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No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD.RAPIDA was an open-label, single-arm, prospective, multicenter clinical trial. Adult patients with moderately-to-severely active luminal CD, anti-TNF-naïve, and unresponsive to conventional therapy were treated with adalimumab. Clinical disease activity, QoL and inflammatory biomarkers were measured at day 4, and weeks 1, 2, 4, and 12 after treatment initiation.Eighty-six patients were included in the intention-to-treat (ITT) analyses. Clinical disease activity was reduced from a median of 9.0 points to 6.0 points at day 4. Clinical response (≥ 3-point reduction in the Harvey-Bradshaw Index, HBI) was achieved by 61.6% (d4) and 75.6% (w1) of patients in the ITT population (median 2.5 days) and with non-responder imputation (NRI), by 55.8% and 53.4%, respectively. The proportion of patients in clinical remission (HBI5) at weeks 2 and 4 in the ITT population was 54.7% and 62.8%, respectively (median 7.0 days), and 38.4% and 45.3% in the NRI population. All QoL scores significantly improved and inflammatory biomarkers significantly decreased from day 4 onwards (p0.0001).Rapid clinical response and remission, improvement in QoL and fatigue, and a reduction of inflammatory biomarkers were achieved with adalimumab as early as day 4 in adult anti-TNF-naïve patients with moderately-to-severely active CD.

Background: To evaluate the cost-effectiveness of tofacitinib in comparison to vedolizumab for the treatment of moderate-to-severe ulcerative colitis (UC) after failure or intolerance to conventional therapy (bio-naive) or first-line biologic treatment (bio-experienced), from the Spanish National Health System (NHS) perspective. Methods: A lifetime Markov model with eight-week cycles was developed including five health states: remission, response, active UC, remission after surgery, and death. Response and remission probabilities (for induction and maintenance periods) were obtained from a multinomial network meta-analysis. Drug acquisition – biosimilar prices included – (ex-factory price with mandatory deductions), adminis- tration, surgery, patient management, and adverse event management costs (€, year 2019) were considered. A 3% discount rate (cost/outcomes) was applied. Probabilistic and deterministic sensitivity analyses (PSA) were conducted. Results: Tofacitinib was dominant versus vedolizumab (both in bio-naive and bio-experienced patients) entailing total cost savings of €23,816 (bio-naïve) and €11,438 (bio-experienced). Differences in quality- adjusted life-year (QALY) were smaller than 0.1 for both populations. PSA results showed that tofacitinib has a high probability of being cost-effective (bio-naïve: 82.5%; bio-experienced: 90.6%) versus vedolizumab. Conclusions: From the Spanish NHS perspective, tofacitinib could be a dominant treatment (less costly and more effective) in comparison to vedolizumab, with relevant cost savings and similar QALY gains.

Resumen Introduccion Desde la publicacion de la primera edicion de la Guia en 2013, se ha generado mucha informacion en torno al tratamiento de la colitis ulcerosa, y se han introducido nuevos farmacos y protocolos de actuacion. La practica clinica ha variado substancialmente, lo que justifica nuevas aproximaciones y una revision exhaustiva, asi como la actualizacion de la evidencia. Material y metodos Se utiliza nuevamente metodologia GRADE, apoyados en una herramienta electronica ( https://gradepro.org ). Los escenarios clinicos son los mismos que en la version previa (induccion y mantenimiento en brote grave y en brote leve-moderado), asi como las variables y su evaluacion. En la guia actualizada, en relacion a la version previa, se eliminan tres preguntas, se anaden 14 y se mantienen 30, con un total de 44 preguntas clinicas. Tras una exhaustiva revision de la evidencia, se actualizan las recomendaciones. Resultados De las 44 preguntas analizadas, en dos de ellas no se ha podido establecer ninguna recomendacion por muy baja calidad de la evidencia, mientras que en las 42 restantes, basados en diferentes grados de calidad de evidencia, se ha formulado una recomendacion de acuerdo con el sistema GRADE. En 25 de estas preguntas la recomendacion final es fuerte a favor; en seis, fuerte en contra; mientras que en siete es debil a favor, y en cuatro debil en contra. Siguiendo los escenarios y las recomendaciones, se proponen seis algoritmos como guia sencilla en la toma de decisiones practicas. Conclusiones Esta actualizacion de la guia previa publicada en 2013 intenta dar respuesta basada en la metodologia GRADE a las diferentes preguntas que nos hacemos diariamente a la hora de decidir el tratamiento mas adecuado de nuestros pacientes con colitis ulcerosa en los diferentes escenarios clinicos.

