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.