Isabella Visuri[1], Carl Eriksson[1,2], Sara Karlqvist[1], Byron Lykiardopoulos[3], Per Karlén[4], Olof Grip[5], Charlotte Söderman[6], Sven Almer[7,8], Erik Hertervig[5], Jan Marsal[5], Carolina Malmgren[9], Jenny Delin[10], Hans Strid[11], Mats Sjöberg[12], Daniel Bergemalm[1], Henrik Hjortswang[3,13] and Jonas Halfvarson[1]; The SWIBREG SVEAH Study Group

Affiliates

Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden[1], Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden[2], Department of Gastroenterology and Hepatology, Linköping University, Linköping, Sweden[3], Department of Internal Medicine, Danderyd Hospital, Stockholm, Sweden[4], Department of Gastroenterology, Skåne University Hospital, Malmö/Lund, Sweden[5], Department of Internal Medicine, Capio St Göran Hospital, Stockholm, Sweden[6], Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden[7], IBD-Unit, Division of Gastroenterology, Karolinska University Hospital, Stockholm, Sweden[8], Takeda Pharma AB, Stockholm, Sweden[9], Department of Gastroenterology, Ersta Hospital, Stockholm, Sweden[10], Department of Internal Medicine, Södra Älvsborgs Hospital, Borås, Sweden[11], Department of Internal Medicine, Skaraborgs Hospital, Lidköping, Sweden[12], Department of Health, Medicine, and Caring Sciences, Linköping University, Linköping, Sweden[13]

Abstract

Background: Real-world data on long-term outcomes of vedolizumab (VDZ) are scarce.
Methods: We aimed to assess long-term outcomes (up to three years) of VDZ in the treatment of IBD. This was a nationwide, observational, multicentre extension of the SVEAH study. After re-consent, clinical and demographic data on patients with Crohn’s disease (CD) (n=68) and ulcerative colitis (UC) (n=46) treated with VDZ were prospectively recorded using an electronic Case Report Form integrated with the Swedish Inflammatory Bowel Disease Register (SWIBREG). The primary outcome was clinical remission (defined as Harvey-Bradshaw Index (HBI) ≤4 in CD and partial Mayo Clinic score ≤2 in UC) at 104 and 156 weeks, respectively, among patients with a response/remission at 12 weeks after starting VDZ. Secondary outcomes included biochemical response and quality of life measures.
Results: Clinical and demographical characteristics of patients with CD and UC are shown in Table 1. Of the 53 CD patients with a response/remission at 12 weeks, 40 (75%) patients were in remission at 104 weeks and 42 (79%) at 156 weeks. Correspondingly, 25/31 (81%) patients with UC, with a response/remission at 12 weeks, were in remission at 104 weeks and 22/31 (71%) at 156 weeks. The median CRP concentrations (mg/L) decreased from 5 at baseline to 4 at 156 weeks in CD (p=0.01, n=53) and from 5 to 4 in UC (p=0.03, n=34). Correspondingly, median f-calprotectin (μg/g) decreased from 641 to 114 at 156 weeks in CD (p<0.01, n=26) and from 387 to 37 in UC (p=0.02, n=17). Improvement was seen in each dimension of the Short health scale (p<0.01 for each dimension, CD, n=51; UC, n=33) and the EuroQol 5-Dimensions, 5-Levels index value (p<0.01, CD, n=39; UC, n=30).
Conclusion: VDZ was associated with high long-term persistence rates and improvements in clinical, biochemical and health related quality of life measures after three years in this prospective national SVEAH extension study.