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Long-term outcomes of vedolizumab in inflammatory bowel disease : the Swedish prospective multicentre SVEAH extension study

Visuri, Isabella ; Eriksson, Carl ; Karlqvist, Sara ; Lykiardopoulos, Byron ; Karlén, Per ; Grip, Olof LU ; Söderman, Charlotte ; Almer, Sven LU ; Hertervig, Erik and Marsal, Jan LU , et al. (2023) In Therapeutic Advances in Gastroenterology 16.
Abstract

Background: Real-world data on long-term outcomes of vedolizumab (VDZ) are scarce. Objective: To assess long-term outcomes (up to 3 years) of VDZ in treating inflammatory bowel disease (IBD). Design: A nationwide, prospective multicentre extension of a Swedish observational study on VDZ assessing Effectiveness And Healthcare resource utilization in patients with IBD (SVEAH). Methods: After re-consent, data of 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 IBD Register (SWIBREG). The primary outcome was clinical remission (defined as Harvey–Bradshaw Index ⩽4 in CD and partial Mayo score ⩽2 in UC)... (More)

Background: Real-world data on long-term outcomes of vedolizumab (VDZ) are scarce. Objective: To assess long-term outcomes (up to 3 years) of VDZ in treating inflammatory bowel disease (IBD). Design: A nationwide, prospective multicentre extension of a Swedish observational study on VDZ assessing Effectiveness And Healthcare resource utilization in patients with IBD (SVEAH). Methods: After re-consent, data of 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 IBD Register (SWIBREG). The primary outcome was clinical remission (defined as Harvey–Bradshaw Index ⩽4 in CD and partial Mayo score ⩽2 in UC) at 104 and 156 weeks in patients with a response and/or remission 12 weeks after starting VDZ. Secondary outcomes included health-related quality of life (HRQoL) and biochemical outcomes. Results: VDZ continuation rates were high at weeks 104 and 156, 88% and 84%, respectively, for CD and 87% and 78%, respectively, for UC. Of the 53 CD patients with a response/remission at 12 weeks, 40 (75%) patients were in remission at 104 weeks and 42 (79%) patients at 156 weeks. For UC, these numbers were 25/31 (81%) and 22/31 (71%), respectively. Improvements were seen in 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). Median plasma-C-reactive protein concentrations (mg/L) decreased from 5 at baseline to 4 in CD (p = 0.01, n = 53) and from 5 to 4 in UC (p = 0.03, n = 34) at 156 weeks. Correspondingly, median faecal-calprotectin (µg/g) decreased from 641 to 114 in CD patients (p < 0.01, n = 26) and from 387 to 37 in UC patients (p = 0.02, n = 17). Conclusion: VDZ demonstrated high continuation rates and was associated with improvements in clinical outcomes, HRQoL measures and inflammatory markers at 2 and 3 years after treatment initiation in this prospective national SVEAH extension study. Registration: ENCePP registration number: EUPAS22735.

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Contribution to journal
publication status
published
subject
keywords
Crohn’s disease, inflammatory bowel disease, real-world data, ulcerative colitis, vedolizumab
in
Therapeutic Advances in Gastroenterology
volume
16
publisher
SAGE Publications
external identifiers
  • pmid:37274297
  • scopus:85161292810
ISSN
1756-283X
DOI
10.1177/17562848231174953
language
English
LU publication?
no
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Publisher Copyright: © The Author(s), 2023.
id
ddebc965-fc0a-4d24-99e3-159b6cecf0f4
date added to LUP
2023-06-29 15:56:18
date last changed
2024-04-19 23:10:36
@article{ddebc965-fc0a-4d24-99e3-159b6cecf0f4,
  abstract     = {{<p>Background: Real-world data on long-term outcomes of vedolizumab (VDZ) are scarce. Objective: To assess long-term outcomes (up to 3 years) of VDZ in treating inflammatory bowel disease (IBD). Design: A nationwide, prospective multicentre extension of a Swedish observational study on VDZ assessing Effectiveness And Healthcare resource utilization in patients with IBD (SVEAH). Methods: After re-consent, data of 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 IBD Register (SWIBREG). The primary outcome was clinical remission (defined as Harvey–Bradshaw Index ⩽4 in CD and partial Mayo score ⩽2 in UC) at 104 and 156 weeks in patients with a response and/or remission 12 weeks after starting VDZ. Secondary outcomes included health-related quality of life (HRQoL) and biochemical outcomes. Results: VDZ continuation rates were high at weeks 104 and 156, 88% and 84%, respectively, for CD and 87% and 78%, respectively, for UC. Of the 53 CD patients with a response/remission at 12 weeks, 40 (75%) patients were in remission at 104 weeks and 42 (79%) patients at 156 weeks. For UC, these numbers were 25/31 (81%) and 22/31 (71%), respectively. Improvements were seen in the Short Health Scale (p &lt; 0.01 for each dimension; CD, n = 51; UC, n = 33) and the EuroQol 5-Dimensions, 5-levels index value (p &lt; 0.01; CD, n = 39; UC, n = 30). Median plasma-C-reactive protein concentrations (mg/L) decreased from 5 at baseline to 4 in CD (p = 0.01, n = 53) and from 5 to 4 in UC (p = 0.03, n = 34) at 156 weeks. Correspondingly, median faecal-calprotectin (µg/g) decreased from 641 to 114 in CD patients (p &lt; 0.01, n = 26) and from 387 to 37 in UC patients (p = 0.02, n = 17). Conclusion: VDZ demonstrated high continuation rates and was associated with improvements in clinical outcomes, HRQoL measures and inflammatory markers at 2 and 3 years after treatment initiation in this prospective national SVEAH extension study. Registration: ENCePP registration number: EUPAS22735.</p>}},
  author       = {{Visuri, Isabella and Eriksson, Carl and Karlqvist, Sara and Lykiardopoulos, Byron and Karlén, Per and Grip, Olof and Söderman, Charlotte and Almer, Sven and Hertervig, Erik and Marsal, Jan and Malmgren, Carolina and Delin, Jenny and Strid, Hans and Sjöberg, Mats and Bergemalm, Daniel and Hjortswang, Henrik and Halfvarson, Jonas}},
  issn         = {{1756-283X}},
  keywords     = {{Crohn’s disease; inflammatory bowel disease; real-world data; ulcerative colitis; vedolizumab}},
  language     = {{eng}},
  month        = {{01}},
  publisher    = {{SAGE Publications}},
  series       = {{Therapeutic Advances in Gastroenterology}},
  title        = {{Long-term outcomes of vedolizumab in inflammatory bowel disease : the Swedish prospective multicentre SVEAH extension study}},
  url          = {{http://dx.doi.org/10.1177/17562848231174953}},
  doi          = {{10.1177/17562848231174953}},
  volume       = {{16}},
  year         = {{2023}},
}