Resumen Introduccion Ustekinumab, anticuerpo monoclonal que bloquea las interleucinas 12/23, ha demostrado en ensayos clinicos su eficacia para inducir y mantener la remision clinica en la enfermedad de Crohn (EC). Su efectividad y su seguridad en la practica clinica real es menos conocida y podria diferir respecto a los ensayos. Objetivo Evaluar en la practica clinica su efectividad y seguridad (pauta de induccion intravenosa esencialmente), como induccion y a largo plazo, en pacientes con EC refractarios a tratamiento biologico. Material y metodos Analisis retrospectivo multicentrico (6 hospitales aragoneses), que incluye a todos los pacientes (N = 69) con EC en tratamiento con ustekinumab (fuese con induccion intravenosa o subcutanea) que hubiesen alcanzado al menos 16 semanas de seguimiento. La respuesta o remision clinica se ha evaluado en las semanas 16, 24, 32 y 48 mediante el indice de Harvey-Bradshaw. Resultados Se han incluido un total de 69 pacientes, edad media 42 anos, 54% hombres. Un 89,86% (IC 95% [0,805, 0,949]) de los pacientes ha presentado mejoria clinica en la semana 16 (15,95% remision, 73,92% respuesta). En el seguimiento posterior dicha respuesta se ha mantenido. Se han identificado mediante un modelo de regresion ordinal la edad (OR 0,95, p = 0.028) y el habito tabaquico (OR 0,19, p = 0,027) como predictores de mala respuesta al tratamiento, mientras que la necesidad de cambio de biologico por efecto adverso (OR 96, p = 0,00017) y por perdida de respuesta secundaria (OR 7,07, p = 0,034) han sido factores predictores de buena respuesta. No se han reportado efectos adversos graves que obligasen a interrumpir el tratamiento con ustekinumab. Conclusion Ustekinumab es efectivo y seguro en la practica clinica real para lograr la induccion y el mantenimiento de la respuesta en pacientes con EC refractaria. El tabaco y la edad han mostrado ser predictores de mala respuesta, mientras que la indicacion por efecto adverso a biologico previo y por perdida de respuesta secundaria han mostrado ser predictores de buena respuesta.

Recollemos nesta colección sete dos oito traballos premiados no que foi a terceira edición do Premio UDC Sustentabilidade a Traballos de Fin de Grao e Mestrado, correspondente ao ano 2020. A resolución desta convocatoria fíxose pública o 5 de xuño de 2021, Día Mundial do Medio Ambiente, e con ela a UDC celebrou a efeméride aínda no marco das restricións derivadas da alarma sanitaria da covid. A convocatoria destes premios xurdiu dunha proposta recibida desde a Facultade de Ciencias da Educación no marco do programa internacional Green Campus, e que finalmente a Oficina de Medio Ambiente materializou. Con ela búscase avanzar na sustentabilidade curricular, fortalecer a vinculación co currículo do traballo en sustentabilidade nos centros da UDC e promover a sensibilización e participación activa do estudantado. Esta terceira edición dos premios dirixiuse a traballos realizados no ano 2020. Presentouse un total de 29 traballos, 19 de grao e 10 de mestrado, de 11 centros diferentes e de catro das cinco grandes áreas de coñecemento (a ausente foi, neste caso, Arte e Humanidades). Cómpre salientarmos que, dado o carácter transversal da sustentabilidade, como xa pon de manifesto o programa Green Campus ao falar de «vinculación ao currículo», todas as áreas de coñecemento están chamadas a participar e son igualmente candidatas a estes premios. Seguindo os criterios da convocatoria, a comisión avaliadora valorou a calidade da memoria publicable, a relación coa temática da sustentabilidade e a orixinalidade dos traballos, así como a súa achega aos obxectivos de desenvolvemento sustentable (ODS) da ONU e ao compromiso social da UDC, alén da aplicabilidade dos estudos e as investigacións aos propios campus e centros da UDC. Desexamos que esta iniciativa contribúa a manter e mellorar o pulo pola sustentabilidade na UDC.

