135 results on '"A Gutiérrez Casbas"'
Search Results
2. Position statement of the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis on sexuality and inflammatory bowel disease
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Calvo Moya, Marta, Mesonero Gismero, Francisco, Suárez Ferrer, Cristina, Hernández-Camba, Alejandro, Aguas Peris, Mariam, González-Lama, Yago, Millán Scheiding, Mónica, Camacho Martel, Laura, Echarri Piudo, Ana, Vera Mendoza, María Isabel, Zabana Abdo, Yamile, Mañosa Ciria, Míriam, Rodríguez-Moranta, Francisco, Barreiro-de Acosta, Manuel, Gutiérrez Casbas, Ana, Suarez Ferrer, Cristina, Vásquez Carlón, Danízar, García Benasach, Fátima, Delgado Oliva, Francisco José, Alonso Sebastián, Isabel, Gallardo Arriero, Vanesa, Bella Castillo, Pablo, Cano Sanz, Noelia, Serrano Labajos, Ruth, Valdivia Martínez, Antonio, Pérez Restoy, Lourdes, and Mañosa Ciria, Miriam
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- 2024
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3. Impact of mesalazine on the response to COVID-19 vaccination in patients with inflammatory bowel disease: Results of a prospective multicentre study of GETECCU (VACOVEII study)
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Casas Deza, Diego, Julián Gomara, Ana Belén, Caudevilla Biota, Eva, Beltrán, Belén, Domènech, Eugeni, Gutiérrez Casbas, Ana, Mañosa, Miriam, Zabana, Yamile, Roc Alfaro, Lourdes, Valverde Romero, Emilio, García González, Elena, Sicilia, Beatriz, Laredo, Viviana, Alcalá Escriche, Maria José, Madero Velázquez, Lucia, Ferreiro-Iglesias, Rocío, Palmero Pérez, Antonia, Calafat, Margalida, Rubio Iturria, Saioa, Moraleja Yudego, Irene, Ber Nieto, Yolanda, García Mateo, Sandra, Gisbert, Javier P., Vicente Lidón, Raquel, Arias, Lara, Alfambra, Erika, Doñate Borao, Ana Belén, Peña González, Elena, Corsino Roche, Pilar, Vicuña Arregui, Miren, Elorza, Ainara, Domínguez Cajal, Manuel, Chaparro, María, Barreiro-de Acosta, Manuel, and García-López, Santiago
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- 2024
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4. Documento de posicionamiento. Recomendaciones del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa sobre sexualidad y enfermedad inflamatoria intestinal
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Calvo Moya, Marta, Mesonero Gismero, Francisco, Suárez Ferrer, Cristina, Hernández-Camba, Alejandro, Aguas Peris, Mariam, González-Lama, Yago, Millán Scheiding, Mónica, Camacho Martel, Laura, Echarri Piudo, Ana, Isabel Vera Mendoza, María, Zabana Abdo, Yamile, Mañosa Ciria, Míriam, Rodríguez-Moranta, Francisco, Barreiro-de Acosta, Manuel, Gutiérrez Casbas, Ana, Suarez Ferrer, Cristina, Vásquez Carlón, Danízar, García Benasach, Fátima, Delgado Oliva, Francisco José, Alonso Sebastián, Isabel, Gallardo Arriero, Vanesa, Bella Castillo, Pablo, Cano Sanz, Noelia, Vera Mendoza, María Isabel, Serrano Labajos, Ruth, Valdivia Martínez, Antonio, Pérez Restoy, Lourdes, and Mañosa Ciria, Miriam
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- 2024
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5. Impacto de la mesalazina en la respuesta a la vacunación contra la COVID-19 en pacientes con enfermedad inflamatoria intestinal. Resultados de un estudio prospectivo multicéntrico de GETECCU (VACOVEII)
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Casas Deza, Diego, Julián Gomara, Ana Belén, Caudevilla Biota, Eva, Beltrán, Belén, Domènech, Eugeni, Gutiérrez Casbas, Ana, Mañosa, Miriam, Zabana, Yamile, Roc Alfaro, Lourdes, Valverde Romero, Emilio, García González, Elena, Sicilia, Beatriz, Laredo, Viviana, Alcalá Escriche, Maria José, Madero Velázquez, Lucia, Ferreiro-Iglesias, Rocío, Palmero Pérez, Antonia, Calafat, Margalida, Rubio Iturria, Saioa, Moraleja Yudego, Irene, Ber Nieto, Yolanda, García Mateo, Sandra, Gisbert, Javier P., Vicente Lidón, Raquel, Arias, Lara, Alfambra, Erika, Doñate Borao, Ana Belén, Peña González, Elena, Corsino Roche, Pilar, Vicuña Arregui, Miren, Elorza, Ainara, Domínguez Cajal, Manuel, Chaparro, María, Barreiro-de Acosta, Manuel, and García-López, Santiago
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- 2024
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6. Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis
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Rodríguez-Moranta, Francisco, Argüelles-Arias, Federico, Hinojosa del Val, Joaquín, Iborra Colomino, Marisa, Martín-Arranz, M. Dolores, Menchén Viso, Luis, Muñoz Núñez, Fernando, Ricart Gómez, Elena, Sánchez-Hernández, José Germán, Valdés-Delgado, Teresa, Guardiola Capón, Jordi, Barreiro-de Acosta, Manuel, Mañosa Ciria, Míriam, Zabana Abdo, Yamile, and Gutiérrez Casbas, Ana
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- 2024
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7. Monitorización terapéutica de los fármacos biológicos en la enfermedad inflamatoria intestinal. Documento de Posicionamiento del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
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Rodríguez-Moranta, Francisco, Argüelles-Arias, Federico, Hinojosa del Val, Joaquín, Iborra Colomino, Marisa, Martín-Arranz, M. Dolores, Menchén Viso, Luis, Muñoz Núñez, Fernando, Ricart Gómez, Elena, Sánchez-Hernández, José Germán, Valdés-Delgado, Teresa, Guardiola Capón, Jordi, Barreiro-de Acosta, Manuel, Mañosa Ciria, Míriam, Zabana Abdo, Yamile, and Gutiérrez Casbas, Ana
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- 2024
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8. Optimizing treatment of mild to moderate ulcerative colitis: CU-forum Delphi consensus
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Sans Cuffi, Miquel, Argüelles Arias, Federico, Echarri Piudo, Ana, Ginard Vicens, Daniel, Gutiérrez Casbas, Ana, and Marín-Jiménez, Ignacio
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- 2023
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9. Optimización del tratamiento de la colitis ulcerosa leve a moderada: Consenso Delphi CU-Forum
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Sans Cuffi, Miquel, Argüelles Arias, Federico, Echarri Piudo, Ana, Ginard Vicens, Daniel, Gutiérrez Casbas, Ana, and Marín-Jiménez, Ignacio
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- 2023
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10. DOP80 Prevalence and factors associated with Inflammatory Bowel Disease (IBD) activity during pregnancy: updated data from the DUMBO Registry
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Chaparro, M, primary, García Donday, M, additional, Núñez Ortiz, A, additional, Calviño Suarez, C, additional, Rubio Iturria, S, additional, Sánchez Azofra, M, additional, Calvo Moya, M, additional, Pérez-Martínez, I, additional, Fernández-Clotet, A, additional, Alfambra, E, additional, Marín Pedrosa, S, additional, Diz-Lois Palomares, M T, additional, Hernandez, V, additional, Ruiz-Cerulla, A, additional, Casanova, M J, additional, Rivero, M, additional, Huguet, J M, additional, Vicente Lidón, R, additional, Árias García, L, additional, Guerra, I, additional, Hervías Cruz, D, additional, Gutiérrez Casbas, A, additional, Bejarano, A, additional, Camargo Camero, R, additional, Rodríguez-Lago, I, additional, Aguas, M, additional, De Jorge Turrión, M Á, additional, Masedo Gonzalez, Á, additional, López Serrano, P, additional, Valldosera Gomis, G, additional, Ceballos, D, additional, Bujanda, L, additional, Molina Arriero, G, additional, Vega Villaamil, P, additional, Van Domselaar, M, additional, Boscá Watts, M M, additional, Lucendo, A J, additional, Zúñiga de Mora-Figueroa, B, additional, Busquets, D, additional, and Gisbert, J P, additional
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- 2024
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11. DOP60 Prevalence of undiagnosed inflammatory Bowel Disease in patients with spondyloarthritis: EISER Study
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Gutiérrez Casbas, A, primary, Rodríguez-Lago, I, additional, Marín-Jiménez, I, additional, Plaza, Z, additional, Gratacós, J, additional, Trujillo, E, additional, Pérez-Pampín, E, additional, Barreiro de Acosta, M, additional, Aznar-Esquivel, A, additional, Carrillo, M, additional, García-Vivar, M L, additional, Muñoz-Villafranca, M D C, additional, Ladehesa, L, additional, Iglesias-Flores, E, additional, Merino, C, additional, González-Lama, Y, additional, Arévalo, M, additional, Calvet, X, additional, Brandy-García, A, additional, Izquierdo-Romero, M, additional, Manrique, S, additional, Olmedo, R, additional, García-LLorente, J F, additional, Zugaza, J, additional, Ros-Vilamajo, I, additional, Rull, N, additional, Pinto-Tasende, J A, additional, Ucha, P, additional, González, C, additional, Rodríguez-Martín, F, additional, Serrano, S, additional, Domínguez-Alvaro, M, additional, Prado-Galbarro, F J, additional, and Sanz, J, additional
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- 2024
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12. P132 Overexpression of miR-376a-3p in exosomes circulating in peripheral blood of patients with Crohn's disease
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Caparrós, E, primary, García, I, additional, Madero Velázquez, L, additional, Mira, C, additional, Martínez, A, additional, Gutiérrez Casbas, A, additional, and Francés, R, additional
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- 2024
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13. P1228 The EISER Study: Identifying Microbial Factors Associated with Subclinical Gut Inflammation in Psoriatic Arthritis Patients Who Develop Inflammatory Bowel Disease
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Marín Jimenez, I, primary, Boix-Amorós, A, additional, Blank, R B, additional, Cantor, A, additional, Sanz Sanz, J, additional, Gutiérrez-Casbas, A, additional, Gratacós, J, additional, Rodríguez-Lago, I, additional, Trujillo, E, additional, Plaza, Z, additional, Domínguez-Álvaro, M, additional, Díaz-González, F, additional, Cañete, J D, additional, Scher, J U, additional, and Clemente, J C, additional
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- 2024
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14. P949 Effectiveness and safety of rectal tacrolimus in patients with ulcerative colitis. TACRO-TOPIC study. A multicenter study from the young group of GETECCU
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Fuentes-Valenzuela, E, primary, Bastón-Rey, I, additional, García-Alonso, F J, additional, Leo Carnerero, E, additional, Garcia de la Filia, I, additional, Pedraza Pérez, A, additional, Sáiz Chumillas, R M, additional, Pascual Oliver, A, additional, Muñoz Villafranca, C, additional, Moreno, V, additional, Suárez Ferrer, C, additional, Molina Arriero, G, additional, Ferreiro-Iglesias, R, additional, Vega Villaamil, P, additional, Gardeazábal Mateos, D, additional, Segarra-Ortega, J X, additional, Garrido Marín, A, additional, Doallo, A I, additional, Elosua, A, additional, Alonso-Galán, H, additional, Brunet- Mas, E, additional, Jimenez García, N, additional, López Romero-Salazar, F, additional, Velayos, B, additional, Carballo-Folgoso, L, additional, Pérez Santamaría, C, additional, Mata Román, L, additional, Núñez Ortiz, A, additional, Barrio, J, additional, Barreiro-de Acosta, M, additional, and Gutiérrez-Casbas, A, additional
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- 2024
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15. P211 Impact of celiac disease on the outcome of Inflammatory Bowel Disease
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Alonso, I, primary, Ramos, L, additional, Hernández-Camba, A, additional, Yagüe-Caballero, C, additional, Vicente Lidón, R, additional, Taxonera, C, additional, García-Brenes, M A, additional, Gisbert, J P, additional, Chaparro, M, additional, Madero Velázquez, L, additional, Carrillo-Palau, M, additional, Arranz Hernández, L, additional, Castro Senosiain, B, additional, García de la Filia Molina, I, additional, Rojas-Feria, M, additional, López Romero-Salazar, F, additional, Bastón-Rey, I, additional, Sánchez-Azofra, M, additional, Riestra, S, additional, Pérez-Galindo, P, additional, Ortega Moya, S P, additional, Brunet-Mas, E, additional, Sanz Segura, P, additional, Caballero-Mateos, A M, additional, Calafat, M, additional, Botella Mateu, B, additional, Manceñido Marcos, N, additional, Rodríguez-Lago, I, additional, Suárez-Ferrer, C, additional, and Gutiérrez Casbas, A, additional
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- 2024
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16. Dysbiotic microbiota interactions in Crohn’s disease
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Esther Caparrós, Reiner Wiest, Michael Scharl, Gerhard Rogler, Ana Gutiérrez Casbas, Bahtiyar Yilmaz, Marcin Wawrzyniak, and Rubén Francés
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crohn’s disease ,microbiota ,inflammation ,fibrosis ,dysbiosis ,bacterial translocation ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Crohn’s disease (CD) is a major form of inflammatory bowel disease characterized by transmural inflammation along the alimentary tract. Changes in the microbial composition and reduction in species diversity are recognized as pivotal hallmarks in disease dynamics, challenging the gut barrier function and shaping a pathological immune response in genetically influenced subjects. The purpose of this review is to delve into the modification of the gut microbiota cluster network during CD progression and to discuss how this shift compromises the gut barrier integrity, granting the translocation of microbes and their products. We then complete the scope of the review by retracing gut microbiota dysbiosis interactions with the main pathophysiologic factors of CD, starting from the host’s genetic background to the immune inflammatory and fibrotic processes, providing a standpoint on the lifestyle/exogenous factors and the potential benefits of targeting a specific gut microbiota.
