AI Article Synopsis
- The study assessed long-term outcomes of vedolizumab (VDZ) over three years for patients with inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC).
- High continuation rates of VDZ treatment were observed, with 88% of CD patients and 87% of UC patients still on the medication after 104 weeks.
- Significant improvements were reported in clinical remission rates and health-related quality of life, with decreases in inflammatory markers, indicating VDZ is an effective long-term treatment for IBD.
Article 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) ( = 68) and ulcerative colitis (UC) ( = 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 ( < 0.01 for each dimension; CD, = 51; UC, = 33) and the EuroQol 5-Dimensions, 5-levels index value ( < 0.01; CD, = 39; UC, = 30). Median plasma-C-reactive protein concentrations (mg/L) decreased from 5 at baseline to 4 in CD ( = 0.01, = 53) and from 5 to 4 in UC ( = 0.03, = 34) at 156 weeks. Correspondingly, median faecal-calprotectin (µg/g) decreased from 641 to 114 in CD patients ( < 0.01, = 26) and from 387 to 37 in UC patients ( = 0.02, = 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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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10236258 | PMC |
| http://dx.doi.org/10.1177/17562848231174953 | DOI Listing |
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