Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment...

Vedolizumab is a gut-selective, anti-α₄β₇ integrin antibody treatment for ulcerative colitis (UC) and Crohn's disease (CD).

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).

A phase IIIb/IV clinical study.

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).

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.

In this prospective longitudinal study, patients had high persistence with vedolizumab Q8W. SAE, relapse, and reescalation to Q4W dosing rates were low.

The study protocol was registered at ClinicalTrials.gov (https://clinicaltrials.gov/; NCT02743806).