Sammanfattning
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.
| Originalspråk | engelska |
|---|---|
| Tidskrift | Therapeutic Advances in Gastroenterology |
| Volym | 16 |
| DOI | |
| Status | Published - 2023 jan. 1 |
| Externt publicerad | Ja |
Bibliografisk information
Funding Information:The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by Takeda (ENCePP registration number: EUPAS22735). The study was initiated, planned and undertaken by the investigators. The sponsors provided financial help for setting up the eCRF, entering data in the eCRF, investigator meetings, monitoring during and after the study was closed and administrative work. The sponsor did not have access to raw data and was not involved in any of the analyses. The local hospitals paid for the VDZ. This work was supported by the Swedish government’s agreement on medical training and research [grant number OLL-836791 to CE; grant number OLL-934569 to SK; grant numbers OLL-929900 and OLL-960775 to IV].
Funding Information:
We acknowledge Malin Olsson, Åsa Smedberg, Ida Gustavsson and the Department of Clinical Research Support, Örebro University Hospital for administrative support and all involved patients, clinicians and nurses’ for their efforts and contributions. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by Takeda (ENCePP registration number: EUPAS22735). The study was initiated, planned and undertaken by the investigators. The sponsors provided financial help for setting up the eCRF, entering data in the eCRF, investigator meetings, monitoring during and after the study was closed and administrative work. The sponsor did not have access to raw data and was not involved in any of the analyses. The local hospitals paid for the VDZ. This work was supported by the Swedish government’s agreement on medical training and research [grant number OLL-836791 to CE; grant number OLL-934569 to SK; grant numbers OLL-929900 and OLL-960775 to IV].
Publisher Copyright:
© The Author(s), 2023.
Ämnesklassifikation (UKÄ)
- Gastroenterologi