title: Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG).
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.
authors.affiliation: a Department of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden.
authors.forename: Carl
authors.initials: C
authors.lastname: Eriksson
authors.affiliation: b Immunology Section , Lund University , Lund , Sweden.|c Department of Gastroenterology , Skåne University Hospital , Lund , Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Marsal
authors.affiliation: a Department of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden.
authors.forename: Daniel
authors.initials: D
authors.lastname: Bergemalm
authors.affiliation: d Department of Internal Medicine , Ystad Hospital , Ystad , Sweden.
authors.forename: Lina
authors.initials: L
authors.lastname: Vigren
authors.affiliation: e Department of Medicine , Center for Digestive Diseases, Karolinska University Hospital , Karolinska Institutet , Solna , Stockholm , Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Björk
authors.affiliation: e Department of Medicine , Center for Digestive Diseases, Karolinska University Hospital , Karolinska Institutet , Solna , Stockholm , Sweden.
authors.forename: Michael
authors.initials: M
authors.lastname: Eberhardson
authors.affiliation: f Department of Public Health and Clinical Medicine , Umeå University , Umeå , Sweden.
authors.forename: Pontus
authors.initials: P
authors.lastname: Karling
authors.affiliation: g Department of Internal Medicine , St Göran Hospital , Stockholm , Sweden.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Söderman
authors.affiliation: h Department of Clinical and Experimental Medicine, Linköping University and Department of Surgery , Linköping University Hospital , Linköping , Sweden.
authors.forename: Pär
authors.initials: P
authors.lastname: Myrelid
authors.affiliation: i Department of Clinical Epidemiology and Biostatistics, School of Medical Sciences , Örebro University , Örebro , Sweden.|j Department of Medical Epidemiology and Biostatistics , Karolinska Institutet , Stockholm , Sweden.
authors.forename: Yang
authors.initials: Y
authors.lastname: Cao
authors.affiliation: k Center for Clinical Research Dalarna , Uppsala University , Falun , Sweden.
authors.forename: Daniel
authors.initials: D
authors.lastname: Sjöberg
authors.affiliation: l Department of Medical Sciences, Section of Gastroenterology and Hepatology , Uppsala University , Uppsala , Sweden.
authors.forename: Mari
authors.initials: M
authors.lastname: Thörn
authors.affiliation: m Department of Internal Medicine , Danderyd Hospital , Stockholm , Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Karlén
authors.affiliation: c Department of Gastroenterology , Skåne University Hospital , Lund , Sweden.
authors.forename: Erik
authors.initials: E
authors.lastname: Hertervig
authors.affiliation: n Department of Internal Medicine , Södra Älvsborgs Sjukhus , Borås , Sweden.
authors.forename: Hans
authors.initials: H
authors.lastname: Strid
authors.affiliation: j Department of Medical Epidemiology and Biostatistics , Karolinska Institutet , Stockholm , Sweden.|o Department of Pediatrics , Örebro University Hospital , Örebro , Sweden.
authors.forename: Jonas F
authors.initials: JF
authors.lastname: Ludvigsson
authors.affiliation: e Department of Medicine , Center for Digestive Diseases, Karolinska University Hospital , Karolinska Institutet , Solna , Stockholm , Sweden.
authors.forename: Sven
authors.initials: S
authors.lastname: Almer
authors.affiliation: a Department of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden.
authors.forename: Jonas
authors.initials: J
authors.lastname: Halfvarson
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D005243:Feces / Q000737:chemistry; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D012042:Registries; D013548:Sweden; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D039841:Leukocyte L1 Antigen Complex; D014409:Tumor Necrosis Factor-alpha; C543529:vedolizumab
keywords: Crohn’s disease; Vedolizumab; clinical practice; inflammatory bowel disease; ulcerative colitis