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Background Female sex has been associated with a worse response to anti-TNF drugs and with discontinuation of these drugs in immune-mediated diseases. Data in Inflammatory Bowel Disease (IBD) are unclear. The aims of study are to assess possible differences in long-term treatment persistence and safety of biological drugs between women and men with IBD. Methods Multicenter observational study carried out with data from the ENEIDA registry. Patients diagnosed with Crohn's disease (CD) or ulcerative colitis (UC) who receive or have received biological drugs, and have had a minimum treatment follow-up of 6 months, were included. We evaluated the first biological treatment used in the patient. Statistic analysis; Regression logistic models were used for safety evaluation. Kaplan-Meier curves, Log-Rank test and COX regression were used to treatment persistance. Results A total of 51,595 patients with IBD were evaluated [ 25,947 with CD (13238 men and 12709 women) and 25,648 with UC (13596 men and 12052 women)]. Mean follow up of 13 years. Biologic use: 28.7% of the evaluated patients had been treated with at least one biologic drug. Biologics use in UC was less common in women than in men (15.5% vs. 17.2%, OR (95%CI): 0.88 (0.81-0.94), p= 0.001) and there were no differences between sexes in CD ( 45.7% in men, 44.7% in women). Infliximab (IFX) and adalimumab (ADA) were the most used drugs (in 8914 and 5269 patients, respectively). Safety evaluation. Women suffered more frequently adverse effects to IFX and ADA than men, being the withdrawal of IFX and ADA due to adverse effects also significantly more frequent in women than in men. Biological treatment persistence in patients with IBD was longer in men than in women [median 3.1 years vs. 2.3 years, p < 0.001]. Female sex was a risk factor of biologic discontinuation [adjusted hazard ratio [aHR] (95%CI): 1.20 (1.14-1.25), p Figure 1. Conclusion 1.The use of biologics in ulcerative colitis seems to be higher in men than in women. 2. Female sex is an independent risk factor for the development of adverse effects to IFX and ADA and for the discontinuation of these drugs. 3. The long-term persistence of IFX and ADA (as first biological treatments) is low, being higher in men compared to women.

PURPOSE: We describe our series of 4 patients with megalencephaly-capillary malformation syndrome (MCAP) and review the literature in order to assess the optimal treatment for the associated hydrocephalus. METHODS: We review our institutional series of hydrocephalus associated with MCAP and review the literature, analyzing the causes that could originate the hydrocephalus and the different types of treatments proposed for them. RESULTS: Of our patients treated with ventriculoperitoneal (VP) shunt, one suffered a surgical revision of the shunt and died due to a cranial trauma unrelated to her syndrome or the previous shunt surgery, and the other did not undergo surgical revisions until the end of her follow-up. Our patients treated with endoscopic third ventriculostomy (ETV) have improved their symptomatology and have not suffered of any complications related to the hydrocephalus after the ETV surgery. CONCLUSIONS: We update the treatment of MCAP-associated hydrocephalus and propose ETV as a valid treatment, as it seems a safe procedure with a low rate of complications.

Background and importance Rasmussen's Encephalitis (RE) is a chronic and progressive childhood disease caused by an inflammatory disorder that affects a cerebral hemisphere. On the other hand, Gliomatosis Cerebri (GC) is a rare primary neoplastic glial process with a diffuse and infiltrative growth. Clinical presentation We present two clinical cases with a history of continuous focal epilepsy refractory to antiepileptic drugs. They share similar clinical and radiologic features, but a different histopathological diagnosis. A brain biopsy was needed to distinguish GC from a RE. Conclusion The debut of a drug-resistant epilepsy with focal seizures and an ipsilateral progressive hemiparesis suggests the diagnosis of RE. However, there are other entities such as GC, which, despite its rarity, should be considered in the differential diagnosis. So, in some cases, histological diagnosis is needed.

