Clinical Experience with Vedolizumab in Anti-TNF Refractory IBD Patients
B. Christopher1, O. Aoko2, C.Garry1, E.Anderson2, M.Forry3, M.Kennedy1, M. O’Sullivan1, A. O'Toole3, S. Patchett3, C. Smyth1, S. Sengupta2, RJ.Farrell1
1Department of Gastroenterology, Connolly Hospital Blanchardstown, Dublin, Ireland, 2Our Lady of Lourdes Hospital, Drogheda, Ireland, 3Beaumont Hospital, Dublin, Ireland
The approval of Vedolizumab (VDZ) in 2014 for the treatment of moderate-to-severe Inflammatory Bowel Diease (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) and a potential role as a rescue therapy post anti-TNF therapy.
We evaluated the efficacy of VDZ in anti-TNF refractory IBD patients attending 3 teaching hospitals (Connolly Hospital, Beaumont, Our Lady of Lourdes Hospital, Drogheda) affiliated with Royal College of Surgeons in Ireland. VDZ was administered intravenously at weeks 0, 2, 6 and 8 at a dose of 300mg. Patients' characteristics, disease severity pre-infusion and clinical response at week 12 were assessed.
Clinical response among CD patients was assessed using the Harvey Bradshaw Index (HBI) and Mayo score was used for UC.
Between November 2014 and March 2016, 19 patients (13 CD, 6 UC / 12 females, 7 males) received a total of 86 VDZ infusions. Patients’ mean age was 36 years (20 – 55). 2 patients who were started on VDZ recently have not reached week 12 of treatment. All 19 patients had undergone prior anti-TNF including 16 patients (84%) who had both infusion and subcutaneous anti-TNF. Thirteen patients were on concomitant immunomodulators (68%) while 8 patients (42%) had prior colonic resections. The mean pre-VDZ baseline HBI was 8 and Mayo score was 9. At week 12, 10 of 11 (91%) CD patients showed ≥3 point reduction and 5 of 6 (83%) UC patients had ≥3 point reduction in their scores. 15 of 17 patients (88%) had shown clinical response. There were no reported infusion reactions or adverse events among our VDZ cohort.
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 among anti-TNF naive IBD patients, in clinical practice VDZ remains second-line therapy to anti-TNF.