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Start Over Author "Delgado-Guillena, P" Topic ustekinumab
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1. Long-term benefit of ustekinumab in ulcerative colitis in clinical practice: ULISES study.

Author

Chaparro M, Hermida S, Acosta D, Fernández-Clotet A, Barreiro-de Acosta M, Hernández Martínez Á, Arroyo M, Bosca-Watts MM, Diz-Lois Palomares MT, Menchén L, Martínez Cadilla J, Leo-Carnerero E, Muñoz Villafranca C, Sierra-Ausín M, González-Lama Y, Riestra S, Sendra Rumbeu P, Cabello Tapia MJ, García de la Filia I, Vicente R, Ceballos D, Pajares Villarroya R, Ramírez de la Piscina P, Martín-Arranz MD, Ramos L, Ruiz-Cerulla A, Martínez-Pérez TJ, San Miguel Amelivia E, Calvet X, Huguet JM, Keco-Huerga A, Lorente Poyatos RH, Muñoz JF, Ponferrada-Díaz Á, Sicilia B, Delgado-Guillena P, Gómez Delgado E, Rancel-Medina FJ, Alonso-Galán H, Herreros B, Rivero M, Varela P, Bermejo F, García Sepulcre M, Gimeno-Pitarch L, Kolle-Casso L, Márquez-Mosquera L, Martínez Tirado P, Ramírez C, Sesé Abizanda E, Dueñas Sadornil C, Fernández Rosáenz H, Gutiérrez Casbas A, Madrigal Domínguez RE, Nantes Castillejo Ó, Ber Nieto Y, Botella Mateu B, Frago Larramona S, López Serrano P, Rubio Mateos JM, Torrá Alsina S, Iyo E, Fernández Forcelledo JL, Hernández L, Rodríguez-Grau MC, Monfort Miquel D, Van Domselaar M, López Ramos C, Ruiz Barcia MJ, and Gisbert JP

Subjects
Humans, Male, Female, Retrospective Studies, Adult, Middle Aged, Treatment Outcome, Remission Induction, Severity of Illness Index, Ustekinumab therapeutic use, Colitis, Ulcerative drug therapy
Abstract

Background: Ustekinumab is approved for ulcerative colitis (UC)., Aims: To assess the durability of ustekinumab in patients with UC and its short-term effectiveness, durability and tolerability in clinical practice., Methods: Retrospective, multicentre study of patients who had received their first ustekinumab dose at least 16 weeks before inclusion. Patients were followed until treatment discontinuation or last visit. Only patients with active disease at the start of ustekinumab treatment were considered in the effectiveness analysis. Patients who stopped ustekinumab before their last visit were considered not to be in subsequent remission., Results: We included 620 patients; 155 (25%) discontinued ustekinumab during follow-up (median 12 months). Rate of discontinuation was 20% per patient-year of follow-up. Anaemia at baseline (hazard ratio, HR 1.5; 95% confidence interval [CI] 1.1-2.1), steroids at baseline (HR 1.5; 95% CI 1.06-2.08) and more severe clinical activity at baseline (HR 1.5; 95% CI 1.09-2.06) were associated with higher risk of discontinuation. At the end of induction, 226 (40%) patients were in steroid-free clinical remission. Moderate-severe vs mild disease activity at baseline (odds ratio [OR] 0.3; 95% CI 0.2-0.5), male sex (OR 0.5; 95% CI 0.4-0.8), and increased number of previous biologics (OR 0.6; 95% CI 0.6-0.8) were associated with lower likelihood of steroid-free clinical remission at week 16. One hundred and seventy-six patients (28%) had at least one adverse event. We observed no negative impact of ustekinumab on extraintestinal manifestations and/or immune-mediated diseases., Conclusions: Ustekinumab durability in UC was relatively high, and treatment was effective in highly refractory patients. The safety profile was consistent with previous studies., (© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Published
2024
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2. Ustekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn's disease: Results from the ENEIDA registry.

