma load, were more likely to be part of the high PTSD/high NWA profile or the high PTSD/low NWA profile in comparison to low PTSD/low NWA profile. Participants who reported having experienced torture were more likely to be part of the high PTSD/high NWA profile in comparison to low PTSD/low NWA profile. Gender did not differentiate between the profiles.Conclusions: This study reveals that among treatment-seeking refugees resettled in the Netherlands, there are distinct profiles of PTSD and NWA. These profiles indicate that PTSD and NWA are not uniformly experienced among refugees, emphasizing the diversity in their psychological responses to trauma. Among individuals experiencing severe PTSD symptoms, a subgroup was identified of individuals who additionally exhibited negative assumptions about themselves, others, and the world. Recognizing this heterogeneity is crucial in both research and clinical practice, particularly in the context of refugee mental health. Directions for future research are discussed.

Three profiles of PTSD and negative world assumptions were identified in a group of treatment-seeking refugees.Directions for future research and the importance of recognizing heterogeneity in psychological responses to traumatic experiences in refugees are discussed.

Associations between individual cognitive factors, mode of exposure and depression symptoms in practitioners working with aversive crime material.

Background: There is extensive literature on front-line officers and investigators exposure to trauma and its negative impact on them. However, there are analytical practitioners in law enforcement who indirectly work with the traumatic experiences of other people daily, but are seldom the focus of academic research.Objective: Our goal was to conduct the first international study with these practitioners to identify the risk of depression symptoms and establish whether potentially modifiable risk factors (belief in a just world, mental imagery and thought suppression) and work-related characteristics (medium of exposure) are associated with depression.Method: 99 analysts and secondary investigators employed in police and law enforcement organizations from the UK, Europe and Canada participated in the study. The online survey was advertised to employees via their employers but hosted without employer access. Multiple regression was used to analyze the data.Results: After controlling for age, gender, ethnicity, previous exposure to trauma, and marital status, four potential risk factors were identified. Analytical practitioners with vivid mental imagery, those exposed to crime material via auditory and visual means, those who suppressed intrusive thoughts, and those who believed in a just world reported more depressive symptoms.Conclusions: The majority of our sample reported clinical levels of depressive symptoms. Four potential risk factors accounted for just under half of the variance in depression scores. We consider strategies that can be used to mitigate the potential negative influence of these factors and suggest that these are established as risk factors for depression symptoms via future longitudinal research.

Analytical practitioners are exposed to aversive crime material on a daily basis. The impact of their work and the individual and work-related risk factors are currently unknown.In this sample, 52% of analytical practitioners had moderate depression symptoms, and 37% had severe depression symptoms.Modality of exposure (both auditory and visual exposure), belief in a just world, thought suppression, and mental imagery are potential modifiable risk factors.

The Effectiveness of Guselkumab in Patients With Hidradenitis Suppurativa Under Clinical Practice Conditions: A Spanish Multicentre Retrospective Study / fectividad de guselkumab en pacientes con hidradenitis supurativa en condiciones de práctica clínica: estudio retrospectivo y multicéntrico en España

Background Hidradenitis suppurativa (HS) is a chronic skin condition causing lesions in which high levels of interleukin (IL)-23 and T-helper 17 cells are found. Adalimumab remains the only approved treatment. Guselkumab, an antibody targeting the p19 protein subunit of extracellular IL-23, is approved for the treatment of moderate–severe psoriasis, but evidence on its efficacy in treating HS is limited.Objectives To assess the effectiveness and safety of guselkumab in treating moderate–severe HS under clinical practice conditions. Methods A multicentre retrospective observational study was carried out in 13 Spanish Hospitals including adult HS patients treated with guselkumab within a compassionate use programme (March 2020–March 2022). Data referred to patient demographic and clinical characteristics at treatment initiation (baseline), patient-reported outcomes (Numerical Pain Rating Scale [NPRS] and Dermatology Life Quality Index [DLQI]), physician scores (International Hidradenitis Suppurativa Severity Score System [IHS4], HS Physical Global Score [HS-PGA] and Hidradenitis Suppurativa Clinical Response [HiSCR]) were recorded at baseline and at 16, 24, and 48 weeks of treatment. Results A total of 69 patients were included. Most (84.10%) had severe HS (Hurley III) and had been diagnosed for over ten years (58.80%). The patients had been subjected to multiple non-biological (mean 3.56) or biological (mean 1.78) therapies, and almost 90% of those treated with biologics had received adalimumab (AU)

Antecedentes La hidradenitis supurativa (HS) es una situación cutánea crónica que causa lesiones en las que se encuentran altos niveles de interleucina (IL)-23 y células TH-17 colaboradoras, siendo adalimumab el único tratamiento aprobado. Guselkumab, un anticuerpo que focaliza la subunidad de la proteína p19 de IL-23 extracelular, ha sido aprobado para tratar la psoriasis de moderada a severa, siendo limitada la evidencia sobre su eficacia en el tratamiento de la HS. Objetivos Evaluar la efectividad y seguridad de guselkumab para el tratamiento de la HS de moderada a severa, en condiciones de práctica clínica. Métodos Se llevó a cabo un estudio observacional retrospectivo y multicéntrico en 13 hospitales españoles, que incluyó pacientes adultos de HS tratados con guselkumab, dentro de un programa de uso compasivo (de marzo de 2020 a marzo de 2022). Se registraron al inicio y a las 16, 24 y 48 semanas de tratamiento los datos referentes a las características demográficas y clínicas de los pacientes, los resultados reportados por el paciente (Numerical Pain Rating Scale [NPRS] y Dermatology Life Quality Index [DLQI]), puntuaciones del facultativo (International Hidradenitis Suppurativa Severity Score System [IHS4], HS Physical Global Score [HS-PGA] e Hidradenitis Suppurativa Clinical Response [HiSCR]). Resultados Se incluyó un total de 69 pacientes, de los cuales la mayoría (84,10%) tenían HS severa (Hurley III) y habían sido diagnosticados hacía más de 10 años (58,80%). Dichos pacientes habían sido sometidos a múltiples terapias no biológicas (media 3,56) o biológicas (media 1,78), y casi el 90% de los tratados con biológicos habían recibido adalimumab. Se observó una reducción significativa de las puntuaciones IHS4, HS-PGA, NPRS y DLQI desde el inicio hasta las 48 semanas del tratamiento con guselkumab (total p<0,01). Se logró HiSCR en el 58,33% y el 56,52% de los pacientes, a las 16 y 24 semanas, respectivamente (AU)

