Tero Ylisaukko-Oja1,2,3, Jaakko Aaltonen1, Heikki Nuutinen4, Timo Blomster5, Airi Jussila6, Markku Pajala7, Kimmo Salminen4, Veikko Moilanen8, Kalle Hakala9, Mikko Kellokumpu10, Kari Toljamo11, Henna Rautiainen12, Juha Kuisma13, Markku Peräaho14, Pauliina Molander15, Jouni Silvennoinen16, Ville Liukkonen16, Hans Henricson17, Jyrki Tillonen18, Mirva Esterinen19, Christian Nielsen20, Eija Hirsi21, Margus Lääne22, Ulla-Maija Suhonen23, Ilkka Vihriälä24, Petri Mäkelä25, Mika Puhto26, Jari Punkkinen27, Hannu Sulonen28, Sauli Herrala2, Jari Jokelainen2,3,29, Klaus Tamminen1, Taina Sipponen30. 1. a Takeda Oy , Helsinki , Finland. 2. b MedEngine Oy , Helsinki , Finland. 3. c Faculty of Medicine , Center for Life Course Health Research University of Oulu , Oulu , Finland. 4. d Division of Gastroenterology, Department of Medicine , Turku University Hospital , Turku , Finland. 5. e Division of Gastroenterology, Department of Medicine , Oulu University Hospital , Oulu , Finland. 6. f Department of Gastroenterology and Alimentary Tract Surgery , Tampere University Hospital , Tampere , Finland. 7. g Department of Internal Medicine , Kuopio University Hospital , Kuopio , Finland. 8. h Department of Internal Medicine , Satakunta Central Hospital , Pori , Finland. 9. i Department of Internal Medicine , Kanta-Häme Central Hospital , Hämeenlinna , Finland. 10. j Department of Internal Medicine , Lapland Central Hospital , Rovaniemi , Finland. 11. k Department of Internal Medicine , TYKS Salo Hospital , Salo , Finland. 12. l Department of Gastroenterology , Helsinki University Hospital/Jorvi Hospital , Espoo , Finland. 13. m Department of Internal Medicine , HUS Hyvinkää Hospital , Hyvinkää , Finland. 14. n Department of Internal Medicine , Central Hospital of Central Finland , Jyväskylä , Finland. 15. o Department of Gastroenterology , Helsinki University Hospital/Peijas Hospital , Vantaa , Finland. 16. p Department of Gastroenterology , North Karelia Central Hospital , Joensuu , Finland. 17. q Department of Internal Medicine , Hospital Pietarsaari , Pietarsaari , Finland. 18. r Department of Internal Medicine , Päijät-Häme Central Hospital , Lahti , Finland. 19. s Department of Internal Medicine , Savonlinna Central Hospital , Savonlinna , Finland. 20. t Department of Internal Medicine , Vaasa Central Hospital , Vaasa , Finland. 21. u Department of Internal Medicine , South Karelia Central Hospital , Lappeenranta , Finland. 22. v Department of Internal Medicine , Seinäjoki Central Hospital , Seinäjoki , Finland. 23. w Department of Internal Medicine , Kainuu Central Hospital , Kajaani , Finland. 24. x Department of Internal Medicine , Central Ostrobothnia Central Hospital , Kokkola , Finland. 25. y Department of Internal Medicine , Turku City Hospital , Turku , Finland. 26. z Department of Internal Medicine , Mikkeli Central Hospital , Mikkeli , Finland. 27. aa Department of Internal Medicine , HUS Porvoo Hospital , Porvoo , Finland. 28. ab Department of Internal Medicine , Forssa Hospital , Forssa , Finland. 29. ac Unit of Primary Health Care , Oulu University Hospital , Oulu , Finland. 30. ad Department of Gastroenterology , Helsinki University Hospital and University of Helsinki , Helsinki , Finland.
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.
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 IBDpatients.
Authors: B Bokemeyer; M Ghiani; A Fuchs; B Deiters; F Hardtstock; A Brandes; J Knop; H D Orzechowski; T Wilke Journal: Int J Colorectal Dis Date: 2020-05-18 Impact factor: 2.571
Authors: Petros Zezos; Boyko Kabakchiev; Adam V Weizman; Geoffrey C Nguyen; Neeraj Narula; Kenneth Croitoru; A Hillary Steinhart; Mark S Silverberg Journal: J Can Assoc Gastroenterol Date: 2018-11-22
Authors: Carl Eriksson; Sara Rundquist; Vyron Lykiardopoulos; Ruzan Udumyan; Per Karlén; Olof Grip; Charlotte Söderman; Sven Almer; Erik Hertervig; Jan Marsal; Jenny Gunnarsson; Carolina Malmgren; Jenny Delin; Hans Strid; Mats Sjöberg; David Öberg; Daniel Bergemalm; Henrik Hjortswang; Jonas Halfvarson Journal: Therap Adv Gastroenterol Date: 2021-07-03 Impact factor: 4.409
Authors: Bharati Kochar; Yue Jiang; Aaron Winn; Edward L Barnes; Christopher F Martin; Millie D Long; Michael D Kappelman Journal: Crohns Colitis 360 Date: 2019-08-29
Authors: Renske Wilhelmina Maria Pauwels; Annemarie Charlotte de Vries; Christien Janneke van der Woude Journal: J Gastroenterol Hepatol Date: 2020-05-04 Impact factor: 4.029