Author

Mañosa M, Fernández-Clotet A, Nos P, Martín-Arranz MD, Manceñido N, Carbajo A, Hinojosa E, Hernández-Camba A, Muñoz-Pérez R, Boscá-Watts M, Calvo M, Sierra-Ausín M, Sánchez-Rodríguez E, Barreiro-de Acosta M, Núñez-Alonso A, Zabana Y, Márquez L, Gisbert JP, Guardiola J, Sáinz E, Delgado-Guillena P, Busquets D, van Domselaar M, Girona E, Lorente R, Casas-Deza D, Huguet JM, Maestro S, Cabello MJ, Castro J, Iborra M, Cañete F, Calafat M, and Domènech E

Subjects
Humans, Tumor Necrosis Factor Inhibitors therapeutic use, Registries, Retrospective Studies, Treatment Outcome, Ustekinumab therapeutic use, Crohn Disease drug therapy, Crohn Disease prevention & control, Crohn Disease surgery
Abstract

Background: Anti-TNF agents are the only effective biological agents for the prevention of postoperative recurrence (POR) in Crohn's disease (CD). However, they are contraindicated or have been shown to fail in some patients. Although ustekinumab and vedolizumab were licensed for CD some years ago, data in this setting are scarce., Methods: All CD patients in whom ustekinumab or vedolizumab was prescribed for the prevention of POR within three months of ileocolonic resection with anastomosis were identified from the ENEIDA registry. The development of endoscopic, clinical and surgical POR was registered., Results: Forty patients were treated for the prevention of POR with ustekinumab and 25 were treated with vedolizumab. Eighty per cent had at least one risk factor for POR (prior resections, active smoking, perianal disease or penetrating disease behaviour). All the patients had been exposed to anti-TNF therapy. After a median follow-up of 17 and 26 months, the cumulative probability of clinical POR at 12 months after surgery was 32% and 30% for ustekinumab and vedolizumab, respectively. Endoscopic assessment within the first 18 months after surgery was available for 80% of the patients on ustekinumab and 70% for those on vedolizumab. The rate of endoscopic POR was 42% for ustekinumab and 40% for vedolizumab. One patient treated with ustekinumab and two with vedolizumab underwent a new intestinal resection., Conclusions: Ustekinumab and vedolizumab seem to be effective in the prevention of POR in patients at high risk. Our results warrant controlled trials comparing these drugs with conventional therapies., Competing Interests: Declaration of Competing Interest MM has served as a speaker, consultant and advisory member for or has received research funding from AbbVie, Gilead, Janssen, MSD, Pfizer, Shire Pharmaceuticals, Faes, Takeda, Tillots; PN has served as a speaker, consultant and advisory member for or has received research funding from MSD, Abbvie, Janssen, Takeda, Roche, Sandoz, Ferring, Adacyte, Faes Farma, Kern Pharma, Pfizer, Shire Pharmaceuticals, Vifor Pharma, Chiesi and Tillots; MDM-A has served as a speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Hospira, Pfizer, Takeda, Janssen, Shire Pharmaceuticals, Tillotts Pharma, FaesPharma; MB-W has served as a speaker, consultant and advisory member for or has received research funding from MSD, Ferring, Abbvie, Janssen, Biogen and Takeda; MC has served as a speaker, consultant and advisory member for or has received research funding from MSD, Abbvie, Takeda, Jannsen, Pfizer, Otsuka Pharmaceutical, Chiesi, Ferring, Shire Pharmaceuticals and Dr. Falk Pharma; MS-A has served as a speaker, consultant and advisory member for or has received research funding from Takeda, Janssen, MSD, Abbvie, Ferring, Chiesi, Tillots and Pfizer; MBA has served as a speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Gillead, Celgene, Pfizer, Sandoz, Biogen, Fresenius, Ferring, Faes Farma, Dr. Falk Pharma, Chiesi, Gebro Pharma, Adacyte and Vifor Pharma; YZ has served as a speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Takeda, Kern Pharma, Biogen; JPG has served as a speaker, consultant and advisory member for or has received research funding from MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene, Gilead, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, and Vifor Pharma; JG has served as a speaker, consultant and advisory member for or has received research funding from Roche, MSD, Abbvie, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Chiesi and GE Healthcare; DB has served as a speaker, consultant and advisory member for or has received research funding from Abbvie, Janssen, Ferring, Pfizer, and Takeda; DC-D has served as a speaker, consultant and advisory member for or has received research funding from MSD, Ferring, Abbvie, Janssen, Faes Farma, Pfizer, Tillots and Takeda; SM has served as a speaker, consultant and advisory member for or has received research funding from MSD, Ferring, Abbvie, Janssen, Pfizer and Takeda; LM has served as a speaker and advisory member for or has received research funding from MSD, Takeda, Janssen, Abbvie and Pfizer; FC has served as a speaker, consultant and advisory member for or has received research funding from Takeda, Janssen, MSD, and Ferring; MC has served as a speaker, consultant and advisory member for or has received research funding from Takeda, Janssen, Faes Farma, and MSD; ED has served as a speaker, consultant and advisory member for or has received research funding from AbbVie, Adacyte Therapeutics, Celltrion, Gilead, Janssen, Kern Pharma, MSD, Pfizer, Roche, Samsung, Takeda, Tillots, Ferring, and Thermofisher; the remaining authors have no potential conflicts to declare., (Copyright © 2022. Published by Elsevier Ltd.)