A physiographic-based multilinear regression model supported by GIS was developed to estimate spatial rainfall variability in the Southwest Iberian Peninsula. The area study includes a wide diversity of landscape features and comprises four Portuguese regions and one Spanish province (totalizing 28,860 km(2)). The region suffers a very strong Mediterranean influence, with a major cleavage between winter and summer seasons. Thus, the analysis was carried out separately for the wet (October to March) and dry (April to September) semesters. From an initial set of 10 explanatory physiographic variables, five were selected to be used in the multilinear regression, as they allowed generating models by map algebra that fitted well with the last 40 years of monthly rainfall data records. These records were obtained from 163 weather stations, filtered from an initial set of 230 (142 stations in Portugal and 88 in Spain). The correlation between the physiographic-based multilinear regression model and a model obtained by interpolation from rainfall historical data showed to be good or very good in approximately 75% of the area under study. Results show that physiographic-based models can be effectively used to estimate rainfall where there is a lack of rain gauges, or to densify spatial resolution of rainfall between rain gauges. info:eu-repo/semantics/publishedVersion

Objetivo La medida de los resultados percibidos por el paciente en la asistencia de la enfermedad inflamatoria intestinal (EII) adquiere cada vez más importancia. Existe una herramienta sencilla y validada en inglés para este fin: el «IBD-Control». Nuestro objetivo es traducirlo al español, adaptarlo y validarlo. Pacientes y métodos Se tradujo el IBD-Control, generando el instrumento en español «EII-Control», y se validó prospectivamente. Los pacientes cumplimentaban el EII-Control y otros cuestionarios que servían de comparadores de referencia. El gastroenterólogo realizaba una valoración global de la enfermedad, calculaba índices de actividad y registraba el tratamiento. Un subgrupo de pacientes repitió toda la valoración en una segunda visita. Se analizó también la utilidad de escalas resumidas del EII-Control (el EII-Control-8 y el EII-Control-EVA). Resultados Se incluyeron 249 pacientes con EII (101 repitieron la segunda visita). Estándares psicométricos del test: consistencia interna: α de Cronbach para EII-Control 0,83 con fuerte correlación entre EII-Control-8 y EII-Control-EVA (r = 0,5); reproducibilidad: correlación intraclase 0,70 para EII-Control; validez de constructo: correlaciones de moderadas a fuertes entre EII-Control, EII-Control-8 y EII-Control-EVA frente a comparadores; validez discriminante: p

COVID-19; Immunosuppression; Inflammatory bowel disease COVID-19; Immunosupressió; Malaltia inflamatòria intestinal COVID-19; Inmunosupresión; Enfermedad inflamatoria intestinal (1) Scant information is available concerning the characteristics that may favour the acquisition of COVID-19 in patients with inflammatory bowel disease (IBD). Therefore, the aim of this study was to assess these differences between infected and noninfected patients with IBD. (2) This nationwide case−control study evaluated patients with inflammatory bowel disease with COVID-19 (cases) and without COVID-19 (controls) during the period March−July 2020 included in the ENEIDA of GETECCU. (3) A total of 496 cases and 964 controls from 73 Spanish centres were included. No differences were found in the basal characteristics between cases and controls. Cases had higher comorbidity Charlson scores (24% vs. 19%; p = 0.02) and occupational risk (28% vs. 10.5%; p < 0.0001) more frequently than did controls. Lockdown was the only protective measure against COVID-19 (50% vs. 70%; p < 0.0001). No differences were found in the use of systemic steroids, immunosuppressants or biologics between cases and controls. Cases were more often treated with 5-aminosalicylates (42% vs. 34%; p = 0.003). Having a moderate Charlson score (OR: 2.7; 95%CI: 1.3−5.9), occupational risk (OR: 2.9; 95%CI: 1.8−4.4) and the use of 5-aminosalicylates (OR: 1.7; 95%CI: 1.2−2.5) were factors for COVID-19. The strict lockdown was the only protective factor (OR: 0.1; 95%CI: 0.09−0.2). (4) Comorbidities and occupational exposure are the most relevant factors for COVID-19 in patients with IBD. The risk of COVID-19 seems not to be increased by immunosuppressants or biologics, with a potential effect of 5-aminosalicylates, which should be investigated further and interpreted with caution.