[Artículo traducido] Efectividad de guselkumab en pacientes con hidradenitis supurativa en condiciones de práctica clínica: estudio retrospectivo y multicéntrico en España / The Effectiveness of Guselkumab in Patients With Hidradenitis Suppurativa Under Clinical Practice Conditions: A Spanish Multicentre Retrospective Study

Antecedentes La hidradenitis supurativa (HS) es una situación cutánea crónica que causa lesiones en las que se encuentran altos niveles de interleucina (IL)-23 y células TH-17 colaboradoras, siendo adalimumab el único tratamiento aprobado. Guselkumab, un anticuerpo que focaliza la subunidad de la proteína p19 de IL-23 extracelular, ha sido aprobado para tratar la psoriasis de moderada a severa, siendo limitada la evidencia sobre su eficacia en el tratamiento de la HS. Objetivos Evaluar la efectividad y seguridad de guselkumab para el tratamiento de la HS de moderada a severa, en condiciones de práctica clínica. Métodos Se llevó a cabo un estudio observacional retrospectivo y multicéntrico en 13 hospitales españoles, que incluyó pacientes adultos de HS tratados con guselkumab, dentro de un programa de uso compasivo (de marzo de 2020 a marzo de 2022). Se registraron al inicio y a las 16, 24 y 48 semanas de tratamiento los datos referentes a las características demográficas y clínicas de los pacientes, los resultados reportados por el paciente (Numerical Pain Rating Scale [NPRS] y Dermatology Life Quality Index [DLQI]), puntuaciones del facultativo (International Hidradenitis Suppurativa Severity Score System [IHS4], HS Physical Global Score [HS-PGA] e Hidradenitis Suppurativa Clinical Response [HiSCR]). Resultados Se incluyó un total de 69 pacientes, de los cuales la mayoría (84,10%) tenían HS severa (Hurley III) y habían sido diagnosticados hacía más de 10 años (58,80%). Dichos pacientes habían sido sometidos a múltiples terapias no biológicas (media 3,56) o biológicas (media 1,78), y casi el 90% de los tratados con biológicos habían recibido adalimumab. Se observó una reducción significativa de las puntuaciones IHS4, HS-PGA, NPRS y DLQI desde el inicio hasta las 48 semanas del tratamiento con guselkumab (total p<0,01). Se logró HiSCR en el 58,33% y el 56,52% de los pacientes, a las 16 y 24 semanas, respectivamente (AU)

Background Hidradenitis suppurativa (HS) is a chronic skin condition causing lesions in which high levels of interleukin (IL)-23 and T-helper 17 cells are found. Adalimumab remains the only approved treatment. Guselkumab, an antibody targeting the p19 protein subunit of extracellular IL-23, is approved for the treatment of moderate–severe psoriasis, but evidence on its efficacy in treating HS is limited.Objectives To assess the effectiveness and safety of guselkumab in treating moderate–severe HS under clinical practice conditions. Methods A multicentre retrospective observational study was carried out in 13 Spanish Hospitals including adult HS patients treated with guselkumab within a compassionate use programme (March 2020–March 2022). Data referred to patient demographic and clinical characteristics at treatment initiation (baseline), patient-reported outcomes (Numerical Pain Rating Scale [NPRS] and Dermatology Life Quality Index [DLQI]), physician scores (International Hidradenitis Suppurativa Severity Score System [IHS4], HS Physical Global Score [HS-PGA] and Hidradenitis Suppurativa Clinical Response [HiSCR]) were recorded at baseline and at 16, 24, and 48 weeks of treatment. Results A total of 69 patients were included. Most (84.10%) had severe HS (Hurley III) and had been diagnosed for over ten years (58.80%). The patients had been subjected to multiple non-biological (mean 3.56) or biological (mean 1.78) therapies, and almost 90% of those treated with biologics had received adalimumab (AU)

Transformações no mundo do trabalho em saúde: os(as) trabalhadores(as) e desafios futuros / Transformations in the world of healthcare work: workers and future challenges

Resumo O artigo versa sobre o mundo do trabalho da saúde, especialmente no SUS no contexto da pandemia no Brasil. O artigo utilizou dados das pesquisas "Condições de trabalho dos profissionais de saúde no contexto da COVID-19 no Brasil" e "Os trabalhadores invisíveis da saúde: condições de trabalho e saúde mental no contexto da COVID-19 no Brasil". A análise dos dados comprova que a pandemia evidenciou problemas estruturais existentes no âmbito do Sistema Único de Saúde, envolvendo a gestão da FTS o que pode ser interpretado como mais um dos reflexos das desigualdades socioeconômicas já existentes no país. Destacam-se: a reduzida oferta de educação permanente, a regulação do cuidado híbrido, precarização, desproteção no ambiente de trabalho, frágil biossegurança levando a trágicas taxas de adoecimento e mortes de trabalhadores da saúde. Conclui mostrando a importância de formulação de políticas públicas no âmbito da gestão da educação e do trabalho no SUS que assegurem a discussão sobre cuidado híbrido como nova forma de atuar sem perder qualidade, a necessidade de se rever questões referentes a: educação permanente, proteção, valorização e redução das desigualdades apontadas entre os contingentes profissionais analisados nesse artigo.

