Introduction

Vedolizumab. (VDZ) is an α4β7 integrin antagonist licensed to treat moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD). We provide long-term real-world data on outcomes after VDZ discontinuation.

Methods

A consecutive cohort of 193 adult IBD patients initiated on VDZ between May 2015 and June 2019 was retrospectively reviewed up to June 2020. Primary outcomes were post-VDZ relapse, biologic and surgical event rates. VDZ discontinuation for remission was classified as treatment for at least 6 months with 3 months corticosteroid-free clinical remission pre-discontinuation. Statistics: Continuous variables (median, interquartile ranges (IQR), Mann–Whitney U- test); categorical variables (frequency, percentages, chi-square test).

Results

Data from 90 CD and 103 UC patients was analysed. Prior biologic exposure (Adalimumab 57.5% (111/193); Infliximab 46.6% (90/193); Ustekinumab in CD 42.2% (38/90)) was high overall. Total all-cause VDZ discontinuation rate was 74.4% (67/90) in CD and 56.3% (58/103) in UC with the majority discontinuing within year 1 (CD: n = 44; UC: n = 35) as compared to years 2, 3 or greater (CD: n = 13, 8, 2; UC: n = 11, 6, 7). Of these patients, 77.6% (52/67) with CD and 63.8% (37/58) with UC required another biologic. A majority with CD persisted on subsequent Ustekinumab (68%; 30/44) or anti-TNF (71%; 5/7) by the end of the study period. In UC, 26% (7/27) persisted on an anti-TNF and 64% (7/11) on Tofacitinib (Table 1). 17 patients were retreated with VDZ having discontinued it for remission (CD: n = 7; UC: n = 10). The median duration of VDZ retreatment was 164 [IQR: 87-189] weeks for CD and 165 [IQR: 126-205] weeks for UC (duration follow-up from first VDZ discontinuation for CD: 46 [IQR: 30-56] weeks; UC: 46 [IQR: 16-77] weeks). Of this larger cohort, there was no significant difference in relapse rate on VDZ retreatment between CD and UC (14% (n = 1) vs. 30% (n = 3), p = 0.6029)). A large minority of patients underwent subsequent surgery (CD: 38.8% (26/67); UC: 29.3% (17/59) with the median interval to surgery greatest in UC (CD: 21 (IQR: 9-71) vs. UC 63 (IQR: 12-84) weeks, p = 0.2409). Most CD patients who had surgery post VDZ (61.5%, 16/26) had had 2 prior biologics as compared to none who had VDZ first line (p = 0.184) whereas in UC, biologic exposure had less impact on surgery rate (p = 0.592).

Conclusions

Our data suggests VDZ recapture for relapse following discontinuation of therapy for remission, sequencing Ustekinumab after VDZ in complex/refractory CD and anti-TNF therapy before or after VDZ in UC are options in the management algorithm of IBD.

	Year	Citations

Abstract

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