P560 Clinical outcomes of vedolizumab maintenance treatment for Korean patients with inflammatory bowel disease who failed anti-TNF therapy: A KASID prospective multicenter cohort study
Oh, K.(1);Kim, J.(2);Kim, N.(3);Yoon, H.(4);Lee, K.M.(5);Park, D.I.(6);Choi, C.H.(7);Lee, C.K.(8);Eun, C.S.(9);Kang, S.B.(10);Kim, E.S.(11);Kim, Y.S.(12);Jung, S.A.(13);Jung, Y.(14);Kim, T.O.(15);Park, S.J.(16);Im, J.P.(17);Seo, G.S.(18);Ye, B.D.(19);
(1)University of Ulsan College of Medicine- Asan Medical Center, Gastroenterology, Seoul, Korea- Republic Of;(2)Keimyung University School of Medicine, Internal Medicine, Daegu, Korea- Republic Of;(3)Asan Medical Center, Biostatistics and Clinical Epidemiology, Seoul, Korea- Republic Of;(4)Seoul National University Bundang Hospital, Internal Medicine, Seongnam, Korea- Republic Of;(5)St. Vincent's Hospital- College of Medicine- The Catholic University of Korea, Internal Medicine, Seoul, Korea- Republic Of;(6)Kangbuk Samsung Hospital- Sungkyunkwan University School of Medicine, Internal Medicine, Seoul, Korea- Republic Of;(7)Chung-Ang University College of Medicine, Internal Medicine, Seoul, Korea- Republic Of;(8)Kyung Hee University College of Medicine, Gastroenterology, Seoul, Korea- Republic Of;(9)Hanyang University Guri Hospital, Internal Medicine, Guri, Korea- Republic Of;(10)Daejeon St. Mary's Hospital- College of Medicine- The Catholic University of Korea, Internal Medicine, Daejeon, Korea- Republic Of;(11)Kyungpook National University- School of Medicine, Internal Medicine, Daegu, Korea- Republic Of;(12)Seoul Paik Hospital- Inje University College of Medicine, Internal Medicine, Seoul, Korea- Republic Of;(13)Ewha Womans University School of Medicine, Internal Medicine, Seoul, Korea- Republic Of;(14)Soonchunhyang University College of Medicine, Medicine, Cheonan, Korea- Republic Of;(15)Haeundae Paik Hospital- Inje University College of Medicine, Internal Medicine, Busan, Korea- Republic Of;(16)Severance Hospital- Yonsei University College of Medicine, Internal Medicine and Institute of Gastroenterology, Seoul, Korea- Republic Of;(17)Seoul National University College of Medicine, Internal Medicine and Liver Research Institute, Seoul, Korea- Republic Of;(18)Wonkwang University School of Medicine, Internal Medicine, Iksan, Korea- Republic Of;(19)University of Ulsan College of Medicine- Asan Medical Center, Gastroenterology and Inflammatory Bowel Disease Center, Seoul, Korea- Republic Of; IBD Research Group of the Korean Association for the Study of Intestinal Diseases
Background
We investigated the real-life effectiveness and safety of vedolizumab maintenance treatment among Korean patients with Crohn’s disease (CD) or ulcerative colitis (UC) who previously failed anti-tumour necrosis factor (anti-TNF) therapy.
Methods
Adult patients with CD or UC who have previously failed anti-TNF therapy and received vedolizumab were prospectively enrolled from 16 hospitals in Korea. The primary outcome was clinical remission at week 54. Clinical remission was defined as a Crohn’s disease activity index (CDAI) <150 and a partial Mayo score ≤2 with a combined rectal bleeding and stool frequency subscore ≤1. We also analyzed factors associated with clinical remission at week 54.
Results
Between August 2017 to July 2020, a total of 165 patients (81 with CD and 84 with UC) received vedolizumab therapy, of whom 154 patients (93.3%) (75 with CD and 79 with UC) received vedolizumab maintenance therapy (Table 1). Clinical remission and response rates at week 54 were 22.2% and 24.1% among patients with CD and 41.4% and 45.7% among patients with UC, respectively (Figure 1A and 1B). Among 70 patients with UC with baseline Mayo endoscopic subscore ≥2, endoscopic remission (Mayo endoscopic subscore ≤1) at week 54 was observed in 19 patients (27.1%). Out of 50 patients with CD with ulcers in baseline endoscopy, 2 patients (4%) showed a disappearance of ulcers at week 54 (Figure 1C). In the multivariable analysis, age at baseline (adjusted odds ration [aOR] 1.065, 95% confidence interval [CI] 1.003–1.131, P=0.041) and Mayo endoscopic subscore at baseline (aOR 0.141, 95% CI 0.026–0.746, P=0.021) were significantly associated with clinical remission at week 54 among patients with UC (Table 2). No factors were found to be associated with clinical remission at week 54 among patients with CD. Among patients who experienced one or more adverse events (n=134, 81.2%), serious adverse events occurred in 82 patients (49.7%) (Table 3). Disease exacerbation was the most common adverse events (n=89, 53.9%).
Conclusion
The real-life effectiveness of vedolizumab maintenance treatment for Korean patients with UC who failed anti-TNF therapy was generally similar with the outcomes reported from the previous Western studies. A substantial proportion of patients with CD experienced a loss of response during the first year of treatment. Less severe disease at baseline was associated with clinical remission at 1 year of vedolizumab therapy among patients with UC.