Abstract This article addresses the world of healthcare work, especially in the Brazilian Unified Healthcare System (SUS) in the context of the COVID-19 pandemic in Brazil. This study used data from the following surveys: "Working conditions of health professionals in the context of COVID-19 in Brazil" and "The Invisible health workers: working conditions and mental health in the context of COVID-19 in Brazil". Data analysis proves that the pandemic highlighted existing structural problems within SUS, involving the issue of healthcare workforce (HWF) management, which can be interpreted as another reflection of the socioeconomic inequalities that already exist in the country. This article highlights: the reduced provision of permanent education, the regulation of hybrid care, precariousness, a lack of protection in the work environment, as well as fragile biosecurity leading to tragic rates of illness and death of health workers. Our study concludes by showing the importance of formulating public policies in the scope of education and work management in SUS that ensure the discussion on hybrid care as a new way of acting without losing quality, together with the need to review issues related to permanent education, protection, valuation, and reduction of inequalities pointed out among the professional contingents analyzed in this article.

The Effectiveness of Guselkumab in Patients With Hidradenitis Suppurativa Under Clinical Practice Conditions: A Spanish Multicentre Retrospective Study. / [Artículo traducido] Efectividad de guselkumab en pacientes con hidradenitis supurativa en condiciones de práctica clínica: estudio retrospectivo y multicéntrico en España.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic skin condition causing lesions in which high levels of interleukin (IL)-23 and T-helper17 cells are found. Adalimumab remains the only approved treatment. Guselkumab, an antibody targeting the p19 protein subunit of extracellular IL-23, is approved for the treatment of moderate-severe psoriasis, but evidence on its efficacy in treating HS is limited. OBJECTIVES: To assess the effectiveness and safety of guselkumab in treating moderate-severe HS under clinical practice conditions. METHODS: A multicentre retrospective observational study was carried out in 13 Spanish hospitals including adult HS patients treated with guselkumab within a compassionate use programme (March 2020-March 2022). Data referred to patient demographic and clinical characteristics at treatment initiation (baseline), patient-reported outcomes (Numerical Pain Rating Scale [NPRS] and Dermatology Life Quality Index [DLQI]), physician scores (International Hidradenitis Suppurativa Severity Score System [IHS4], HS Physical Global Score [HS-PGA] and Hidradenitis Suppurativa Clinical Response [HiSCR]) were recorded at baseline and at 16, 24, and 48weeks of treatment. RESULTS: A total of 69 patients were included. Most (84.10%) had severe HS (HurleyIII) and had been diagnosed for over ten years (58.80%). The patients had been subjected to multiple non-biological (mean: 3.56) or biological (mean: 1.78) therapies, and almost 90% of those treated with biologics had received adalimumab. A significant decrease in IHS4, HS-PGA, NPRS, and DLQI scores was observed from baseline to 48weeks of guselkumab treatment (all P<.01). HiSCR was achieved in 58.33% and 56.52% of the patients at 16 and 24weeks, respectively. Overall, 16 patients discontinued treatment, mostly due to inefficacy (n=7) or loss of efficacy (n=3). No serious adverse events were observed. CONCLUSIONS: Our results indicate that guselkumab may be a safe and effective therapeutic alternative for patients with severe HS that fail to respond to other biologics.

The Effectiveness of Guselkumab in Patients With Hidradenitis Suppurativa Under Clinical Practice Conditions: A Spanish Multicentre Retrospective Study.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic skin condition causing lesions in which high levels of interleukin (IL)-23 and T-helper 17 cells are found. Adalimumab remains the only approved treatment. Guselkumab, an antibody targeting the p19 protein subunit of extracellular IL-23, is approved for the treatment of moderate-severe psoriasis, but evidence on its efficacy in treating HS is limited. OBJECTIVES: To assess the effectiveness and safety of guselkumab in treating moderate-severe HS under clinical practice conditions. METHODS: A multicentre retrospective observational study was carried out in 13 Spanish Hospitals including adult HS patients treated with guselkumab within a compassionate use programme (March 2020-March 2022). Data referred to patient demographic and clinical characteristics at treatment initiation (baseline), patient-reported outcomes (Numerical Pain Rating Scale [NPRS] and Dermatology Life Quality Index [DLQI]), physician scores (International Hidradenitis Suppurativa Severity Score System [IHS4], HS Physical Global Score [HS-PGA] and Hidradenitis Suppurativa Clinical Response [HiSCR]) were recorded at baseline and at 16, 24, and 48 weeks of treatment. RESULTS: A total of 69 patients were included. Most (84.10%) had severe HS (Hurley III) and had been diagnosed for over ten years (58.80%). The patients had been subjected to multiple non-biological (mean 3.56) or biological (mean 1.78) therapies, and almost 90% of those treated with biologics had received adalimumab. A significant decrease in IHS4, HS-PGA, NPRS, and DLQI scores was observed from baseline to 48 weeks of guselkumab treatment (all p<0.01). HiSCR was achieved in 58.33% and 56.52% of the patients at 16 and 24 weeks, respectively. Overall, 16 patients discontinued treatment, mostly due to inefficacy (n=7) or loss of efficacy (n=3). No serious adverse events were observed. CONCLUSIONS: Our results indicate that guselkumab may be a safe and effective therapeutic alternative for patients with severe HS that fail to respond to other biologics.

