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* = Presenting author

P539 Clinical experience with vedolizumab in anti-TNF refractory inflammatory bowel patients

B. Christopher*1, O. Aoko2, A. O’Toole3, S. Patchett3, C. Smyth1, S. Sengupta2, R. Farrell1

1Connolly Hospital Blanchardstown, Department of Gastroenterology, Dublin, Ireland, 2Our Lady of Lourdes Hospital, Department of Gastroenterology, Drogheda, Ireland, 3Beaumont Hospital, Department of Gastroenterology, Dublin, Ireland

Background

The approval of vedolizumab (VDZ) in 2014 for the treatment of moderate-to-severe inflammatory bowel disease (IBD) offers gastroenterologists a gut-specific biologic alternative to anti-tumour necrosis factors (anti-TNF) therapy in patients with refractory disease. Gut selective blockade of lymphocyte trafficking by VDZ, an α4β7 integrin antibody, has been shown in clinical trials to offer effective induction and maintenance therapy in both ulcerative colitis (UC) and Crohn’s disease (CD) patients1,2 and a potential role as a rescue therapy post anti-TNF therapy.3,4

Methods

We evaluate the efficacy of VDZ in a cohort of biologic refractory IBD patients attending 3 teaching hospitals affiliated with Royal College of Surgeons in Ireland. VDZ was administered intravenously at weeks 0, 2, 6, and 8 at a dose of 300 mg. Patients’ characteristics and disease severity at first VDZ infusion and clinical response at week 12 post treatment were assessed. Clinical response amongst CD patients was assessed using the Harvey–Bradshaw Index (HBI), and the full-partial Mayo score was used for UC patients.

Results

Between November 2014 and November 2015, 18 patients (10 CD and 8 UC, 10 females and 8 males) received a total of 63 VDZ infusions. One CD patient had her VDZ held because she was pregnant, and 3 other patients were due to start treatment in the coming month. The mean age for our VDZ cohort was 35 years (range 20–55). All 18 patients had undergone prior anti-TNF, including 13 patients (72%) who had undergone both infusion and subcutaneous anti-TNF therapies. Further, 12 patients were on concomitant immunodulators (67%), and 6 patients (38%) had prior colonic resections. The mean pre-VDZ baseline HBI was 8, and partial Mayo score was 9. At week 12, 7 of our CD patients showed ≥ 3-point reduction in their HBI, and 6 of our 8 UC patients had ≥ 3-point reduction in their Mayo scores. There were no reported infusion reactions or adverse events amongst our VDZ cohort.

Conclusion

Vedolizumab is safe, well tolerated, and effective in our refractory IBD cohort all of whom had failed or lost response to prior anti-TNF therapy. Despite clinical trials suggesting superior efficacy amongst anti-TNF naïve IBD patients in clinical practice, VDZ remains second-line therapy to anti-TNF.

References

[1] Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2013;369(8):711–21.

[2] Feagan BG, Rutgeerts P, Sands BE, et al, (2013), Vedolizumab as induction and maintenance therapy for ulcerative colitis, NEJM

[3] Sands BE, Feagan BG, Rutgeerts P, et al. Effects of vedolizumab induction therapy for patients with Crohn’s disease in whom tumour necrosis factor antagonist treatment has failed. Gastroenterol 2014;147(3):618–27.

[4] Bryant R, Sandborn W, Travis S. Introducing vedolizumab to clinical practice: who, when, and how? J Crohns Colitis2015;9: 356–66.