P1150 Relapse rate following withdrawal of vedolizumab and ustekinumab in patients with inflammatory bowel disease - a multicenter retrospective controlled study
Authors: Albshesh A , Kucha P , Pugliese D , Amiot A , Mahajna H , Eder P , Savarino E V , Vavricka S , Castiglione F , Imperatore N , Krznaric Z , Abitbol C M , Hen O , Zaborowska M , Carbonnel F , Cuccia G , Lorenzon G , Zittan E , Zagórowicz E , Maniero D , Ben-Horin S , Kopylov U 
Published: January 2025

Background

The outcomes of vedolizumab (VDZ) or ustekinumab (UST) cessation in terms of clinical remission in routine practice are unknown. More data is needed to establish the relapse rates following treatment cessation

Methods

This was a retrospective, observational, multicenter study. We included adult IBD patients who had withdrawn anti-TNF and non-anti-TNF therapy including VDZ or UST after achieving clinical remission and had available follow-up data for one year following treatment discontinuation or until relapse occurred. This study aimed to assess the clinical relapse rates after discontinuing non-anti-TNF and to identify potential predictors of relapse after therapy discontinuation

Results

A total of 223 patients were included (112 patients (50.2%) with Crohn’s disease (CD) and 111 patients (49.8%) with Ulcerative Colitis (UC)).

In CD patients, 40.2% withdrew non-anti-TNF therapy (51% VDZ and 49% UST) and 59.8% anti-TNF therapy. There was no significant difference in terms of C-reactive protein (CRP), fecal calprotectin, active disease (endoscopy ± imaging) at time of drug withdrawal. The overall relapse rate was 71% (82% for non-anti-TNF therapy and 63% for anti-TNF, respectively, p=0.019) (Figure 1). The median time to relapse was 11 months (6,20) (10 (6,16) vs 15 (7,41) respectively, p = 0.034). Therapy reinduction was required in 65% (80% vs 55%, respectively, p= 0.009). Therapy reinduction showed an overall response rate of 83.5% within a median of 2 months, with a remission rate of 52% in 3 months. The significant predictors of relapse in the multivariate logistic regression model were non-anti-TNF therapy (OR 3.28, 95% CI: 1.25–9.58, p = 0.029) and younger age at diagnosis (OR 0.17, 95% CI: 0.05–0.48, p = 0.001).

Among the UC patients, 55% withdrew non-anti-TNF therapy (91.8% VDZ and 8.2% UST), and 45% withdrew anti-TNF. There was no significant difference in terms of CRP, fecal calprotectin, active disease (endoscopy ± imaging). The overall relapse rate was 74% (79% vs 68%, respectively, p=0.28) (figure 2). The median time to relapse was 8.6 months (6,15.25) vs 12.5 (6.25,25.25) respectively, p = 0.132). Therapy reinduction was required in 64% (67% vs 60% respectively; p = 0.55). Therapy reinduction showed an overall response rate of 77.4% within a median of 1 month, with a remission rate of 60.5% achieved in 3 months. There were no significant predictors of relapse in UC.

Conclusion

We observed high relapse rates following the cessation of biologic therapies in IBD patients, particularly among those discontinuing non-anti-TNF compared to anti-TNF therapies in CD. There was no significant difference in the relapse rate in UC patients. Reinduction of therapy was highly effective