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

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.
Competing Interests: IV has served as a speaker for Takeda. CE has received grant support/lecture fee/advisory board from Takeda, Janssen Cilag, Pfizer and AbbVie. SK has served as a speaker for Takeda. BL: None. PK: None. OG has received consultant fees from Ferring, Takeda, Janssen, AbbVie, Pfizer and Tillotts Pharma. CS: None. SA has received research grants from Karolinska Institutet, Thuréus foundation and Janssen, as well as served as a consultant for Takeda, Janssen. EH has served as a speaker, consultant or advisory board member for AbbVie, Gilead, Janssen, Pfizer and Takeda. JM has served as a speaker, consultant or advisory board member for AbbVie, Bayer, BMS, Hospira, Janssen, MSD, Pfizer, Sandoz, Takeda and UCB and has received grant support from AbbVie, Calpro AS, Fresenius Kabi, Pfizer, SVAR Life Science and Takeda. CM serves as an employee at Takeda. JD: None. HS has served as a speaker or advisory board member for AbbVie, Ferring, Janssen, Pfizer, Takeda, Gilead and Tillotts Pharma. MS: None. DB has received personal fees from Ferring, Takeda, Janssen and BMS outside the submitted work. HH has served as a speaker, consultant or advisory board member for AbbVie, Janssen, Pfizer, Takeda, Tillotts Pharma, Vifor Pharma and received grant support from Ferring and Tillotts Pharma. JH has served as a speaker, consultant and/or advisory board member for AbbVie, Aqilion, BMS, Celgene, Celltrion, Ferring, Galapagos, Gilead, Hospira, Janssen, MEDA, Medivir, MSD, Novartis, Pfizer, Prometheus Laboratories Inc, Sandoz, Shire, Takeda, Thermo Fisher Scientific, Tillotts Pharma and Vifor Pharma. JH has also received grant support from Janssen, MSD and Takeda.
(© The Author(s), 2023.)