Published
2023
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3. Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry.

Author

Chaparro M, Garre A, Iborra M, Sierra-Ausín M, Barreiro-de Acosta M, Fernández-Clotet A, de Castro L, Boscá-Watts M, Casanova MJ, López-García A, Lorente R, Rodríguez C, Carbajo AY, Arroyo MT, Gutiérrez A, Hinojosa J, Martínez-Pérez T, Villoria A, Bermejo F, Busquets D, Camps B, Cañete F, Manceñido N, Monfort D, Navarro-Llavat M, Pérez-Calle JL, Ramos L, Rivero M, Angueira T, Camo Monterde P, Carpio D, García-de-la-Filia I, González-Muñoza C, Hernández L, Huguet JM, Morales VJ, Sicilia B, Vega P, Vera I, Zabana Y, Nos P, Suárez Álvarez P, Calviño-Suárez C, Ricart E, Hernández V, Mínguez M, Márquez L, Hervías Cruz D, Rubio Iturria S, Barrio J, Gargallo-Puyuelo C, Francés R, Hinojosa E, Del Moral M, Calvet X, Algaba A, Aldeguer X, Guardiola J, Mañosa M, Pajares R, Piqueras M, García-Bosch O, López Serrano P, Castro B, Lucendo AJ, Montoro M, Castro Ortiz E, Mesonero F, García-Planella E, Fuentes DA, Bort I, Delgado-Guillena P, Arias L, Iglesias A, Calvo M, Esteve M, Domènech E, and Gisbert JP

Subjects
Female, Humans, Infusions, Intravenous, Male, Middle Aged, Prospective Studies, Registries, Remission Induction, Ustekinumab administration & dosage, Colitis, Ulcerative drug therapy, Ustekinumab therapeutic use
Abstract

Background and Aims: The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed to evaluate the durability, effectiveness, and safety of ustekinumab in UC in real life., Methods: Patients included in the prospectively maintained ENEIDA registry, who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score [PMS]>2], were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at Week 16., Results: A total of 95 patients were included. At Week 16, 53% of patients had response [including 35% of patients in remission]. In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at Weeks 24 and 52, respectively; 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at Week 16, 63% at Week 56, and 59% at Week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection., Conclusions: Ustekinumab is effective in both the short and the long term in real life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab., (© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2021
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4. Impact of Biological Agents on Postsurgical Complications in Inflammatory Bowel Disease: A Multicentre Study of Geteccu

