Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety

Background: Vedolizumab is a gut-selective, anti-α4β7 integrin antibody treatment for ulcerative colitis (UC) and Crohn’s disease (CD). Objectives: Long-term vedolizumab treatment persistence and safety were evaluated in patients who completed GEMINI LTS (NCT00790933) or VERSIFY (NCT02425111) clinical trials and continued treatment in the open-label vedolizumab extended access program (XAP). Design: A phase IIIb/IV clinical study. Methods: This phase IIIb/IV, prospective, multinational study (NCT02743806) was conducted from August 2016 to January 2023 in adults with UC/CD treated with vedolizumab 300 mg intravenous every 8/4 weeks (Q8W/Q4W). Results: Of 331 (UC, 142; CD, 189) patients enrolled, 311 from GEMINI LTS (UC, 142; CD, 169) and 20 with CD from VERSIFY, most (295/331) started the XAP study on Q8W dosing (UC, 93% (132/142); CD, 86% (163/189)). The mean (SD) disease duration at XAP study baseline was 14 (7) years for UC and 3 (7) years for CD. Vedolizumab Q8W treatment persistence for ⩾6 months without relapse was 98% (129/132) for UC and 95% (154/163) for CD. Twenty-seven patients (9%) were re-escalated from Q8W to Q4W dosing: UC, 8% (11/132); CD, 10% (16/163). The mean (SD) vedolizumab treatment duration in the XAP was 3.5 (1.6) years for UC and 3.6 (1.7) years for CD. In the UC and CD groups, 13% and 16% of patients had serious adverse events (SAEs), respectively (1% per group was treatment related); two (1%) and four (2%) had serious infections, respectively, none related to treatment. One patient died from chronic obstructive pulmonary disease. Conclusion: In this prospective longitudinal study, patients had high persistence with vedolizumab Q8W. SAE, relapse, and reescalation to Q4W dosing rates were low. Trial registration: The study protocol was registered at ClinicalTrials.gov (https://clinicaltrials.gov/; NCT02743806).