Malaltia de Crohn; Factors predictius; Ustekinumab Enfermedad de Crohn; Factores predictivos; Ustekinumab Crohn’s disease; Predictive factors; Ustekinumab Ustekinumab has shown efficacy in Crohn’s Disease (CD) patients. To identify patient profiles of those who benefit the most from this treatment would help to position this drug in the therapeutic paradigm of CD and generate hypotheses for future trials. The objective of this analysis was to determine whether baseline patient characteristics are predictive of remission and the drug durability of ustekinumab, and whether its positioning with respect to prior use of biologics has a significant effect after correcting for disease severity and phenotype at baseline using interpretable machine learning. Patients’ data from SUSTAIN, a retrospective multicenter single-arm cohort study, were used. Disease phenotype, baseline laboratory data, and prior treatment characteristics were documented. Clinical remission was defined as the Harvey Bradshaw Index ≤ 4 and was tracked longitudinally. Drug durability was defined as the time until a patient discontinued treatment. A total of 439 participants from 60 centers were included and a total of 20 baseline covariates considered. Less exposure to previous biologics had a positive effect on remission, even after controlling for baseline disease severity using a non-linear, additive, multivariable model. Additionally, age, body mass index, and fecal calprotectin at baseline were found to be statistically significant as independent negative risk factors for both remission and drug survival, with further risk factors identified for remission. This work was supported by Janssen-Cilag Spain. This sponsor had a partial role in study design, analysis, and interpretation of data.

OBJECTIVES 1)To analyze evidence about poor adherence / non-adherence including their prevalences, associated factors, and interventions in ulcerative colitis (UC) patients; 2)To provide a framework to improve poor adherence / non-adherence. METHODS A qualitative approach was applied. A literature review was performed using Medline. Primary searches were performed with Mesh and free texts to identify articles that analyzed prevalence, causes, associated factors, and interventions designed to improve poor adherence/ non-adherence in UC patients. The studies' quality was evaluated using the Oxford scale. The results were presented and discussed in a nominal group meeting, comprising a multidisciplinary committee of six gastroenterologists, one psychologist, one nurse, and one patient. Several overarching principles and recommendations were generated. A consensus procedure was implemented via a Delphi process during which each committee member produced a score ranging from 0 = totally disagree to 10 = totally agree. Agreement was considered if at least 70% of the participants voted ≥7. RESULTS The literature review included 75 articles. Non-adherence rates ranged from 7%-72%. We found a great variability in the methods employed to assess adherence, associated factors, and interventions designed to improve adherence. Overall, eight overarching principles and six recommendations were generated, all of them achieving the pre-established agreement level, including, among others, the identification, classification, and management of non-adherence. CONCLUSIONS Poor adherence / non-adherence are common in UC patients, being a relevant clinical concern. Health professionals should address this issue and actively involve the patients in implementing effective and individualized interventions to improve adherence.