Author

García, M. J., Rivero, M., Miranda-Bautista, J., Bastón-Rey, I., Mesonero, F., Leo-Carnerero, E., Casas-Deza, D., Cagigas Fernández, C., Martin-Cardona, A., El Hajra, I., Hernández-Aretxabaleta, N., Pérez-Martínez, I., Fuentes-Valenzuela, E., Jiménez, N., Rubin de Célix, C., Gutiérrez, A., Suárez Ferrer, C., Huguet, J. M., Fernández-Clotet, A., González-Vivó, M., Del Val, B., Castro-Poceiro, J., Melcarne, L., Dueñas, C., Izquierdo, M., Monfort, D., Bouhmidi, A., Ramírez de la Piscina, P., Romero, E., Molina, G., Zorrilla, J., Calvino-Suárez, C., Sánchez, E., Núñez, A., Sierra, O., Castro, B., Zabana, Y., González-Partida, I., De la Maza, S., Castaño, A., Nájera-Muñoz, R., Sánchez-Guillén, L., Riat Castro, M., Rueda, J. L., Benítez, J. M., Delgado-Guillena, P., Tardillo, C., Peña, E., Frago-Larramona, S., Rodríguez-Grau. M. C., Plaza, R., Pérez-Galindo, P., Martínez-Cadilla, J., Menchén, L., Barreiro-De Acosta, M., Sánchez-Aldehuelo, R., De la Cruz, M. D., Lamuela, L. J., Marín, I., Nieto-García, L., López San Román, A., Herrera, J. M., Chaparro, M., Gisbert, J. P., Young Group of GETECCU, [García MJ, Rivero M] Gastroenterology Department, Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Instituto de Investigación Sanitaria Valdecilla (IDIVAL), Santander, Spain. [Miranda-Bautista J] Gastroenterology Department, Hospital Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), and Departamento de Medicina, Universidad Complutense, Madrid, Spain. [Bastón-Rey I] Gastroenterology Department, Hospital Universitario Clínico de Santiago, Santiago de Compostela, Spain. [Mesonero F] Gastroenterology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. [Leo-Carnerero E] Gastroenterology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Delgado-Guillena P] Gastroenterology Department, Hospital General de Granollers, Granollers, Spain, Hospital General de Granollers, [Jose Garcia, Maria] Univ Cantabria, Hosp Univ Marques de Valdecilla, Inst Invest Sanitaria Valdecilla IDIVAL, Gastroenterol Dept, Santander 37008, Spain, [Rivero, Montserrat] Univ Cantabria, Hosp Univ Marques de Valdecilla, Inst Invest Sanitaria Valdecilla IDIVAL, Gastroenterol Dept, Santander 37008, Spain, [Castro, Beatriz] Univ Cantabria, Hosp Univ Marques de Valdecilla, Inst Invest Sanitaria Valdecilla IDIVAL, Gastroenterol Dept, Santander 37008, Spain, [Miranda-Bautista, Jose] Univ Complutense, Hosp Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon IiSGM, Gastroenterol Dept, Madrid 28009, Spain, [Menchen, Luis] Univ Complutense, Hosp Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon IiSGM, Gastroenterol Dept, Madrid 28009, Spain, [Marin, Ignacio] Univ Complutense, Hosp Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon IiSGM, Gastroenterol Dept, Madrid 28009, Spain, [Miranda-Bautista, Jose] Univ Complutense, Dept Med, Madrid 28009, Spain, [Menchen, Luis] Univ Complutense, Dept Med, Madrid 28009, Spain, [Marin, Ignacio] Univ Complutense, Dept Med, Madrid 28009, Spain, [Baston-Rey, Iria] Hosp Univ Clin Santiago, Gastroenterol Dept, Santiago De Compostela 15706, Spain, [Calvino-Suarez, Cristina] Hosp Univ Clin Santiago, Gastroenterol Dept, Santiago De Compostela 15706, Spain, [Barreiro-De Acosta, Manuel] Hosp Univ Clin Santiago, Gastroenterol Dept, Santiago De Compostela 15706, Spain, [Nieto-Garcia, Laura] Hosp Univ Clin Santiago, Gastroenterol Dept, Santiago De Compostela 15706, Spain, [Mesonero, Francisco] Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid 28034, Spain, [Sanchez, Eugenia] Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid 28034, Spain, [Sanchez-Aldehuelo, Ruben] Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid 28034, Spain, [Lopez-San Roman, Antonio] Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid 28034, Spain, [Leo-Carnerero, Eduardo] Hosp Univ Virgen del Rocio, Gastroenterol Dept, Seville 41013, Spain, [Nunez, Andrea] Hosp Univ Virgen del Rocio, Gastroenterol Dept, Seville 41013, Spain, [Dolores De la Cruz, Maria] Hosp Univ Virgen del Rocio, Gastroenterol Dept, Seville 41013, Spain, [Manuel Herrera, Jose] Hosp Univ Virgen del Rocio, Gastroenterol Dept, Seville 41013, Spain, [Casas-Deza, Diego] Hosp Univ Miguel Servet, Inst Invest Sanitaria Aragon IISA, Gastroenterol Dept, Zaragoza 50009, Spain, [Sierra, Olivia] Hosp Univ Miguel Servet, Inst Invest Sanitaria Aragon IISA, Gastroenterol Dept, Zaragoza 50009, Spain, [Javier Lamuela, Luis] Hosp Univ Miguel Servet, Inst Invest Sanitaria Aragon IISA, Gastroenterol