N/A
Completed N=409
A Study to Observe Vedolizumab and Anti-tumour Necrosis Factors (Anti-TNFs) Outcomes in Real-world Biologic Ulcerative Colitis (UC) and Crohn's Disease (CD) Participants
Colitis, Ulcerative · Crohn Disease
Source: ClinicalTrials.gov NCT03710486 ↗
Enrolled (actual)
409
Serious AEs
21.0%
Results posted
May 2024
Primary outcomePrimary: Percentage of Participants With One or More Treatment Intensifications for CD Participants — 30.7; 42.1 percentage of participants — p==0.13202
Summary
The purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and second line) vedolizumab versus other biologics at least 6 months post-treatment initiation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With One or More Treatment Intensifications for CD Participants |
30.7; 42.1 | =0.13202 |
| PRIMARY Percentage of Participants With One or More Treatment Intensifications for UC Participants |
43.5; 39.5 | =0.5861 |
| PRIMARY Number of Participants With Reasons for Treatment Modifications in CD Participants |
6; 6; 2; 13; 2; 3 | — |
| PRIMARY Number of Participants With Reasons for Treatment Modifications in UC Participants |
8; 9; 6; 6; 0; 2 | — |
| PRIMARY Percentage of Participants Who Discontinued Index Therapy for CD Participants |
38.8; 49.3 | =0.1648 |
| PRIMARY Percentage of Participants Who Discontinued Index Therapy for UC Participants |
39.6; 50.0 | =0.1732 |
| PRIMARY Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation |
20; 16 | — |
| PRIMARY Time to Switching for Vedolizumab Participants |
11.29; 8.62 | — |
| PRIMARY Time to Discontinuation for CD Participants |
7.1; 10.7 | =0.2011 |
| PRIMARY Time to Discontinuation for UC Participants |
9.0; 10.1 | =0.6939 |
| PRIMARY Percentage of Participants With Clinical Response at 14 Weeks for CD Participants |
68.1; 88.2 | =0.0071 sig |
| PRIMARY Percentage of Participants With Clinical Response at 52 Weeks for CD Participants |
74.8; 69.8 | =0.4809 |
| PRIMARY Percentage of Participants With Clinical Response at 14 Weeks for UC Participants |
81.2; 80.5 | =0.9150 |
| PRIMARY Percentage of Participants With Clinical Response at 52 Weeks for UC Participants |
75.6; 73.2 | =0.7254 |
| PRIMARY Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants |
56.2; 79.3 | =0.0051 sig |
| PRIMARY Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants |
51.3; 66.5 | =0.0653 |
| PRIMARY Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants |
52.2; 54.7 | =0.7629 |
| PRIMARY Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants |
56.6; 62.0 | =0.4895 |
| PRIMARY Percentage of Participants With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants |
69.1; 74.6 | =0.4458 |
| PRIMARY Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants |
72.9; 73.4 | =0.9471 |
| PRIMARY Percentage of Participants With Biochemical Remission Based on CRP at 14 Weeks for UC Participants |
58.5; 77.2 | =0.0104 sig |
| PRIMARY Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for UC Participants |
60.4; 85.2 | =0.0011 sig |
| PRIMARY Percentage of Participants With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants |
72.9; 73.4 | =0.9471 |
| PRIMARY Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for CD Participants |
45.7; 73.4 | =0.0104 sig |
| PRIMARY Percentage of Participants With Biochemical Remission Based on FCP at 14 Weeks for UC Participants |
60.4; 85.2 | =0.0011 sig |
| PRIMARY Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for UC Participants |
59.7; 53.7 | =0.5400 |
| PRIMARY Percentage of Participants With Endoscopic Response at 52 Weeks for CD Participants |
69.7; 65.7 | =0.8123 |
| PRIMARY Percentage of Participants With Endoscopic Response at 52 Weeks for UC Participants |
44.8; 78.2 | =0.0282 sig |
| PRIMARY Percentage of Participants With Endoscopic Remission at 52 Weeks for CD Participants |
43.5; 40.5 | =0.8584 |
| PRIMARY Percentage of Participants With Endoscopic Remission at 52 Weeks for UC Participants |
35.5; 36.6 | =0.9474 |
| SECONDARY Percentage of Participants With Adverse Events and Serious Adverse Events |
50.7; 58.4; 33.4; 55.0; 26.5; 23.2 | =0.3103 |
| SECONDARY Incidence Rate of Adverse Events and Serious Adverse Events |
8.53; 9.53; 8.83; 10.64; 4.62; 2.31 | =0.4784 |
| SECONDARY Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events |
11.6; 19.6; 2.1; 8.5; 2.3; 5.5 | =0.1681 |
| SECONDARY Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events |
1.15; 2.70; 0.23; 1.10; 0.29; 0.53 | =0.0239 sig |
| SECONDARY Percentage of Participants With Infections, Serious Infections and Malignancies |
4.1; 19.8; 6.4; 17.8 | =0.0044 sig |
| SECONDARY Incidence Rate of Infections, Serious Infections and Malignancies |
0.48; 1.75; 0.75; 2.42 | =0.0152 sig |
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis of moderate to severe UC or CD documented in the medical chart.
- Received at least one dose of vedolizumab or other biologic (infliximab, adalimumab, or golimumab [UC only]) during the eligibility period.
- Received the biologic treatment as first-line or second line biologic for UC or CD.
- Has a minimum of six months of follow-up between date of starting biologic therapy (index event) and the date of completion of the participant pre-selection registry.
Exclusion Criteria
- Received vedolizumab or another biologic as part of an interventional clinical trial ever in their lifetime (includes index treatment).
- Index treatment was another biologic therapy other than vedolizumab, infliximab, adalimumab, or golimumab (UC only).
- Initiated index treatment as combination therapy with two biologic agents.
- The biologic was prescribed for treatment of perianal disease.
- Received biologic therapy before the index period for a disease other than inflammatory bowel disease.
- Medical chart is unavailable.
Data sourced from ClinicalTrials.gov (NCT03710486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.