Resumen Objetivo Los objetivos principales son describir la practica de la ventilacion mecanica en un periodo de 18 anos en Mexico y estimar los cambios en la mortalidad de los pacientes criticos con ventilacion mecanica invasiva (VMI). Diseno Subanalisis retrospectivo de un estudio prospectivo y observacional en 1998, 2004, 2010 y 2016. Ambito Unidades de Cuidados Intensivos (UCI) de Mexico. Participantes Pacientes adultos que ingresaron consecutivamente en la UCI, durante un mes y que recibieron VMI durante mas de 12 h o ventilacion mecanica no invasiva durante mas de una hora. El seguimiento se realizo hasta 28 dias despues de la inclusion. Intervenciones Ninguna. Variables de interes Edad, sexo, gravedad al ingreso estimada por el SAPS II, parametros de la gasometria arterial diaria, variables de tratamiento y complicaciones, fecha y estado al alta de la UCI y del hospital. Resultados Se incluyo a 959 pacientes en 81 UCI. El volumen corriente (VC) ha disminuido significativamente tanto en pacientes con criterios de SDRA (de 8,5 ml/kg de peso estimado en 1998 a 6 ml/kg en 2016; p Conclusiones La practica clinica de la VMI en las UCI de Mexico se ha modificado a lo largo de un periodo de 18 anos. El cambio mas significativo es la estrategia ventilatoria basada en VC bajos. Estos cambios no se han asociado a cambios significativos en la mortalidad.

Objective The main study objectives were to describe the practice of mechanical ventilation over an 18-year period in Mexico, and estimate changes in mortality among critical patients subjected to invasive mechanical ventilation (IMV). Design A retrospective subanalysis of a prospective observational study conducted in 1998, 2004, 2010 and 2016 was carried out. Setting Intensive Care Units (ICUs) in Mexico. Participants Adult patients consecutively enrolled in the ICU during one month and who underwent IMV for more than 12 h or noninvasive mechanical ventilation for more than one hour. Follow-up was performed up to a maximum of 28 days after inclusion. Interventions None. Principal variables of interest Age, sex, severity upon admission as estimated by SAPS II, parameters of daily arterial blood gases, treatment and complication variables, date and status at discharge from the ICU and from hospital. Results A total of 959 patients were included in 81 ICUs. Tidal volume (vt) decreased significantly both in patients with acute respiratory distress syndrome (ARDS) criteria (estimated 8.5 mL/kg b.w. in 1998 to 6 mL/kg in 2016; P Conclusions The clinical practice of IMV in Mexican ICUs has been modified over a period of 18 years. The most significant change is the ventilatory strategy based on low vt. These changes have not been associated with significant changes in mortality.

Vagus nerve stimulation (VNS) is a surgical treatment available for patients affected by generalized refractory epilepsy. The authors report the case of a 15-year-old girl affected by CHD2-related myoclonic encephalopathy and BLM haploinsufficiency due to a deletion of 15q25.3q26.2 region, who suffered from secondary hemophagocytic lymphohistiocytosis (SHLH) after a VNS wound infection. SHLH has sporadically been described in epileptic patients. Based on indirect evidence that shows immune dysregulation in patients with CHD2 mutations and BLM mutations, we hypothesize that the genetic background of this patient may have played a critical role in the development of the syndrome.

We describe a laser-plasma platform for photon-photon collision experiments to measure fundamental quantum electrodynamic processes such as the linear Breit-Wheeler process with real photons. The platform has been developed using the Gemini laser facility at the Rutherford Appleton Laboratory. A laser wakefield accelerator and a bremsstrahlung convertor are used to generate a collimated beam of photons with energies of hundreds of MeV, that collide with keV x-ray photons generated by a laser heated plasma target. To detect the pairs generated by the photon-photon collisions, a magnetic transport system has been developed which directs the pairs onto scintillation-based and hybrid silicon pixel single particle detectors. We present commissioning results from an experimental campaign using this laser-plasma platform for photon-photon physics, demonstrating successful generation of both photon sources, characterisation of the magnetic transport system and calibration of the single particle detectors, and discuss the feasibility of this platform for the observation of the Breit-Wheeler process. The design of the platform will also serve as the basis for the investigation of strong-field quantum electrodynamic processes such as the nonlinear Breit-Wheeler and the Trident process, or eventually, photon-photon scattering. We describe a laser–plasma platform for photon–photon collision experiments to measure fundamental quantum electrodynamic processes. As an example we describe using this platform to attempt to observe the linear Breit–Wheeler process. The platform has been developed using the Gemini laser facility at the Rutherford Appleton Laboratory. A laser Wakefield accelerator and a bremsstrahlung convertor are used to generate a collimated beam of photons with energies of hundreds of MeV, that collide with keV x-ray photons generated by a laser heated plasma target. To detect the pairs generated by the photon–photon collisions, a magnetic transport system has been developed which directs the pairs onto scintillation-based and hybrid silicon pixel single particle detectors (SPDs). We present commissioning results from an experimental campaign using this laser–plasma platform for photon–photon physics, demonstrating successful generation of both photon sources, characterisation of the magnetic transport system and calibration of the SPDs, and discuss the feasibility of this platform for the observation of the Breit–Wheeler process. The design of the platform will also serve as the basis for the investigation of strong-field quantum electrodynamic processes such as the nonlinear Breit–Wheeler and the Trident process, or eventually, photon–photon scattering.

