1. Short and long-term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry.
- Author
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Chaparro M, Garre A, Ricart E, Iborra M, Mesonero F, Vera I, Riestra S, García-Sánchez V, Luisa De Castro M, Martin-Cardona A, Aldeguer X, Mínguez M, de-Acosta MB, Rivero M, Muñoz F, Andreu M, Bargalló A, González-Muñoza C, Pérez Calle JL, García-Sepulcre MF, Bermejo F, Huguet JM, Cabriada JL, Gutiérrez A, Mañosa M, Villoria A, Carbajo AY, Lorente R, García-López S, Piqueras M, Hinojosa E, Arajol C, Sicilia B, Conesa AM, Sainz E, Almela P, Llaó J, Roncero O, Camo P, Taxonera C, Domselaar MV, Pajares R, Legido J, Madrigal R, Lucendo AJ, Alcaín G, Doménech E, and Gisbert JP
- Subjects
- Adult, Antibodies, Monoclonal, Humanized adverse effects, Colitis, Ulcerative diagnosis, Colitis, Ulcerative drug therapy, Colitis, Ulcerative epidemiology, Communicable Diseases chemically induced, Communicable Diseases diagnosis, Communicable Diseases epidemiology, Crohn Disease diagnosis, Crohn Disease drug therapy, Crohn Disease epidemiology, Female, Follow-Up Studies, Gastrointestinal Agents adverse effects, Humans, Inflammatory Bowel Diseases epidemiology, Male, Middle Aged, Prospective Studies, Remission Induction, Spain epidemiology, Treatment Outcome, Antibodies, Monoclonal, Humanized therapeutic use, Gastrointestinal Agents therapeutic use, Inflammatory Bowel Diseases diagnosis, Inflammatory Bowel Diseases drug therapy, Registries
- Abstract
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., (© 2018 John Wiley & Sons Ltd.)
- Published
- 2018
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