• Am. J. Gastroenterol. · Nov 2020

    Ustekinumab for Perianal Crohn's Disease: The BioLAP Multicenter Study From the GETAID.

    • Constance Chapuis-Biron, Julien Kirchgesner, Benjamin Pariente, Yoram Bouhnik, Aurélien Amiot, Stéphanie Viennot, Mélanie Serrero, Mathurin Fumery, Matthieu Allez, Laurent Siproudhis, Anthony Buisson, Guillaume Pineton de Chambrun, Vered Abitbol, Stéphane Nancey, Ludovic Caillo, Laurianne Plastaras, Guillaume Savoye, Elise Chanteloup, Marion Simon, Nina Dib, Sylvie Rajca, Morgane Amil, Anne-Laure Parmentier, Laurent Peyrin-Biroulet, Lucine Vuitton, and GETAID BioLAP Study Group.
    • Department of Gastroenterology, University Hospital of Besançon, University Bourgogne Franche-Comté, Besançon, France.
    • Am. J. Gastroenterol. 2020 Nov 1; 115 (11): 1812-1820.

    IntroductionNew therapeutic options for patients with Crohn's disease (CD) with perianal lesions failing anti-tumor necrosis factor (TNF) agents are needed. We aimed to assess the effectiveness of ustekinumab in perianal CD (pCD) and predictors of clinical success in a real-life multicenter cohort.MethodsWe conducted a national multicenter retrospective cohort study in patients with either active or inactive pCD who received ustekinumab. In patients with active pCD at treatment initiation, the success of ustekinumab was defined by clinical success at 6 months assessed by the physician's judgment without additional medical or surgical treatment for pCD. Univariate and multivariable logistic regression analyses were performed to identify predictors of success. In patients with inactive pCD at ustekinumab initiation, the pCD recurrence-free survival was calculated using the Kaplan-Meier method.ResultsTwo hundred seven patients were included, the mean age was 37.7 years, the mean duration of CD was 14.3 years, and the mean number of prior perianal surgeries was 2.8. Two hundred five (99%) patients had previously been exposed to at least 1 anti-TNF and 58 (28%) to vedolizumab. The median follow-up time was 48 weeks; 56/207 (27%) patients discontinued therapy after a median time of 43 weeks. In patients with active pCD, success was reached in 57/148 (38.5%) patients. Among patients with setons at initiation, 29/88 (33%) had a successful removal. The absence of optimization was associated with treatment success (P = 0.044, odds ratio 2.74; 95% confidence interval: 0.96-7.82). In multivariable analysis, the number of prior anti-TNF agents (≥3) was borderline significant (P = 0.056, odds ratio 0.4; 95% confidence interval: 0.15-1.08). In patients with inactive pCD at initiation, the probability of recurrence-free survival was 86.2% and 75.1% at weeks 26 and 52, respectively.DiscussionUstekinumab appears as a potential effective therapeutic option in perianal refractory CD. Further prospective studies are warranted.

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