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- 2021
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17. OP37 Is the withdrawal of anti-tumour necrosis factor in inflammatory bowel disease patients in remission feasible without increasing the risk of relapse? Results from the randomised clinical trial of GETECCU (EXIT)
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M Chaparro, M García Donday, S Riestra, A J Lucendo, J M Benítez, M Navarro-Llavat, J Barrio, V J Morales-Alvarado, M Rivero, D Busquets, E Leo Carnerero, O Merino Ochoa, O Nantes Castillejo, P Navarro, M Van Domselaar, A Gutiérrez Casbas, I Alonso-Abreu, R Mejuto, L Fernández Salazar, M Iborra, M D Martín-Arranz, J R Pineda, M J Sampedro, K Serra Nilsson, A Bouhmidi Assakali, L Batista, C Muñoz Villafranca, I Rodríguez-Lago, D S Ceballos Santos, I Guerra, M Mañosa, I Marín Jimenez, I Vera Mendoza, M Barreiro-de Acosta, E Domènech, M Esteve, V García-Sánchez, P Nos, J Panés, and J P Gisbert
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Gastroenterology ,General Medicine - Abstract
Background Background: The feasibility of anti-TNF discontinuation in inflammatory bowel disease (IBD) must be proven in clinical trials including patients in clinical, endoscopic, and radiologic remission at the time of anti-TNF withdrawal to make recommendations for clinical practice. Aims Primary: to compare the rates of clinical remission at 1 year in patients who discontinue anti-TNF treatment vs. those who continue treatment. Secondary objectives: to know the effect of anti-TNF withdrawal on relapse-free time, mucosal healing and safety; and to identify predictive factors for relapse. Methods Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis (UC) or Crohn’s disease (CD) in clinical remission for > 6 months were randomised to maintain anti-TNF treatment [maintenance arm (MA)] or to withdraw it [withdrawal arm (WA)]. Patients who were on infliximab (IFX) received IFX 5 mg/kg or an intravenous placebo every 8 weeks, while patients on adalimumab (ADA) received subcutaneous ADA 40 mg or placebo every other week. Patients were followed-up until month 12 or up to the time of clinical relapse, whichever came first. Inclusion and exclusion criteria, trial scheme and definitions are summarized in figures 1a, 1b and 1c. Results were analysed by intention-to-treat (ITT) and by per-protocol (PP). Local investigators were blinded to faecal calprotectin (FC) and IFX and ADA trough levels. On-site monitoring was performed to assess data quality. Results 159 patients were screened, from whom 140 were randomised and comprised the ITT cohort: 70 allocated to the MA and 70 to the WA. Fifteen patients dropped out before the end of follow-up (12 months or relapse), leaving 63 patients in the MA and 62 patients in the WA for the PP analysis. The characteristics of patients in the MA and WA were similar (figure 2). The proportions of patients who maintained clinical remission -59/70 (84%), 95% confidence interval (CI)=74-92% in the MA vs. 53/70 (76%), 95%CI=64-85% in the WA- and who remained without significant endoscopic lesions at the end of follow-up were similar between groups (figures 3a, 3b, 3c). Only the proportion of patients with FC >250 mg/g was higher in the WA at the end of follow-up (figure 3d). Maintenance of clinical remission was no different between groups (figure 4). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar between groups (4% in MA vs. 7% in WA). Conclusion Anti-TNF withdrawal in selected IBD patients in clinical, endoscopic, and radiologic remission could be feasible without an increase in the risk of clinical relapse. Long-term follow-up of these patients is warranted.
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- 2023
18. Epidemiology and hospital resources use in the treatment of ulcerative colitis at gastroenterology units in Spain (EPICURE study)
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Ignacio Marín-Jiménez, Cristina Saro, Verónica Díaz, Manuel Barreiro-de Acosta, María Gómez-García, and Ana Gutiérrez Casbas
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colitis ,incidence ,patient care ,prevalence ,Spain ,ulcerative epidemiology ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Background and aim: Nationwide epidemiological data on ulcerative colitis (UC) in Spain are lacking. The primary objective was to assess the epidemiology of UC at hospital gastroenterology units and the use of hospital resources (characteristics and facilities) for the management of UC in Spain. Methods: A retrospective, multicenter, epidemiological, crosssectional study (EPICURE study) analyzed data from hospital registries and records from UC patients admitted and treated in 2011 at a representative selection of Spanish sites. The prevalence of UC in gastroenterology units was calculated as the total UC patients divided by the total inhabitants covered by those sites. Incidence was defined as the number of new UC cases during 2011 divided by the total inhabitants covered by those sites. Results: In 2011, a total of 42,000 patients were attended for UC in gastroenterology units in Spain with a prevalence rate of 88.7 UC cases (95% CI: 69.6–106.0) per 100,000 inhabitants. The incidence rate was of 5.7 cases (95% CI: 1.2–10.8)/100,000 inhabitants. Six percent of patients being attended for UC were hospitalized in the 58 units analyzed in 2011. There were 1075 hospitalizations related to UC in total (approximately 14 per gastroenterology unit; median hospital stay length: 8 days). Six out of 1000 UC patients underwent colectomy in 2011. Near one third (32.7%) were emergency colectomies. Most hospitals had specific IBD units (87.9%) and colorectal surgeons (93.1%). Conclusions: Our study provides the first national data on the prevalence and incidence of UC in gastroenterology units in Spain. Hospitalization and surgical burden associated with UC was low.
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- 2018
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19. Real‐world outcomes of switching from adalimumab originator to adalimumab biosimilar in patients with inflammatory bowel disease: The ADA‐SWITCH study
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Casanova, María José, primary, Nantes, Óscar, additional, Varela, Pilar, additional, Vela‐González, Milagros, additional, Rivero, Montserrat, additional, Sierra‐Gabarda, Olivia, additional, Riestra, Sabino, additional, Acosta, Manuel Barreiro‐de, additional, del Mar Martín‐Rodríguez, María, additional, Gargallo‐Puyuelo, Carla Jerusalén, additional, Reygosa, Cristina, additional, Muñoz, Roser, additional, de la Filia‐Molina, Irene García, additional, Núñez‐Ortiz, Andrea, additional, Kolle, Lilyan, additional, Calafat, Margalida, additional, Huguet, José María, additional, Iglesias‐Flores, Eva, additional, Martínez‐Pérez, Teresa de Jesús, additional, Bosch, Orencio, additional, Duque‐Alcorta, José María, additional, Frago‐Larramona, Santiago, additional, Van Domselaar, Manuel, additional, González‐Cosano, Víctor Manuel, additional, Bujanda, Luis, additional, Rubio, Saioa, additional, Mancebo, Alejo, additional, Castro, Beatriz, additional, García‐López, Santiago, additional, de Francisco, Ruth, additional, Nieto‐García, Laura, additional, Laredo, Viviana, additional, Gutiérrez‐Casbas, Ana, additional, Mesonero, Francisco, additional, Leo‐Carnerero, Eduardo, additional, Cañete, Fiorella, additional, Ruiz, Lucía, additional, Gros, Beatriz, additional, del Moral‐Martínez, María, additional, Rodríguez, Cristina, additional, Chaparro, María, additional, and Gisbert, Javier P., additional
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- 2023
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20. Real‐world outcomes of switching from adalimumab originator to adalimumab biosimilar in patients with inflammatory bowel disease: The <scp>ADA‐SWITCH</scp> study
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María José Casanova, Óscar Nantes, Pilar Varela, Milagros Vela‐González, Montserrat Rivero, Olivia Sierra‐Gabarda, Sabino Riestra, Manuel Barreiro‐de Acosta, María del Mar Martín‐Rodríguez, Carla Jerusalén Gargallo‐Puyuelo, Cristina Reygosa, Roser Muñoz, Irene García de la Filia‐Molina, Andrea Núñez‐Ortiz, Lilyan Kolle, Margalida Calafat, José María Huguet, Eva Iglesias‐Flores, Teresa de Jesús Martínez‐Pérez, Orencio Bosch, José María Duque‐Alcorta, Santiago Frago‐Larramona, Manuel Van Domselaar, Víctor Manuel González‐Cosano, Luis Bujanda, Saioa Rubio, Alejo Mancebo, Beatriz Castro, Santiago García‐López, Ruth de Francisco, Laura Nieto‐García, Viviana Laredo, Ana Gutiérrez‐Casbas, Francisco Mesonero, Eduardo Leo‐Carnerero, Fiorella Cañete, Lucía Ruiz, Beatriz Gros, María del Moral‐Martínez, Cristina Rodríguez, María Chaparro, and Javier P. Gisbert
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Hepatology ,Gastroenterology ,Pharmacology (medical) - Published
- 2023
21. Optimización del tratamiento de la colitis ulcerosa leve a moderada: Consenso Delphi CU-Forum
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Miquel Sans Cuffi, Federico Argüelles Arias, Ana Echarri Piudo, Daniel Ginard Vicens, Ana Gutiérrez Casbas, and Ignacio Marín-Jiménez
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Hepatology ,Gastroenterology - Published
- 2023
22. P171 Subfertility in young patients with Crohn′s disease. A case-control study
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Gutiérrez Casbas, A, primary, Bernal, L, additional, Zapater, P, additional, Herreros, B, additional, Rodríguez, A, additional, Muñoz, R, additional, Madero, L, additional, Orts, B, additional, Belen, O, additional, Sempere, L, additional, Torregrosa, M E, additional, Moreno-Pérez, O, additional, and Francés, R, additional
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- 2023
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23. P424 Do antiTNF through levels correlate with joint extraintestinal manifestations (EIM) activity in Inflammatory bowel disease (IBD) patients?
