Marian Bátovský
Vedolizumab is registered and in 2016 also categorised in Slovakia for the biological therapy of moderate to severe active
ulcerative colitis in patients with the previous failure of conventional or anti-TNF alpha therapy. Vedolizumab has
received in the EU and USA approval for treatment of ulcerative colitis and Crohn´s disease on the basis of encouraging
results from GEMINI I-III placebo-controlled trial programmes in the field of inflammatory bowel disease and promising
safety data. Also severe real-life clinical studies confirmed good effectivity and safety of this new anti-integrin therapy.
For colitis ulcerosa, trial data show the sustained benefit of vedolizumab predominantly in bionaive patients and
in patients with the middle activity of this disease. Data for Crohn´s disease are less dramatic, but still demonstrated
a population level effect that will translate into important clinical benefits for some patients – after repeated bowel resection,
with negative prognostic factors, with risk of aggressive CD course, in polymorbid patients, patients after opportunistic
infection, after cured malignancy and with refractory pouchitis.