Background Vedolizumab is a monoclonal antibody for the treatment of ulcerative colitis and Crohn’s disease.
Purpose The aim of this study was to determine the effectiveness and safety of vedolizumab in our hospital since its inclusion in the pharmaceutical guide in April 2016 to the current date (17 months).
Material and methods We performed a prospective, longitudinal, observational study of patients starting treatment with vedolizumab in a general hospital.
The inclusión criteria for this study were adult patients diagnosed with ulcerative colitis or Crohn’s disease, treated with vedolizumab. We collected demographic variables (age, sex), clinical information (time from diagnosis to treatment with vedolizumab, prior lines of treatment and number of anti-TNF alpha received previously), efficiency results (reducing doses of corticoids, variation in haemoglobin, C-reactive protein, faecal calprotectin and number of bowel movements from the beginning of treatment with vedolizumab until today) and adverse reactions to vedolizumab.
Results Thirty patients were treated with vedolizumab, 22 (73.3%) females and eight (26.6%) males, with an average age of 51.7 years (SD 36–65), median time since diagnosis 9.7 years (3–19 SD), number of previous treatments five (2–9 SD) and anti-TNF alpha 31 (1–4 SD).
With regard to efficiency, a significant decrease in stool frequency was reported in 33.3% of patients, and corticosteroid doses in 66.6% of patients. Significant improvements in haemoglobin levels were observed in nine patients (30%), in C-reactive protein in 20 patients (66.6%) and in faecal calprotectin in nine patients (30%).
During the period of study, 30% of the patients required hospitalisation due to severe outbreaks of the disease: one of them discontinued treatment.
Only six patients experienced adverse events: four acneiform eruptions and two fever during vedolimumab infusion. None discontinued treatment because of these side-effects.
Conclusion Vedolizumab is an alternative treatment in patients with ulcerative colitis and Crohn’s disease who fail to respond to anti-TNF therapies. Based on our clinical experience, this medicament shows a modest efficiency because 30% of the patients experienced severe outbreaks and good tolerance, and none of the patients discontinued treatment because of these side-effects.
Reference and/or Acknowledgements 1. Baumgart DC, Sandborn WJ. Crohn’s disease. Lancet2012;380(9853):1590–1605. doi:10.1016/S0140-6736(12)60026-9
No conflict of interest
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