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Madero Velázquez, L, primary, Jovani, V, additional, Andrés, M, additional, Más, P, additional, Aguas, M, additional, Vicens, E, additional, Ojeda, A, additional, Noguera-Pons, J R, additional, Ranieri, L, additional, Zabana, Y, additional, Pujol, M, additional, Barreiro de Acosta, M, additional, Pérez-Pampin, E, additional, Bernal, L, additional, Belen, O, additional, Moreno, V, additional, García, M F, additional, Sempere, L, additional, Zapater, P, additional, and Gutiérrez Casbas, A, additional
- Published
- 2023
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24. P383 Real-life experience of the efficacy, safety and pharmacokinetic data of switching from intravenous to subcutaneous infliximab in inactive inflammatory bowel disease patients. Results from the ENEIDA registry
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Iborra Colomino, M I, primary, Garrido Marín, A, additional, Caballol Oliva, B, additional, Huguet Malavés, J M, additional, Arias García, L, additional, Mesonero Gismero, F, additional, Fernández Prada, S J, additional, Boscá Watts, M M, additional, Ponferrada Díaz, Á, additional, Calvet Calvo, X, additional, Gutiérrez Casbas, A, additional, Ordás Jiménez, I, additional, Ruiz Sanchez, L, additional, Sicilia Aladren, B, additional, Garcia de la Filia, I, additional, Domènech Morral, E, additional, and Nos Mateu, P, additional
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- 2023
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25. P824 Sexual Dysfunction among young patients with Crohn′s disease. A Spanish case control study
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Gutiérrez Casbas, A, primary, Madero Velázquez, L, additional, Herreros, B, additional, Zapater, P, additional, Rodríguez, A, additional, Muñoz, R, additional, Bernal, L, additional, Orts, B, additional, Belen, O, additional, Sempere, L, additional, Moreno-Pérez, O, additional, and Francés, R, additional
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- 2023
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26. OP37 Is the withdrawal of anti-tumour necrosis factor in inflammatory bowel disease patients in remission feasible without increasing the risk of relapse? Results from the randomised clinical trial of GETECCU (EXIT)
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Chaparro, M, primary, García Donday, M, additional, Riestra, S, additional, Lucendo, A J, additional, Benítez, J M, additional, Navarro-Llavat, M, additional, Barrio, J, additional, Morales-Alvarado, V J, additional, Rivero, M, additional, Busquets, D, additional, Leo Carnerero, E, additional, Merino Ochoa, O, additional, Nantes Castillejo, O, additional, Navarro, P, additional, Van Domselaar, M, additional, Gutiérrez Casbas, A, additional, Alonso-Abreu, I, additional, Mejuto, R, additional, Fernández Salazar, L, additional, Iborra, M, additional, Martín-Arranz, M D, additional, Pineda, J R, additional, Sampedro, M J, additional, Serra Nilsson, K, additional, Bouhmidi Assakali, A, additional, Batista, L, additional, Muñoz Villafranca, C, additional, Rodríguez-Lago, I, additional, Ceballos Santos, D S, additional, Guerra, I, additional, Mañosa, M, additional, Marín Jimenez, I, additional, Vera Mendoza, I, additional, Barreiro-de Acosta, M, additional, Domènech, E, additional, Esteve, M, additional, García-Sánchez, V, additional, Nos, P, additional, Panés, J, additional, and Gisbert, J P, additional
- Published
- 2023
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27. Withdrawal of Anti-Tumour Necrosis Factor in Inflammatory Bowel Disease Patients in Remission: A Randomised Placebo-Controlled Clinical Trial of GETECCU
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Gisbert, Javier P., primary, García-Donday, María, additional, Riestra, Sabino, additional, Lucendo, Alfredo J., additional, Benítez, José Manuel, additional, Navarro-Llavat, Mercè, additional, Barrio, Jesús, additional, Morales-Alvarado, Víctor J., additional, Rivero, Montserrat, additional, Busquets, David, additional, Leo Carnerero, Eduardo, additional, Merino Ochoa, Olga, additional, Nantes Castillejo, Oscar, additional, Navarro, Pablo, additional, Van Domselaar, Manuel, additional, Gutiérrez Casbas, Ana, additional, Alonso-Abreu, Inmaculada, additional, Mejuto, Rafael, additional, Fernández Salazar, Luis, additional, Iborra, Marisa, additional, Martin-Arranz, Maria Dolores, additional, Pineda, Juan Ramón, additional, Sampedro, Manuela Josefa, additional, Serra Nilsson, katja, additional, Bouhmidi Assakali, Abdel, additional, Batista, Lissette, additional, Muñoz Villafranca, Carmen, additional, Rodríguez-Lago, Iago, additional, Ceballos Santos, Daniel Sebastián, additional, Guerra, Iván, additional, Mañosa, Miriam, additional, Marín Jiménez, Ignacio, additional, Torrella, Emilio, additional, Vera, Isabel, additional, Casanova, María José, additional, De Francisco, Ruth, additional, Arias-González, Laura, additional, Marín Pedrosa, Sandra, additional, García-Bosch, Orlando, additional, García-Alonso, Francisco Javier, additional, Delgado-Guillena, Pedro, additional, García, María José, additional, Torrealba, Leyanira, additional, Núñez-Ortiz, Andrea, additional, Vicuña Arregui, Miren, additional, Bosca-Watts, Marta Maia, additional, Blázquez, Isabel, additional, Acosta, Diana, additional, Garre, Ana, additional, Baldán, Montse, additional, Martínez, Concepción, additional, Barreiro-de Acosta, Manuel, additional, Domènech, Eugeni, additional, Esteve, Maria, additional, García-Sánchez, Valle, additional, Nos, Pilar, additional, Panés, Julian, additional, and Chaparro, Maria, additional
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- 2023
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28. Using Interpretable Machine Learning to Identify Baseline Predictive Factors of Remission and Drug Durability in Crohn’s Disease Patients on Ustekinumab
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Chaparro, María, primary, Baston-Rey, Iria, additional, Fernández Salgado, Estela, additional, González García, Javier, additional, Ramos, Laura, additional, Diz-Lois Palomares, María Teresa, additional, Argüelles-Arias, Federico, additional, Iglesias Flores, Eva, additional, Cabello, Mercedes, additional, Rubio Iturria, Saioa, additional, Núñez Ortiz, Andrea, additional, Charro, Mara, additional, Ginard, Daniel, additional, Dueñas Sadornil, Carmen, additional, Merino Ochoa, Olga, additional, Busquets, David, additional, Iyo, Eduardo, additional, Gutiérrez Casbas, Ana, additional, Ramírez de la Piscina, Patricia, additional, Boscá-Watts, Marta Maia, additional, Arroyo, Maite, additional, García, María José, additional, Hinojosa, Esther, additional, Gordillo, Jordi, additional, Martínez Montiel, Pilar, additional, Velayos Jiménez, Benito, additional, Quílez Ivorra, Cristina, additional, Vázquez Morón, Juan María, additional, Huguet, José María, additional, González-Lama, Yago, additional, Muñagorri Santos, Ana Isabel, additional, Amo, Víctor Manuel, additional, Martín Arranz, María Dolores, additional, Bermejo, Fernando, additional, Martínez Cadilla, Jesús, additional, Rubín de Célix, Cristina, additional, Fradejas Salazar, Paola, additional, López San Román, Antonio, additional, Jiménez, Nuria, additional, García-López, Santiago, additional, Figuerola, Anna, additional, Jiménez, Itxaso, additional, Martínez Cerezo, Francisco José, additional, Taxonera, Carlos, additional, Varela, Pilar, additional, de Francisco, Ruth, additional, Monfort, David, additional, Molina Arriero, Gema, additional, Hernández-Camba, Alejandro, additional, García Alonso, Francisco Javier, additional, Van Domselaar, Manuel, additional, Pajares-Villarroya, Ramón, additional, Núñez, Alejandro, additional, Rodríguez Moranta, Francisco, additional, Marín-Jiménez, Ignacio, additional, Robles Alonso, Virginia, additional, Martín Rodríguez, María del Mar, additional, Camo-Monterde, Patricia, additional, García Tercero, Iván, additional, Navarro-Llavat, Mercedes, additional, García, Lara Arias, additional, Hervías Cruz, Daniel, additional, Kloss, Sebastian, additional, Passey, Alun, additional, Novella, Cynthia, additional, Vispo, Eugenia, additional, Barreiro-de Acosta, Manuel, additional, and Gisbert, Javier P., additional
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- 2022
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29. Effectiveness and Safety of Ustekinumab in Elderly Patients with Crohn’s Disease: Real World Evidence From the ENEIDA Registry
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Casas-Deza, Diego, primary, Lamuela-Calvo, Luis Javier, additional, Gomollón, Fernando, additional, Arbonés-Mainar, José Miguel, additional, Caballol, Berta, additional, Gisbert, Javier P, additional, Rivero, Montserrat, additional, Sánchez-Rodríguez, Eugenia, additional, Arias García, Lara, additional, Gutiérrez Casbas, Ana, additional, Merino, Olga, additional, Márquez, Lucía, additional, Laredo, Viviana, additional, Martín-Arranz, María Dolores, additional, López Serrano, Pilar, additional, Riestra Menéndez, Sabino, additional, González-Muñoza, Carlos, additional, de Castro Parga, Luisa, additional, Calvo Moya, Marta, additional, Fuentes-Valenzuela, Esteban, additional, Esteve, Maria, additional, Iborra, Marisa, additional, Dura Gil, Miguel, additional, Barreiro-De Acosta, Manuel, additional, Lorente-Poyatos, Rufo Humberto, additional, Manceñido, Noemí, additional, Calafat, Margalida, additional, Rodríguez-Lago, Iago, additional, Guardiola Capo, Jordi, additional, Payeras, Maria Antonia, additional, Morales Alvarado, Víctor Jair, additional, Tardillo, Carlos, additional, Bujanda, Luis, additional, Muñoz-Nuñez, José Fernando, additional, Ber Nieto, Yolanda, additional, Bermejo, Fernando, additional, Almela, Pedro, additional, Navarro-Llavat, Mercè, additional, Martínez Montiel, Pilar, additional, Rodríguez Gutiérrez, Cristina, additional, Van Domselaar, Manuel, additional, Sesé, Eva, additional, Martínez Pérez, Teresa, additional, Ricart, Elena, additional, Chaparro, María, additional, García, María José, additional, López-Sanromán, Antonio, additional, Sicilia, Beatriz, additional, Orts, Beatriz, additional, López-García, Alicia, additional, Martín-Arranz, Eduardo, additional, Pérez-Calle, José Lázaro, additional, de Francisco, Ruth, additional, García-Planella, Esther, additional, Domènech, Eugeni, additional, and García-López, y Santiago, additional
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- 2022
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30. ECCO Topical Review: Roadmap to optimal peri-operative care in IBD
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Shaji Sebastian, Jonathan P Segal, Charlotte Hedin, Gianluca Pellino, Paulo Gustavo Kotze, Michel Adamina, Marjo Campmans-Kuijpers, Justin Davies, Annemarie C de Vries, Ana Gutiérrez Casbas, Alaa El-Hussuna, Pascal Juillerat, Susanna Meade, Monica Millán, Antonino Spinelli, Gastroenterology & Hepatology, Sebastian, Shaji, Segal, Jonathan P, Hedin, Charlotte, Pellino, Gianluca, Kotze, Paulo Gustavo, Adamina, Michel, Campmans-Kuijpers, Marjo, Davies, Justin, de Vries, Annemarie C, Gutiérrez Casbas, Ana, El-Hussuna, Alaa, Juillerat, Pascal, Meade, Susanna, Millán, Monica, and Spinelli, Antonino
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Gastroenterology ,General Medicine ,610 Medizin und Gesundheit - Abstract
Background and aims Despite the advances in medical therapies, a significant proportion of patients with inflammatory bowel diseases [IBD] require surgical intervention. This Topical Review aims to offer expert consensus practice recommendations for peri-operative care to optimize outcomes of IBD patients who undergo surgery. Methods A multidisciplinary panel of IBD healthcare providers systematically reviewed aspects relevant to peri-operative care in IBD. Consensus statements were developed using Delphi methodology. Results A total of 20 current practice positions were developed following systematic review of the current literature covering use of medication in the peri-operative period, nutritional assessment and intervention, physical and psychological rehabilitation and prehabilitation, and immediate postoperative care. Conclusion Peri-operative planning and optimization of the patient are imperative to ensure favourable outcomes and reduced morbidity. This Topical Review provides practice recommendations applicable in the peri-operative period in IBD patients undergoing surgery.
