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Poster presentations: Clinical: Therapy and Observation 2020

P348 Clinical outcomes and response predictors of vedolizumab treatment for anti-TNF-failed patients with IBD in Korea: A prospective multicenter cohort study

J. Kim1, H. Yoon2, K.M. Lee3, S.A. Jung4, D.I. Park5, C.H. Choi6, E.S. Kim7, Y. Jung8, C.S. Eun9, T.O. Kim10, S.B. Kang11, Y.S. Kim12, G.S. Seo13, C.K. Lee14, J.P. Im15, S.J. Park16, J.S. Byeon1, S.J. Myung1, S.K. Yang1, B.D. Ye1

1Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea Republic of, 2Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea Republic of, 3Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea Republic of, 4Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea Republic of, 5Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital- Sungkyunkwan University School of Medicine, Seoul, Korea Republic of, 6Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea Republic of, 7Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea Republic of, 8Division of Gastroenterology, Department of Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea Republic of, 9Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea Republic of, 10Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea Republic of, 11Division of Gastroenterology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Daejeon, Korea Republic of, 12Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea Republic of, 13Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea Republic of, 14Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea Republic of, 15Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea Republic of, 16Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea Republic of

Background

Vedolizumab (VDZ) inhibits gut lymphocyte trafficking by binding to α4β7 integrin, which can be effective for patients with Crohn’s disease (CD) or ulcerative colitis (UC). We aimed to investigate the clinical outcomes and response predictors of VDZ treatment for Korean patients with CD or UC, who were previously failed to anti-tumour necrosis factor (TNF) therapy.

Methods

Between August 2017 and November 2019, a total of 159 patients with CD (n = 81) or UC (n = 78) received a VDZ induction therapy from 16 centres and were prospectively enrolled. Of those, patients who were evaluated at week 14 after three induction doses of VDZ (week 0, 2, and 6) were analysed. The co-primary endpoints were corticosteroid-free clinical remission and endoscopic remission/response (for UC) at week 14. We also analysed predictors of corticosteroid-free clinical remission, persistence of vedolizumab and safety.

Results

A total of 153 patients were analysed (CD, 77 [50.3%]; male, 94 [61.4%]; median age, 40 years [range, 17–80]; median disease duration, 8.0 years [range, 0.1–38.0]). All patients had previously experienced failures to at least one anti-TNF agent (one, 105 [68.6%]; two, 44 [28.8%]; three, 4 [2.6%]). Corticosteroid-free clinical remission/response rates in CD and UC patients were 44.6%/51.8% and 39.4%/62.0%, respectively. In patients with UC, endoscopic remission and response rates defined by Mayo endoscopic subscore/ulcerative colitis endoscopic index of severity were 33.8%/14.1% and 55.4%/39.1%, respectively. Multivariate analysis revealed that a clinical response at week 6 were associated with a corticosteroid-free clinical remission at week 14 in both CD (Odds ratio [OR] 33.84, 95% confidence interval [CI] 6.25–183.31, p < 0.001) and UC (OR 12.22, 95% CI 1.30–115.28, p = 0.029). In addition, UC patients with higher baseline levels of C-reactive protein (CRP) and faecal calprotectin were less likely to be in corticosteroid-free clinical remission (CRP > 0.31 mg/dl: OR 0.05, 95% CI 0.00–0.60, p = 0.019; faecal calprotectin > 2,000 μg/g: OR 0.04, 95% CI 0.00–0.93, p = 0.045). The cumulative probabilities of continuing VDZ after one year were 48.7% for CD and 65.7% for UC, respectively. During median 10 months of follow-up periods (range, 3–26 months), disease exacerbation was the most common adverse event (n = 73, 47.7%), followed by nasopharyngitis (n = 23, 15.0%) and arthralgia (n = 19, 12.4%).

Conclusion

In anti-TNF-failed Korean patients with CD and UC, VDZ induction therapy was effective with an acceptable safety profile. Early clinical response and higher inflammatory burden at baseline were associated with corticosteroid-free clinical remission after VDZ induction therapy.