Tak Vdz-4066
Posted Date: Sep 24, 2024
- Investigator: Anita Afzali
- Specialties:
- Type of Study: Observational/Survey
Background and Rationale Crohn’s disease (CD) is an inflammatory bowel disease (IBD) with relapsing and remitting inflammation of the gastrointestinal tract. Vedolizumab (VDZ) (ENTYVIO®), a gut-selective humanized monoclonal antibody, was the first anti-integrin approved that selectively antagonizes a4ß7 gastrointestinal integrin. The GEMINI clinical trials have demonstrated the efficacy and safety of VDZ for the treatment of moderate-to-severe CD, which included biologic-naive (bio-naive) patients and patients who did not respond to prior anti-TNFa treatment. In the real world, the original EVOLVE studies on biologic-naive patients with CD across Canada, the US, and Greece showed that first-line VDZ and anti-TNFa treatments yielded similar rates of clinical effectiveness up to 2 years post-index treatment initiation, and that VDZ had a superior safety profile compared with anti-TNFa treatments. Alternatively, ustekinumab (UST) (STELARA®), a monoclonal antibody targeting the p40 subunit of interleukin-12/interleukin -23, was demonstrated to be safe and effective in both biologic-exposed and bio-naive patients with moderate to severe CD in the UNIFI trial. In anti-TNFa-refractory patients with CD, UST has been shown to be effective for the induction and maintenance of clinical remission. Results of the EVOLVE Expansion study, a real-world non-interventional medical chart review study comparing VDZ and UST in bio-naive patients with CD in Belgium, Switzerland, and Australia, demonstrated similar rates of clinical effectiveness as well as similar incidences of safety outcomes for patients treated with VDZ or UST up to 36 months post-index treatment initiation. Key differences between the treatment cohorts in this study included higher rates of mucosal healing in patients receiving VDZ and greater treatment persistence in patients receiving UST. Long-term maintenance of treatment effectiveness has not been demonstrated in patients from the US and Canada. Furthermore, many patients receiving VDZ or UST in the real-world setting are biologic-experienced (i.e., anti-TNFa-experienced) when they initiate VDZ or UST treatment, and outcomes in biologic-experienced patients should be further elucidated. Thus, the aim of this study is to provide real-world evidence, through medical records abstraction, on the effectiveness, treatment patterns, health resource utilization (HRU), and frequency of adverse events of VDZ as first- or later-line treatment. Outcomes of UST-treated patients will be similarly gathered to allow for estimates of comparative effectiveness as exploratory research questions.
Criteria:
Criteria For Inclusion: 1. Patient Received At Least One Dose Of Vdz Or Ust (Study Index) At One Of The Participating Study Sites During The Eligibility Period. 2. Patient Had A Documented Diagnosis Of Cd In Their Medical Chart (At Or Prior To The Study Index). 3. Patient Was 18 Years Of Age Or Older At Study Index. 4. Patient Has A Minimum Of 6-Months Of Follow-Up At Their Study Index Site (Defined As At Least One Care Encounter 6 Months (Or Later) Following Their Index Date).
Keywords:
Vedo, Usta, Ibd
For More Information:
Rebecca Crum, Rn-Bsn
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crumra@ucmail.uc.edu