Background and Aims Clinical trials and real-life studies with ustekinumab in Crohn’s disease [CD] have revealed a good efficacy and safety profile. However, these data are scarcely available in elderly patients. Therefore, we aim to assess the effectiveness and safety of ustekinumab in elderly patients with CD. Methods Elderly patients [>60 years old] from the prospectively maintained ENEIDA registry treated with ustekinumab due to CD were included. Every patient was matched with two controls under 60 years of age, according to anti-tumour necrosis factor use and smoking habit. Values for the Harvey–Bradshaw Index [HBI], endoscopic activity, C-reactive protein [CRP] and faecal calprotectin [FC] were recorded at baseline and at weeks 16, 32 and 54. Results In total, 648 patients were included, 212 of whom were elderly. Effectiveness was similar between young and elderly patients during the follow-up. Steroid-free remission was similar at week 16 [54.6 vs 51.4%, p = 0.20], 32 [53.0% vs 54.5%, p = 0.26] and 54 [57.8% vs 51.1%, p = 0.21]. Persistence of ustekinumab as maintenance therapy was similar in both age groups [log-rank test; p = 0.91]. There was no difference in the rate of adverse effects [14.2% vs 11.2%, p = 0.350], including severe infections [7.1% vs 7.3%, p = 1.00], except for the occurrence of de novo neoplasms, which was higher in older patients [0.7% vs 4.3%, p = 0.003]. Conclusions Ustekinumab is as effective in elderly patients with CD as it is in non-elderly patients. The safety profile also seems to be similar except for a higher rate of de novo neoplasms, probably related to the age of the elderly patients.

Research about the variability of sand size inside the hopper of a trailing suction dredger has yet to be done, despite its importance for beach nourishment projects. In this study, several samples were taken using different methodologies during dredging for a particular case of beach nourishment on board one dredger. Sampling was carried out with a tube core and a Van Veen grab at the surface when the hopper was full of sand. The results showed problems with the Van Veen grab, the standard methodology used for sampling aboard a dredger. This method should be reconsidered in the future because surface samples were not representative of the whole hopper due to the bias of higher percentage of shell pieces. According to the results, the core tubes introduced by percussion were the only useful method in determining average sand parameters closer to the values obtained for the borrow site. Moreover, cores also showed a linear correlation between sand size and depth: D50 increased 20% from the surface to 1 m depth; this is a sixth of the hopper depth of this study case. Regrettably, the manual percussion procedure could not reach depths greater than 1 m.

BACKGROUND There are limited data of ustekinumab administered according to the doses recommended in the UNITI studies. AIM To assess the real-world, short-term effectiveness of ustekinumab in refractory Crohn's disease (CD) METHODS: Multicentre study of CD patients starting ustekinumab after June 2017 at the recommend dose (260, 390 or 520 mg based on weight ~6 mg/kg IV week 0 and 90 mg subcutaneously week 8). Values for Harvey-Bradshaw Index (HBI), C-reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 8 and 14. Demographic and clinical data, previous treatments, AEs and hospitalisations were documented. Possible predictors of clinical remission were examined. RESULTS Three hundred and five patients were analysed (≥2 previous anti-TNFα therapies 64% and vedolizumab 29%). At baseline, 217 (72%) had an HBI >4 points. Of these, 101 (47%) and 126 (58%) achieved clinical remission at weeks 8 and 14, respectively. FC levels returned to normal (

Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the "IBD-Control". Our aim is to translate it into Spanish, adapt and validate it.The IBD-Control was translated into the Spanish instrument "EII-Control" and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed.A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status.The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.

The size and great dynamism of coastal systems require faster and more automated mapping methods like the use of a remotely piloted aircraft system (RPAS) or unmanned aerial vehicle (UAV). This method allows for shorter intervals between surveys. The main problem for surveying using low-altitude digital photogrammetry in beach areas is their visual homogeneity. Obviously, the fewer the homologous points defined by the program, the lower the accuracy. Moreover, some factors influence the error performed in photogrammetric techniques, such as flight height, flight time, percentage of frame overlap (side and forward), and the number of ground control points (GCPs). A total of 72 different cases were conducted varying these factors, and the results were analyzed. Among the conclusions, it should be highlighted that the error for noon flights is almost double that for the early morning flights. Secondly, there is no appreciable difference regarding the side overlap. But, on the other side, RMSE increased to three times (from 0.05 to 0.15 m) when forward overlap decreased from 85% to 70%. Moreover, relative accuracy is 0.05% of the flying height which means a significant increase in error (66%) between flights performed at 60 and 100 m height). Furthermore, the median of the error for noon flights (0.12 m) is almost double that for the early morning flights (0.07 m) because of the higher percentage of grids with data for early flights. Therefore, beach levelings must never be performed at noon when carried out by RPAS. Eventually, a new parameter has been considered: the relationship between the number of GCPs and the surface to be monitored. A minimum value of 7 GCP/Ha should be taken into account when designing a beach leveling campaign using RPAS., Fundacion Campus Tecnologico de Algeciras; Coastal Engineering Research group (University of Cadiz)

