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. | 949 ALRIC et AL.

Comparative effectiveness of ustekinumab or vedolizumab after one year in 130 patients with anti‐TNF‐refractory Crohn’s disease

“…Comparison between the two treatment groups is limited by the small number of patients. It is unlikely, however, that our findings are reflective of sample size limitations as our findings are consistent with that reported previously 15,26 . Our centre does not mandate endoscopic follow‐up and therefore we do not have data on mucosal healing.…”

“…It is possible but unlikely that our universal policy of treating patients with 8‐weekly and not 12‐weekly ustekinumab in anti‐TNF refractory Crohn's disease may have accounted for some of the efficacy differences. However, it is noteworthy that other real‐world cohorts which utilised a 8‐ or 12‐weekly ustekinumab dosing schedule also showed superior effectiveness of ustekinumab compared to vedolizumab 6,26 . Moreover, dose titration to 4‐weekly vedolizumab was also allowed within our study.…”

Letter: choosing between ustekinumab and vedolizumab in anti‐TNF refractory Crohn’s disease—the devil is in the detail

“…DvL has received educational grants or research support from Pfizer, Takeda, Ferring, Shire and has received consultancy and/or speaker's fees from Pfizer, Janssen, AbbVie, Ferring, Vifor and Emerge Health. Ashish Srinivasan 1,2,3 Peter De Cruz 1,4 Daniel R. van Langenberg 1,3…”

Letter: effectiveness of ustekinumab or vedolizumab in Crohn's disease following anti‐TNF failure—getting closer to the truth?

“…There is ongoing controversy about whether ustekinumab is superior to vedolizumab in patients with Crohn's disease (CD) refractory to anti‐tumour necrosis factor (anti‐TNF) agents 1‐3 . Among these, the prospective head‐to‐head comparison study 1 performed by Biemans et al indicated that ustekinumab is associated with superior outcomes compared to vedolizumab.…”