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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.

Background Ustekinumab is a monoclonal antibody that inhibits interleukins (IL)- 12 and -23 and it is approved for the treatment of Crohn's disease (CD) and more recently also ulcerative colitis (UC). Our aim was to evaluate the effectiveness and safety of Ustekinumab, as well as to identify possible predictive factors of response in a real-life setting. Methods Observational, retrospective, and multicenter study carried out in 4 hospitals in Andalusia. Adult patients with a confirmed diagnosis of CD treated with Ustekinumab from 2017 to 2019 were included. Clinical response was analyzed at 3, 6, and 12 months of treatment. Clinical disease activity was assessed with the Harvey Bradshaw index (HBI) and the Crohn's Disease Activity Index (CDAI), and the biochemical response was assessed with analytical parameters such as CRP and ESR. One-year ustekinumab drug-survival was analyzed. Results 98 patients were analyzed (mean age 43 and 52% men). 56% had failed to ≥2 previous biologicals therapies. At 3 months, 69% of the patients were in response and 40.8% in remission. At 6 months, 56% were in clinical remission. At 12 months, 73.7% in clinical response and 60.5% in remission. Corticosteroid-free remission was 32.4%, 44%, 47.4% at 3, 6, and 12 months, respectively. The cumulative survival at one year of treatment with ustekinumab was 85.3%. Biochemical parameters, such as CRP and ESR showed a statistically significant decrease between baseline and control levels at 3, 6, and 12 months. A lower HBI at baseline and female sex were predictors of corticosteroid-free clinical remission in a univariate analysis. In the multivariate analysis, no variables were found as predictors of corticosteroid-free clinical remission Conclusion: Ustekinumab therapy is safe and useful inducing a clinical response in more than 50% of patients including patients who have failed other biological therapies.

Secondary non-response to biological treatments tends to occur in a high number of patients who undergo treatment with antiTNF, and it has also been observed in patients treated with vedolizumab or ustekinumab. The initial rescue guideline recommends intensifying the treatment by reducing the interval or increasing maintenance dosage. In the case of ustekinumab, the patients who began this treatment prior to its approval for treatment of Crohn's disease, were given a subcutaneous induction with no defined guideline and a maintenance dosage of 90 mg every eight weeks. Following secondary non-response in these patients, it was proposed that rescue be undertaken via intravenous reinduction adjusted for weight. We present a case of a patient with Crohn's disease with failure to respond to infliximab, adalimumab and vedolizumab who began treatment with ustekinumab prior to official approval. There was non-response at eight months but remission was achieved after reinduction with ustekinumab, adjusted for weight. This rescue guideline could be a cost-effective way to reinduce remission in this group of patients.

In recent months, cases of IBD have been reported in the context of treatment with secukinumab, a monoclonal antibody that blocks IL-17A and which is used in the treatment of certain rheumatic disorders. We present a case of a patient with psoriatic arthritis, with a first-degree relative who had suffered ulcerative colitis, who presented with onset ulcerative colitis in the weeks following treatment initiation with this drug.

Background The ideal length of treatment with thiopurines in patients with ulcerative colitis (UC) in sustained remission remains unknown. It is widely accepted that the drug withdrawal is associated with a worse outcome. The aim of this study was to analyze the outcome after this withdrawal and to identify predictors of relapse. Methods A multicenter and retrospective study was designed. A total of 102 patients with UC who discontinued thiopurines in a situation of sustained remission were included. All the patients were followed up until last revision or until relapse (understood as the occurrence of signs and symptoms of UC that required a rescue treatment). Results After thiopurines withdrawal, overall relapse was recorded in 32.35% of the patients: 18.88% in the first year, 36.48% in the third, and 43.04% in the fifth year after withdrawal. On multivariate analysis, predictors of relapse were the time from diagnosis of UC until the starting of thiopurines (hazard ratio [HR], 1.01; 95% confidence interval [CI], 1.01-1.02; P = 0.039), the number of relapses before the withdrawal (HR, 1.3; 95% CI, 1.01-1.66; P = 0.029), pancolitis (HR, 5.01; 95% CI, 1.95-26.43; P = 0.028), the duration of treatment with thiopurines (HR, 0.15; 95% CI, 0.03-0.66; P = 0.013) and the situation of biological remission at withdrawal (HR, 0.004; 95% CI, 0.0001-0.14; P = 0.002). Conclusions The withdrawal of thiopurines in patients with UC, although in sustained remission, is related to a high relapse rate. Clinical variables such as the extent of the disease, the duration of treatment or time from diagnosis to the start of thiopurines should be considered before stopping these drugs.

