A Study on Infections in Adults With Ulcerative Colitis/Crohn's Disease

Infection Outcomes Among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025

More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or CD. Medicines that treat UC/CD, however, might make it easier for older adults to get infections.

The main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha).

The study will include people aged 65 years and older UC or CD who used either ENTYVIO with ustekinumab or a TNF-alpha inhibitor between 2016 and 2025.

Data will be collected from existing Medicare databases.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Ulcerative Colitis
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 23900

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • Takeda Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

United States (US) adult participants diagnosed with UC or CD who initiated ENTYVIO or other AMTs will be included in this study.

Description

Inclusion Criteria:

UC Study Cohort:

Participants will be included if they had:

-Greater than or equal to (>=) 1 medical (for Medicare fee-for-service [FFS], Part A/B) or pharmacy claim (for Medicare FFS, Medicare Part D) for an approved AMT for UC during the participant identification period.

Note: Claim should be on or after the food and drug administration (FDA) treatment-specific approval dates for each drug.

The date of the first claim during the participant identification period will be designated the Index Date, and the corresponding AMT, the index AMT.

• >=2 medical (for Medicare FFS, Part A/B) claims, at least 30 days apart, with an ICD-10-CM code for UC during the baseline period or on the Index Date.
• Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.

CD Study Cohort:

Participants will be included if they had:

- >=1 medical (for Medicare FFS, Part A/B) or pharmacy claim (for Medicare FFS, Part D) for an approved AMT for CD during the Participant Identification Period.

Note: Claim should be on or after the FDA treatment-specific approval dates for each drug.

The date of the first claim during the Patient Identification Period will be designated the Index Date, and the corresponding AMT, the index AMT.

• >=2 medical (for Medicare FFS, Part A/B) claims, at least 30 days apart, with an ICD-10-CM code for CD during the Baseline Period or on the Index Date.
• Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.

If a participant has both a UC and CD diagnosis during the baseline period or on the index date, the diagnosis most proximate to or on the index date will be used to categorize the participant as having UC or CD.

Exclusion Criteria:

Participants with any of the following will be excluded from the analysis:

• Any evidence of AMT utilization during the Baseline Period.
• Participants with at least 2 ICD-10-CM codes for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, non-infectious uveitis, or psoriatic arthritis during the Baseline Period.
• Participants with 2 or more ICD-10-CM codes for non-dermatologic malignancy during the Baseline Period.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with UC; Participants diagnosed with UC who initiated treatment with ENTYVIO or other advanced medical therapies (AMTs) will be identified using a claims-based algorithm. This algorithm incorporates International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes, National Drug Codes (NDC), and Healthcare Common Procedural Coding System (HCPCS) codes to retrospectively assess the safety outcomes data over a period of approximately four months.	Other: No intervention; This is an observational study, no intervention will be administered.
Participants with CD; Participants diagnosed with CD who initiated treatment with ENTYVIO or other AMTs will be identified using a claims-based algorithm. This algorithm incorporates ICD-10-CM codes, NDC, and HCPCS codes to retrospectively assess the safety outcomes data over a period of approximately four months.	Other: No intervention; This is an observational study, no intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Hospitalized Due to Serious Infections	Serious infections will include infections of the respiratory tract, skin and soft tissue, genitourinary tract, gastrointestinal tract, central nervous system, and septicemia/sepsis. The intraabdominal infections, perianal infections, tuberculosis, and other opportunistic infections will not be considered under serious infection requiring hospitalization.	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Non-serious Infections	Non-serious infections will include any primary diagnosis of infection that is not associated with hospitalization.	Up to 4 months

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: Vedolizumab-4081; EUPAS1000000767 (Other Identifier: HMA-EMA RWD Catalogue)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No