Adhesión real al dimetilfumarato en pacientes con esclerosis múltiple remitente-recurrente / Actual adherence to dimethyl fumarate in patients with relapsing-remitting multiple sclerosis

Introducción: La esclerosis múltiple es una enfermedad neurológica crónica con numerosos tratamientos modificadores de la enfermedad disponibles, incluido el dimetilfumarato (DMF), una terapia de primera línea para la esclerosis múltiple remitente-recurrente. Aunque las tasas de discontinuación del DMF suelen ser bajas en los ensayos clínicos, la falta de adhesión al tratamiento se asocia con peores resultados clínicos. Evaluar la adhesión en el mundo real y los factores predictivos es fundamental para mejorar los resultados clínicos de los pacientes. Este estudio evaluó la adhesión al DMF durante 24 meses en una cohorte de pacientes tratados en un centro portugués. Pacientes y métodos: Estudio prospectivo no intervencionista, de un solo centro, con un seguimiento de 24 meses. El estudio incluyó a pacientes adultos con esclerosis múltiple remitente-recurrente tratados con DMF en la práctica clínica habitual. Se calculó la adhesión al DMF y se consideró que los pacientes eran adherentes si el valor estaba por encima del 80%. Se compararon variables clínicas y sociodemográficas entre grupos. Resultados: De los 80 pacientes incluidos, el 74% eran mujeres, con una edad media de 39 años y una edad media en el momento del diagnóstico de 32 años. Veintiséis pacientes no habían recibido tratamiento previo. La adhesión varió entre el 93, el 82 y el 87,5% a los 6, 12 y 24 meses, respectivamente. No se encontraron diferencias entre los pacientes que no habían recibido tratamiento previo y los que sí lo habían recibido. Conclusión: Este análisis en el mundo real mostró una adhesión significativa al tratamiento con DMF durante dos años por parte de los pacientes portugueses. No obstante, estos resultados deben interpretarse considerando los cambios sustanciales en las consultas externas y las diversas restricciones periódicas debidas a la pandemia de COVID-19, que afectaron en gran medida al seguimiento de los pacientes y a la recopilación de datos.(AU)

Introduction: Multiple sclerosis is a chronic neurological disease with numerous disease-modifying treatments available, including dimethyl fumarate (DMF), a first-line therapy for relapsing-remitting multiple sclerosis. Although rates of discontinuation of DMF are generally low in clinical trials, non-adherence to treatment is associated with poorer clinical outcomes. Assessing real-world adherence and predictive factors is critical to be able to improve clinical outcomes for patients. This study evaluated adherence to DMF over 24 months in a cohort of patients treated in a Portuguese healthcare centre. Patients and methods: A prospective, non-interventional, single-centre study with 24 months’ follow-up was conducted. The study included adult patients with relapsing-remitting multiple sclerosis treated with DMF in routine clinical practice. Adherence to DMF was calculated and patients were considered to have adhered if the value was above 80%. Clinical and socio-demographic variables were compared between groups. Results: Of the 80 patients included, 74% were women, with a mean age of 39 years and a mean age of 32 years at diagnosis. Twenty-six patients had not received any previous treatment. Adherence varied between 93, 82 and 87.5% at 6, 12 and 24 months, respectively. No differences were found between patients who had not received any prior treatment and those who had been treated. Conclusion: This real-world analysis showed significant adherence to DMF treatment by Portuguese patients over a period of two years. However, these results must be interpreted in the light of the substantial changes in outpatient consultations and the various periodic restrictions due to the COVID-19 pandemic, which had an important effect on patient follow-up and data collection.(AU)

Clinical Unmet Needs and Treatment Patterns of Paediatric Psoriasis Patients: A Real-World Evidence Study in Spain / Necesidades clínicas no satisfechas y patrones de tratamiento de los pacientes pediátricos con psoriasis: estudio de evidencia en el mundo real en España

Background and objective Real-world evidence of paediatric psoriasis (PsO) is lacking in Spain. The purpose of this study was to identify physician-reported disease burden and current treatment patterns in a real-world paediatric PsO patient cohort in Spain. This will enhance our understanding of the disease and contribute to the development of regional guidelines. Material and method This retrospective analysis of a cross-sectional market research survey assessed the clinical unmet needs and treatment patterns in patients with paediatric PsO in Spain, as reported by their primary care and specialist physicians, using data collected as part of the Adelphi Real World Paediatric PsO Disease-Specific Program (DSP™) between February and October 2020. Results Survey data from 57 treating physicians were included (71.9% [N=41] dermatologists, 17.6% [N=10] general practitioners/primary care physicians, and 10.5% [N=6] paediatricians); the final analysis included 378 patients. At sampling, 84.1% (318/378) of patients had mild disease, 15.3% (58/378) had moderate disease and 0.5% (2/378) had severe disease. Retrospectively reported physician-judged severity at the time of PsO diagnosis recorded 41.8% (158/378) of patients with mild disease, 51.3% (194/378) with moderate disease and 6.9% (26/378) with severe disease. Overall, 89.3% (335/375) of patients were currently receiving topical PsO therapy, while 8.8% (33/375), 10.4% (39/375) and 14.9% (56/375) of patients were currently receiving phototherapy, conventional systemics and biologics, respectively. Conclusions These real-world data reflect the current burden and treatment landscape of paediatric PsO in Spain. The management of patients with paediatric PsO could be improved by further educating healthcare professionals and developing regional guidelines (AU)