RESUMEN Introducción: la anemia ferropénica es una manifestación común y muy relevante de la enfermedad inflamatoria intestinal (EII). Aunque se han publicado guías de práctica clínica y puestas al día sobre el tema, el manejo práctico de esta complicación dista de ser óptimo. Objetivo: conocer el manejo real, las necesidades y las limitaciones de la anemia en la EII mediante una encuesta a especialistas de digestivo. Material y métodos: encuesta telemática autoadministrada, realizada entre abril- mayo 2017, y dirigida a socios de la SEPD con actividad clínica. La encuesta incluye cuatro apartados: demografía de los participantes, monitorización, tratamiento y limitaciones/necesidades. Resultados: ciento veintidós encuestas evaluables procedentes de todas las comunidades autónomas. La anemia ferropénica se considera una manifestación frecuente de la EII y que se monitoriza en todos los pacientes mediante determinación de la hemoglobina y la ferritina. En caso de anemia, los encuestados consideran necesario descartar la existencia de actividad de la EII, aunque solo el 14,8% indica el hierro intravenoso si la EII está activa. La dosis necesaria de hierro intravenoso es mayoritariamente calculada según las necesidades del paciente, pero solo el 33,1% utiliza dosis por infusión de 1 g o más elevadas. Conclusiones: la encuesta "Gestiona Hierro EII" sobre el manejo de la anemia en la EII demuestra una alta calidad asistencial, pero con aspectos a mejorar como la indicación de hierro intravenoso en los pacientes con actividad, el uso de hierro intravenoso de altas dosis o la aplicación de algoritmos en la práctica asistencial. ABSTRACT Introduction: iron deficiency anemia is a common and very relevant manifestation of inflammatory bowel disease (IBD). Although clinical practice guidelines have been published and updated on this subject, the management in the daily practice of this complication is far from optimal. Objective: to determine the actual management, needs and limitations of anemia in IBD by means of a survey of gastroenterology specialists. Material and methods: a self-administered telematic survey was carried out between April and May 2017 and was sent to SEPD members. The survey included four sections: participant demographics, monitoring, treatment and limitations/needs. Results: a total of 122 evaluable surveys were received from all Spanish autonomous communities. Iron deficiency anemia is considered as a frequent manifestation of IBD and is monitored in all patients via the measurement of hemoglobin and ferritin. In the case of anemia, the survey respondents found it necessary to rule out the presence of IBD activity. However, only 14.8% prescribed intravenous iron when IBD was active. The required dose of intravenous iron is mainly calculated according to patient needs but only 33.1% of clinicians infused doses of 1 g or more. Conclusions: the "Gestiona Hierro EII" survey on the management of anemia in IBD demonstrated a high quality of care, even though some aspects need to be improved. These included the prescription of intravenous iron for patients with disease activity, the use of high-dose intravenous iron and the implementation of algorithms into clinical practice.

