Abstract Background Vedolizumab is an integrin blocker and anti-inflammatory agent for treatment of moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC). Therapy persistence reflects both efficacy and tolerability. This study evaluated 36-month persistence on vedolizumab and explored baseline predictors of maintaining standard dosing without need for escalation. Methods A retrospective analysis included 155 IBD patients (CD: 52, UC: 103) treated with vedolizumab at our centre. Patients were aged 19–78 years, 73 were males. We assessed long-term maintenance on standard dosing versus shift to optimisation, reversion from early optimisation back to standard dosing, and occurrence of therapy change. Additionally, we calculated the proportion of patients who required therapy change and the average time to change, all stratified by diagnosis. Baseline predictors used were fecal calprotectin and CRP; Mayo endoscopic subscore and disease extent for UC; disease location, behaviour, and age at diagnosis for CD; sex; therapy line; and age at therapy initiation — were entered into multivariable logistic models to identify associations with persistence. Results At week 14 decision on further treatment was made. Three patients discontinued early (two primary non-response, one surgery). All other patients continued standard (SD) or optimised dosing (OD). Among 78 patients on SD at week 14, 54 (69.2%) maintained SD to month 36 (CD: 9/17; UC: 45/61), and 13 (16.7%) required optimisation without later change. Of 74 patients on OD at week 14, 25 (33.8%) reverted to stable SD (CD: 12; UC: 13), after an average of 22.5 months in CD and 18 months in UC. Over the 36-month follow-up, the proportion of patients on SD increased from 50.3% at week 14 to 64.2% at month 36, while optimisation rates decreased from 47.8% to 32.1%. Therapy switch and discontinuation remained low (7% and 1%, respectively) throughout the study period. Overall therapy-change rate was 13.54% during 36 months (6.45% occurred in 1st year of therapy). Comparing patients who switched therapy to those who remained on SD through month 36, only higher baseline fecal calprotectin was significantly associated with therapy change (p = 0.045). In multivariable logistic models stratified by diagnosis, none of the baseline factors predicted the need for therapy optimisation neither in UC nor CD patients. Conclusion Vedolizumab showed strong long-term persistence with increasing rates of stable standard dosing over 36 months and consistently low optimisation and therapy-change rates. Higher baseline fecal calprotectin was associated with therapy change. Ongoing monitoring remains essential to guide treatment adjustments. Conflict of interest: Vuksanovic, Sasa: No conflict of interest Spirić, Jelena: No conflicts Toplicanin, Aleksandar: No conflict of interest Jovicic, Ivana: No conflict of interest Đuranović, Srđan: No conflict of interest Pavlovic Markovic, Aleksandra: No conflict of interest Sokic Milutinovic, Aleksandra: No conflict of interest
Vuksanović et al. (2026) studied this question.