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P277 Real life effectiveness and safety of vedolizumab induction and maintenance therapy for Korean IBD patients in whom anti-TNF treatment failed: a prospective cohort study

J. Kim*1, N. S. Ham2, E. H. Oh2, E. M. Song2, E. J. Youn2, E. J. Kwon3, Y. K. Cho3, S. W. Hwang2,4, S. H. Park2,4, D-H. Yang2, J-S. Byeon2, S-J. Myung2, S-K. Yang2,4, B. D. Ye1,4

1University of Ulsan College of Medicine, Asan Medical Center, Department of Gastroenterology, Seoul, South Korea, 2University of Ulsan College of Medicine, Asan Medical Center, Gastroenterology, Seoul, South Korea, 3University of Ulsan College of Medicine, Asan Medical Center, Nursing, Seoul, South Korea, 4University of Ulsan College of Medicine, Asan Medical Center, Inflammatory Bowel Disease Center, Seoul, South Korea

Background

Vedolizumab (VDZ) is a gut-selective monoclonal antibody blocking α4β7 integrin, which can be effective for patients with inflammatory bowel disease (IBD). We aimed to investigate the clinical effectiveness and safety of VDZ therapy for Korean patients with Crohn’s disease (CD) or ulcerative colitis (UC) in whom anti-tumour necrosis factor therapy (TNF) failed previously.

Methods

Between August 2017 and October 2018, a total of 54 patients with CD (n = 36) or UC (n = 18) were started on VDZ therapy and prospectively enrolled in the ASAN VDZ registry. Of those, data of patients who were evaluated at Week 14 after completing induction therapy and those evaluated at Week 53–57 were analysed. The co-primary outcomes were corticosteroid-free clinical remission (both for CD and UC) and endoscopic remission/response (for UC) at Week 14 and Week 53–57, respectively. Safety after initiating VDZ was also evaluated.

Results

A total of 47 patients were evaluated at Week 14 (CD, 30 [63.8%]; male, 31 [66.0%]; median age, 36 years [range, 19–71]; median disease duration, 8.9 years [range, 0.1–26.7]). At Week 14, corticosteroid-free clinical remission/response rates in CD and UC patients were 37.5%/37.5% and 11.8%/35.3%, respectively. In patients with UC, endoscopic remission and response rates defined by Mayo endoscopic subscore (MES)/ulcerative colitis endoscopic index of severity (UCEIS) were 23.5%/5.9% and 47.1%/29.4%, respectively. Twelve out of 47 patients (25.5%, 7 CD and 5 UC) were evaluated at Week 53–57. Corticosteroid-free clinical remission/response rates in CD and UC patients at Week 53–57 were 50%/50% and 20%/40%, respectively. In patients with CD, combined endoscopic mucosal healing and radiologic healing were observed in one patient (14.3%). In patients with UC, endoscopic remission and response rates at Week 53–57 defined by MES/UCEIS were 40%/20% and 60%/40%, respectively. Out of 47 patients, shortening of VDZ dosing interval was required in 17 patients (36.2%) and five patients (10.6%) discontinued VDZ therapy after a median period of 41 weeks (range, 26–46 weeks) due to poor response. IBD exacerbation was the most common adverse events which was observed in 21 patients (44.7%). Arthralgia, nasopharyngitis, and headache were observed in 13 (27.7%), 10 (21.3%), and 8 patients (17.0%), respectively. IBD-related admissions occurred in 6 patients (12.8%).

Conclusion

In Korean IBD patients with prior failures to anti-TNF therapy, VDZ induction and maintenance therapy may be effective with acceptable safety profile. Further long-term follow-up studies with larger number of patients are required to prove the effectiveness and safety of VDZ.