Dept, Zaragoza 50009, Spain, [Cagigas Fernandez, Carmen] Hosp Univ Marques de Valdecilla, Dept Gen & Digest Surg, Colorectal Unit, Santander 39008, Spain, [Martin-Cardona, Albert] Hosp Univ Mutua Terrassa, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Gastroenterol Dept, Terrassa 08221, Spain, [Zabana, Yamile] Hosp Univ Mutua Terrassa, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Gastroenterol Dept, Terrassa 08221, Spain, [El Hajra, Ismael] Hosp Univ Puerta de Hierro, Gastroenterol Dept, Majadahonda 28220, Spain, [Gonzalez-Partida, Irene] Hosp Univ Puerta de Hierro, Gastroenterol Dept, Majadahonda 28220, Spain, [Hernandez-Aretxabaleta, Nerea] Hosp Univ Basurto, Gastroenterol Dept, Bilbao 48013, Spain, [De la Maza, Saioa] Hosp Univ Basurto, Gastroenterol Dept, Bilbao 48013, Spain, [Perez-Martinez, Isabel] Hosp Univ Cent Asturias, Inst Invest Sanitaria Principado Asturias ISPA 33, Dept Gastroenterol, Oviedo 33011, Spain, [Castano, Andres] Hosp Univ Cent Asturias, Inst Invest Sanitaria Principado Asturias ISPA 33, Dept Gastroenterol, Oviedo 33011, Spain, [Fuentes-Valenzuela, Esteban] Hosp Univ Rio Hortega, Gastroenterol Dept, Valladolid 47012, Spain, [Najera-Munoz, Rodrigo] Hosp Univ Rio Hortega, Gastroenterol Dept, Valladolid 47012, Spain, [Jimenez, Nuria] Hosp Gen Univ Elche, Gastroenterol Dept, Alicante 03203, Spain, [Rubin de Celix, Cristina] Univ Autonoma Madrid UAM, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP,Ctr Invest, Madrid 28006, Spain, [Castro, Micaela Riat] Univ Autonoma Madrid UAM, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP,Ctr Invest, Madrid 28006, Spain, [Chaparro, Maria] Univ Autonoma Madrid UAM, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP,Ctr Invest, Madrid 28006, Spain, [Gisbert, Javier P.] Univ Autonoma Madrid UAM, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP,Ctr Invest, Madrid 28006, Spain, [Gutierrez, Ana] Hosp Gen Alicante, Gastroenterol Dept, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Inst Invest Sanitaria & Biomed Alicante ISABIAL, Alicante 03010, Spain, [Suarez Ferrer, Cristina] Hosp Univ La Paz, Gastroenterol Dept, Madrid 28046, Spain, [Luis Rueda, Jose] Hosp Univ La Paz, Gastroenterol Dept, Madrid 28046, Spain, [Maria Huguet, Jose] Hosp Gen Univ Valencia, Gastroenterol Dept, Valencia 46014, Spain, [Fernandez-Clotet, Agnes] Hosp Clin Barcelona, Gastroenterol Dept, Barcelona 08036, Spain, [Gonzalez-Vivo, Maria] Hosp del Mar, Gastroenterol Dept, Barcelona 08003, Spain, [Del Val, Blanca] Hosp Rafael Mendez, Gastroenterol Dept, Lorca 30817, Spain, [Castro-Poceiro, Jesus] Hosp St Joan Despi Moises Broggi, Gastroenterol Dept, Barcelona 08970, Spain, [Melcarne, Luigi] Hosp Univ Parc Tauli, Gastroenterol Dept, Sabadell, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona 08208, Spain, [Duenas, Carmen] Hosp Univ Caceres, Gastroenterol Dept, Caceres 10003, Spain, [Izquierdo, Marta] Hosp Univ Cabuenes, Gastroenterol Dept, Gijon 33203, Spain, [Monfort, David] Consorcio Sanitario Terrasa, Gastroenterol Dept, Barcelona 08227, Spain, [Bouhmidi, Abdel] Hosp Santa Barbara, Gastroenterol Dept, Puertollano 13500, Spain, [Ramirez De la Piscina, Patricia] Hosp Univ Vitoria Gasteiz, Gastroenterol Dept, Vitoria 01002, Spain, [Romero, Eva] Hosp Clin Univ Valencia, Gastroenterol Dept, Valencia 46010, Spain, [Molina, Gema] Hosp Arquitecto Marcide, Gastroenterol Dept, Ferrol 15405, Spain, [Zorrilla, Jaime] Hosp Univ Gregorio Maranon, Dept Colorectal & Gastrointestinal Surg, Madrid 28009, Spain, [Sanchez-Guillen, Luis] Hosp Gen Univ Elche, Dept Colorectal & Gastrointestinal Surg, Alicante 03203, Spain, [Manuel Benitez, Jose] Hosp Reina Sofia, Gastroenterol Dept, IMIBIC, Cordoba 14004, Spain, [Delgado-Guillena, Pedro] Hosp Gen Granollers, Gastroenterol Dept, Granollers 08042, Spain, [Tardillo, Carlos] Hosp Nuestra Sanora de la Candelaria, Gastroenterol Dept, Tenerife 38010, Spain, [Pena, Elena] Hosp Royo Villanova, Gastroenterol Dept, Zaragoza 50007, Spain, [Frago-Larramona, Santiago] Complejo Hosp Soria, Gastroenterol Dept, Soria 42005, Spain, [Carmen Rodriguez-Grau, Maria] Hosp Univ Henares, Gastroenterol Dept, Coslada 28002, Spain, [Plaza, Rocio] Hosp Univ Infanta Leonor, Gastroenterol Dept, Madrid 28031, Spain, [Perez-Galindo, Pablo] Complejo Hosp Univ Pontevedra, Gastroenterol Dept, Pontevedra 36071, Spain, [Martinez-Cadilla, Jesus] Hosp Alvaro Cunqueiro Vigo, Gastroenterol Dept, Vigo 36312, Spain, and Spanish Working Group in Crohn's Disease and Ulcerative Colitis (GETECCU)