Antecedente y objetivo En España se carece de evidencia sobre psoriasis (PsO) pediátrica en el mundo real. El objetivo de este estudio fue identificar la carga de la enfermedad reportada por el facultativo y los patrones actuales de tratamiento en una cohorte de pacientes psoriásicos pediátricos en el mundo real. Ello ampliará nuestra comprensión de la enfermedad y contribuirá al desarrollo de directrices regionales. Material y método Este análisis retrospectivo transversal de una encuesta de investigación mercado evaluó las necesidades clínicas no satisfechas y los patrones de tratamiento en pacientes con PsO pediátrica en España, según lo reportado por sus médicos de atención primaria y especialistas, utilizando datos recopilados como parte del Disease-specific program (DSP™) de Adelphi para PsO pediátrica en el mundo real, entre los meses de febrero y octubre de 2020. Resultados Se incluyeron los datos de la encuesta realizada a 57 facultativos médicos tratantes (71,9% [N=41] de dermatólogos, 17,6% [N=10] de médicos generales de atención primaria y 10,5% [N=6] de pediatras); el análisis final incluyó 378 pacientes. En la muestra, el 84,1% (318/378) de los pacientes padeció enfermedad leve, el 15,3% (58/378) enfermedad moderada y el 0,5% (2/378) enfermedad severa. De acuerdo con el reporte retrospectivo, la gravedad juzgada por el facultativo en el momento de diagnosticarse la PsO pediátrica registró un 41,8% (158/378) de pacientes con enfermedad leve, un 51,3% (194/378) con enfermedad moderada y un 6,9% (26/378) con enfermedad severa. En general, el 89,3% (335/375) de los pacientes recibía en la actualidad terapia tópica para PsO pediátrica, mientras que el 8,8% (33/375), el 10,4% (39/375) y el 14,9% (56/375) de los pacientes recibía en la actualidad fototerapia, sistémicos y biológicos convencionales, respectivamente. Conclusiones Estos datos del mundo real reflejan la carga actual y el panorama de la PsO pediátrica en España (AU)

[Artículo traducido] Necesidades clínicas no satisfechas y patrones de tratamiento de los pacientes pediátricos con psoriasis: estudio de evidencia en el mundo real en España / Clinical Unmet Needs and Treatment Patterns of Paediatric Psoriasis Patients: A Real-World Evidence Study in Spain

Antecedente y objetivo En España se carece de evidencia sobre psoriasis (PsO) pediátrica en el mundo real. El objetivo de este estudio fue identificar la carga de la enfermedad reportada por el facultativo y los patrones actuales de tratamiento en una cohorte de pacientes psoriásicos pediátricos en el mundo real. Ello ampliará nuestra comprensión de la enfermedad y contribuirá al desarrollo de directrices regionales. Material y método Este análisis retrospectivo transversal de una encuesta de investigación mercado evaluó las necesidades clínicas no satisfechas y los patrones de tratamiento en pacientes con PsO pediátrica en España, según lo reportado por sus médicos de atención primaria y especialistas, utilizando datos recopilados como parte del Disease-specific program (DSP™) de Adelphi para PsO pediátrica en el mundo real, entre los meses de febrero y octubre de 2020. Resultados Se incluyeron los datos de la encuesta realizada a 57 facultativos médicos tratantes (71,9% [N=41] de dermatólogos, 17,6% [N=10] de médicos generales de atención primaria y 10,5% [N=6] de pediatras); el análisis final incluyó 378 pacientes. En la muestra, el 84,1% (318/378) de los pacientes padeció enfermedad leve, el 15,3% (58/378) enfermedad moderada y el 0,5% (2/378) enfermedad severa. De acuerdo con el reporte retrospectivo, la gravedad juzgada por el facultativo en el momento de diagnosticarse la PsO pediátrica registró un 41,8% (158/378) de pacientes con enfermedad leve, un 51,3% (194/378) con enfermedad moderada y un 6,9% (26/378) con enfermedad severa. En general, el 89,3% (335/375) de los pacientes recibía en la actualidad terapia tópica para PsO pediátrica, mientras que el 8,8% (33/375), el 10,4% (39/375) y el 14,9% (56/375) de los pacientes recibía en la actualidad fototerapia, sistémicos y biológicos convencionales, respectivamente. Conclusiones Estos datos del mundo real reflejan la carga actual y el panorama de la PsO pediátrica en España (AU)

