Summary: 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.

CT-P13 is a biosimilar of the reference product (RP) infliximab, with demonstrated efficacy and safety for some inflammatory arthritides. It was approved for the treatment of Crohn disease (CD) on that basis, without specific studies examining its effects in CD. To compare the effectiveness and safety of CT-P13 and RP in infliximab-naive patients with CD. Comparative equivalence cohort study. Système National des Données de Santé (SNDS), a French nationwide health administrative database (1 March 2015 to 30 June 2017). 5050 infliximab-naive patients with CD who were older than 15 years, had started treatment with RP (n = 2551) or CT-P13 (n = 2499), and had no other indications for infliximab. The primary outcome was a composite end point of death, CD-related surgery, all-cause hospitalization, and reimbursement of another biologic therapy. Equivalence was defined as a 95% CI of the hazard ratio (HR) of CT-P13 versus RP in a multivariable marginal Cox model situated within prespecified margins (0.80 to 1.25). Overall, 1147 patients in the RP group and 952 patients in the CT-P13 group met the composite end point (including 838 and 719 hospitalizations, respectively). In multivariable analysis of the primary outcome, CT-P13 was equivalent to RP (HR, 0.92 [95% CI, 0.85 to 0.99]). No differences in safety outcomes were observed between the 2 groups: serious infections (HR, 0.82 [CI, 0.61 to 1.11]), tuberculosis (HR, 1.10 [CI, 0.36 to 3.34]), and solid or hematologic cancer (HR, 0.66 [CI, 0.33 to 1.32]). The SNDS does not contain all relevant clinical data (for example, disease activity). This analysis of real-world data indicates that the effectiveness of CT-P13 is equivalent to that of RP for infliximab-naive patients with CD. No difference was observed for safety outcomes. Caisse Nationale de l'Assurance Maladie.

Anti–tumor necrosis factor (anti-TNF) is an effective treatment for inflammatory bowel disease (IBD). Women with IBD who take anti-TNFs and become pregnant will have to decide whether to continue o... Visual Anti-TNF After 24 Weeks of Pregnancy. Anti–tumor necrosis factor (anti-TNF) is an effective treatment for inflammatory bowel disease (IBD). Women with IBD who take anti-TNFs and bec... Background: Continuation of biologics for inflammatory disorders during pregnancy is still a difficult decision. Many women with inflammatory bowel diseases (IBDs) stop anti–tumor necrosis factor (...