The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti‐tumour necrosis factor

Abstract
Background There is no head‐to‐head trial comparing ustekinumab and vedolizumab in patients with Crohn’s disease (CD) refractory to anti‐tumour necrosis factor (anti‐TNF). Aim To compare the effectiveness and safety of ustekinumab and vedolizumab in patients with CD refractory to anti‐TNF in a multicentre retrospective observational cohort. Methods All consecutive patients with CD refractory or intolerant to anti‐TNF who initiated either vedolizumab or ustekinumab were included between May 2014 and August 2018. Clinical remission, steroid‐free clinical remission (SFCR) and treatment persistence were assessed at week 48 with intention‐to‐treat analysis and propensity scores weighted comparison. Results A total of 239 patients were included, 107 received ustekinumab and 132 received vedolizumab. At week 48, ustekinumab was associated with a higher clinical remission rate (54.4% vs 38.3%; odds ratios, OR = 1.92, 95% CI [1.09‐3.39]) and treatment persistence (71.5% vs 49.7%; OR = 2.54, 95% CI [1.40‐4.62]) than vedolizumab. The rate of SFCR did not differ significantly between ustekinumab and vedolizumab (44.7% vs 34.0%; OR = 1.57, 95% CI [0.88‐2.79]). Subgroup analyses showed that ustekinumab was associated with a higher clinical remission rates at week 48 in patients with ileal location (OR = 3.49, 95% CI [1.33‐9.17) and penetrating behaviour (OR = 6.58, 95% CI [1.91‐22.68]). Regardless of the treatment group, combination therapy at initiation was associated with a higher clinical remission rate at week 48 (OR = 1.93, 95% CI [1.09‐3.43]). Conclusion This study suggests that ustekinumab is associated with a higher rate of clinical remission and treatment persistence than vedolizumab after 48 weeks of follow‐up, in patients with CD refractory or intolerant to anti‐TNF. The rate of SFCR was not significantly different.