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P368 Vedolizumab in inflammatory bowel disease: a retrospective single-centre study

C. Larsson*1, M. Henriksen1, L-P. Jelsness-Jørgensen1,2, A. Rekvin3, F. Lerang1

1Hospital Sykehuset Østfold, Department of Gastroenterology, Sarspborg, Norway, 2Østfold University College, Halden, Norway, 3Hospital Sykehuset Østfold, Department of Research, Sarspborg, Norway

Background

Vedolizumab is an integrin receptor antagonist used when anti-TNF treatment has failed or is contraindicated in moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). The aim of this study was to evaluate efficacy and side effects of vedolizumab in daily clinical practice.

Methods

A review of medical records for the time period 2014–2018 at Østfold Hospital Trust was performed. Symptoms (based on the Mayo score and the Harvey–Bradshaw Index) and the use of concomitant medications were recorded at 4–6 months, 12 months, >12 months and if applicable, after discontinuation of the treatment. Measurements of faecal calprotectin and vedolizumab drug levels were obtained. The disease activity was classified as complete remission (CR), partial response (PR) or non-response (NR) based on calprotectin levels, symptoms and endoscopy/radiology findings. Calprotectin < 100 mg/kg was used as a marker for CR, 100–300 mg/kg for PR and >300 mg/kg for NR.

Results

A total number of 77 patients (53% with UC) received vedolizumab during the defined period, of which 4/77 were biological-naïve. In 52/77, one biological drug had been used prior to vedolizumab treatment, while 21/77 had used ≥2. Before starting vedolizumab, 65% of CD patients had undergone IBD-related surgery. CR was achieved in 13/77 (17%) and PR in 28/77 (36%). A total number of 36/77 was defined as NR at the most recent follow-up. The mean time of observation was 15 months (median 13, range 2–49 months). Time until achieved CR was 4–6 months (n = 1), 12 months (n = 7) and >12 months (n = 5). Discontinuation of treatment occurred in 28 patients (36%) (therapeutic failure = 16/28, therapeutic failure + side effects = 4/28, side effects only = 4/28, and other causes =4/28). In CD, 14% had undergone surgical intervention during treatment and 6% following discontinuation of vedolizumab. In UC, 32% underwent colectomy shortly after termination (mean/median time between discontinuation and colectomy: 3.4/2 months).

CRPR
Calprotectin (mean/median) mg/kg60.9/23.0369.0/186.0
Vedolizumab (mean/median) mg/l22.7/20.424.6/22.9

F-calprotectin and p-vedolizumab in CR and PR.

Conclusion

Half of the patients who received vedolizumab responded to treatment, of which 2/3 had PR and 1/3 had CR. The effect tends to be better in UC compared with CD. One in five patients had CR and this effect was noted mainly from 12 months and/or more of active treatment. It is of utmost importance to carry out an objective assessment of therapeutical response before 12 months to evaluate if there is indication for continuation or cessation of treatment.