作者
María Chaparro,Ana Garre,Elena Ricart,Marisa Iborra,Francisco Mesonero,Isabel Vera,Sabino Riestra,Valle García–Sánchez,María Luisa de Castro,Albert Martín‐Cardona,Xavier Aldeguer,Miguel Mínguez,Manuel Barreiro‐de Acosta,Montserrat Rivero,Fernándo Muñoz,Montserrat Andreu,Ana Bargalló,Carlos González‐Muñoza,J L Pérez Calle,Mariana Fe García-Sepulcre,Fernando Bermejo,José María Huguet,José Luis Cabriada,Ana Gutiérrez,Míriam Mañosa,Albert Villòria,Ana Yaiza Carbajo,R Lorente,Santiago García-López,Marta Piqueras,Esther Hinojosa,C Aràjol,Beatriz Sicilia,Ana Conesa,Empar Sáinz,Pedro Almela,Jordina Llaó,Óscar Roncero,Patricia Camo,Carlos Taxonera,Manuel Van Domselaar,Ramón Pajares,Jesús Legido,R Madrigal,Alfredo J. Lucendo,Guillermo Alcaín,Eugeni Domènech,Javier P. Gisbert
摘要
Effectiveness of vedolizumab in real world clinical practice is unknown.To evaluate the short and long-term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD).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.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.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.