This work presents some of the results obtained from a survey research that is currently being conducted among water users in the Barbate River basin area. The purpose of the survey questionnaires is to evaluate the use, opinions and extent of knowledge of the local population about water resources, especially groundwater, in the region. The questionnaires are also aimed at assessing citizens’ perception of potential impacts on surface and groundwater resources, their evolution in the last decades regarding aspects such as quantity and quality, or the effects of climate change among others through the lens of their own experience. This information is of major importance in a space such as the Barbate River basin, where the marked seasonal pattern of precipitation, the prevalence of the primary sector (agriculture and livestock farming) as the main economic engine of the region and the increasing pressures and demands on hydrogeological systems are decisive factors in the development of management strategies. First-hand knowledge of citizens’ perception is crucial to promote the cooperation between water users, manage conflicts and create synergies in a context of global change.

In recent years, the Copernicus programme developed by the European Space Agency (ESA) has enabled to improve our knowledge on the functioning of hydrological systems and water management. The added value of Copernicus lies in its open access and adequate time–space resolution that in combination with other datasets on land use, climate or hydrology makes it a powerful tool to monitor irrigated areas, assess irrigation performance or identify illegal abstractions. The present work is focused on the exploitation of the Benalup aquifer, which is located in the Barbate River Basin (Southern Spain) and has been declared as in poor quantitative and qualitative status by the Public Administration. The use of remote sensing techniques has allowed to identify the time–space distribution of irrigation in agricultural plots supplied with groundwater, the only available hydric resource in the area. The results obtained reveal a marked seasonality in the existing crops and a mismatch between the irrigated plots that have been identified by remote sensing techniques and those with irrigation license. This study evidences the potential of remote sensing for promoting a sustainable water use through the identification of illegal groundwater pumping that is of major importance in a context of climate change.

The uncertainty in traditional hydrological modeling is a challenge that has not yet been overcome. This research aimed to provide a new method called the hybrid causal&ndash, hydrological (HCH) method, which consists of the combination of traditional rainfall&ndash, runoff models with novel hydrological approaches based on artificial intelligence, called Bayesian causal modeling (BCM). This was implemented by building nine causal models for three sub-basins of the Barbate River Basin (SW Spain). The models were populated by gauging (observing) short runoff series and from long and short hydrological runoff series obtained from the T&eacute, mez rainfall&ndash, runoff model (T-RRM). To enrich the data, all series were synthetically replicated using an ARMA model. Regarding the results, on the one hand differences in the dependence intensities between the long and short series were displayed in the dependence mitigation graphs (DMGs), which were attributable to the insufficient amount of data available from the hydrological records and to climate change processes. The similarities in the temporal dependence propagation (basin memory) and in the symmetry of DMGs validate the reliability of the hybrid methodology, as well as the results generated in this study. Consequently, water planning and management can be substantially improved with this approach.

Background Data on the long-term administration of ustekinumab in recommended doses are limited. Aim To assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn's disease (CD). Methods Multicenter study of CD patients starting ustekinumab at the recommended dose, followed for 1 year. Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs) and hospitalisations were documented. Potential predictors of remission were examined. Results A total of 407 patients were analysed. The initial maintenance dose of 90 mg SC was administered every 12, 8 and 4 weeks in 56 (14%), 347 (85%) and 4 (1%) patients, respectively. After 52 weeks, treatment was discontinued in 112 patients (27.5%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal in 44% and 54% of patients at weeks 26 and 52, and CRP returned to normal in 36% and 37% of patients at weeks 26 and 52, respectively. AEs were recorded in 60 patients. The use of fewer previous anti-TNFα agents and ileal localisation were associated with clinical remission, and endoscopic severity was associated with poor response. No factors correlated with endoscopic remission. Conclusion After 52 weeks, ustekinumab demonstrated effectiveness to induce clinical and endoscopic remission with safety in patients with refractory CD.

