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Multicenter Study
. 2018 Feb;53(2):158-167.
doi: 10.1080/00365521.2017.1416160. Epub 2017 Dec 19.

High treatment persistence rate and significant endoscopic healing among real-life patients treated with vedolizumab - a Finnish Nationwide Inflammatory Bowel Disease Cohort Study (FINVEDO)

Tero Ylisaukko-Oja  1   2   3 , Jaakko Aaltonen  1 , Heikki Nuutinen  4 , Timo Blomster  5 , Airi Jussila  6 , Markku Pajala  7 , Kimmo Salminen  4 , Veikko Moilanen  8 , Kalle Hakala  9 , Mikko Kellokumpu  10 , Kari Toljamo  11 , Henna Rautiainen  12 , Juha Kuisma  13 , Markku Peräaho  14 , Pauliina Molander  15 , Jouni Silvennoinen  16 , Ville Liukkonen  16 , Hans Henricson  17 , Jyrki Tillonen  18 , Mirva Esterinen  19 , Christian Nielsen  20 , Eija Hirsi  21 , Margus Lääne  22 , Ulla-Maija Suhonen  23 , Ilkka Vihriälä  24 , Petri Mäkelä  25 , Mika Puhto  26 , Jari Punkkinen  27 , Hannu Sulonen  28 , Sauli Herrala  2 , Jari Jokelainen  2   3   29 , Klaus Tamminen  1 , Taina Sipponen  30
Affiliations
Multicenter Study

High treatment persistence rate and significant endoscopic healing among real-life patients treated with vedolizumab - a Finnish Nationwide Inflammatory Bowel Disease Cohort Study (FINVEDO)

Tero Ylisaukko-Oja et al. Scand J Gastroenterol. 2018 Feb.

Abstract

Objectives: The efficacy and tolerability of vedolizumab in the treatment of inflammatory bowel diseases (IBD) has been demonstrated in an extensive GEMINI clinical trial programme. Clinical trials represent highly selected patient populations and, therefore, it is important to demonstrate effectiveness in real-life clinical practice. We set out to assess real-world treatment outcomes of vedolizumab in a nationwide cohort of treatment refractory Finnish Crohn's disease (CD) and ulcerative colitis (UC) patients.

Methods: This was a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centers with a diagnosis of UC or CD who had at least one vedolizumab infusion since the availability of the product in Finland, were included in the study. Data were collected retrospectively from medical charts at baseline, week 14, and month 6. The primary outcome measure was treatment persistence 24 weeks post-vedolizumab initiation.

Results: A total of 247 patients were included (108 CD, 139 UC). A total of 75.0% (n = 81) of all CD patients and 66.2% (n = 92) of all UC patients, were persistent on vedolizumab therapy for 6 months post treatment initiation. At month 6, 41.8% (28/67) of the treatment persistent CD patients and 73.3% (63/86) of the treatment persistent UC patients achieved clinical remission. Significant improvement in endoscopic scores were observed among treatment persistent patients (CD, n = 17, ΔSES-CD=-5.5, p = .008; UC, n = 26, ΔMayo endoscopic score =-0.5, p = .003) at month 6.

Conclusions: Vedolizumab provides an effective and well-tolerated treatment option in real-world clinical practice even among treatment refractory IBD patients.

Keywords: Biological therapy; Crohn’s disease; endoscopy; real-world effectiveness; ulcerative colitis; vedolizumab.

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