The outcome of Crohn's disease patients refractory to anti-TNF and either vedolizumab or ustekinumab

Aims: The aims of this study were to describe outcomes in patients with Crohn's disease who fail antitumor necrosis factor (TNF) and either vedolizumab or ustekinumab. Methods: Multicenter, retrospective study of 100 patients with Crohn's disease who failed anti-TNF and either vedolizumab or ustekinumab from 2015 to 2019. Using multivariable Cox regression, we sought to identify factors associated with need for surgery. Results: 75 patients received a third line treatment, resulting in 23 (30.7%) clinical remission at week 48. Among the 71 patients included after vedolizumab failure, 46 received ustekinumab, resulting in 46 (28.3%) clinical remission; 13 patients were retreated with an anti-TNF, resulting in 13 (46.2%) clinical remission. Among the 29 patients included after ustekinumab failure, 12 were retreated with an anti-TNF, resulting in 2 (16.7%) clinical remission. The rate of surgery-free survival at 48 weeks was 76.5% (95% confidence interval 68.4% - 85.4%). In multivariable analysis, ileal disease localization (hazard ratio 9.0, 95% confidence interval 1.0-81.9) was associated with a higher risk of surgery. Conclusion: In patients with Crohn's disease who have failed anti-TNF and either vedolizumab or ustekinumab, at week 48, the surgery rate is 23.5% and the remission rate after a third line biologic therapy is 30.7%. (C) 2020 Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l.