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- 2022
31. P118 Inflammatory Bowel Disease Unclassified and Ulcerative Colitis: different outcomes? Multicenter case-control study (Spanish ENEIDA registry)
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M Gonzalez Vivo, M Urpí Ferreruela, B Castro Senosiain, I Pérez-Martínez, J Barrio, L Codesido Prado, B Caballol Oliva, V Pedrera Roman, M Piqueras Cano, F Rodríguez Moranta, M J Casanova González, L Ramos, M Iborra, C Tardillo Marin, M Barreiro-de Acosta, R H Lorente Poyatos, B Orts Jorquera, L Bujanda Fernández, Y Zabana, A López-García, S Riestra, P Vega-Villaamil, M Montoro, J P Gisbert, P Nos, G E Rodriguez Gonzalez, M Porto Silva, A Gutiérrez-Casbas, E Domenech, and L Márquez
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Gastroenterology ,General Medicine - Abstract
Background Patients with inflammatory bowel disease (IBD) are often classified as ulcerative colitis (UC) and Crohn’s disease (CD). However, in some cases this categorization is not possible and these patients are labelled as inflammatory bowel disease unclassified (IBDU) -or indeterminate colitis if histologic analysis of surgical specimens is possible-.The aims of this study were to compare the prognosis and therapeutic requirements in patients with IBDU and UC, and to identify potential predictive factors of reclassification as UC or CD. Methods Retrospective, observational, multicenter and case-control study of Spanish ENEIDA registry promoted by GETECCU. IBDU patients were identified from 18 centers. Every case of IBDU was matched with 2 patients of ulcerative colitis of the same hospital by sex, age at diagnosis and disease extent (in the patchy colitis subgroup, every case was matched with 1 extensive colitis and 1 left colitis). Results 231 IBDU patients and 469 UC patients were included. Only 15 IBDU patients met current criteria of indeterminate colitis. In the IBDU group 59.7% patients were males and the mean of age at diagnosis was 43.3 years. Disease extent was distributed in 14 proctitis, 59 left-sided colitis, 87 extensive colitis and 53 patchy colitis. 13.9% had rectal sparing and 31.9% presented ileitis. Thirteen percent were smokers at diagnosis, 5.6% had perianal disease and 15.9% had extraintestinal manifestations. Table 1: baseline characteristics of IBDU and UC group. When comparing IBDU to UC patients, there were no statistical differences between proportion of patients that needed immunosuppressants (35.7% vs 37.7%, p=0.558) and biological therapy (27.3% vs 24.3%, p=0.415). Regarding surgery for medically refractory disease, UC patients had higher surgical rates, although these differences did not reach statistical significance (2.6% vs 0.5%, p= 0.062). Figure 1: immunosuppressants, biological and surgery rates. Overall mortality rates were similar in both groups (5.1% in IBDU vs 2.6% in UC); with only one case related to IBD in IBDU group. During follow-up, 67 IBDU patients (31%) were reclassified (32 UC, 34 CD, 1 indeterminate colitis). 25% of patients were reclassified within 46 months of follow-up (Figure 2: Kaplan-Meier curve of reclassification). Neither clinical, biochemical (C- reactive protein, albumin, hemoglobin) nor endoscopic variable (rectal sparing, ileitis) was associated with change in diagnosis. Conclusion In clinical practice, there were no statistical differences in prognosis, therapeutic requirements and surgical treatment between IBDU and UC patients. Two thirds of patients remained classified as IBDU during the follow-up. No predictive factors of reclassification have been identified.
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- 2022
32. P424 Do antiTNF through levels correlate with joint extraintestinal manifestations (EIM) activity in Inflammatory bowel disease (IBD) patients?
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L Madero Velázquez, V Jovani, M Andrés, P Más, M Aguas, E Vicens, A Ojeda, J R Noguera-Pons, L Ranieri, Y Zabana, M Pujol, M Barreiro de Acosta, E Pérez-Pampin, L Bernal, O Belen, V Moreno, M F García, L Sempere, P Zapater, and A Gutiérrez Casbas
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Gastroenterology ,General Medicine - Abstract
Background Inflammatory arthropathies are the most common EIM associated to IBD with a prevalence of 20-50% for axial inflammation and 5-20% for peripheral arthritis. AntiTNF is the preferred treatment in patients with axial spondiloarthritis (AxSp) intolerant or refractory to NSAIDs and has shown efficacy in peripheral arthritis (pSp) as well. Nevertheless, an optimal antiTNF through level has not been yet stablished in this clinical setting. Thus, our aims were to evaluate the correlation between antiTNF through levels and joint EIM activity in IBD patients. Methods We conducted a prospective, multicenter cohort study. IBD patients diagnosed with articular EIM (AxSp, pSp or both) under antiTNF treatment at least 6 months were included. Anti-TNF concentrations were measured using ELISA. Blood samples were obtained just before the administration of the drug (trough levels), and an simultaneous evaluation by a reumatologist was performed. Definitions: inactive AxSp = ASDAS-CRP Results A total of 78 patients were included: Median age 52 ±15, 45% women, 82% CD (56% ileal; 18% colic; 24% ileocolic; 2% upper gastrointestinal involvement; 22% stricturing behaviour; 16% penetrating; 14% perianal disease), 18% UC (61% extensive, 15% left-sided, 23% proctitis), 11% had another EIM. HLA B-27 was present in 26% patients. Distribution of spondiloartrhopaties was: AxSp 42%, pSp 37%, or both 20%. Among CD patients, 18,9% presented clinical activity (n=14). Mean IBD disease duration was 11± 9,7 years. Fourteen patients (18%) were also under immunosupressive treatment .Through levels distributed by joint activity are shown in table 1.Figure 1 shows distribution of adalimumab through levels by AxSp activity. Conclusion No correlation between antiTNF through levels and joint EIM activity was found in these preliminary results. However, patients with active axial Sp treated with adalimumab had lower through levels than those with inactive axial Sp.
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- 2023
33. P824 Sexual Dysfunction among young patients with Crohn′s disease. A Spanish case control study
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A Gutiérrez Casbas, L Madero Velázquez, B Herreros, P Zapater, A Rodríguez, R Muñoz, L Bernal, B Orts, O Belen, L Sempere, O Moreno-Pérez, and R Francés
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Gastroenterology ,General Medicine - Abstract
Background Sexuality is a complex entity and a major determinant of quality of life in patients diagnosed with inflammatory bowel disease (IBD). It has been estimated that sexual dysfunction (SD) affects 30% of women and 5% of men in the general population as well as 50% in women and 25% in men with IBD. Objectives To compare the rates of SD between young female and male patients with Crohn's disease (CD) and healthy controls matched by age and sex and to search for predictors of SD in CD patients. Methods Observational, case-control, prospective study including CD patients with CD, 18-40 years of age. Age and sex-matched (2:1) healthy controls (HC) were selected. Demographic characteristics of all subjects and clinical features of CD were collected. The variables explored were SD in women (Index of Female Sexual Function (IFSF), SD in men (International Index of Erectile Function [IIFE-15]) and presence of anxiety-depression (Hospital Anxiety/Depression Scale [HADS]). Results A total of 163 subjects were included: 83 men (58 CD, median 28 years (RIQ 24-36) and 25 male HC, median 31 years (RIQ 26-37) and 80 women (50 female CD, median 26 years (RIQ 21-36) and 30 HC, median 28 (RIQ 26-32). 24% of women with CD and 8% of men had clinical activity (HBI >4). Table 1 summarizes main clinical characteristics of overall study population. Demographic characteristics of men with CD and HC were not significantly different. Sedentary lifestyle was more common among women with CD vs HC (46% vs 3.3%, p SD in men, measured by IIFE, was more common in CD patients than among HC, 14/58 (24%) vs 1/25 (4%), p=0.031. CD male patients scored significantly lower than HC regarding overall sexual satisfaction 8 (6-9) vs 9 (8-10), p=0,02. Erectile dysfunction occurred only in CD (7/46, 15%), p= 0.08. Female SD was, likewise more frequent in women with CD vs female HC, (18/50 (38%) CD vs 3/30 (12%) HC,p=0.017), and female CD patients scored significantly lower with regard sexual desire (5 vs 7, p=0.008), arousal (9.0 vs 11, p=0.06) and lubrication (10 vs 13, p=0.04) than female HC. Logistic regression analysis showed that only anxiety was associated with SD in women, finding no associated risk factors with SD in CD male patients. Conclusion CD patients present a disease activity-independent higher risk of SD compared to the general population. Domain affected in male patients is impairment of satisfaction whereas lubrication, sexual desire and arousal, being associated with anxiety, are affected in female CD patients.
