Comparative effectiveness of ustekinumab versus infliximab in the management of perianal fistulizing Crohn's disease: a retrospective study in China.

BACKGROUND/AIMS: Ustekinumab (UST) and infliximab (IFX) are both effective in the treatment of perianal fistulizing Crohn's disease (CD), but limited research has focused on comparing the efficacy of UST versus IFX in this field. This study aimed to compare the effectiveness of UST or IFX in treating perianal fistula of CD patients naive to biological agents in a real-world setting.

METHODS

A retrospective cohort study included patients with perianal fistulizing CD treated with UST or IFX was conducted to evaluate the rates of luminal and perianal fistula response and remission at 6 months after treatment.

RESULTS

Ninety-seven patients (49 UST and 48 IFX) were enrolled. Compared to IFX, UST exhibited significantly higher rates of treatment success (89.8% vs. 50.0%, P< 0.001) and intestinal clinical response (85.7% vs. 68.8%, P= 0.048), but no significant differences in fistula remission, fistula response, fistula closure, intestinal clinical remission, endoscopic remission and endoscopic response was observed. Furthermore, multivariate analyses demonstrated complexity of fistula was conversely associated with fistula remission between the UST and IFX groups. Finally, the rates of disease relapse and operation in the IFX group were higher as compared to the UST group during follow-up.

CONCLUSIONS

UST may serve as a promising alternative to IFX for the treatment of perianal fistulizing CD.