Since the first edition of the Guidelines was published in 2013, much information has been generated around the treatment of ulcerative colitis, and new drugs and action protocols have been introduced. Clinical practice has changed substantially, warranting new approaches and a comprehensive review and update of the evidence.Once again, we used the GRADE approach, supported by an electronic tool (https://gradepro.org). The clinical scenarios are the same as in the previous version (induction and maintenance in severe and mild-moderate flare-ups), as are the variables and their evaluation. However, in the updated guidelines, three questions have been deleted, 14 added and 30 maintained, making a total of 44 clinical questions. After an exhaustive review of the evidence, the recommendations are now updated.Of the 44 questions analysed, no recommendation could be established in two due to the very low quality of the evidence, while in the other 42, based on different degrees of quality of evidence, recommendations were made according to the GRADE system. In 25 of these questions the final recommendation is strongly in favour, in six strongly against, in seven weakly in favour and in four weakly against. According to the scenarios and recommendations, six algorithms are proposed as a simple guide for practical decision-making.The aim of this update of the 2013 guidelines is to provide answers, based on the GRADE approach, to the different questions we ask ourselves daily when deciding the most appropriate treatment for our patients with ulcerative colitis in the different clinical scenarios.

This is the peer reviewed version of the following article: Changes in the requirement for early surgery in inflammatory bowel disease in the era of biological agents. Journal of Gastroenterology and Hepatology (2020): 29 April, which has been published in final form at https://doi.org/10.1111/jgh.15084. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions, Biological therapies may be changing the natural history of inflammatory bowel diseases, reducing the need for surgical intervention. We aimed to assess whether the availability of anti‐TNF agents impacts the need for early surgery in Crohn's disease (CD) and ulcerative colitis (UC). Methods Retrospective, cohort study of patients diagnosed within a 6‐year period before and after the licensing of anti‐TNFs (1990‐1995 and 2007‐2012 for CD; 1995‐2000 and 2007‐2012 for UC) were identified in the ENEIDA Registry. Surgery‐free survival curves were compared between cohorts. Results A total of 7,370 CD patients (2,022 in Cohort 1 and 5,348 in Cohort 2) and 8,069 UC patients (2,938 in Cohort 1 and 5,131 in Cohort 2) were included. Immunosuppressants were used significantly earlier and more frequently in both CD and UC post‐biological cohorts. The cumulative probability of surgery was lower in CD following anti‐TNF approval (16% and 11%, 22% and 16%, and 29% and 19%, at 1, 3 and 5 years, respectively p

