Carl Eriksson1, Jan Marsal2,3, Daniel Bergemalm1, Lina Vigren4, Jan Björk5, Michael Eberhardson5, Pontus Karling6, Charlotte Söderman7, Pär Myrelid8, Yang Cao9,10, Daniel Sjöberg11, Mari Thörn12, Per Karlén13, Erik Hertervig3, Hans Strid14, Jonas F Ludvigsson10,15, Sven Almer5, Jonas Halfvarson1. 1. a Department of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden. 2. b Immunology Section , Lund University , Lund , Sweden. 3. c Department of Gastroenterology , Skåne University Hospital , Lund , Sweden. 4. d Department of Internal Medicine , Ystad Hospital , Ystad , Sweden. 5. e Department of Medicine , Center for Digestive Diseases, Karolinska University Hospital , Karolinska Institutet , Solna , Stockholm , Sweden. 6. f Department of Public Health and Clinical Medicine , Umeå University , Umeå , Sweden. 7. g Department of Internal Medicine , St Göran Hospital , Stockholm , Sweden. 8. h Department of Clinical and Experimental Medicine, Linköping University and Department of Surgery , Linköping University Hospital , Linköping , Sweden. 9. i Department of Clinical Epidemiology and Biostatistics, School of Medical Sciences , Örebro University , Örebro , Sweden. 10. j Department of Medical Epidemiology and Biostatistics , Karolinska Institutet , Stockholm , Sweden. 11. k Center for Clinical Research Dalarna , Uppsala University , Falun , Sweden. 12. l Department of Medical Sciences, Section of Gastroenterology and Hepatology , Uppsala University , Uppsala , Sweden. 13. m Department of Internal Medicine , Danderyd Hospital , Stockholm , Sweden. 14. n Department of Internal Medicine , Södra Älvsborgs Sjukhus , Borås , Sweden. 15. o Department of Pediatrics , Örebro University Hospital , Örebro , Sweden.
Abstract
OBJECTIVES: Clinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness. MATERIALS AND METHODS: Patients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw index <5 in Crohn's disease (CD) and Patient Simple Clinical Colitis Activity index <3 in ulcerative colitis (UC). RESULTS: Two-hundred forty-six patients (147 CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergone ≥1 surgical resection. After a median follow-up of 17 (IQR: 14-20) months, 142 (58%) patients remained on vedolizumab. In total, 54% of the CD- and 64% of the UC patients were in clinical remission at the end of follow-up, with the clinical activity decreasing (p < .0001 in both groups). Faecal-calprotectin decreased in CD (p < .0001) and in UC (p = .001), whereas CRP decreased in CD (p = .002) but not in UC (p = .11). Previous anti-TNF exposure (adjusted HR: 4.03; 95% CI: 0.96-16.75) and elevated CRP at baseline (adjusted HR: 2.22; 95% CI: 1.10-4.35) seemed to be associated with discontinuation because of lack of response. Female sex was associated with termination because of intolerance (adjusted HR: 2.75; 95% CI: 1.16-6.48). CONCLUSION: Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.
OBJECTIVES: Clinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness. MATERIALS AND METHODS:Patients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw index <5 in Crohn's disease (CD) and Patient Simple Clinical Colitis Activity index <3 in ulcerative colitis (UC). RESULTS: Two-hundred forty-six patients (147 CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergone ≥1 surgical resection. After a median follow-up of 17 (IQR: 14-20) months, 142 (58%) patients remained on vedolizumab. In total, 54% of the CD- and 64% of the UC patients were in clinical remission at the end of follow-up, with the clinical activity decreasing (p < .0001 in both groups). Faecal-calprotectin decreased in CD (p < .0001) and in UC (p = .001), whereas CRP decreased in CD (p = .002) but not in UC (p = .11). Previous anti-TNF exposure (adjusted HR: 4.03; 95% CI: 0.96-16.75) and elevated CRP at baseline (adjusted HR: 2.22; 95% CI: 1.10-4.35) seemed to be associated with discontinuation because of lack of response. Female sex was associated with termination because of intolerance (adjusted HR: 2.75; 95% CI: 1.16-6.48). CONCLUSION:Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.
Authors: Christopher Andrew Lamb; Nicholas A Kennedy; Tim Raine; Philip Anthony Hendy; Philip J Smith; Jimmy K Limdi; Bu'Hussain Hayee; Miranda C E Lomer; Gareth C Parkes; Christian Selinger; Kevin J Barrett; R Justin Davies; Cathy Bennett; Stuart Gittens; Malcolm G Dunlop; Omar Faiz; Aileen Fraser; Vikki Garrick; Paul D Johnston; Miles Parkes; Jeremy Sanderson; Helen Terry; Daniel R Gaya; Tariq H Iqbal; Stuart A Taylor; Melissa Smith; Matthew Brookes; Richard Hansen; A Barney Hawthorne Journal: Gut Date: 2019-09-27 Impact factor: 23.059
Authors: Neeraj Narula; Farhad Peerani; Joseph Meserve; Gursimran Kochhar; Khadija Chaudrey; Justin Hartke; Prianka Chilukuri; Jenna Koliani-Pace; Adam Winters; Leah Katta; Eugenia Shmidt; Robert Hirten; David Faleck; Malav P Parikh; Diana Whitehead; Brigid S Boland; Siddharth Singh; Sashidhar Varma Sagi; Monika Fischer; Shannon Chang; Morris Barocas; Michelle Luo; Karen Lasch; Matthew Bohm; Dana Lukin; Keith Sultan; Arun Swaminath; David Hudesman; Nitin Gupta; Bo Shen; Sunanda Kane; Edward V Loftus; Corey A Siegel; Bruce E Sands; Jean-Frederic Colombel; William J Sandborn; Parambir S Dulai Journal: Am J Gastroenterol Date: 2018-06-27 Impact factor: 10.864
Authors: Philipp Schreiner; Markus F Neurath; Siew C Ng; Emad M El-Omar; Ala I Sharara; Taku Kobayashi; Tadakazu Hisamatsu; Toshifumi Hibi; Gerhard Rogler Journal: Inflamm Intest Dis Date: 2019-07-09