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OP26 Long-term safety of vedolizumab in ulcerative colitis and Crohn’s disease: final results from the GEMINI LTS study

S. Vermeire1, J-F. Colombel2, B. G. Feagan3, W. J. Sandborn4, B. E. Sands2, S. Danese5, G. D’Haens6, R. Panaccione7, D. T. Rubin8, I. Shafran9, A. Parfionovas10, R. Rogers*10, R. A. Lirio10, E. V. LoftusJr11

1University Hospitals Leuven, Leuven, Belgium, 2Icahn School of Medicine at Mount Sinai, New York, USA, 3Western University, London, Canada, 4University of California San Diego, La Jolla, USA, 5Humanitas University, Milan, Italy, 6Academic Medical Centre, Amsterdam, The Netherlands, 7University of Calgary, Calgary, Canada, 8University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, USA, 9Shafran Gastroenterology Research Center, Winter Park, USA, 10Takeda Pharmaceuticals, Cambridge, USA, 11Mayo Clinic College of Medicine, Rochester, USA

Background

Vedolizumab (VDZ), a gut-selective, humanised, α4β7 integrin monoclonal antibody, was approved in 2014 in the USA and EU to treat moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). GEMINI long-term safety (LTS) is the longest VDZ continuous treatment study to date and provides unique data for VDZ therapeutic profiling. We report the final GEMINI LTS safety and efficacy findings.

Methods

GEMINI LTS was a multi-national, multi-centre, open-label, Phase 3 study (NCT00790933/EudraCT 2015-000480-14). Patients with UC or CD received VDZ 300 mg IV every 4 weeks after they completed or withdrew from a Phase 2 study or one of the GEMINI Phase 3 studies or enrolled as VDZ-naïve de novo patients. Treatment continued until study completion or loss to follow-up (eg, after VDZ approval or expanded-access programme availability at the local site). Long-term safety was the primary endpoint and efficacy was an exploratory endpoint.

Results

A total of 894 patients with UC and 1349 with CD enrolled in GEMINI LTS for a planned treatment duration of 9 years. All patients had received ≥1 prior conventional therapy (Table 1). Adverse events (AEs) occurred in 93% of UC patients and 96% of CD patients; most frequent were UC (36%) and CD (35%) exacerbations and nasopharyngitis (UC, 28%; CD, 25%; Table 2). No new trends were observed for infections, malignancies, infusion-related reactions, or hepatic events. Serious AEs (SAEs) were reported in 31% of UC patients and 41% of CD patients; disease exacerbation was the most frequent SAE in both cohorts (UC, 13%; CD, 17%). VDZ was discontinued due to AEs in 15% of UC patients and 17% of CD patients, with UC or CD exacerbation (9% and 8%, respectively) the most frequent reason for discontinuation. There were no cases of progressive multi-focal leukoencephalopathy and 10 (UC, 4; CD, 6) deaths during the study. Clinical response was maintained long-term in patients who continued to receive VDZ throughout the entire study; however, the efficacy analysis was limited due to the expected, protocol-defined, patient loss to follow-up.

Conclusion

The final GEMINI LTS results provide evidence that VDZ has a safety profile suitable for long-term treatment of UC and CD. In this carefully monitored population receiving VDZ in a clinical trial setting, there continue to be no unexpected or new safety concerns.

Abstract OP026 – Table 1. Baseline demographics and clinical characteristics.

Abstract OP026 – Table 2. Safety overview.