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

Takeda

Status: Not yet enrolling

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT07250815

EUPAS1000000767 (Other Identifier)

Vedolizumab-4081

Details and patient eligibility

About

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.

Enrollment: 23,900 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

23,900 participants in 2 patient groups

Participants with UC

Description:

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.

Treatment:

Other: No intervention

Participants with CD

Description:

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.

Treatment:

Other: No intervention