Background There are limited data of long-term ustekinumab administered according to the doses recommended in the UNITI studies. The objective of this study was to assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn’s disease (CD) (LONG-CROHNUSK Study). Methods Multicentre study of CD patients starting ustekinumab at the recommended dose based on weight ~6 mg/kg IV week 0, 90 mg SC week 8 and maintenance 90 mg SC every 8 or 12 weeks and with 1 year of follow-up. Values for 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), surgeries and hospitalisations were documented. Potential predictors of clinical and endoscopic remission were examined. Results Four hundred and seven patients were analysed (Table 1). For the maintenance dose, ustekinumab 90 mg was administered SC every 12, 8 and 4 weeks in 56 (14%), 318 (84.5%) and 7 (1.5%) patients, respectively. An interval reduction was applied for 118 patients (29%). Before 52 weeks, treatment discontinuation occurred in 71 patients (17%). 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 ( Conclusion This is the first study to show the real-world long-term effectiveness, endoscopic improvement and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients.

Background To analyze hospitalization episodes with an ICD-9 diagnosis code of influenza (codes 487 and 488) in any diagnostic position from 2009 to 2015 in the Spanish hospital surveillance system. Methods Information about age, length of stay in hospital, mortality, comorbidity with an influenza diagnosis code between 1 October 2009 and 30 September 2015 was obtained from the National Surveillance System for Hospital Data (Conjunto Mínimo Básico de Datos, CMBD). Results 52,884 hospital admissions were obtained. A total of 24,527 admissions corresponded to diagnoses ICD-9 code 487 (46.4%), and 28,357 (53.6%) corresponded to ICD-9 code 488. The global hospitalization rates were 8.7 and 10.6 per 100,000 people, respectively. Differences between the two diagnostic groups were found for each of the six analyzed seasons. The diagnostic ICD-9-CM 488, male gender, and high-risk patients classified by risk vaccination groups showed direct relationship with inpatient hospital death. Conclusions Influenza diagnosis was present in a significant number of hospital admissions. The code used for diagnosis (ICD-9-CM 488), male sex, age groups and associated risk clinical conditions showed a direct relationship with inpatient hospital fatality.

Sensory processing in the cortex adapts to the history of stimulation but the mechanisms are not understood. Imaging the primary visual cortex of mice we find here that an increase in stimulus contrast is not followed by a simple decrease in gain of pyramidal cells; as many cells increase gain to improve detection of a subsequent decrease in contrast. Depressing and sensitizing forms of adaptation also occur in different types of interneurons (PV, SST and VIP) and the net effect within individual pyramidal cells reflects the balance of PV inputs, driving depression, and a subset of SST interneurons driving sensitization. Changes in internal state associated with locomotion increase gain across the population of pyramidal cells while maintaining the balance between these opposite forms of plasticity, consistent with activation of both VIP-SST and SST-PV disinhibitory pathways. These results reveal how different inhibitory microcircuits adjust the gain of pyramidal cells signalling changes in stimulus strength.

Background The quantification of rejection treatment efficacy has been insufficient using traditional markers due, in part, to the lagging response of serum creatinine and histologic alterations on biopsy specimens. Donor-derived cell-free DNA (dd-cfDNA) is a molecular marker of injury that may assess allograft injury after rejection. Methods Retrospective review of the DART study identified 70 patients who had a clinically indicated biopsy, simultaneous dd-cfDNA measurement, and at least one follow-up dd-cfDNA within 3 months post-treatment. Thirty-five patients had no biopsy–proven rejection and no rejection treatment (NR), 16 patients had no biopsy–proven rejection but did receive rejection treatment (CR), 9 patients had diagnosis of ABMR/mixed rejection on biopsy and received rejection treatment (ABMR), and 10 patients had diagnosis of TCMR and received rejection treatment (TCMR). The CR, ABMR, and TCMR groups combined to form a rejection (R) group. Results In the R group, median dd-cfDNA values at baseline and 1 month were 0.62% and 0.35% (n=21 pairs, p=0.34), and at baseline and 2-3 months were 0.77% and 0.21% (n=23 pairs, p=0.002). In TCMR, median dd-cfDNA values at baseline and 1 month were 1.13% and 0.37% (n=5 pairs, p=0.63), and at baseline and 2-3 months were 0.25% and 0.12% (n=9 pairs, p=0.004). In ABMR, median dd-cfDNA values at baseline and 1 month were 1.61% and 1.2 % (n=6 pairs, p>0.99), and at baseline and 2-3 months were 3.85% and 1.32% (n=6 pairs, p=0.09). In CR, median dd-cfDNA values at baseline and 1 month were 0.31% and 0.29% (n=10 pairs, p=0.38), and at baseline and 2-3 months were 0.38% and 0.17% (n=8 pairs, p=0.31). Lastly, in NR, median dd-cfDNA values at baseline and 1 month were 0.23% and 0.18% (n=21 pairs, p=0.10), and at baseline and 2-3 months were 0.33% and 0.17% (n=26 pairs, p=0.003). Changes in serum creatinine across 1 month and 2-3 months following rejection were similar. Conclusions dd-cfDNA may be a useful dynamic biomarker to assess the health of the kidney allograft following rejection treatment.