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- 2023
34. P383 Real-life experience of the efficacy, safety and pharmacokinetic data of switching from intravenous to subcutaneous infliximab in inactive inflammatory bowel disease patients. Results from the ENEIDA registry
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M I Iborra Colomino, A Garrido Marín, B Caballol Oliva, J M Huguet Malavés, L Arias García, F Mesonero Gismero, S J Fernández Prada, M M Boscá Watts, Á Ponferrada Díaz, X Calvet Calvo, A Gutiérrez Casbas, I Ordás Jiménez, L Ruiz Sanchez, B Sicilia Aladren, I Garcia de la Filia, E Domènech Morral, and P Nos Mateu
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Gastroenterology ,General Medicine - Abstract
Background Recently, a subcutaneous formulation of biosimilar infliximab (CT-P13) (SC-IFX) has been approved for inflammatory bowel disease (IBD). The aims of this study were to evaluate efficacy, safety, pharmacokinetics and patient experience following a switching to SC-IFX in patients who are in clinical remission on IV-IFX maintenance treatment. Methods Multicentre, descriptive, and observational study including Crohn’s disease (CD) and ulcerative colitis (UC) patients who were going to be changed from IV-IFX to SC-IFX on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD–GETECCU). All patients were on clinical and biological remission at least 24 weeks before changing. Demographic and disease data, clinical activity (Harvey-Bradshaw index for CD and mayo index for UC), analytical data (C reactive protein (CRP) and fecal calprotectin (FC), as well as trough levels were collected at baseline, at 12 and 24 weeks. Results One hundred and fifty-five patients were included: 54 UC (35%) and 91 (65%) CD; 44% women and 56% men; age 45.5 years (32-55). IV-IFX was mainly administered due to active disease (72%) and perianal disease (7%) and during 32 months [range 14-56]. Pre-switch, 78 (50.3%) were on 8-weekly dosing of IV-IFX, 77 (49.7%) were with intensification dose and the half (50.3%) were on concomitant immunomodulatory therapy. SC-IFX was mainly switching by COVID-19 pandemic (60%), to increase through levels (15%) or patient request (25%). The majority of patients (140, 90%) remained with standard dose, 8 (5%) required dose intensification (120 mg weekly in 4 and 240 mg every 2 weeks in 4) and 7 (4.5%) had successful de-escalation (120 mg every 3 weeks in 4 and 120 mg every 4 weeks in 3). Clinical indices, CRP levels and FC remained unchanged (Figure). Median SC-IFX levels significantly increased from baseline of 4.5 μg/dl [range 2.6-9.2] to 14 μg/dl [range 9.5-16.2] at week 12 and 13.2 μg/dl [range 10.4-19.7] at week 24. No factors (immunossupresor, body mass index, disease location) were associated with the increase of IFX trough levels. During 24 weeks of follow-up, 16 of the 78 patients (20.5%) stopped immunosuppressant treatment. The adverse events were recorded in 9 patients (5.8%), 4 (2.6%) were hospitalized and 4 (2.6%) had surgery (one of them for perianal disease). Nine patients (5.8%) stopped SC-IFX (1 primary failure, 2 loss of response, 4 adverse events, 1 voluntarily, and 1 surgery). Conclusion The switch from IV to SC IFX maintains clinical remission safely in IBD patients, offers higher drug levels and a good patient acceptance. However, the significance of higher drug levels with SC-IFX requires further exploration.
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- 2023
35. 60 - ¿SE CORRELACIONAN LOS NIVELES DE ANTI-TNF CON LA ACTIVIDAD DE LAS MANIFESTACIONES EXTRAINTESTINALES (MEI) ARTICULARES EN PACIENTES CON ENFERMEDAD INFLAMATORIA INTESTINAL (EII)?
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Lucía Madero Velázquez, Vega Jovani, Mariano Andrés, Patricio Más, Mariam Aguas, Elvira Vicens, Asunción Ojeda, Raúl Noguera, Laura Rainieri, Yamile Zabana, Manel Puyol, Manuel Barreiro-de Acosta, Eva Pérez Pampín, Lorena Bernal, Olivia Belén, Mariana Fe García Sepulcre, Laura Sempere, Pedro Zapater, and Ana Gutiérrez Casbas
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Hepatology ,Gastroenterology - Published
- 2023
36. 39 - SUBFERTILIDAD EN PACIENTES JÓVENES CON ENFERMEDAD DE CROHN: ESTUDIO DE CASOS-CONTROLES
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A. Gutiérrez Casbas, L. Bernal, P. Zapater, B. Herreros, A. Rodríguez, R. Muñoz, L. Madero, B. Orts, O. Belén, L. Sempere, M.E. Torregrosa, O. Moreno-Pérez, and R. Francés
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Hepatology ,Gastroenterology - Published
- 2023
37. 55 - IMPACTO DE LA MESALAZINA EN LA RESPUESTA A LA VACUNACIÓN CONTRA EL COVID-19 EN PACIENTES CON ENFERMEDAD INFLAMATORIA INTESTINAL. RESULTADOS DE UN ESTUDIO PROSPECTIVO MULTICÉNTRICO DE GETECCU (VACOVEII)
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Ana Belén Julián Gomara, Diego Casas Deza, Raquel Vicente Lidón, Belén Beltrán, Eugeni Domenech, Ana Gutiérrez Casbas, Miriam Mañosa, Yamile Zabana, Eva Caudevilla Biota, Pilar Corsino Roche, Andrea Pascual Oliver, Laura Franco Fobe, Silvia Pina Echevarría, Elena García González, Erika Alfambra, Viviana Laredo, Beatriz Sicilia, Lorena Arias, Belén Doñate Borao, Lucia Madero Velázquez, Rocío Ferreiro Iglesias, Antonia Palmero Pérez, Margalida Calafat, Saioa Rubio Iturria, Irene Moraleja Yudego, Yolanda Ber Nieto, Sandra García Mateo, Javier Gisbert, Manuel Barreiro de Acosta, and Santiago García López
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Hepatology ,Gastroenterology - Published
- 2023
38. 58 - DISFUNCIÓN SEXUAL ASOCIADA A ENFERMEDAD DE CROHN
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Ana Gutiérrez Casbas, Lucía Madero Velázquez, Belen Herreros, Pedro Zapater, Andrés Rodríguez, Roser Muñoz, Lorena Bernal, Beatriz Orts, Olivia Belén Galipienso, Laura Sempere, Óscar Moreno Peréz, and Rubén Francés
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Hepatology ,Gastroenterology - Published
- 2023
39. ¿ES FACTIBLE LA SUSPENSIÓN DEL TRATAMIENTO ANTI-TNF EN PACIENTES CON ENFERMEDAD INFLAMATORIA INTESTINAL EN REMISIÓN SIN AUMENTAR EL RIESGO DE RECIDIVA? RESULTADOS DEL ENSAYO CLÍNICO ALEATORIZADO DE GETECCU (EXIT)
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María Chaparro, María García Donday, Sabino Riestra, Alfredo J Lucendo, José Manuel Benítez, Mercè Navarro-Llavat, Jesús Barrio, Víctor J. Morales-Alvarado, Montserrat Rivero, David Busquets, Eduardo Leo Carnerero, Olga Merino Ochoa, Óscar Nantes Castillejo, Pablo Navarro, Manuel van Domselaar, Ana Gutiérrez Casbas, Inmaculada Alonso-Abreu, Rafael Mejuto, Luis Fernández Salazar, Marisa Iborra, María Dolores Martín-Arranz, Juan Ramón Pineda, Manuela Josefa Sampedro, Katja Serra Nilsson, Abdel Bouhmidi Assakali, Lissette Batista, Carmen Muñoz Villafranca, Iago Rodríguez-Lago, Daniel Sebastián Ceballos Santos, Iván Guerra, Miriam Mañosa, Ignacio Marín Jiménez, Emilio Torrella, Isabel Vera Mendoza, María José Casanova, Ruth de Francisco, Laura Arias-González, Sandra Marín Pedrosa, Orlando García-Bosch, Francisco Javier García-Alonso, Pedro Delgado- Guillena, María José García, Leyanira Torrealba, Andrea Núñez-Ortiz, Miren Vicuña Arregui, Marta Maia Bosca-Watts, Isabel Blázquez, Diana Acosta, Ana Garre, Concepción Martínez, Manuel Barreiro-de Acosta, Eugeni Domènech, María Esteve, Valle García-Sánchez, Pilar Nos, Julian Panés, and Javier P. Gisbert
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Hepatology ,Gastroenterology - Published
- 2023
40. RESPUESTA A LA VACUNACIÓN CONTRA EL COVID-19 E IMPACTO NEGATIVO DEL TRATAMIENTO INMUNOSUPRESOR EN PACIENTES CON ENFERMEDAD INFLAMATORIA INTESTINAL. RESULTADOS DE UN ESTUDIO PROSPECTIVO MULTICÉNTRICO DE GETECCU (VACOVEII)
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Ana Belén Julián Gomara, Diego Casas Deza, Raquel Vicente Lidón, Belén Beltrán, Eugeni Domenech, Ana Gutiérrez Casbas, Miriam Mañosa, Yamile Zabana, Eva Caudevilla Biota, Pilar Corsino Roche, Eva María Sierra Moros, Laura Franco Fobe, Silvia Pina Echevarría, Elena García González, Erika Alfambra, Viviana Laredo, Beatriz Sicilia, Lorena Arias, Belén Doñate Borao, Lucia Madero Velázquez, Rocío Ferreiro Iglesias, Antonia Palmero Pérez, Margalida Calafat, Saioa Rubio Iturria, Irene Moraleja Yudego, Yolanda Ber Nieto, Sandra García Mateo, Javier Gisbert, Manuel Barreiro de Acosta, and y Santiago García López
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Hepatology ,Gastroenterology - Published
- 2023
41. Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST):an open-label, multicentre, randomised phase 3b trial
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Silvio Danese, Severine Vermeire, Geert D'Haens, Julian Panés, Axel Dignass, Fernando Magro, Maciej Nazar, Manuela Le Bars, Marjolein Lahaye, Lioudmila Ni, Ivana Bravata, Frederic Lavie, Marco Daperno, Milan Lukáš, Alessandro Armuzzi, Mark Löwenberg, Daniel R Gaya, Laurent Peyrin-Biroulet, Rodolfo Rocca, Susana Lopes, Flavio Caprioli, Sandro Ardizzone, Ana Echarri Piudo, Paolo Gionchetti, Xavier Roblin, Ursula Seidler, David Andersson, Kamal Patel, Pierre Desreumaux, Simone Saibeni, Gustav From, Miroslav Fedurco, Milos Gregus, Yoram Bouhnik, Andreas Luegering, Rocco Cosintino, Ivan Bunganic, Jaime Ramos, Mariam Aguas Peris, Olivier Dewit, Mariabeatrice Principi, Emma Wesley, Paula Lago, Stephane Nancey, María Dolores Martín Arranz, Pieter Hindryckx, Ambrogio Orlando, Andrea Geccherle, Maria Laura Annunziata, Bu'hussain Hayee, Jozef Balaz, Francisco Portela, Cyrielle Gilletta, Torsten Kucharzik, Miguel Mínguez, Javier Pérez Gisbert, Ana Gutiérrez Casbas, Edouard Louis, Marco Marino, Gareth Parkes, Fraser Cummings, Bindia Jharap, Jens Kjeldsen, Luís Correia, Paula Ministro, Matthias Ebert, Erik Hertervig, Dirk Staessen, Joris Dutré, Arnaud Colard, Graham Morrison, Henning Glerup, Jens Frederik Dahlerup, Frank Wolfhagen, Marian Batovsky, Martin Molnar, Barbora Kadleckova, Paulo Caldeira, David Laharie, Xavier Hebuterne, Bruno Bonaz, Matthieu Allez, Andreas Fischer, Joaquín Ernesto Hinojosa Del Val, Miriam Mañosa Ciria, Jose Manuel Herrera Justiniano, Charlotte Soderman, Rajiv Chandy, Craig Mowat, Peter Irving, Jan Fallingborg, Jan Matous, Tomas Douda, Romain Altwegg, Jose Manuel Benitez, María Teresa Arroyo Villarino, Jordi Guardiola Capón, Daniel Ginard Vicenc, Pieter Dewint, Sven Almer, Sebastien Kindt, Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and hepatology, Clinical sciences, and Gastroenterology
