P0664Risk of relapse and retreatment success after vedolizumab discontinuation in patients with IBD in long-standing remission: a retrospective study from the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)

Background Discontinuation of anti-TNF agents after sustained remission leads to relapse in about half of cases within one year, but data on other biologics remain limited. This study aimed to assess the risk of recurrence after vedolizumab (VDZ) discontinuation in patients with inflammatory bowel disease (IBD) who achieved sustained steroid-free remission on standard maintenance regimen. Methods Patients with IBD who stopped VDZ after at least 6 months of steroid-free remission (defined as combined clinical and endoscopic remission at last assessment) between 2017 and 2025 were retrospectively included. A control group of patients maintaining VDZ after a comparable remission period was used. The primary outcome was the rate of any recurrence (clinical, biochemical, or endoscopic) in the discontinuation vs the control group. Secondary outcomes included the evaluation of clinical, biochemical, and endoscopic recurrence rates. Univariable and multivariable Cox regression models were used to identify predictors of relapse, with results expressed as hazard ratios (HRs) and 95% confidence intervals (CIs). Recurrence-free survival was analysed with Kaplan-Meier curves and compared with the log-rank test. Results Overall, 165 patients were included: 67 in the discontinuation group and 98 controls, with a median follow-up of 36 months (IQR 16-51) (Table 1). At 12 months, 15 (22%) patients in the discontinuation group vs 4 (4%) in the control group showed any recurrence (p < 0.01). Over the entire follow-up, 41 patients (61%) who discontinued and 18 patients (18%) who continued VDZ experienced any recurrence (p < 0.01). Kaplan-Meier analysis showed a significantly higher recurrence-free survival among patients continuing VDZ across all definitions of recurrence (Figure 1). VDZ discontinuation was independently associated with a higher risk of any recurrence at both univariable (HR 5.2, 95%CI 2.9-9.1, p < 0.01) and multivariable analysis (HR 5.2, 95%CI 2.9-9.6, p < 0.01), with no significant effect of other covariates. Increased risks in the discontinuation group were also observed for secondary endpoints, including endoscopic recurrence (HR 3.6, 95%CI 1.7-7.9, p < 0.01). Among patients who relapsed after discontinuation, 26 (63%) restarted VDZ, of whom 6 (23%) achieved clinical remission at 6 months. Conclusion VDZ discontinuation, even after sustained remission, carries a high recurrence risk and low recapture rates, suggesting to approach withdrawal cautiously pending further evidence. Conflict of interest: Dragoni, Gabriele: Grant: ECCO Grant 2020 ECCO/AOCC Travel Grant 2021 ECCO IIS Registry Grant 2023 ECCO/IBUS Research Grant 2023 Personal Fees: - Speaker’s fees from: 2020: Novartis 2022: Janssen 2023: Alfasigma, Janssen, Pfizer, and Takeda 2024: Ferring, Johnson & Johnson, Eli Lilly, Pfizer, and Takeda 2025: Abbvie, Alfasigma, Ferring, Eli Lilly, LionHealth, Pfizer, Takeda - Advisory board fees from: 2023: Celltrion Healthcare and Pfizer 2024: AbbVie 2025: AbbVie, Johnson & Johnson Dr. Innocenti, Tommaso: Speaker fees from Aurora Biofarma, and Ferring. Travel grants from Abbvie, Alfasigma, Celltrion, Eli Lilly, Ferring, Malesci, Pfizer. Festa, Stefano: Personal Fees: Consultant and/or Advisory board member for: Takeda, Johnson & Johnson, Pfizer, Galapagos, Abbvie, Ferring, Eli Lilly Felice, Carla: Advisory board for AbbVie, MSD, J & J . Rizzello, Fernando: No conflict of interest Viola, Anna: No conflict of interest Baccini, Flavia: No conflict of interest Balestrieri, Paola: Advisory board for Alfasigma- Janssen- Abbvie- Takeda- Eli Lilly Pugliese, Daniela: Consultant/Lectures fees from: AbbVie, Takeda, Johnson, Pfizer, Alfasigma, MSD, Lilly, Celltrion. Mattana, Marco: No conflict of interest Cocomazzi, Francesco: No conflict of interest Savarino, Edoardo Vincenzo: Personal Fees: Takeda, Abbvie, MSD, Janssen, Sofar Zappia, Federica: No conflict of interest Panarese, Alba: No conflict of interest Ribaldone, Davide Giuseppe: Davide Giuseppe Ribaldone declares the following paid consultancies, lecture fees for the past two years: Johnson & Johnson, Takeda, Celltrion, Alfasigma, Pfizer, Eli Lilly, Abbvie, Sandoz Bertani, Lorenzo: No conflict of interest Piagnani, Alessandra: No conflict of interest Bezzio, Cristina: Personal Fees: I received consulting/advisory board/lecture fees from Alfa Sigma, AbbVie, Celltrion, Eli Lilly, Ferring, Gilead, Johnson & Johnson MSD, Pfizer and Takeda Di Paolo, Dhanai: No conflict of interest Viganò, Chiara: Consultancy and lecture fees from: AbbVie, Galapagos, Janssen-Cilag, Johnson & Johnson, Pfizer, Takeda, Celltrion, Alfasigma, Eli Lilly and research grant from Celltrion and Pfizer. Spagnuolo, Rocco: No conflict of interest Ricci, Chiara: No conflict of interest Mocci, Giammarco: No conflict of interest Fantini, Massimo Claudio: MCF has acted as a consultant for: AbbVie, AlfaSigma, Celgene, Celltrion, Gilead, Pfizer, MSD, Bristol-Meyer, Takeda, Johnson & Johnson, Roche, Galapagos, Biogen, Sandoz, Eli-Lilly, Lionhealth, Teva, Giuliani, Dr Falk Pharma, Sanofi he has received financial support for research from Johnson & Johnson and Pfizer.