RESUMEN Introducción: la anemia ferropénica es una manifestación común y muy relevante de la enfermedad inflamatoria intestinal (EII). Aunque se han publicado guías de práctica clínica y puestas al día sobre el tema, el manejo práctico de esta complicación dista de ser óptimo. Objetivo: conocer el manejo real, las necesidades y las limitaciones de la anemia en la EII mediante una encuesta a especialistas de digestivo. Material y métodos: encuesta telemática autoadministrada, realizada entre abril- mayo 2017, y dirigida a socios de la SEPD con actividad clínica. La encuesta incluye cuatro apartados: demografía de los participantes, monitorización, tratamiento y limitaciones/necesidades. Resultados: ciento veintidós encuestas evaluables procedentes de todas las comunidades autónomas. La anemia ferropénica se considera una manifestación frecuente de la EII y que se monitoriza en todos los pacientes mediante determinación de la hemoglobina y la ferritina. En caso de anemia, los encuestados consideran necesario descartar la existencia de actividad de la EII, aunque solo el 14,8% indica el hierro intravenoso si la EII está activa. La dosis necesaria de hierro intravenoso es mayoritariamente calculada según las necesidades del paciente, pero solo el 33,1% utiliza dosis por infusión de 1 g o más elevadas. Conclusiones: la encuesta "Gestiona Hierro EII" sobre el manejo de la anemia en la EII demuestra una alta calidad asistencial, pero con aspectos a mejorar como la indicación de hierro intravenoso en los pacientes con actividad, el uso de hierro intravenoso de altas dosis o la aplicación de algoritmos en la práctica asistencial.

Common variable immunodeficiency (CVID) is the most frequent primary antibody deficiency. It is characterized by recurrent bacterial infections, and occurrence of autoimmune and neoplastic diseases is also frequent; there is also a high prevalence of gastrointestinal diseases. There are reports of inflammatory bowel disease in this entity, but incidence is low (2-4 %). We present the case of a patient with common variable immunodeficiency suffering a chronic diar-rhoea episode and who was diagnosed with ileocaecal Crohn's-like disease after performing intestinal transit, CT abdomen and colonoscopy with biopsy. It was first treated with prednisone but on -showing cortisone dependency, treatment with azathioprine and adalimumab was started, with good results.

Background: Fecal biomarkers, especially fecal calprotectin, are useful for predicting endoscopic activity in Crohn’s disease; however, the cut-off point remains unclear. The aim of this paper was to analyze whether faecal calprotectin and M2 pyruvate kinase are good tools for generating highly accurate scores for the prediction of the state of endoscopic activity and mucosal healing. Methods: The simple endoscopic score for Crohn’s disease and the Crohn’s disease activity index was calculated for 71 patients diagnosed with Crohn’s. Fecal calprotectin and M2-PK were measured by the enzyme-linked immunosorbent assay test. Results: A fecal calprotectin cut-off concentration of ≥ 170 μg/g (sensitivity 77.6%, specificity 95.5% and likelihood ratio +17.06) predicts a high probability of endoscopic activity, and a fecal calprotectin cut-off of ≤ 71 μg/g (sensitivity 95.9%, specificity 52.3% and likelihood ratio -0.08) predicts a high probability of mucosal healing. Three clinical groups were identified according to the data obtained: endoscopic activity (calprotectin ≥ 170), mucosal healing (calprotectin ≤ 71) and uncertainty (71 > calprotectin < 170), with significant differences in endoscopic values (F = 26.407, p < 0.01). Clinical activity or remission modified the probabilities of presenting endoscopic activity (100% vs 89%) or mucosal healing (75% vs 87%) in the diagnostic scores generated. M2-PK was insufficiently accurate to determine scores. Conclusions: The highly accurate scores for fecal calprotectin provide a useful tool for interpreting the probabilities of presenting endoscopic activity or mucosal healing, and are valuable in the specific clinical context.

Phenotypic Characteristics and Use of Therapeutic Resources in Elderly-Onset Inflammatory Bowel Disease: A Multicentre, Case-Control Study Miriam Manosa, Margalida Calafat, Ruth de Francisco, Carmen Garcia Caparros, Maria Jose Casanova, Patricia Huelin, Marta Calvo, Luis Fernandez Salazar, Miguel Minguez, Alexandra Ruiz-Cerulla, Yamile Zabana, Guillermo Bastida, Joaquin Hinojosa, Lucia Marquez, Manuel Barreiro-de Acosta, Xavier Calvet, David Monfort, Rosario Gomez, Esther Rodriguez, Jose Maria Huguet, Maria Rojas-Feria, Daniel Hervias, Ramon Atienza, David Busquets, Eva Zapata, Carmen Duenas-Sadornil, Mara Charro, Francesc J. Martinez-Cerezo, Rocio Plaza, Juan Maria Vazquez Moron, Javier P. Gisbert, Eduard Cabre, Eugeni Domenech