Background: Although not fully understood, diabetes mellitus is thought to be associated with cardiac fibrosis and stiffness due to alteration of myocardial extracellular matrix. Newer cardiac magnetic resonance techniques may be able to identify extracellular matrix expansion by measuring extracellular volume fraction (ECV). We used cardiac magnetic resonance to evaluate the association of alteration in the extracellular matrix with diabetic status and its implications on incident heart failure events and all-cause mortality. Methods: We studied 442 patients who underwent comprehensive contrast cardiac magnetic resonance to assess cardiac morphology and function, left ventricular replacement fibrosis, and pre-post contrast T1 mapping to quantify ECV. The cohort did not have coexisting pathologies associated with ECV alteration. We categorized our final cohort based on diabetic status using criteria from the American Diabetic Association. Subsequent heart failure hospitalization and all-cause death were ascertained. Results: Our patients were predominantly white with a median age of 57 with 48% being men. Compared with nondiabetes mellitus, diabetes mellitus was significantly associated with elevated ECV after adjusting for clinical and imaging covariates: β coefficient 1.33 (95% CI, 0.22–2.44); P =0.02. Over a median follow-up of 24.5 (interquartile range, 14.8–33.4) months, 52 deaths and 24 heart failure events occurred. Patients with diabetes mellitus and elevated ECV had the worst outcomes compared with patients with diabetes mellitus and normal ECV or nondiabetics. Elevated ECV remained an independent predictor of outcomes (hazard ratio, 3.31 [95% CI, 1.93–5.67]; P Conclusions: Elevated ECV is an independent predictor of mortality among patients with diabetes mellitus and may have an additive effect with diabetes mellitus on outcomes. ECV may represent a novel noninvasive biomarker to evaluate severity of diabetic heart disease.

Mixotrophy is a dominant metabolic strategy in ecosystems worldwide. Shifts in temperature (T) and light (i.e. the ultraviolet portion of spectrum (UVR)) are key abiotic factors that modulate the conditions under which an organism is able to live. However, whether the interaction between both drivers alters mixotrophy in a global-change context remains unassessed. To determine the T × UVR effects on relative electron transport rates, nonphotochemical quenching, bacterivory, and bacterial production, we conducted an experiment with Isochrysis galbana populations grown mixotrophically, which were exposed to 5°C of cooling and warming with respect to the control (19°C) with (or without) UVR over light-dark cycles and different timescales. At the beginning of the experiment, cooling inhibited the relative electron transport and bacterivory rates, whereas warming depressed only bacterivory regardless of the radiation treatment. By the end of the experiment, warming and UVR conditions stimulated bacterivory. These reduced relative electron transport rates (c. 50% (warming) and > 70% (cooling)) were offset by increased (35%) cumulative bacterivory rates under warming and UVR conditions. We propose that mixotrophy constitutes an energy-saving and a compensatory mechanism to gain carbon (C) when photosynthesis is impaired, and highlight the need to consider the natural environmental changes affecting the populations when we test the impacts of interacting global-change drivers.

