TY - JOUR
T1 - Relapse rate following withdrawal of vedolizumab and ustekinumab in patients with inflammatory bowel disease - a multicenter retrospective controlled study. The VEDUST-EXIT Study
AU - Albshesh, Ahmad
AU - Kucha, Piotr
AU - Pugliese, Daniela
AU - Amiot, Aurélien
AU - Mahajna, Hussein
AU - Eder, Piotr
AU - Savarino, Edoardo Vincenzo
AU - Vavricka, Stephan
AU - Castiglione, Fabiana
AU - Imperatore, Nicola
AU - Krznaric, Zeljko
AU - Abitbol, Chaya Mushka
AU - Hen, Or
AU - Zaborowska, Marta
AU - Carbonnel, Franck
AU - Cuccia, Giuseppe
AU - Lorenzon, Greta
AU - Zittan, Eran
AU - Zagórowicz, Edyta
AU - Maniero, Daria
AU - Ben-Horin, Shomron
AU - Kopylov, Uri
N1 - Publisher Copyright:
© 2025
PY - 2025
Y1 - 2025
N2 - Background and aims: Approximately half of patients with IBD in clinical remission flare within 12 months of withdrawing anti-TNF therapy. However, the risk following non-anti-TNF withdrawal is poorly studied. The aim of this study was to assess the clinical relapse rate following the withdrawal of non-anti-TNF therapy. Methods: This retrospective, observational, multicenter study included adult IBD patients who withdrew anti-TNF or non-anti-TNF therapy (vedolizumab, ustekinumab) after achieving clinical remission and had available follow-up data for at least one year following treatment withdrawal or until relapse occurred. Results: A total of 223 patients were included [50.2 % with Crohn's disease (CD) and 49.8 % with ulcerative colitis (UC)], of these 106 withdrew non-anti-TNF therapy and 117 withdrew anti-TNF therapy. Relapse occurred in 72 % within a median time to relapse of 13 months [6,27] and was higher in the non-anti-TNF vs. the anti-TNF groups (80 % vs. 65 %, p = 0.016), with shorter time to relapse (11 vs. 15 months, p = 0.002). In CD patients, the relapse rate was 71 % (82 % vs 63 %, respectively, p = 0.019). The response rate after therapy reinduction was 83.5 % (86.1 % vs 81 %, respectively; p = 0.81). Among UC patients the relapse rate was 74 % (79 % vs 68 %, respectively; p = 0.28). The response rate after therapy reinduction was 77.4 % (87.8 % vs 63.3 %, respectively; p = 0.25). Longer treatment duration before remission was the strongest predictor, significantly reducing relapse risk (HR 0.93 per month, 95 % CI 0.92–0.94, p < 0.001). Conclusion: High relapse rates were observed following the withdrawal of biologic therapies in IBD patients, particularly among those withdrawing non-anti-TNF in CD. Relapse risk appears driven more by disease course and treatment history than drug class, underscoring the need for individualized withdrawal decisions.
AB - Background and aims: Approximately half of patients with IBD in clinical remission flare within 12 months of withdrawing anti-TNF therapy. However, the risk following non-anti-TNF withdrawal is poorly studied. The aim of this study was to assess the clinical relapse rate following the withdrawal of non-anti-TNF therapy. Methods: This retrospective, observational, multicenter study included adult IBD patients who withdrew anti-TNF or non-anti-TNF therapy (vedolizumab, ustekinumab) after achieving clinical remission and had available follow-up data for at least one year following treatment withdrawal or until relapse occurred. Results: A total of 223 patients were included [50.2 % with Crohn's disease (CD) and 49.8 % with ulcerative colitis (UC)], of these 106 withdrew non-anti-TNF therapy and 117 withdrew anti-TNF therapy. Relapse occurred in 72 % within a median time to relapse of 13 months [6,27] and was higher in the non-anti-TNF vs. the anti-TNF groups (80 % vs. 65 %, p = 0.016), with shorter time to relapse (11 vs. 15 months, p = 0.002). In CD patients, the relapse rate was 71 % (82 % vs 63 %, respectively, p = 0.019). The response rate after therapy reinduction was 83.5 % (86.1 % vs 81 %, respectively; p = 0.81). Among UC patients the relapse rate was 74 % (79 % vs 68 %, respectively; p = 0.28). The response rate after therapy reinduction was 77.4 % (87.8 % vs 63.3 %, respectively; p = 0.25). Longer treatment duration before remission was the strongest predictor, significantly reducing relapse risk (HR 0.93 per month, 95 % CI 0.92–0.94, p < 0.001). Conclusion: High relapse rates were observed following the withdrawal of biologic therapies in IBD patients, particularly among those withdrawing non-anti-TNF in CD. Relapse risk appears driven more by disease course and treatment history than drug class, underscoring the need for individualized withdrawal decisions.
KW - Biologic therapy withdrawal
KW - Predictors of Relapse
KW - Relapse rates
KW - Therapy reinduction
KW - Ustekinumab
KW - Vedolizumab
UR - https://www.scopus.com/pages/publications/105019983531
U2 - 10.1016/j.dld.2025.09.032
DO - 10.1016/j.dld.2025.09.032
M3 - Article
C2 - 41152096
AN - SCOPUS:105019983531
SN - 1590-8658
JO - Digestive and Liver Disease
JF - Digestive and Liver Disease
ER -