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

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.

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 9573

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators will use Medicare data from 2006-2011. 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 coritcosteroids as defined below. To assure full coverage, patients will be required to have Parts A, B, and D Medicare coverage.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
anti-TNF - no intervention; Patients who are new users of anti-TNF therapy	Other: No intervention; There is no intervention
Corticosteroids - no intervention; Patients initiating corticosteroids	Other: No intervention; There is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	See Outcome Measure Description above

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Patient-Centered Outcomes Research Institute; University of Alabama at Birmingham; Duke University; Crohn's and Colitis Foundation

Publications and helpful links

General Publications

• Bewtra M, Reed SD, Johnson FR, Scott FI, Gilroy E, Sandler RS, Chen W, Lewis JD. Variation Among Patients With Crohn's Disease in Benefit vs Risk Preferences and Remission Time Equivalents. Clin Gastroenterol Hepatol. 2020 Feb;18(2):406-414.e7. doi: 10.1016/j.cgh.2019.05.010. Epub 2019 May 14.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Patient Preference
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Colitis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis, Ulcerative
• Other Study ID Numbers: 818347