High treatment persistence rate and significant endoscopic healing among real-life patients treated with vedolizumab – a Finnish Nationwide Inflammatory Bowel Disease Cohort Study (FINVEDO)<sup>*</sup>
Creators: name: Ylisaukko-Oja, Tero
name: Aaltonen, Jaakko
name: Nuutinen, Heikki
name: Blomster, Timo
name: Jussila, Airi
name: Pajala, Markku
name: Salminen, Kimmo
name: Moilanen, Veikko
name: Hakala, Kalle
name: Kellokumpu, Mikko
name: Toljamo, Kari
name: Rautiainen, Henna
name: Kuisma, Juha
name: Peräaho, Markku
name: Molander, Pauliina
name: Silvennoinen, Jouni
name: Liukkonen, Ville
name: Henricson, Hans
name: Tillonen, Jyrki
name: Esterinen, Mirva
name: Nielsen, Christian
name: Hirsi, Eija
name: Lääne, Margus
name: Ulla-Maija Suhonen
name: Vihriälä, Ilkka
name: Mäkelä, Petri
name: Puhto, Mika
name: Punkkinen, Jari
name: Sulonen, Hannu
name: Herrala, Sauli
name: Jokelainen, Jari
name: Tamminen, Klaus
name: Sipponen, Taina
Publisher: name: Taylor & Francis
Year: 2017
Subjects: subject: Medicine
subject: Pharmacology
subject: Biotechnology
subject: 39999 Chemical Sciences not elsewhere classified
subject: FOS: Chemical sciences
subject: FOS: Chemical sciences
subject: Ecology
subject: FOS: Biological sciences
subject: FOS: Biological sciences
subject: Immunology
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: Cancer
subject: 110309 Infectious Diseases
subject: FOS: Health sciences
subject: FOS: Health sciences
subject: 60506 Virology

description: <b>Objectives:</b> 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. <b>Methods:</b> 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. <b>Results:</b> A total of 247 patients were included (108 CD, 139 UC). A total of 75.0% (<i>n</i> = 81) of all CD patients and 66.2% (<i>n</i> = 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, <i>n</i> = 17, ΔSES-CD=−5.5, <i>p</i> = .008; UC, <i>n</i> = 26, ΔMayo endoscopic score =−0.5, <i>p</i> = .003) at month 6. <b>Conclusions:</b> Vedolizumab provides an effective and well-tolerated treatment option in real-world clinical practice even among treatment refractory IBD patients.