Real World Data on Vedolizumab Concentration and Outcomes in Inflammatory Bowel Disease (IBD) Patients Switching From Intravenous (IV) to Subcutaneous (SC) Vedolizumab in University Hospital Center Osijek

Prospective, Non-interventional, Observational Study in Cohort of Patients With IBD at University Hospital Center Osijek Switching From IV to SC Vedolizumab to Observe Vedolizumab Serum Concentration and Treatment Outcomes

Inflammatory bowel disease consists of ulcerative colitis (UC) or Crohn's disease (CD). The main aim of this study is to describe real-world data on vedolizumab serum concentration and treatment outcomes in cohort of patients treated at the Department of Gastroenterology and Hepatology of University Hospital Center Osijek. Study will be recruiting patients who switched from intravenous to subcutaneous vedolizumab according to routine clinical practice.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Detailed Description

This is a non-interventional, prospective study of participants with IBD who switched from intravenous to subcutaneous vedolizumab in the real world setting.

The study will enroll approximately 30 participants. The data will be collected at the Department of Gastroenterology and Hepatology of University Hospital Center Osijek. All the participants will be assigned to a single observational cohort. All procedures (e.g., blood draw for serum trough concentration of vedolizumab, stool collection for fecal calprotectin or colonoscopy) will be done for routine clinical care. Data will be collected at baseline and at 6-12 months after switch from intravenous to subcutaneous vedolizumab. At baseline, data on age, gender, body mass, diagnosis, time from diagnosis, prior and concomitant therapy for IBD, comorbidities, time from switch from vedolizumab IV to vedolizumab SC, and vedolizumab serum trough concentration during vedolizumab IV therapy, will be collected. At control visit, data on concomitant therapy, adverse events, hospitalization, surgery and vedolizumab serum trough concentration during vedolizumab SC therapy, will be collected. For evaluation of disease remission at baseline and at control visit, Harvey-Bradshaw index (HBI) for Crohn's disease and Partial Mayo score (PMS) for ulcerative colitis (HBI <5 or PMS <2); or value of fecal calprotectin (<150 µ/g); or Simple Endoscopic Score for Crohn's disease (SES-CD) and Mayo endoscopic subscore (MES) for ulcerative colitis (SES-CD <3 or MES <2), will be used.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • Klinički bolnički centar Osijek (University Hospital Center Osijek)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with UC or CD receiving vedolizumab treatment in accordance with the approved SmPC.

Description

Inclusion Criteria:

1. 18 years and older
2. Diagnosis of IBD (UC or CD)
3. Signed informed consent
4. Switched to or planning to switch from vedolizumab IV to vedolizumab SC
5. Disease remission at the time of switch (according to clinical, laboratory or endoscopic parameters)

Exclusion Criteria:

1. Corticosteroid therapy at time of switch from vedolizumab IV to vedolizumab SC

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with IBD; Participants diagnosed with IBD (UC or CD) who switched from vedolizumab IV to vedolizumab SC treatment during routine clinical practice, will be observed prospectively for up to 12 months from switch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Serum Vedolizumab Through Concentration After Switching from Vedolizumab IV to Vedolizumab SC		Up to 12 months from switch
Percentage of Participants in Remission After Switching to Vedolizumab SC	Remission status will be defined by clinical scores (Harvey-Bradshaw index <5 or Partial Mayo score <2), by fecal calprotectin (< 150 mcg/g; if done) or by endoscopic score (SES-CD<3 or Mayo endoscopic subscore<2; if done).	Up to 12 months from switch
Rate of Hospitalizations After Switching to Vedolizumab SC	Hospitalizations due to inflammatory bowel disease activity or complications will be taken into account.	Up to 12 months from switch
Rate of Surgery After Switching to Vedolizumab SC	Surgery due to inflammatory bowel disease activity or complications will be taken into account.	Up to 12 months from switch
Rate of Treatment Change After Switching to Vedolizumab SC	Treatment change is defined as start of corticosteroid therapy, switch to vedolizumab IV again or switch to another biologic or small molecule.	Up to 12 months from switch

Collaborators and Investigators

• Sponsor: Osijek University Hospital
• Collaborators: Josip Juraj Strossmayer University of Osijek
• Investigators: Principal Investigator: Vlasta Oršić Frič, MD, University Hospital Center Osijek

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Colitis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis, Ulcerative
• Other Study ID Numbers: DGH01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No