Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics (PPOD)

University of Pennsylvania

Status: Completed

Conditions: Colitis, Ulcerative; Crohn's Disease; Inflammatory Bowel Diseases

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02316678

818347

Details and patient eligibility

About

The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious infections, and reduced short term mortality risks, and therefore has a more favorable benefit to harm profile than corticosteroids for inflammatory bowel disease.

Full description

The investigators will conduct a comparative effectiveness study among Medicare Parts A, B, and D beneficiaries with inflammatory bowel disease. The investigators will compare the incidence of severe infection, bowel resection surgery, and death among new users of anti-tumor necrosis factor therapies and corticosteroids. The investigators will compute propensity scores to describe the propensity for treatment with anti-tumor necrosis factor drugs compared to corticosteroids, and will match corticosteroids and anti-tumor necrosis factor drug treated patients on the propensity score. Cox regression will be employed to assess the hazard ratio for each of the outcomes.

Enrollment: 9,573 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients will be required to have at least two diagnosis of inflammatory bowel disease within the 6 months prior to initiating anti-TNF therapy or corticosteroids. To assure full coverage, patients will be required to have Parts A, B, and D Medicare coverage.

Exclusion criteria

1. Diagnosis of rheumatoid arthritis, psoriasis, ankylosing spondylitis, or psoriatic arthritis in the 6 months period prior to initiation of the therapy.
2. Less than 6 months of follow-up time within the data source prior to initiation of the therapy.
3. Diagnosis of cancer in the 6 months prior to initiation of the study medication.
4. Initiation of anti-TNF therapies within the first 6 months following surgery.
5. Patients who are in managed care plans (Medicare Part C).

Trial design

9,573 participants in 2 patient groups

anti-TNF - no intervention

Description:

Patients who are new users of anti-TNF therapy

Treatment:

Other: No intervention

Corticosteroids - no intervention

Description:

Patients initiating corticosteroids

Treatment:

Other: No intervention