TY - JOUR
T1 - An Objective Comparison of Vedolizumab and Ustekinumab Effectiveness in Crohn's Disease Patients' Failure to TNF-Alpha Inhibitors
AU - Onali, Sara
AU - Pugliese, Daniela
AU - Caprioli, Flavio Andrea
AU - Orlando, Ambrogio
AU - Biancone, Livia
AU - Nardone, Olga Maria
AU - Imperatore, Nicola
AU - Fiorino, Gionata
AU - Cappello, Maria
AU - Viola, Anna
AU - Principi, Maria Beatrice
AU - Bezzio, Cristina
AU - Aratari, Annalisa
AU - Carparelli, Sonia
AU - Mazzuoli, Silvia
AU - Manguso, Francesco
AU - Grossi, Laurino
AU - Bodini, Giorgia
AU - Ribaldone, Davide
AU - Mocci, Giammarco
AU - Miranda, Agnese
AU - Minerba, Luigi
AU - Favale, Agnese
AU - Grova, Mauro
AU - Scucchi, Ludovica
AU - Segato, Simone
AU - Fries, Walter
AU - Castiglione, Fabiana
AU - Armuzzi, Alessandro
AU - Fantini, Massimo C.
PY - 2022
Y1 - 2022
N2 - INTRODUCTION:The use of ustekinumab and vedolizumab as second-line therapies in patients with Crohn's disease (CD) in which tumour necrosis factor alpha inhibitors (TNFi) failed is still debated. The aim of this study was to compare, in a large multicenter observational retrospective cohort, the effectiveness of ustekinumab and vedolizumab as second-line therapies, as assessed by clinical and objective outcomes including endoscopy and gastrointestinal imaging.METHODS:Clinical response, remission, and steroid-free remission at weeks 26 and 52 were evaluated in a retrospective propensity score-weighted and propensity score-matched cohort of patients in which TNFi failed. Objective response and remission were evaluated by 1 or more techniques among endoscopy, magnetic resonance/computed tomography enteroclysis, and small bowel ultrasound.RESULTS:A total of 470 patients with CD (239 treated with ustekinumab and 231 treated with vedolizumab) were included in the study. At week 26, clinical outcomes were similar between the 2 groups. At week 52, clinical remission (ustekinumab 42.5% vs vedolizumab 55.5%, P = 0.01) and steroid-free remission (ustekinumab 40.6% vs vedolizumab 51.1%, P = 0.038) rates were significantly higher in vedolizumab-treated patients. Three hundred two patients (hundred thirty-five treated with ustekinumab and hundred sixty-seven treated with vedolizumab) had an objective evaluation of disease activity at baseline and week 52. At week 52, objective response and remission rates were similar between the 2 groups. Clinical response at week 26 predicted steroid-free remission at week 52 in both ustekinumab-treated and vedolizumab-treated patients. Safety profiles were similar between the 2 groups.DISCUSSION:In patients with CD in which TNFi failed, both ustekinumab and vedolizumab showed similar clinical effectiveness after 26 weeks of treatment. At 1 year, vedolizumab was associated with a higher rate of clinical remission when compared with ustekinumab. However, no difference was observed between the 2 groups when objective outcomes were investigated at this time point.
AB - INTRODUCTION:The use of ustekinumab and vedolizumab as second-line therapies in patients with Crohn's disease (CD) in which tumour necrosis factor alpha inhibitors (TNFi) failed is still debated. The aim of this study was to compare, in a large multicenter observational retrospective cohort, the effectiveness of ustekinumab and vedolizumab as second-line therapies, as assessed by clinical and objective outcomes including endoscopy and gastrointestinal imaging.METHODS:Clinical response, remission, and steroid-free remission at weeks 26 and 52 were evaluated in a retrospective propensity score-weighted and propensity score-matched cohort of patients in which TNFi failed. Objective response and remission were evaluated by 1 or more techniques among endoscopy, magnetic resonance/computed tomography enteroclysis, and small bowel ultrasound.RESULTS:A total of 470 patients with CD (239 treated with ustekinumab and 231 treated with vedolizumab) were included in the study. At week 26, clinical outcomes were similar between the 2 groups. At week 52, clinical remission (ustekinumab 42.5% vs vedolizumab 55.5%, P = 0.01) and steroid-free remission (ustekinumab 40.6% vs vedolizumab 51.1%, P = 0.038) rates were significantly higher in vedolizumab-treated patients. Three hundred two patients (hundred thirty-five treated with ustekinumab and hundred sixty-seven treated with vedolizumab) had an objective evaluation of disease activity at baseline and week 52. At week 52, objective response and remission rates were similar between the 2 groups. Clinical response at week 26 predicted steroid-free remission at week 52 in both ustekinumab-treated and vedolizumab-treated patients. Safety profiles were similar between the 2 groups.DISCUSSION:In patients with CD in which TNFi failed, both ustekinumab and vedolizumab showed similar clinical effectiveness after 26 weeks of treatment. At 1 year, vedolizumab was associated with a higher rate of clinical remission when compared with ustekinumab. However, no difference was observed between the 2 groups when objective outcomes were investigated at this time point.
KW - n/a
KW - n/a
UR - http://hdl.handle.net/10807/302179
U2 - 10.14309/ajg.0000000000001773
DO - 10.14309/ajg.0000000000001773
M3 - Article
SN - 0002-9270
VL - 117
SP - 1279
EP - 1287
JO - THE AMERICAN JOURNAL OF GASTROENTEROLOGY
JF - THE AMERICAN JOURNAL OF GASTROENTEROLOGY
ER -