Background and objective Real-world evidence of paediatric psoriasis (PsO) is lacking in Spain. The purpose of this study was to identify physician-reported disease burden and current treatment patterns in a real-world paediatric PsO patient cohort in Spain. This will enhance our understanding of the disease and contribute to the development of regional guidelines. Material and method This retrospective analysis of a cross-sectional market research survey assessed the clinical unmet needs and treatment patterns in patients with paediatric PsO in Spain, as reported by their primary care and specialist physicians, using data collected as part of the Adelphi Real World Paediatric PsO Disease-Specific Program (DSP™) between February and October 2020. Results Survey data from 57 treating physicians were included (71.9% [N=41] dermatologists, 17.6% [N=10] general practitioners/primary care physicians, and 10.5% [N=6] paediatricians); the final analysis included 378 patients. At sampling, 84.1% (318/378) of patients had mild disease, 15.3% (58/378) had moderate disease and 0.5% (2/378) had severe disease. Retrospectively reported physician-judged severity at the time of PsO diagnosis recorded 41.8% (158/378) of patients with mild disease, 51.3% (194/378) with moderate disease and 6.9% (26/378) with severe disease. Overall, 89.3% (335/375) of patients were currently receiving topical PsO therapy, while 8.8% (33/375), 10.4% (39/375) and 14.9% (56/375) of patients were currently receiving phototherapy, conventional systemics and biologics, respectively. Conclusions These real-world data reflect the current burden and treatment landscape of paediatric PsO in Spain. The management of patients with paediatric PsO could be improved by further educating healthcare professionals and developing regional guidelines (AU)

Clinical Unmet Needs and Treatment Patterns of Paediatric Psoriasis Patients: A Real-World Evidence Study in Spain. / [Artículo traducido] Necesidades clínicas no satisfechas y patrones de tratamiento de los pacientes pediátricos con psoriasis: estudio de evidencia en el mundo real en España.

BACKGROUND AND OBJECTIVE: Real-world evidence of paediatric psoriasis (PsO) is lacking in Spain. The purpose of this study was to identify physician-reported disease burden and current treatment patterns in a real-world paediatric PsO patient cohort in Spain. This will enhance our understanding of the disease and contribute to the development of regional guidelines. MATERIAL AND METHOD: This retrospective analysis of a cross-sectional market research survey assessed the clinical unmet needs and treatment patterns in patients with paediatric PsO in Spain, as reported by their primary care and specialist physicians, using data collected as part of the Adelphi Real World Paediatric PsO Disease-Specific Program (DSP™) between February and October 2020. RESULTS: Survey data from 57 treating physicians were included (71.9% [N = 41] dermatologists, 17.6% [N = 10] general practitioners/primary care physicians, and 10.5% [N = 6] paediatricians); the final analysis included 378 patients. At sampling, 84.1% (318/378) of patients had mild disease, 15.3% (58/378) had moderate disease and 0.5% (2/378) had severe disease. Retrospectively reported physician-judged severity at the time of PsO diagnosis recorded 41.8% (158/378) of patients with mild disease, 51.3% (194/378) with moderate disease and 6.9% (26/378) with severe disease. Overall, 89.3% (335/375) of patients were currently receiving topical PsO therapy, while 8.8% (33/375), 10.4% (39/375) and 14.9% (56/375) of patients were currently receiving phototherapy, conventional systemics and biologics, respectively. CONCLUSIONS: These real-world data reflect the current burden and treatment landscape of paediatric PsO in Spain. The management of patients with paediatric PsO could be improved by further educating healthcare professionals and developing regional guidelines.

Análise de impacto orçamentário dos inibidores da PARP no tratamento do carcinoma de ovário avançado a partir de evidências de mundo real sob a perspectiva de um hospital federal referência em oncologia / Budget impact analysis of PARP inhibitors in the treatment of advanced ovarian cancer from on real-world evidence the perspective of a federal hospital reference in oncology

Objetivo: Avaliar o impacto orçamentário do tratamento com iPARP como primeira linha de manutenção, comparado ao tratamento-padrão a partir de evidências de mundo real sob a perspectiva de um hospital público referência em oncologia no Rio de Janeiro. Métodos: Foi aplicada uma análise de impacto orçamentário para estimar a introdução das tecnologias iPARP, olaparibe e niraparibe, em comparação com o cenário referência, utilizando dados de eficácia e evidências de mundo real, e considerando os custos globais de tratamento da doença em cinco anos. Este estudo foi aprovado pelo Comitê de Ética em Pesquisa, CAAE: 95157018.9.0000.5274. Resultados: A análise demonstrou que o cenário referência apresentou um impacto orçamentário no valor de R$ 3.578.768,04 em cinco anos. No cenário alternativo, o custo incremental do olaparibe chegou a ser 23,8% maior, comparado ao niraparibe, atingindo um custo de R$ 23.736.459,20 versus R$ 18.076.951,81, respectivamente. Os parâmetros que apresentaram maior impacto nas análises para a tecnologia olaparibe foram a difusão da tecnologia e o preço do medicamento. Contudo, para o niraparibe, os parâmetros de maior impacto foram a duração do tratamento, a difusão da tecnologia e a dose utilizada, demonstrando maior suscetibilidade de variação. Conclusão: Os iPARP no tratamento de pacientes com carcinoma de ovário avançado, apesar de apresentarem custo incremental de aproximadamente R$ 23 milhões em cinco anos, apontam para uma potencial redução de custos associados à progressão da doença.

Objective: Assess the budgetary impact of treatment with iPARP as a first line of maintenance, compared to standard treatment based on real-world evidence from the perspective of a public hospital reference in oncology at Rio de Janeiro. Methods: A budget impact analysis was applied to estimate the introduction of iPARP, olaparib and niraparib technologies, compared to the reference scenario, using efficacy data and real-world evidence, and considering the global costs of treating the disease in five years. This study was approved by the Research Ethics Committee, CAAE: 95157018.9.0000.5274. Results: The analysis showed that the reference scenario presented a budgetary impact of R$ 3,578,768.04 in five years. In the alternative scenario, the incremental cost of olaparib reached 23.8% higher compared to niraparib, reaching a cost of R$ 23,736,459.20 versus R$ 18,076,951.81, respectively. The parameters that had the greatest impact on the analyzes for the olaparib technology were technology diffusion and drug price. However, for niraparib, the parameters with the greatest impact were the duration of treatment, the diffusion of the technology and the dose used, demonstrating greater susceptibility to variation. Conclusion: iPARP in the treatment of patients with advanced ovarian carcinoma, despite having an incremental cost of approximately R$ 23 million in five years, point to a potential reduction in costs associated with disease progression.