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Adult ,STARDUST ,BLOOD ,Hepatology ,Remission Induction ,Gastroenterology ,Standard of Care ,GUIDELINES ,C-REACTIVE PROTEIN ,Crohn's disease ,Crohn Disease ,MARKER ,randomised phase 3b trial ,MANAGEMENT ,Humans ,Administration, Intravenous ,Ustekinumab - Abstract
Background: A treat-to-target strategy, in which strictly defined treatment targets facilitate decision making in clinical practice, is advocated as an optimised management approach for some chronic disorders. The aim of the STARDUST trial was to assess whether a treat-to-target strategy with early endoscopy, regular biomarker and clinical symptom monitoring, and dose intensification for persistent inflammatory activity, was more successful in achieving endoscopic improvement at week 48 than a clinically driven maintenance strategy in patients with moderate-to-severe active Crohn's disease receiving ustekinumab. Methods: This open-label, multicentre, randomised phase 3b trial included adults with active, moderate-to-severe Crohn's disease (Crohn's Disease Activity Index [CDAI] 220–450 and Simple Endoscopic Score in Crohn's Disease [SES-CD] ≥3) for whom conventional therapy or one biologic therapy, or both, had failed. Patients received intravenous ustekinumab approximating 6 mg/kg at baseline and subcutaneous ustekinumab 90 mg at week 8. At week 16, patients with a CDAI improvement of 70 or more points from baseline were randomly assigned (1:1) to receive standard-of-care or treat-to-target maintenance treatment through week 48. Randomisation was balanced by using randomly permuted blocks and was stratified by biologic history status and baseline SES-CD score. All patients who signed informed consent, who were not screening failures, and who received at least one dose of study treatment were included in week 16 analyses. All patients included in week 16 analyses and randomly assigned to one of the maintenance treatment regimens were included in the week 48 efficacy and safety analyses (ie, on an intention-to-treat basis). Patients assigned to the treat-to-target arm received ustekinumab every 12 weeks or every 8 weeks based on SES-CD improvement from baseline and could escalate to every 4 weeks through week 48 if prespecified targets were missed. Patients assigned to the standard-of-care arm received ustekinumab every 12 weeks or every 8 weeks; those receiving treatment every 12 weeks could escalate per European labelling. The primary efficacy endpoint was endoscopic response at week 48 (SES-CD score ≥50% decrease from baseline), analysed by non-responder imputation. This trial is registered at ClinicalTrials.gov, NCT03107793, and is active but not recruiting. Findings: 498 patients received standard induction treatment, of whom 440 were randomly assigned to the treat-to-target group (n=219) or the standard-of-care group (n=221). At week 48, there was no significant difference in endoscopic response (83 [38%] of 219 patients vs 66 [30%] of 221 patients; p=0·087), endoscopic remission (25 [11%] vs 32 [15%]; p=0·334), mucosal healing (31 [14%] vs 37 [17%]; p=0·449), and clinical remission (135 [62%] vs 154 [70%]; p=0·072) between the two groups; clinical response was significantly lower in the treat-to-target group than in the standard-of-care group (149 [68%] vs 172 [78%]; p=0·020). Other endoscopic, clinical, and biomarker outcomes were generally not significantly different between groups. The most commonly reported treatment-emergent adverse events were nasopharyngitis (29 [13%] of 219 patients in the treat-to-target group vs 29 [13%] of 221 patients in the standard-of-care group), abdominal pain (23 [11%] vs 19 [9%]), arthralgia (24 [11%] vs 19 [9%]), and headache (24 [11%] vs 21 [10%]). Interpretation: Timely escalation of ustekinumab therapy for patients with Crohn's disease, based on early endoscopic response, clinical symptoms, and biomarkers, did not result in significantly better endoscopic outcomes at week 48 than symptom-driven decisions alone. Future studies need to confirm if some subgroups of patient might benefit from a treat-to-target strategy with ustekinumab. Funding: Janssen-Cilag.
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- 2022
42. Immigrant IBD Patients in Spain Are Younger, Have More Extraintestinal Manifestations and Use More Biologics Than Native Patients
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Gutiérrez Casbas, Ana, Zapater, Pedro, Ricart, Elena, González-Vivó, María, Gordillo, Jordi, Olivares, David, Vera, Isabel, Mañosa Ciria, Míriam, Gisbert, Javier P., Aguas, Mariam, Sánchez-Rodríguez, Eugenia, Bosca-Watts, Maia, Laredo, Viviana, Camps, Blau, Marín-Jiménez, Ignacio, Zabana, Yamile, Martín-Arranz, María Dolores, Muñoz, Roser, Navarro, Mercè, Sierra, Eva, Madero, Lucía, Vela, Milagros, Pérez-Calle, José Lázaro, Sainz, Empar, Calvet Calvo, Xavier, Arias, Lara, Morales, Victor, Bermejo, Fernando, Fernández-Salazar, Luis, Van Domselaar, Manuel, De Castro, Luisa, Rodríguez, Cristina, Muñoz-Villafranca, Carmen, Lorente, Rufo, Rivero, Montserrat, Iglesias, Eva, Herreros, Belén, Busquets, David, Riera, Joan, Martínez-Montiel, María Pilar, Roldón, Marta, Roncero, Oscar, Hinojosa, Esther, Sierra Ausín, Mónica, Barrio, Jesús, De Francisco, Ruth, Huguet, José, Merino, Olga, Carpio, Daniel, Ginard, Daniel, Muñoz, Fernando, Piqueras, Marta, Almela, Pedro, Argüelles-Arias, Federico, Alcaín, Guillermo, Bujanda, Luis, Manceñido, Noemí, Lucendo, Alfredo J., Varela, Pilar, Rodríguez-Lago, Iago, Ramos, Laura, Sempere, Laura, Sesé, Eva, Barreiro-de Acosta, Manuel, Domènech, Eugeni, Francés, Rubén, Universitat Autònoma de Barcelona, Gutiérrez Casbas, Ana, Zapater, Pedro, Ricart, Elena, González-Vivó, María, Gordillo, Jordi, Olivares, David, Vera, Isabel, Mañosa Ciria, Míriam, Gisbert, Javier P., Aguas, Mariam, Sánchez-Rodríguez, Eugenia, Bosca-Watts, Maia, Laredo, Viviana, Camps, Blau, Marín-Jiménez, Ignacio, Zabana, Yamile, Martín-Arranz, María Dolores, Muñoz, Roser, Navarro, Mercè, Sierra, Eva, Madero, Lucía, Vela, Milagros, Pérez-Calle, José Lázaro, Sainz, Empar, Calvet Calvo, Xavier, Arias, Lara, Morales, Victor, Bermejo, Fernando, Fernández-Salazar, Luis, Van Domselaar, Manuel, De Castro, Luisa, Rodríguez, Cristina, Muñoz-Villafranca, Carmen, Lorente, Rufo, Rivero, Montserrat, Iglesias, Eva, Herreros, Belén, Busquets, David, Riera, Joan, Martínez-Montiel, María Pilar, Roldón, Marta, Roncero, Oscar, Hinojosa, Esther, Sierra Ausín, Mónica, Barrio, Jesús, De Francisco, Ruth, Huguet, José, Merino, Olga, Carpio, Daniel, Ginard, Daniel, Muñoz, Fernando, Piqueras, Marta, Almela, Pedro, Argüelles-Arias, Federico, Alcaín, Guillermo, Bujanda, Luis, Manceñido, Noemí, Lucendo, Alfredo J., Varela, Pilar, Rodríguez-Lago, Iago, Ramos, Laura, Sempere, Laura, Sesé, Eva, Barreiro-de Acosta, Manuel, Domènech, Eugeni, Francés, Rubén, and Universitat Autònoma de Barcelona
- Abstract
Previous studies comparing immigrant ethnic groups and native patients with IBD have yielded clinical and phenotypic differences. To date, no study has focused on the immigrant IBD population in Spain. Prospective, observational, multicenter study comparing cohorts of IBD patients from ENEIDA-registry who were born outside Spain with a cohort of native patients. We included 13,524 patients (1,864 immigrant and 11,660 native). The immigrants were younger (45 ± 12 vs. 54 ± 16 years, p < 0.001), had been diagnosed younger (31 ± 12 vs. 36 ± 15 years, p < 0.001), and had a shorter disease duration (14 ± 7 vs. 18 ± 8 years, p < 0.001) than native patients. Family history of IBD (9 vs. 14%, p < 0.001) and smoking (30 vs. 40%, p < 0.001) were more frequent among native patients. The most prevalent ethnic groups among immigrants were Caucasian (41.5%), followed by Latin American (30.8%), Arab (18.3%), and Asian (6.7%). Extraintestinal manifestations, mainly musculoskeletal affections, were more frequent in immigrants (19 vs. 11%, p < 0.001). Use of biologics, mainly anti-TNF, was greater in immigrants (36 vs. 29%, p < 0.001). The risk of having extraintestinal manifestations [OR: 2.23 (1.92-2.58, p < 0.001)] and using biologics [OR: 1.13 (1.0-1.26, p = 0.042)] was independently associated with immigrant status in the multivariate analyses. Compared with native-born patients, first-generation-immigrant IBD patients in Spain were younger at disease onset and showed an increased risk of having extraintestinal manifestations and using biologics. Our study suggests a featured phenotype of immigrant IBD patients in Spain, and constitutes a new landmark in the epidemiological characterization of immigrant IBD populations in Southern Europe.
