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Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry
Author(s) -
Chaparro María,
Garre Ana,
Ricart Elena,
Iborra Marisa,
Mesonero Francisco,
Vera Isabel,
Riestra Sabino,
GarcíaSánchez Valle,
Luisa De Castro M.,
MartinCardona Albert,
Aldeguer Xavier,
Mínguez Miguel,
deAcosta Manuel Barreiro,
Rivero Montserrat,
Muñoz Fernando,
Andreu Montserrat,
Bargalló Ana,
GonzálezMuñoza Carlos,
Pérez Calle Jose L.,
GarcíaSepulcre Mariana Fe,
Bermejo Fernando,
Huguet Jose Maria,
Cabriada José L.,
Gutiérrez Ana,
Mañosa Míriam,
Villoria Albert,
Carbajo Ana Y.,
Lorente Rufo,
GarcíaLópez 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.
Publication year - 2018
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.14930
Subject(s) - vedolizumab , medicine , discontinuation , ulcerative colitis , inflammatory bowel disease , crohn's disease , interquartile range , gastroenterology , adverse effect , disease
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.