Background Vedolizumab became available in mid-2014 for the treatment of moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). The Spanish Drug Agency provided a Therapeutic Positioning Report about the clinical recommendation in the use of vedolizumab and its public funds.

Purpose The aim of this study was to describe the clinical outcomes of vedolizumab uses and to verify that the Spanish Agency for Drugs and Health Products recommendations had been followed up concerning its prescription criteria.

Material and methods An observational, retrospective analysis of all patients treated with vedolizumab in a university hospital was done. Patients were identified from June 2015 to June 2017 with the diagnosis of CD or UC, and treated with vedolizumab; Patients were only eligible if they received, at least, complete induction therapy (four doses). Data were collected from patients’ electronic clinical history.

Results Nineteen patients were identified. Infliximab and adalimumab were used prior to vedolizumab in 87% of our patients. Vedolizumab was initiated because of the failure and/or intolerance of two different anti-TNF drugs.

Vedolizumab was used with a mean duration of 35 weeks in UC and 40.6 in CD. In six patients, after a mean 32 week period, treatment had to be stopped: in four loss of response, in one no response and in one surgery was needed. Doses regimen reduction was needed, being useful only temporarily in one patient. In 13 patients, the drug was useful after a followed-up mean period of 37 weeks. Nonetheless, in six patients a doses regimen reduction was needed, being useful in five of them. Vedolizumab allowed a corticoids’ reduction or suppression in five patients and immunosuppressant drugs in three.

The national recommended stop-rule was not followed up in three patients, with seven more doses used (€14,196) without clinical benefit.

In seven patients (36.84%) it was observed that a decrease in healthcare provider was required: visits to family doctor, Emergency Department or hospital admission.

Conclusion Vedolizumab has shown to be useful in patients previously treated with anti-TNF, nonetheless, most of them required a doses regimen reduction. Suppression of corticoids or immunosuppressant drugs is an important goal that can be achieved. A reduced number of patients, without other pharmacological alternatives, remain treated with vedolizumab unless it has to be stopped while surgery is proceeding.

No conflict of interest