Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry. Issue 8 (3rd October 2018)

• Record Type: Journal Article
• Authors: Chaparro, María; Garre, Ana; Ricart, Elena; Iborra, Marisa; Mesonero, Francisco; Vera, Isabel; Riestra, Sabino; García‐Sánchez, Valle; Luisa De Castro, M.; Martin‐Cardona, Albert; Aldeguer, Xavier; Mínguez, Miguel; de‐Acosta, Manuel Barreiro; Rivero, Montserrat; Muñoz, Fernando; Andreu, Montserrat; Bargalló, Ana; González‐Muñoza, Carlos; Pérez Calle, Jose L.; García‐Sepulcre, Mariana Fe; Bermejo, Fernando; Huguet, Jose Maria; Cabriada, José L.; Gutiérrez, Ana; Mañosa, Míriam; Villoria, Albert; Carbajo, Ana Y.; Lorente, Rufo; García‐López, Santiago; Piqueras, Marta; Hinojosa, Esther; Arajol, Clàudia; Sicilia, Beatriz; Conesa, Ana Macho; Sainz, Empar; Almela, Pedro; Llaó, Jordina; Roncero, Oscar; Camo, Patricia; Taxonera, Carlos; Domselaar, Manuel Van; Pajares, Ramón; Legido, Jesús; Madrigal, Rosa; Lucendo, Alfredo J.; Alcaín, Guillermo; Doménech, Eugeni; Gisbert, Javier P.;
• Other Names: Chaparro M. investigator.; Garre A. investigator.; Garre A. investigator.; Bernardo D. investigator.; Bernardo D. investigator.; Ricart E. investigator.; Ricart E. investigator.; Alfaro I. investigator.; Alfaro I. investigator.; Iborra M. investigator.; Iborra M. investigator.; Nos P. investigator.; Nos P. investigator.; Mesonero F. investigator.; Mesonero F. investigator.; López San Román A. investigator.; López San Román A. investigator.; Vera M. investigator.; Vera M. investigator.; Calvo Moya M. investigator.; Calvo Moya M. investigator.; Riestra S. investigator.; Riestra S. investigator.; de Francisco R. investigator.; de Francisco R. investigator.; García‐Sánchez V. investigator.; García‐Sánchez V. investigator.; Iglesias Flores E. investigator.; Iglesias Flores E. investigator.; De Castro L. investigator.; De Castro L. investigator.; Pineda J.R. investigator.; Pineda J.R. investigator.; Martin‐Cardona A. investigator.; Martin‐Cardona A. investigator.; Esteve M. investigator.; Esteve M. investigator.; Busquet D. investigator.; Busquet D. investigator.; Mínguez M. investigator.; Mínguez M. investigator.; Navarro P. investigator.; Navarro P. investigator.; Barreiro de‐Acosta M. investigator.; Barreiro de‐Acosta M. investigator.; Bastón I. investigator.; Bastón I. investigator.; Rivero M. investigator.; Rivero M. investigator.; García M.J. investigator.; García M.J. investigator.; Muñoz F. investigator.; Muñoz F. investigator.; Piñero C. investigator.; Piñero C. investigator.; Andreu M. investigator.; Andreu M. investigator.; Márquez Mosquera L. investigator.; Márquez Mosquera L. investigator.; Bargalló A. investigator.; Bargalló A. investigator.; Navarro‐Llavat M. investigator.; Navarro‐Llavat M. investigator.; Garcia‐Planella E. investigator.; Garcia‐Planella E. investigator.; González‐Muñoza C. investigator.; González‐Muñoza C. investigator.; Pérez Calle J.L. investigator.; Pérez Calle J.L. investigator.; López Serrano P. investigator.; López Serrano P. investigator.; García‐Sepulcre M.F. investigator.; García‐Sepulcre M.F. investigator.; Jiménez N. investigator.; Jiménez N. investigator.; Bermejo F. investigator.; Bermejo F. investigator.; Algaba A. investigator.; Algaba A. investigator.; Huguet J.M. investigator.; Huguet J.M. investigator.; Ruiz L. investigator.; Ruiz L. investigator.; Cabriada J.L. investigator.; Cabriada J.L. investigator.; Rodríguez‐Pescador A. investigator.; Rodríguez‐Pescador A. investigator.; Gutiérrez A. investigator.; Gutiérrez A. investigator.; Sempere Robles L. investigator.; Sempere Robles L. investigator.; Mañosa M. investigator.; Mañosa M. investigator.; Clos‐Parals A. investigator.; Clos‐Parals A. investigator.; Villoria A. investigator.; Villoria A. investigator.; Calvet X. investigator.; Calvet X. investigator.; Barrio J. investigator.; Barrio J. investigator.; Verdejo C. investigator.; Verdejo C. investigator.; Llorente Barrio M. investigator.; Llorente Barrio M. investigator.; Mena R. investigator.; Mena R. investigator.; Maroto N. investigator.; Maroto N. investigator.; Guardiola J. investigator.; Guardiola J. investigator.; Arias García L. investigator.; Arias García L. investigator.; Fernández‐Salazar L. investigator.; Fernández‐Salazar L. investigator.; Sesé E. investigator.; Sesé E. investigator.; Muñoz M. investigator.; Muñoz M. investigator.; Giménez Roca A. investigator.; Domínguez M. investigator.; Domínguez M. investigator.; Alba C. investigator.; Alba C. investigator.; Blázquez Gómez I. investigator.; Blázquez Gómez I. investigator.; Manceñido Marcos N. investigator.; Manceñido Marcos N. investigator.; Arias Rodríguez L. investigator.; Arias Rodríguez L. investigator.; Santamaría A. investigator.; Santamaría A. investigator.; Angueira T. investigator.; Angueira T. investigator.; García A. investigator.; García A. investigator.;
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 48:Issue 8(2018)
• Page Start: 839
• Page End: 851
• Publication Date: 2018-10-03
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.14930
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: Background: Effectiveness of vedolizumab in real world clinical practice is unknown. Aim: To evaluate the short and long‐term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD). Methods: Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey‐Bradshaw index (HBI) in Crohn's disease (CD) and Partial Mayo Score (PMS) in ulcerative colitis (UC). Short‐term response was assessed at week 14. Variables associated with short‐term remission were identified by logistic regression analysis. The Kaplan‐Meier method was used to evaluate the long‐term durability of vedolizumab treatment. Cox model was used to identify factors associated with discontinuation of treatment and loss of response. Results: 521 patients were included (median follow‐up 10 months [interquartile range 5‐18 months]). At week 14, 46.8% had remission and 15.7% clinical response. CD (vs UC), previous surgery, higher CRP concentration and disease severity at baseline were significantly associated with impaired response. The rate of vedolizumab discontinuation was 37% per patient‐year of follow‐up (27.6% in UC and 45.3% in CD, P < 0.01). CD (vs UC), anaemia at baseline, steroids during induction and CRP concentration were associated with lower durability of treatment. Seven per cent of patients developed adverse events, infections being the most frequent. Conclusions: Over 60% of IBD patients respond to vedolizumab. Many patients discontinue treatment over time. CD and disease burden impair both short‐ and long‐term response. Vedolizumab seems to be safe in clinical practice.