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- 2022
43. Nationwide COVID-19-EII Study : Incidence, Environmental Risk Factors and Long-Term Follow-Up of Patients with Inflammatory Bowel Disease and COVID-19 of the ENEIDA Registry
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Zabana, Yamile, Marín-Jiménez, Ignacio, Rodríguez-Lago, Iago, Vera, Isabel, Martín-Arranz, María Dolores, Guerra, Iván, P. Gisbert, Javier, Mesonero, Francisco, Benítez, Olga, Taxonera, Carlos, Ponferrada-Díaz, Ángel, Piqueras, Marta, Lucendo, Alfredo J., Caballol, Berta, Mañosa Ciria, Míriam, Martínez-Montiel, Pilar, Bosca-Watts, Maia, Gordillo, Jordi, Bujanda, Luis, Manceñido, Noemí, Martínez-Pérez, Teresa, López, Alicia, Rodríguez-Gutiérrez, Cristina, García-López, Santiago, Vega, Pablo, Rivero, Montserrat, Melcarne, Luigi, Calvo, Maria, Iborra, Marisa, Barreiro de-Acosta, Manuel, Sicilia, Beatriz, Barrio, Jesús, Pérez-Calle, José Lázaro, Busquets, David, Pérez-Martínez, Isabel, Navarro-Llavat, Mercè, Hernández, Vicent, Argüelles-Arias, Federico, Ramírez Esteso, Fernando, Meijide, Susana, Ramos, Laura, Gomollón, Fernando, Muñoz, Fernando, Suris, Gerard, de Zarate, Jone Ortiz, Huguet, José María, Llaó, Jordina, García-Sepulcre, Mariana Fe, Sierra Ausín, Mónica, Durà, Miguel, Estrecha, Sandra, Fuentes Coronel, Ana María, Hinojosa, Esther, Olivan, Lorenzo, Iglesias, Eva, Gutiérrez Casbas, Ana, Varela, Pilar, Rull, Núria, Gilabert, Pau, Hernández Camba, Alejandro, Brotons, Alicia, Ginard, Daniel, Sesé, Eva, Carpio, Daniel, Aceituno, Montserrat, Cabriada, José Luis, González-Lama, Yago, Jiménez, Laura, Chaparro, María, López-San Román, Antonio, Alba, Cristina, Plaza-Santos, Rocío, Mena, Raquel, Tamarit-Sebastián, Sonsoles, Ricart, Elena, Calafat, Margalida, Olivares, Sonsoles, Navarro, Pablo, Bertoletti, Federico, Alonso-Galán, Horacio, Pajares, Ramón, Olcina, Pablo, Manzano, Pamela, Domènech, Eugeni, Esteve, Maria, Universitat Autònoma de Barcelona, Zabana, Yamile, Marín-Jiménez, Ignacio, Rodríguez-Lago, Iago, Vera, Isabel, Martín-Arranz, María Dolores, Guerra, Iván, P. Gisbert, Javier, Mesonero, Francisco, Benítez, Olga, Taxonera, Carlos, Ponferrada-Díaz, Ángel, Piqueras, Marta, Lucendo, Alfredo J., Caballol, Berta, Mañosa Ciria, Míriam, Martínez-Montiel, Pilar, Bosca-Watts, Maia, Gordillo, Jordi, Bujanda, Luis, Manceñido, Noemí, Martínez-Pérez, Teresa, López, Alicia, Rodríguez-Gutiérrez, Cristina, García-López, Santiago, Vega, Pablo, Rivero, Montserrat, Melcarne, Luigi, Calvo, Maria, Iborra, Marisa, Barreiro de-Acosta, Manuel, Sicilia, Beatriz, Barrio, Jesús, Pérez-Calle, José Lázaro, Busquets, David, Pérez-Martínez, Isabel, Navarro-Llavat, Mercè, Hernández, Vicent, Argüelles-Arias, Federico, Ramírez Esteso, Fernando, Meijide, Susana, Ramos, Laura, Gomollón, Fernando, Muñoz, Fernando, Suris, Gerard, de Zarate, Jone Ortiz, Huguet, José María, Llaó, Jordina, García-Sepulcre, Mariana Fe, Sierra Ausín, Mónica, Durà, Miguel, Estrecha, Sandra, Fuentes Coronel, Ana María, Hinojosa, Esther, Olivan, Lorenzo, Iglesias, Eva, Gutiérrez Casbas, Ana, Varela, Pilar, Rull, Núria, Gilabert, Pau, Hernández Camba, Alejandro, Brotons, Alicia, Ginard, Daniel, Sesé, Eva, Carpio, Daniel, Aceituno, Montserrat, Cabriada, José Luis, González-Lama, Yago, Jiménez, Laura, Chaparro, María, López-San Román, Antonio, Alba, Cristina, Plaza-Santos, Rocío, Mena, Raquel, Tamarit-Sebastián, Sonsoles, Ricart, Elena, Calafat, Margalida, Olivares, Sonsoles, Navarro, Pablo, Bertoletti, Federico, Alonso-Galán, Horacio, Pajares, Ramón, Olcina, Pablo, Manzano, Pamela, Domènech, Eugeni, Esteve, Maria, and Universitat Autònoma de Barcelona
- Abstract
We aim to describe the incidence and source of contagion of COVID-19 in patients with IBD, as well as the risk factors for a severe course and long-term sequelae. This is a prospective observational study of IBD and COVID-19 included in the ENEIDA registry (53,682 from 73 centres) between March-July 2020 followed-up for 12 months. Results were compared with data of the general population (National Centre of Epidemiology and Catalonia). A total of 482 patients with COVID-19 were identified. Twenty-eight percent were infected in the work environment, and 48% were infected by intrafamilial transmission, despite having good adherence to lockdown. Thirty-five percent required hospitalization, 7.9% had severe COVID-19 and 3.7% died. Similar data were reported in the general population (hospitalisation 19.5%, ICU 2.1% and mortality 4.6%). Factors related to death and severe COVID-19 were being aged ≥ 60 years (OR 7.1, 95% CI: 1.8-27 and 4.5, 95% CI: 1.3-15.9), while having ≥2 comorbidities increased mortality (OR 3.9, 95% CI: 1.3-11.6). None of the drugs for IBD were related to severe COVID-19. Immunosuppression was definitively stopped in 1% of patients at 12 months. The prognosis of COVID-19 in IBD, even in immunosuppressed patients, is similar to that in the general population. Thus, there is no need for more strict protection measures in IBD.
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- 2022
44. DOP52 Safety of Inflammatory Bowel Disease drugs during pregnancy and breastfeeding: Mothers and babies’ outcomes (DUMBO registry)
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Javier P. Gisbert, E. Leo Carnerero, I Rodríguez Lago, M T Diz-Lois Palomares, Saioa Rubio, María José Casanova, B Zúñiga de Mora-Figueroa, L Arias García, José María Huguet, M Figueira, Agnès Fernández-Clotet, N. Manceñido Marcos, I Pérez Martínez, R Vicente Lidón, R Rodríguez Insa, Iván Guerra, D. Hervías Cruz, P Martínez Montiel, P Ramírez de la Piscina Urraca, C Calviño Suárez, M Aguas, M Á de Jorge Turrión, L Ramos, A Ruiz Cerulla, A Gutiérrez Casbas, P Lopez Serrano, R Armesto, P Sendra Rumbeu, S Marín Pedrosa, G Molina Arriero, R. Camargo Camero, J M Vázquez Morón, C.A. Tardillo Marín, M. Rivero, C Suarez Ferrer, E Alfambra Cabrejas, Alfredo J. Lucendo, M. Chaparro, Luis Bujanda, and M García Donday
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medicine.medical_specialty ,Pregnancy ,Obstetrics ,business.industry ,Gastroenterology ,medicine ,Breastfeeding ,General Medicine ,medicine.disease ,business ,Inflammatory bowel disease - Abstract
Background Prospective registries are necessary to evaluate the safety of inflammatory bowel disease (IBD) treatment during pregnancy and in children in the long term. Aims The overall aim of DUMBO registry is to know the risk of serious adverse events (SAEs) during pregnancy and in children up to 4 years of age exposed during pregnancy to drugs for IBD (mainly focused on biologics), compared to unexposed children. In this analysis we aim to evaluate the risk of SAEs during pregnancy and the predictive factors of it (mainly focused on IBD drugs). Methods Prospective, observational and multicentre registry, which enrols pregnant women with IBD (Crohn’s disease, ulcerative colitis, IBD-unclassified) over 5 years in 70 centres in Spain. The registry was kicked off in September 2019. SAE was defined based on “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting by European Medicines Agency”. Study protocol is summarized in figure 1. Results 433 women have been included so far; 241 got pregnant at least 9 months before this interim analysis (table 1). Mean age was 34 years, and 17% of women had active disease at any time during pregnancy. 23% of pregnancies were exposed to immumodulators (thiopurines), 25% to biologics and 10% to combo therapy (biologics and immunomodulators). 85 pregnancies (35%) were exposed to biologics (60 anti-TNF, 17 ustekinumab, and 8 vedolizumab) either in combo or in monotherapy. There were 237 newborns (227 singleton and 5 pair of twins), 9 miscarriages and 1 abortion. 72% of patients had vaginal delivery and 28% C-sections (18% due to perianal CD or active disease). A total of 59 pregnancies (24.5%) reported at least one SAE: 32% in exposed to biologics and 20.5% in non-exposed group (p>0.05) (figure 2). Four out of 17 pregnancies exposed to ustekinumab and 3 out of 8 exposed to vedolizumab had SAEs (non-related with the drug). In the multivariate analysis, adjusted by disease activity, in comparison with no immunosuppressive treatment, neither immunosuppressants [Odds ratio (OR)=1.1, 95% confidence interval (CI)=0.3–4.3] nor biologics in monotherapy or in combo (OR=0.8; 95%CI=0.2–3) were associated with higher risk of SAEs. 40 patients (17%) were hospitalised due to complications during pregnancy or delivery (figure 3). Two patients underwent surgery during pregnancy due to IBD complications Conclusion IBD treatment (either immunomodulators or biologics) does not increase the risk of SAEs during pregnancy. Nevertheless, one-quarter of IBD women suffer SAEs during pregnancy and about 20% need hospitalisation, which should be taken into account when managing IBD during pregnancy.
