Background Vedolizumab seems to be an alternative in the treatment of inflammatory bowel disease (IBD), but it needs real-world data to assess its utility.

Purpose To evaluate the effectiveness and safety of vedolizumab in patients with IBD in clinical practice and second, in patients with dose intensification.

Material and methods Retrospective observational study. Inclusion criteria: age≥18 years, IBD (including Crohn’s disease and ulcerative colitis) treated with vedolizumab for at least 12 months. Period of study: December 2014 to September 2018.

The following variables were recorded: age, gender, previous anti-tumour necrosis factor (TNF) treatments, duration of treatment with vedolizumab, dose intensification (interval shortening from 8 to 4 weeks), effectiveness and safety.

Treatment effectiveness was assessed as follows:

Mayo Score (MS) in ulcerative colitis: patients in clinical remission (CR) in the induction period (IP) week 6 and in the maintenance period (MP) week 52 valued with MS ≤2.

Harvey–Bradshaw index (HBI) in Crohn’s disease: patients in CR in the IP and MP, valued with HBI ≤4.

Incidence of drug-related adverse events (AE) reported by the attending physician was used to assess drug safety.

Data was collected from patients’ clinical records and from the computerised physician order entry system (Farhos).

Results Forty-eight patients with IBD were included (62.5% Crohn’s disease and 37.5% ulcerative colitis). The median age was 43.5 years (IQR=19.5) and 62.5% were males. 66.7% of patients had been previously treated with two or more anti-TNF, 22.9% with one anti-TNF and 10.4% were receiving vedolizumab as first-line treatment. The median duration of treatment with vedolizumab was 1.97 years (IQR=0.83). 33.3% of the patients required dose intensification.

Effectiveness: 20.8% of patients achieved CR in the IP and 50% achieved CR in the MP (47.4% in patients with dose intensification and 51.7% with no intensification).

Safety: 27.1% of patients experienced a grade 1 or 2 AE, higher in dose intensification vs no intensification (36.8% vs 20.7%). No severe AE and no treatment discontinuations due to toxicity were reported.

Conclusion Vedolizumab has shown to be a mildly effective drug in clinical practice for the treatment of IBD and is well-tolerated. Patients with dose intensification experienced similar response but a higher AE incidence.

References and/or acknowledgements http://www.aulamedica.es/fh/pdf/8981.pdf

No conflict of interest.