Real-time MRI-guided laser interstitial thermal therapy (LITT) is a challenging procedure due to its technical complexity, as well as the need for efficient multidisciplinary teamwork and transfer of an anesthetized patient between operating room (OR) and magnetic resonance (MR). A highly realistic simulation was developed to design the safest process before being applied to real patients. In this report, authors address the description of the methodology used for this simulation and its purposefulness. The entire image planning, anesthetic, and surgical process were performed on a modified pediatric simulation mannequin with a brain made of medical grade silicone including a hypothalamic hamartoma. Preoperative CT and MR were acquired. Stereotactic insertion of the optical fiber was assisted by the Neuromate® stereotactic robot. Laser ablation was performed with the Medtronic Visualase® MRI-guided system in a 3T Phillips Ingenia® MR scanner. All the stages of the process, participants, and equipment were the same as planned for a real surgery. No critical errors were found in the process design that prevented the procedure from being performed with adequate safety. Specific proposals for team positioning and interaction in patient transfers and in MR room were validated. Some specific elements that could improve safety were identified. Highly realistic simulation has been an extremely useful tool for safely planning LITT, because professionals were able to take actions in the workflow based not on ideas but on lived experiences. It contributed definitively to build a well-coordinated surgical team that worked safely and more efficiently.

The author discusses the public policy implications of current models of disability, arguing that the Americans with Disabilities Act represents the shift from medical to social models and that this shift has resulted in significant progress toward social and economic inclusion for those with disabilities. Yet this vision of society remains incomplete, as the current emphasis on individual accommodation has not led to fundamental social transformation. Drawing on resources in contemporary theologies of disability, the witness of L'Arche, and the author's experience as the parent of a child with significant intellectual and physical disabilities and complex medical needs, the essay calls those with and without disabilities to a life of communion and mutual giving and receiving.

Aim/Purpose: The purpose of this study was to explore how the professional development of two Mexican-American women post-secondary educators was impacted by the reflective literacy practices (RLPs) of their students and themselves. RLPs were defined as verbal and written dialogue that fosters reflection of their learning. Background: Research suggests that RLPs can be empowering for students, yet there is minimal research about the impact that RLPs may have on the post-secondary educators (PSEs) who assign or use them. Methodology: We used critical theory, to conduct a collaborative autoethnographic study exploring how the use of RLPs influenced our professional development as Mexican-American women PSEs. Specifically, we focused on the contrasting nature of three specific concepts related to professional development: (1) voice/silence, (2) masking/expressing of emotions, and (3) empowerment/disempowerment. Contribution: Findings suggest that RLPs help PSEs gain insight about their students and about themselves. These insights facilitate both voice/silence and expressing/masking of emotions within the classroom and during interactions with colleagues. These insights also enable PSEs to enhance their pedagogical voices and to create empowering post-secondary education settings for themselves and for their students. Findings: Two themes emerged in our study: Developing Pedagogical Voice and Becoming Empowered. The first theme had two sub-themes: (1) empowering class discussions and (2) personal experiences that guide our pedagogical voices. The second theme had four sub-themes: (1) dealing with other colleagues, (2) letting go of perfection, (3) 50:50 responsibility, and (4) vulnerability and heart. Recommendations for Practitioners: Our research supports the use of RLPs in post-secondary education settings. However, because our findings also demonstrate how RLPs can contribute to Mexican American PSEs feeling silenced, implications for professionals who work with Mexican American PSEs indicate providing culturally empowering environments that decrease silence. Culturally empowering environments may include research mentorship for Mexican American PSEs, networking opportunities, and diversity recruitment efforts to increase the number of Mexican American women as post-secondary educators. Future Research: Future research should focus on the use of specific types of RLPs, including how technology is changing RLPs.

Valorar el impacto del tratamiento anti-TNF $\upalpha$ en hospitalizaciones y cirugias por enfermedad inflamatoria intestinal (EII). Estudio retrospectivo que compara los ingresos hospitalarios por EII antes y tras el uso de anti-TNF $\upalpha $ , usando como marco de referencia las hospitalizaciones totales del centro y las debidas a enfermedades digestivas. Antes de disponer de los farmacos anti-TNF $\upalpha $ (periodo 1994–2000) los ingresos medicos por EII supusieron el 0,55% del total de los ingresos hospitalarios y el 5,36% de los debidos a patologia digestiva. Una vez disponibles los anti-TNF $\upalpha $ (entre 2001–2010) las hospitalizaciones por EII se redujeron al 0,47% y 3,82% respectivamente, es decir, un 14,54% menos de ingresos medicos por EII respecto de los totales hospitalarios. Con relacion a los debidos a patologias digestivas en su conjunto, los ingresos medicos y quirurgicos por EII se redujeron un 28,73% y un 39,34% respectivamente. La probabilidad de que se produjeran menos ingresos medicos por EII al disponer de anti-TNF $\upalpha $ fue del 45% (OR 1,45; IC 95%: 1,26–1,67; $p < 0{,}001$ ) y del 67% para cirugias en pacientes con EII (OR: 1,67; IC 95%: 1,10–2,54; $p = 0{,}021$ ). En nuestro centro estas cifras suponian una reduccion de 15,3 ingresos medicos/ano y 2,21 cirugias/ano por EII. La disponibilidad de los farmacos anti-TNF $\upalpha $ reduce significativamente los ingresos medicos y quirurgicos en pacientes con EII.