Descripción de la logística para una expedición humanitaria de alta producción quirúrgica de cirugías de cataratas / Logistics description of a high yield cataract surgery non-profitable expedition

Objetivo Describir el método logístico para realizar una campaña humanitaria de alto volumen quirúrgico. Método Estudio descriptivo basado en la experiencia tras múltiples campañas humanitarias con el objetivo de operar cataratas. Resultados El método se basa en la planificación, búsqueda de financiación, captación de voluntarios, acuerdo con el país a colaborar, organización y puesta en marcha de la campaña humanitaria a nivel clínico y quirúrgico. Conclusiones La ceguera por catarata puede ser evitada. Consideramos que con esta planificación otras organizaciones pueden adquirir conocimientos para tomar bases y poder realizar campañas humanitarias similares. La planificación, la coordinación, el apoyo económico, el esfuerzo y la buena voluntad es imprescindible para el buen funcionamiento y desarrollo de una campaña humanitaria exitosa (AU)

Purpose To describe the logistics and methodology of a high yield surgical non-profitable campaign. Methods A descriptive study based on previous non-profitable campaigns dedicated to cataract surgery. Results The method is based on planification, finance acquisition, volunteer support, foreign affairs with the collaborating country where the surgeries are going to be performed, team organization, and overall, summoning all the stated items to materialize a global humanitarian campaign to eradicate cataracts by clinical and surgical procedures. Conclusions Blindness due to cataracts can be over-ruled. We consider that through our planification and methodology, other organizations may acquire some knowledge to improve their methodology and carry out similar volunteering surgical campaigns. Planification, coordination, financial aid, determination, and a strong will power are altogether compulsory for a successful non-profitable surgical campaign (AU)

Clinical Unmet Needs and Treatment Patterns of Paediatric Psoriasis Patients: A Real-World Evidence Study in Spain.

BACKGROUND AND OBJECTIVE: Real-world evidence of paediatric psoriasis (PsO) is lacking in Spain. The purpose of this study was to identify physician-reported disease burden and current treatment patterns in a real-world paediatric PsO patient cohort in Spain. This will enhance our understanding of the disease and contribute to the development of regional guidelines. MATERIAL AND METHOD: This retrospective analysis of a cross-sectional market research survey assessed the clinical unmet needs and treatment patterns in patients with paediatric PsO in Spain, as reported by their primary care and specialist physicians, using data collected as part of the Adelphi Real World Paediatric PsO Disease-Specific Program (DSP™) between February and October 2020. RESULTS: Survey data from 57 treating physicians were included (71.9% [N=41] dermatologists, 17.6% [N=10] general practitioners/primary care physicians, and 10.5% [N=6] paediatricians); the final analysis included 378 patients. At sampling, 84.1% (318/378) of patients had mild disease, 15.3% (58/378) had moderate disease and 0.5% (2/378) had severe disease. Retrospectively reported physician-judged severity at the time of PsO diagnosis recorded 41.8% (158/378) of patients with mild disease, 51.3% (194/378) with moderate disease and 6.9% (26/378) with severe disease. Overall, 89.3% (335/375) of patients were currently receiving topical PsO therapy, while 8.8% (33/375), 10.4% (39/375) and 14.9% (56/375) of patients were currently receiving phototherapy, conventional systemics and biologics, respectively. CONCLUSIONS: These real-world data reflect the current burden and treatment landscape of paediatric PsO in Spain. The management of patients with paediatric PsO could be improved by further educating healthcare professionals and developing regional guidelines.

Prevalencia de diabetes, características epidemiológicas y complicaciones vasculares / Prevalence of diabetes, epidemiological characteristics and vascular complications

Resumen Objetivo: Estimar la prevalencia de diabetes en atención ambulatoria y describir sus características epidemiológicas, comorbilidades y complicaciones vasculares relacionadas. Método: Corte transversal que incluyó la totalidad de adultos afiliados a la prepaga del Hospital Italiano de Buenos Aires en marzo de 2019, Argentina. Resultados: La prevalencia global de diabetes resultó del 8.5% con intervalo de confianza del 95% (IC95%): 8.3-8.6 (12,832 de un total de 150,725 afiliados). El estrato etario con mayor prevalencia fue el grupo entre 65 y 80 años, con un 15.7% (IC95%: 15.3-16.1). Las personas con diabetes presentaban una media de edad de 70 años (desviación estándar: 14), el 52% eran mujeres, y los factores de riesgo cardiovasculares más frecuentemente asociados fueron: dislipidemia (88%), hipertensión arterial (74%) y obesidad (55%). En relación con el control metabólico, el 60% tenía al menos una hemoglobina glucosilada medida en el último año, siendo el 70% de estas menores al 7%. Casi el 80% tiene medido el colesterol vinculado a lipoproteínas de baja densidad (c-LDL) al menos una vez en los últimos dos años, de ellos el 55% presentaba un valor de c-LDL igual o menor a 100 mg/dl. Las complicaciones macrovasculares presentes en orden de frecuencia fueron: infarto agudo de miocardio (11%), accidente cerebrovascular (8%) y enfermedad vascular periférica (4%); mientras que las complicaciones microvasculares resultaron ser neuropatía diabética (4%) y retinopatía (2%). El 7% tuvo pie diabético, con menos del 1% de amputaciones. Conclusiones: La diabetes representa un problema prevalente, incluso en pacientes ancianos. Esta población sigue presentando un elevado riesgo cardiovascular, con escaso cumplimiento de objetivos terapéuticos.

