• María Chaparro, Ana Garre, Elena Ricart, Marisa Iborra, Francisco Mesonero, Isabel Vera, Sabino Riestra, Valle García-Sánchez, M Luisa De Castro, Albert Martin-Cardona, Xavier Aldeguer, Miguel Mínguez, Manuel Barreiro de-Acosta, Montserrat Rivero, Fernando Muñoz, Montserrat Andreu, Ana Bargalló, Carlos González-Muñoza, Jose L Pérez Calle, Mariana Fe García-Sepulcre, Fernando Bermejo, Jose Maria Huguet, José L Cabriada, Ana Gutiérrez, Míriam Mañosa, Albert Villoria, Ana Y Carbajo, Rufo Lorente, Santiago García-López, Marta Piqueras, Esther Hinojosa, Clàudia Arajol, Beatriz Sicilia, Ana Macho Conesa, Empar Sainz, Pedro Almela, Jordina Llaó, Oscar Roncero, Patricia Camo, Carlos Taxonera, Manuel Van Domselaar, Ramón Pajares, Jesús Legido, Rosa Madrigal, Alfredo J Lucendo, Guillermo Alcaín, Eugeni Doménech, Javier P Gisbert, and GETECCU study group.
• Madrid, Spain.
• Aliment. Pharmacol. Ther. 2018 Oct 1; 48 (8): 839-851.

BackgroundEffectiveness of vedolizumab in real world clinical practice is unknown.AimTo evaluate the short and long-term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD).MethodsPatients 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.Results521 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.ConclusionsOver 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.© 2018 John Wiley & Sons Ltd.

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