Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel Disease (IBD)Crohn&Amp;#39;s Disease (CD)Ulcerative Colitis (UC)
- Interventions
- Drug: Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care
- Registration Number
- NCT07123350
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
The goal of this retrospective study is to learn about dosing patterns in patients starting subcutaneous vedolizumab administration and patient outcomes after starting subcutaneous administration.
Patients with IBD who are starting subcutaneous vedolizumab administration between September 1, 2023, and December 31, 2024, as part of normal patient care, will be retrospectively reviewed and analyzed.
- Detailed Description
Vedolizumab intravenous (IV) infusions have been a first-line treatment option for patients with inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC) for over ten years. Recently, vedolizumab has been approved by the Food and Drug Administration for subcutaneous (SC) administration in the United States, offering patients a more convenient treatment option with medication administration at home. Evidence, largely from European countries where the SC formulation of vedolizumab has been available since 2020, shows a durable and potentially improved clinical response when switching to the SC formulation. A high SC treatment persistence has been found, mainly above 80%. Additionally, many patients accept the transition to SC vedolizumab as a safe and feasible treatment option and noting that the shorter treatment duration was specifically advantageous.
Primary Objective: Analyze patient clinical outcomes before and after switching from IV to SC vedolizumab.
Secondary Objective: Evaluate standard and escalated dosing patterns before and after switching from IV to SC vedolizumab.
This is a single center, retrospective research project that will evaluate the initiation of subcutaneous vedolizumab in patients with IBD who are enrolled between September 1, 2023 and December 31, 2024. Follow-up will continue up to December 31, 2025. Patients will not be randomized. Data will be prospectively collected as part of normal clinical practice (documented in the EHR) and retrospectively reviewed and analyzed.
Inclusion Criteria: Patients with CD or UC referred to start subcutaneous vedolizumab from a VUMC IBD provider.
Exclusion Criteria: Patients prescribed SC vedolizumab from a non-VUMC provider. Lost to follow-up or change in provider or medication before SC formulation approved.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Patients with Crohn's Disease or Ulcerative Colitis referred to start SC vedolizumab from a VUMC IBD provider and receive at least 1 dose of subcutaneous vedolizumab
- Age 18 years old or older
- Patients prescribed SC vedolizumab from a non-VUMC provider
- Patients lost to follow-up or change in provider or medication before SC formulation started
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IV to SC switch Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care Patients with Crohn's Disease (CD) or Ulcerative Colitis (UC) referred to switch to subcutaneous vedolizumab from IV vedolizumab from a VUMC IBD provider and receive at least 1 dose of subcutaneous vedolizumab
- Primary Outcome Measures
Name Time Method Remission baseline with IV dosing, and 3, 6, 9, 12 months after switching to SC Remission will be defined if any of the following is met: 1) Clinical remission as written by provider in last office visit note, 2) Endoscopic remission as written by provider from last colonoscopy report, 3) Fecal calprotectin \<250 μg/g, 4) CRP \<5 mg/L (or below cut-off for normal range for the laboratory), 5) In CD, HBI \< 4, or 6) In UC, SCCAI \< 2.5 or endoscopic Mayo score ≤ 1
- Secondary Outcome Measures
Name Time Method Dosing patterns of IV dose/frequency and SC dose/frequency At baseline and up to 12 months after switching standard dosing vs escalated dosing; includes any dose changes of the SC product within 12 months after switching from IV to SC
SIBDQ score Baseline and 12 months post switch to SC Short Inflammatory Bowel Disease Questionnaire
Persistence to SC formulation Up to 12 months after switching Measured by time to discontinuation; will include reason for discontinuation if SC stopped
Adverse events to vedolizumab SC Up to 12 months after switching Adverse events to vedolizumab SC that required change back to IV
Adherence 12 months post switch to SC Measured by PDC
Patient-reported missed doses 12 months post switch to SC For patients filling with Vanderbilt Specialty Pharmacy only; will include reasons for patient-reported missed doses
Maintenance steroid use for IBD 12 months post switch to SC Will determine if maintenance steroids were used for maintenance post switch to SC (yes/no)
Number of steroid prescriptions for flares 12 months before and after switch Based on prescription history in patient chart
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center🇺🇸Nashville, Tennessee, United States