Abstract Objective: To estimate prevalence of diabetes in outpatient care and to describe its epidemiological characteristics, comorbidities, and related vascular complications. Methods: Observational cross-sectional study which included all adults affiliated from a private insurance health plan on March 2019, at Hospital Italiano de Buenos Aires, from Argentina. Results: The global prevalence of diabetes resulted in 8.5% with 95% CI 8.3-8.6 (12,832 out of a total of 150,725 affiliates). The age stratum with the highest prevalence was the group between 65 and 80 years old with 15.7% (95% CI 15.3-16.1). People with diabetes had a mean age of 70 years (SD 14), 52% were women, and the most frequently associated cardiovascular risk factors were: dyslipidaemia (88%), arterial hypertension (74%) and obesity (55%). In relation to metabolic control, 60% had at least one glycosylated hemoglobin measured in the last year, 70% of which were less than 7%. Almost 80% have LDL measured at least once in the last 2 years, 55% of them had an LDL value equal to or less than 100 mg/dl. The macrovascular complications present in order of frequency were: acute myocardial infarction (11%), cerebrovascular accident (8%) and peripheral vascular disease (4%); while the microvascular complications were found to be diabetic neuropathy (4%) and retinopathy (2%). 7% had diabetic foot, with less than 1% amputations. Conclusion: Diabetes represents a prevalent problem, even in elderly patients. This population continues to present a high cardiovascular risk, with little compliance with therapeutic goals.

Use of hospital resources in ICU inpatients with infections caused by carbapenem-resistant Gram-negative bacteria: A real clinical practice-based study in Spain / Uso de recursos hospitalarios en pacientes hospitalizados en UCI debido a infecciones causadas por bacterias gramnegativas resistentes a carbapenémicos: un estudio basado en la práctica clínica real en España

Introduction: Carbapenem-resistant Gram-negative bacteria (CRGN) are an urgent public health threat because of the limited treatment options, its rapid spreading and high clinical impact and mortality rates. However, the burden and the use of resources of these infections have not been investigated. The aim of the current study is to understand the use of resources associated to the clinical management of CRGN infections in real clinical practice conditions. Methods: An observational retrospective chart review study was performed. Data regarding patient demographics, clinical management and use of resources associated to hospitalization were retrieved from clinical charts of ICU inpatients with a confirmed CRGN infection. Three reference Spanish hospitals were selected according to their patient volume and geographical coverage. Descriptive analyses of the clinical management and the use of resources and its cost were performed and then total costs by type of resource were calculated. Results: A total of 130 patients were included in the study. The higher number of patients (n=43; 33%) were between 61 and 70 years old. Ninety-four (72%) patients were male and 115 (88%) suffered from comorbidities. The mean total cost associated to the resources used in patients with CRGN infections hospitalized in ICU was 96,878€ per patient. These total costs included 84,140€ of total hospital stay, 11,021€ of treatments (558€ of antibiotics; 10,463€ of other treatments) and 1717€ costs of diagnostic tests. Conclusions: CRGN infection causes a high use of hospital resources, being the length of stay either in hospital wards or ICU the driver of the total costs. Diagnostic tests and treatments, including antibiotics, represent the lowest part of the use of resources and costs (13% of total costs).(AU)

Introducción: Las bacterias gramnegativas resistentes a carbapenémicos (CRGN) son una amenaza urgente de salud pública por las limitadas opciones de tratamiento, su rápida dispersión y el alto impacto clínico y tasas de mortalidad. Sin embargo, la carga y el uso de recursos de estas infecciones no han sido investigadas. El objetivo de este estudio es comprender el uso de recursos asociado al manejo clínico de las infecciones por CRGN en condiciones de práctica clínica real. Métodos: Se llevó a cabo un estudio observacional retrospectivo de revisión de historias clínicas. Se recogieron datos demográficos, del manejo clínico y del uso de recursos asociado a la hospitalización de historias clínicas de pacientes hospitalizados en UCI con una infección confirmada por CRGN. Se seleccionaron tres hospitales españoles de referencia por su cobertura geográfica. Se realizaron análisis descriptivos del manejo clínico y el uso de recursos y sus costes en episodios de infecciones por CRGN, y se calcularon los costes totales para cada tipo de recurso. Resultados: Se incluyeron en el estudio un total de 130 pacientes. La mayoría de los pacientes (n=43;33%) tenían entre 61-70 años. Noventa y cuatro pacientes (72%) eran hombres y 115 (88%) presentaron comorbilidades. El coste medio total asociado a los recursos usados durante el episodio de infección por CRGN por paciente fue de 96.878€. Este coste total incluye 84.140€ de la estancia en el hospital, 11.021€ de los tratamientos (558€ de antibióticos y 10.463€ de otros tratamientos) y 1.717€ del coste de test diagnósticos. Conclusiones: El episodio de infección por CRGN causa un alto uso de recursos hospitalarios, siendo la duración de la estancia tanto en planta hospitalaria como en UCI el factor con mayor peso de los costes totales. Los test diagnósticos clínicos y los tratamientos, incluyendo los antibióticos, representan la parte más pequeña del uso de recursos y sus costes (13% del coste total).(AU)