Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

University of Pennsylvania9,573 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

9,573

Conditions

Colitis, Ulcerative Inflammatory Bowel Diseases Crohn's Disease

Interventions

No interventionOTHER

There is no intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Mortality Rate

Incidence of death per 1000 person-years Outcome Measure Time Frame:Follow-up was from the date that the participant first met the criteria for either prolonged corticosteroid use or new anti-TNF use until either the patient died, discontinued enrollment in Medicaid or Medicare Part A, B, or D, reached age 90, was newly diagnosed with other immune-mediated diseases or AIDS, or reached the end of the available data, whichever came first, assessed up to 13 years. Follow-up of patients with UC also ended if they were diagnosed with a fistula, as this would usually change the diagnosis to CD.

Time frame: See Outcome Measure Description above

Data from ClinicalTrials.gov

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