Constance Chapuis-Biron1, Julien Kirchgesner2, Benjamin Pariente3, Yoram Bouhnik4, Aurélien Amiot5, Stéphanie Viennot6, Mélanie Serrero7, Mathurin Fumery8, Matthieu Allez9, Laurent Siproudhis10, Anthony Buisson11, Guillaume Pineton de Chambrun12, Vered Abitbol13, Stéphane Nancey14, Ludovic Caillo15, Laurianne Plastaras16, Guillaume Savoye17, Elise Chanteloup18, Marion Simon19, Nina Dib20, Sylvie Rajca21, Morgane Amil22, Anne-Laure Parmentier23, Laurent Peyrin-Biroulet24, Lucine Vuitton1. 1. Department of Gastroenterology, University Hospital of Besançon, University Bourgogne Franche-Comté, Besançon, France. 2. Department of Gastroenterology, Saint-Antoine Hospital, Assitance Publique-Hôpitaux de Paris (AP-HP), Paris, France. 3. Department of Hepatogastroenterology, University Hospital of Lille, Lille, France. 4. Department of Gastroenterology, AP-HP, Hôpital Beaujon, Paris, France. 5. Department of Gastroenterology, AP-HP, Hôpital Henri-Mondor, Paris, France. 6. Department of Hepatogastroenterology, University Hospital of Caen, Caen, France. 7. Department of Gastroenterology, AP-HM, Hôpital Nord, Marseille, France. 8. Department of Hepatogastroenterology, Peritox, University Hospital of Amiens, Amiens, France. 9. Department of Gastroenterology, AP-HP, Hôpital Saint Louis, Paris, France. 10. Department of Hepatogastroenterology, CHU Pontchaillou, University Hospital of Rennes, Rennes, France. 11. Department of Hepatogastroenterology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France. 12. Department of Hepatogastroenterology, University Hospital of Montpellier, Montpellier, France. 13. Department of Gastroenterology, AP-HP, Hôpital Cochin, Paris, France. 14. Department of Gastroenterology, Hospices Civils de Lyon, Lyon Sud Hospital, Lyon, France. 15. Department of Hepatogastroenterology, University Hospital of Nimes, Nimes, France. 16. Department of Hepatogastroenterology, Hospital Pasteur, Colmar, France. 17. Department of Hepatogastroenterology, University Hospital of Rouen. 18. Department of Gastroenterology, Hôpital Paris Saint Joseph, Paris, France. 19. Department of Gastroenterology, Institut Mutualiste Montsouris, Paris, France. 20. Department of Hepatogastroenterology, University Hospital of Angers, Angers, France. 21. Department of Gastroenterology, AP-HP, Hôpital Louis-Mourier, Paris, France. 22. Department of Hepatogastroenterology, Centre hospitalier La Roche-sur-Yon, La Roche-sur-Yon, France. 23. Department of Methodology, University Hospital of Besançon, Besançon, France. 24. Department of Gastroenterology, Inserm U954, University Hospital of Nancy, Lorraine University, Nancy, France.
Abstract
INTRODUCTION: New 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. METHODS: We 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. RESULTS: Two 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. DISCUSSION: Ustekinumab appears as a potential effective therapeutic option in perianal refractory CD. Further prospective studies are warranted.
INTRODUCTION: New 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. METHODS: We 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. RESULTS: Two 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. DISCUSSION: Ustekinumab appears as a potential effective therapeutic option in perianal refractory CD. Further prospective studies are warranted.
Authors: Gala M Godoy Brewer; George Salem; Muhammad A Afzal; Berkeley N Limketkai; Zadid Haq; Maryam Tajamal; Joanna Melia; Mark Lazarev; Florin M Selaru; Alyssa M Parian Journal: BMJ Open Gastroenterol Date: 2021-12