Subjects
Gastroenterología y hepatología, Crohn’s disease, vedolizumab, medicine.medical_specialty, Crohns-disease, Cirurgia - Complicacions, Surgical complications, Productes biològics, Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases::Crohn Disease [DISEASES], Outcomes, Pathological Conditions, Signs and Symptoms::Pathologic Processes::Postoperative Complications [DISEASES], Crohn, Malaltia de, Lower risk, Inflammatory bowel disease, Article, ustekinumab, Vedolizumab, surgery, inflammatory bowel disease, Internal medicine, Ustekinumab, postoperative complications, Medicine, Risk factor, ulcerative colitis, Crohn's disease, preoperative therapy, business.industry, Postoperative infectious complications, Retrospective cohort study, General Medicine, anti-TNF, Metaanalysis, medicine.disease, Resection, mezclas complejas::productos biológicos [COMPUESTOS QUÍMICOS Y DROGAS], Ulcerative colitis, afecciones patológicas, signos y síntomas::procesos patológicos::complicaciones posoperatorias [ENFERMEDADES], Gastrointestinal surgery, enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal::enfermedad de Crohn [ENFERMEDADES], Risk-factors, Ulcerative-colitis, Preoperative steroid use, Complex Mixtures::Biological Products [CHEMICALS AND DRUGS], business, medicine.drug
Abstract

Background: The impact of biologics on the risk of postoperative complications (PC) in inflammatory bowel disease (IBD) is still an ongoing debate. This lack of evidence is more relevant for ustekinumab and vedolizumab. Aims: To evaluate the impact of biologics on the risk of PC. Methods: A retrospective study was performed in 37 centres. Patients treated with biologics within 12 weeks before surgery were considered “exposed”. The impact of the exposure on the risk of 30-day PC and the risk of infections was assessed by logistic regression and propensity score-matched analysis. Results: A total of 1535 surgeries were performed on 1370 patients. Of them, 711 surgeries were conducted in the exposed cohort (584 anti-TNF, 58 vedolizumab and 69 ustekinumab). In the multivariate analysis, male gender (OR: 1.5, 95% CI: 1.2–2.0), urgent surgery (OR: 1.6, 95% CI: 1.2–2.2), laparotomy approach (OR: 1.5, 95% CI: 1.1–1.9) and severe anaemia (OR: 1.8, 95% CI: 1.3–2.6) had higher risk of PC, while academic hospitals had significantly lower risk. Exposure to biologics (either anti-TNF, vedolizumab or ustekinumab) did not increase the risk of PC (OR: 1.2, 95% CI: 0.97–1.58), although it could be a risk factor for postoperative infections (OR 1.5, 95% CI: 1.03–2.27). Conclusions: Preoperative administration of biologics does not seem to be a risk factor for overall PC, although it may be so for postoperative infections.

Published
2021

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