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Ustekinumab for Perianal Crohn's Disease: The BioLAP Multicenter Study From the GETAID
Constance Chapuis-Biron1, Julien Kirchgesner2, Benjamin Pariente3
1Department of Gastroenterology, University Hospital of Besançon, University Bourgogne Franche-Comté, Besançon, France.
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.
Insights
Ustekinumab shows promise for treating perianal Crohn's disease (pCD) in patients refractory to anti-tumor necrosis factor (TNF) agents. Clinical success was observed in 38.5% of active pCD patients, with recurrence-free survival in inactive pCD patients.
Area of Science:
- Gastroenterology
- Immunology
- Clinical Therapeutics
Background:
- Perianal fistulas in Crohn's disease (CD) significantly impact quality of life.
- Patients with perianal CD (pCD) often exhibit refractory disease despite anti-tumor necrosis factor (TNF) therapies.
- There is a critical need for novel therapeutic strategies for advanced pCD.
Purpose of the Study:
- To evaluate the efficacy of ustekinumab in patients with perianal Crohn's disease (pCD).
- To identify predictors of clinical success for ustekinumab treatment in a real-world, multicenter cohort.
- To assess recurrence-free survival in patients with inactive pCD initiating ustekinumab.
Main Methods:
- A retrospective, multicenter cohort study involving 207 patients with active or inactive pCD treated with ustekinumab.
- Clinical success in active pCD was defined as physician-assessed improvement without additional pCD treatment at 6 months.
- Logistic regression and Kaplan-Meier analyses were used to determine success predictors and recurrence-free survival.
Main Results:
- Ustekinumab treatment achieved clinical success in 38.5% (57/148) of patients with active pCD.
- Among patients with setons, 33% (29/88) experienced successful seton removal.
- Recurrence-free survival at 26 and 52 weeks was 86.2% and 75.1%, respectively, in patients with inactive pCD.
Conclusions:
- Ustekinumab demonstrates potential as an effective treatment for refractory perianal Crohn's disease.
- Further prospective research is necessary to confirm these findings and optimize treatment strategies.
- The study highlights ustekinumab as a viable option for patients with limited therapeutic alternatives.