Background Post-marketing data are required to confirm the durability and the long-term benefit and safety of UST in CD in clinical practice. Our aims were: (1) to evaluate the retention rate of UST in CD patients and to identify predictive factors of UST discontinuation; (2) to assess UST short-term effectiveness; (3) to analyse the durability of the response to UST in the long-term; and (4) to evaluate the safety of UST in clinical practice. Methods Retrospective, multicentre study (>60 centres). Patients with active CD [(Harvey–Bradshaw (HBI) >4)] that received at least one dose of UST intravenously before July 2018 were included. Clinical activity plus biochemical parameters were assessed at every UST administration. Clinical remission was defined as HBI score ≤4, and clinical response as a decrease in HBI ≥3 points. Loss of efficacy was defined as reappearance of symptoms that led to intensify the treatment dose, add another medication to control CD, switching or surgery in patients with short-term remission. The retention rate of UST treatment and the cumulative incidence of loss of efficacy were evaluated by survival curves, and predictive factors were assessed by Cox-regression. The short-term response was evaluated at week 8 and after the induction (week 16). Factors associated with short-term remission were assessed by multivariate analysis. Adverse events were recorded. Data quality was assured by remote monitoring. Results 331 CD patients have been included up to date (Table 1). The incidence rate of UST discontinuation was 15% per patient-year of follow-up: 8%, 13% and 20% at 6, 12 and 18 months (Figure 1). Previous surgery was the only factor associated with a higher risk of UST discontinuation [Hazard ratio (HR) = 2.03, 95% confidence interval (CI) = 1.1–3.6]. Short-term efficacy is shown in Figure 2. Previous surgery (OR = 0.3, 95% CI = 0.2–0.6) and higher HBI score at baseline (OR = 0.8, 95% CI=0.8–0.9) were associated with an impaired response to UST at week 16. The cumulative incidence of loss of response was 32% per-patient-year of follow-up (Figure 3); A higher HBI score at baseline was associated with a higher risk of losing response (HR = 1.2, 95% CI = 1.1–1.3). Neither the concomitant treatment with immunosuppressants nor the number of previous biologics were associated with UST short- and long-term benefit. Thirty adverse events were reported in 25 (7%) patients (Table 2). Conclusion Sustain is the largest real clinical practice study of UST to treat CD patients with the longest follow-up reported to date. UST was demonstrated to be effective in real-world use in the short and long run. Safety was consistent with the known profile of UST.

The standardized precipitation index (SPI) provides reliable estimations about the intensity, magnitude and spatial extent of droughts in a variety of time scales based on long-term precipitation series. In this work, we assess the evolution of monthly precipitation in the Barbate River basin (S. Iberian Peninsula) between 1910/11 and 2017/18 through the generation of a representative precipitation series for the 108-year period and the subsequent application of the SPI. This extensive series was obtained after processing all the precipitation data (67 stations) available within and nearby the basin and subsequent complex gap-filling stages. The SPI identified 26 periods of drought, 12 of them severe and 6 extreme, with return periods of 9 and 18 years, respectively. Complementary analysis evidenced changes in precipitation cyclicity, with periodicities of 5 and 7–8 years during the first and second half of the study period, respectively. Additionally, the amplitude of pluviometric oscillations increased during the second half of the period, and extreme events were more frequent. While the decade 1940–1950 was very dry, with precipitation 11% below the basin’s average, 1960–1970 was very humid, with precipitation 23% above average. Contrary to the results of climate change projections specific to this area, a clear downward trend in precipitation is not detected.

Background Biological drugs for moderate-to-severe ulcerative colitis have changed the therapeutic perspective, while small-molecule inhibitors and new promising drugs suggest new options. Aim Assess comparative efficacy and safety of biological and new small oral drugs: commercialized and under-investigation ones for patients naïve to biological drugs. Methods A systematic review was conducted to identify the randomized clinical trials phase 2 or 3, in adults with moderate-to-severe ulcerative colitis treated with biological drugs (infliximab, adalimumab, golimumab, vedolizumab and etrolizumab) or new oral small molecules (tofacitinib and ozanimod) as first line. A Bayesian network metaanalysis was performed to inform comparative efficacy and safety of different treatments. Efficacy outcomes were clinical remission, clinical response and mucosal healing for induction therapy and clinical remission, mucosal healing and sustained clinical remission for maintenance therapy. Safety was assessed with serious adverse events and rates of infections. Results 14 references were included for network meta-analysis. For induction therapy, infliximab was the best drug for induction of clinical response and remission, while ozanimod showed to be the best for induction of mucosal healing. Tofacitinib had the highest rate of maintaining clinical remission. All treatments were similar for serious adverse events, and vedolizumab and tofacitinib had the highest rates of infections. Conclusion This network meta-analysis suggests infliximab may be the best therapeutic option for moderate-to-severe ulcerative colitis. Vedolizumab seems to have better outcomes in maintenance than in induction therapy and it appears superior to golimumab and adalimumab. Tofacitinib, ozanimod and etrolizumab show encouraging results.