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- 2021
45. P263 Influence of Crohn′s Disease phenotype in the retention rate of ustekinumab treatment: SUSTAIN Study
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C Novella, E Vispo, María García, A Gutiérrez Casbas, I Bastón Rey, C Dueñas Sadornil, J Martínez Cadilla, E Iyo, O. Merino Ochoa, M Cabelo, J González García, C Quílez Ivorra, F Argüelles, Javier P. Gisbert, B David, Jordi Gordillo, Mara Charro, S Rubio Iturria, M. Barreiro-de Acosta, P Ramírez de la Piscina, E. Iglesias Flores, B Velayos Jiménez, E Hinojosa, P Martínez Montiel, M Chaparro, M Boscá-Watts, Francisco Javier Bermejo, José María Huguet, Y. Gonzalez Lama, J M Vázque morón, A I Muñagorri Santos, V M Amo, P Fradejas Salazar, A Núñez Ortiz, M D Martín Arranz, Daniel Ginard, L Ramos, M T Diz-Lois Palomares, E Fernández-Salgado, and Maite Arroyo
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medicine.medical_specialty ,Crohn's disease ,business.industry ,Gastroenterology ,General Medicine ,Retention rate ,medicine.disease ,Inflammatory bowel disease ,Phenotype ,Log-rank test ,Internal medicine ,Ustekinumab ,medicine ,Predictor variable ,business ,Survival analysis ,medicine.drug - Abstract
Background Crohn′s disease (CD) is a progressive inflammatory bowel disease that can lead to complications such as strictures or penetrating disease, and ultimately surgery, representing a complex clinical challenge in the care of patients. We aimed to evaluate the influence of CD phenotype in the retention rate of ustekinumab in the Sustain study. Methods Retrospective, multicentre study (>60 sites) including patients with active CD [(Harvey-Bradshaw (HBI)>4)] who received ≥1 dose of ustekinumab intravenously before July 2018. Clinical remission was defined as HBI≤4 and response as ≥3 points decrease from baseline. Loss of response (LoR) was defined as reappearance of symptoms that led to intensifying the treatment dose, adding another medication to control CD, switching or surgery in patients with short-term remission. Disease characteristics were collected (date of diagnosis; location; behaviour: inflammatory, stenosing or penetrating; presence of perianal disease or extraintestinal manifestations; previous surgeries, etc.). The retention rates in patients on ustekinumab depending of their disease phenotype were evaluated by descriptive analysis and Kaplan-Meier survival curves. Survival curves were compared using the log-rank test. Predictive factors were assessed by Cox-regression. Data quality was assured by remote monitoring. Results 463 CD patients were included (Table 1). 87 patients (18.6%) had penetrating CD in our cohort. The probability of maintaining UST treatment was 91% at 6, 83% at 12, 76% at 18 and 73% at 24 months. Similar retention rates were observed in patients with inflammatory (77.6%), stricturing (76.4%) and penetrating (79%) disease behaviour (p>0.05). Figure 1. Conclusion Ustekinumab has shown to be equally effective in the treatment of inflammatory, stricturing and penetrating CD phenotype in Sustain, the largest study evaluating its use in CD in clinical practice, having the longest follow-up period reported to date.
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- 2021
46. Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn’s Disease Patients: The SUSTAIN Study
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Chaparro, María, primary, Baston-Rey, Iria, additional, Fernández-Salgado, Estela, additional, González García, Javier, additional, Ramos, Laura, additional, Diz-Lois Palomares, María Teresa, additional, Argüelles-Arias, Federico, additional, Iglesias Flores, Eva, additional, Cabello, Mercedes, additional, Rubio Iturria, Saioa, additional, Núñez Ortiz, Andrea, additional, Charro, Mara, additional, Ginard, Daniel, additional, Dueñas Sadornil, Carmen, additional, Merino Ochoa, Olga, additional, Busquets, David, additional, Iyo, Eduardo, additional, Gutiérrez Casbas, Ana, additional, Ramírez de la Piscina, Patricia, additional, Boscá-Watts, Marta Maia, additional, Arroyo, Maite, additional, García, María José, additional, Hinojosa, Esther, additional, Gordillo, Jordi, additional, Martínez Montiel, Pilar, additional, Velayos Jiménez, Benito, additional, Quílez Ivorra, Cristina, additional, Vázquez Morón, Juan María, additional, María Huguet, José, additional, González-Lama, Yago, additional, Muñagorri Santos, Ana Isabel, additional, Amo, Víctor Manuel, additional, Martín-Arranz, María Dolores, additional, Bermejo, Fernando, additional, Martínez Cadilla, Jesús, additional, Rubín de Célix, Cristina, additional, Fradejas Salazar, Paola, additional, San Román, Antonio López, additional, Jiménez, Nuria, additional, García López, Santiago, additional, Figuerola, Anna, additional, Jiménez, Itxaso, additional, Martínez Cerezo, Francisco José, additional, Taxonera, Carlos, additional, Varela, Pilar, additional, de Francisco, Ruth, additional, Monfort, David, additional, Molina Arriero, Gema, additional, Hernández Camba, Alejandro, additional, García-Alonso, Francisco Javier, additional, Van Domselaar, Manuel, additional, Pajares Villarroya, Ramón, additional, Núñez, Alejandro, additional, Rodríguez Moranta, Francisco, additional, Marín-Jiménez, Ignacio, additional, Robles Alonso, Virginia, additional, Martín Rodríguez, María del Mar, additional, Camo-Monterde, Patricia, additional, García Tercero, Iván, additional, Navarro Llavat, Mercedes, additional, Arias García, Lara, additional, Hervías Cruz, Daniel, additional, Sulleiro, Sara, additional, Novella, Cynthia, additional, Vispo, Eugenia, additional, Barreiro-de Acosta, Manuel, additional, and Gisbert, Javier P, additional
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- 2022
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47. Hypophosphatemic osteomalacia, a side effect of iron carboxymaltose administration
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Lucía, Madero Velázquez, Roser, Muñoz Pérez, Andrés, Rodríguez, Lorena, Bernal, Beatriz, Orts, Laura, Sempere, and Ana, Gutiérrez Casbas
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Hypophosphatemia ,Iron ,Osteomalacia ,Gastroenterology ,Humans ,General Medicine ,Maltose ,Ferric Compounds - Abstract
Carboxymaltose iron (Ferinject®) is a formulation for intravenous (iv) administration, used for the treatment of iron deficiency anemia and/or iron deficiency when oral administration of iron is not effective or due to intolerance. Its safety profile is excellent with few, but not nonexistent, side effects. Hypophosphatemia has been described as one of them. It is usually mild, transient and asymptomatic. However, in some cases it may be accompanied by nausea, asthenia, in addition to muscular and neurological symptoms and hematological alterations. It is, therefore, a potentially serious adverse effect whose prevalence is unknown and which requires high clinical suspicion to be detected.
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- 2022
48. ECCO Topical Review: Roadmap to optimal peri-operative care in IBD
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Sebastian S, Segal JP, Hedin C, Pellino G, Kotze PG, Adamina M, Campmans-Kuijpers M, Davies J, de Vries AC, Gutiérrez Casbas A, El-Hussuna A, Juillerat P, Meade S, Millán M, and Spinelli A
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BACKGROUND AND AIMS: Despite the advances in medical therapies, a significant proportion of patients with inflammatory bowel diseases (IBD) require surgical intervention. This Topical Review aims to offer expert consensus practice recommendations for peri-operative care to optimise outcomes of IBD patients who undergo surgery. METHODS: A multidisciplinary panel of IBD health care providers systematically reviewed aspects relevant to peri-operative care in IBD. Consensus statements were developed using Delphi methodology. RESULTS: A total of 20 current practice positions were developed following systematic review of the current literature covering use of medication in the peri-operative period, nutritional assessment and intervention, physical and psychological rehabilitation and prehabilitation and immediate postoperative care. CONCLUSION: Peri-operative planning and optimization of the patient are imperative to ensure favourable outcomes and reduced morbidity. This Topical Review provides practice recommendations applicable in the peri-operative period in IBD patients undergoing surgery.
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- 2022
49. Using Interpretable Machine Learning to Identify Baseline Predictive Factors of Remission and Drug Durability in Crohn's Disease Patients on Ustekinumab
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María Chaparro, Iria Baston-Rey, Estela Fernández Salgado, Javier González García, Laura Ramos, María Teresa Diz-Lois Palomares, Federico Argüelles-Arias, Eva Iglesias Flores, Mercedes Cabello, Saioa Rubio Iturria, Andrea Núñez Ortiz, Mara Charro, Daniel Ginard, Carmen Dueñas Sadornil, Olga Merino Ochoa, David Busquets, Eduardo Iyo, Ana Gutiérrez Casbas, Patricia Ramírez de la Piscina, Marta Maia Boscá-Watts, Maite Arroyo, María José García, Esther Hinojosa, Jordi Gordillo, Pilar Martínez Montiel, Benito Velayos Jiménez, Cristina Quílez Ivorra, Juan María Vázquez Morón, José María Huguet, Yago González-Lama, Ana Isabel Muñagorri Santos, Víctor Manuel Amo, María Dolores Martín Arranz, Fernando Bermejo, Jesús Martínez Cadilla, Cristina Rubín de Célix, Paola Fradejas Salazar, Antonio López San Román, Nuria Jiménez, Santiago García-López, Anna Figuerola, Itxaso Jiménez, Francisco José Martínez Cerezo, Carlos Taxonera, Pilar Varela, Ruth de Francisco, David Monfort, Gema Molina Arriero, Alejandro Hernández-Camba, Francisco Javier García Alonso, Manuel Van Domselaar, Ramón Pajares-Villarroya, Alejandro Núñez, Francisco Rodríguez Moranta, Ignacio Marín-Jiménez, Virginia Robles Alonso, María del Mar Martín Rodríguez, Patricia Camo-Monterde, Iván García Tercero, Mercedes Navarro-Llavat, Lara Arias García, Daniel Hervías Cruz, Sebastian Kloss, Alun Passey, Cynthia Novella, Eugenia Vispo, Manuel Barreiro-de Acosta, Javier P. Gisbert, Institut Català de la Salut, [Chaparro M] Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Madrid, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain. [Baston-Rey I] Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain. [Fernández Salgado E] Complejo Hospitalario de Pontevedra, Pontevedra, Spain. [González García J] Hospital Público Comarcal la Inmaculada, Almería, Spain. [Ramos L] Hospital Universitario de Canarias, Tenerife, Spain. [Diz-Lois Palomares MT] Hospital Universitario A Coruña, A Coruña, Spain. [Robles Alonso V] Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
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acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinflamatorios [COMPUESTOS QUÍMICOS Y DROGAS] ,predictive factors ,Factors de risc en les malalties ,Risk factors in diseases ,Crohn’s Disease ,ustekinumab ,Antiinflamatoris - Ús terapèutic ,Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases::Crohn Disease [DISEASES] ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Crohn's Disease ,General Medicine ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal::enfermedad de Crohn [ENFERMEDADES] ,Crohn, Malaltia de - Tractament ,Ciencias de la información::metodologías computacionales::algoritmos::inteligencia artificial::aprendizaje automático [CIENCIA DE LA INFORMACIÓN] ,Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Inflammatory Agents [CHEMICALS AND DRUGS] ,Malaltia de Crohn ,Aprenentatge automàtic ,Information Science::Computing Methodologies::Algorithms::Artificial Intelligence::Machine Learning [INFORMATION SCIENCE] - Abstract
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.
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- 2022
50. Hypophosphatemic osteomalacia, a side effect of iron carboxymaltose administration
- Author
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Madero Velázquez L, Muñoz Pérez R, Rodríguez A, Bernal L, Orts B, Sempere L, and Gutiérrez Casbas A
- Subjects
Hypophosphatemic osteomalacia ,Carboxymaltose iron - Abstract
Carboxymaltose iron (Ferinject®) is a formulation for intravenous (iv) administration, used for the treatment of iron deficiency anemia and/or iron deficiency when oral administration of iron is not effective or due to intolerance. Its safety profile is excellent with few, but not nonexistent, side effects. Hypophosphatemia has been described as one of them. It is usually mild, transient and asymptomatic. However, in some cases it may be accompanied by nausea, asthenia, in addition to muscular and neurological symptoms and hematological alterations. It is, therefore, a potentially serious adverse effect whose prevalence is unknown and which requires high clinical suspicion to be detected.
- Published
- 2022
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