Background The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice. Aims Primary: to evaluate the durability of ustekinumab treatment in UC patients in clinical practice. Secondary: to assess the short-term response (at week 16) and the long-term effectiveness (at maximum follow-up) and to assess the safety of ustekinumab in clinical practice. Methods Patients included in the prospectively maintained ENEIDA registry who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score (PMS) >2] were included. Clinical activity and effectiveness were defined based on PMS. Results 95 patients were included (table 1). At week 16, 53% of patients had clinical response (including 35% of patients in remission) (figure 1). In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with clinical remission. Long-term remission is represented in figure 2. 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at week 16, 63% at week 56, and 59% at week 72 (figure 3); primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. Conclusion Ustekinumab is effective both in the short and the long-term in real-life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.

We sought to determine the relation between myocardial extracellular volume (ECV), left ventricular (LV) diastolic function, and exercise tolerance in patients with hypertrophic cardiomyopathy (HCM). Forty five HCM patients with an ejection fraction >50% and no previous septal reduction therapy underwent imaging by CMR and transthoracic echocardiography. CMR was used to quantify LV volumes, mass, EF, LA volumes, scar burden, pre and post contrast T1 relaxation times and ECV. Echocardiography was used to measure outflow tract gradients, mitral inflow and annular velocities, circumferential strain, systolic, early and late diastolic strain rates. Exercise duration and peak oxygen consumption were noted. HCM patients had increased native T1 relaxation time and ECV vs. controls [ECV controls: 24.7 (23.2–26.4) vs. HCM: 26.8 (24.6–31.3)%, P = 0.014]. Both parameters were significantly associated with LV diastolic dysfunction, circumferential strain, diastolic strain rate and peak oxygen consumption (r = −0.73, P

Background Ustekinumab has shown promising results in ulcerative colitis (UC) in the development program (UNIFI) that should be confirmed in clinical practice. Our aim was to evaluate the effectiveness and safety of ustekinumab in UC in real life. Methods Patients included in the prospectively maintained ENEIDA registry that received at least 1 dose of ustekinumab intravenously due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score (PMS). The short-term response was assessed at week 8 and 16. The last-observation-carried-forward method was used in patients that stopped ustekinumab treatment before week 8 or 16. Variables associated with short-term remission were identified by logistic regression analysis. Data quality was assessed by remote monitoring. Results Forty-seven patients were included (Table 1); all of them had been previously exposed to biologic agents (70% to >2): 100% to anti-TNF and 83% to vedolizumab. A total of 26% had been exposed to tofacitinib. Seventeen patients (36%) had response at week 8 [3 of them (6%) had remission]; 16 patients (34%) had response at week 16 [5 of them (11%) had remission] (Figure 1). There was a statistically significant decrease in C-reactive protein (CRP) concentration during the induction only in patients with a response at week 16 (Figure 2). The proportion of patients with CRP elevated at baseline and at week 8 was higher among non-responders at week 16 (Table 2). In the multivariate analysis, higher PMS at week 8 [odds ratio (OR) = 0.5; 95% confidence interval (CI) = 0.3–0.9)] and CRP over the upper normal limit at week 8 (OR = 0.1; 95% CI = 0.01–0.8) were associated with lower probability of response at week 16; steroids during induction increased the probability of response at week 16 (OR = 8; 95% CI = 1–71). Of patients without response at week 8, only 7% achieved response at week 16. Seventeen out of 31 patients continued ustekinumab beyond week 16, despite being non-responders. Of these 17 patients, 4 reached remission after the third dose, 1 after the fifth and 1 after the seventh one. There were 2 infections, one of them with fatal consequences (in a patient under steroids and tacrolimus due to renal transplant). Conclusion Ustekinumab shows benefit in some UC patients in real practice, even in a very refractory cohort in which the drug was prescribed as last resort. Patient status at week 8 seems to be a good predictor of response after the induction. Safety was consistent with the known profile of ustekinumab.