Colitis, Ulcerative, Crohn's Disease, Inflammatory Bowel Diseases
Conditions
Keywords
Patient Preference
Brief summary
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.
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.
Interventions
OTHERNo intervention
There is no intervention
Sponsors
Crohn's and Colitis Foundation
University of Alabama at Birmingham
Duke University
Patient-Centered Outcomes Research Institute
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | See Outcome Measure Description above | 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. |
Countries
United States
Participant flow
Recruitment details
This is a retrospective cohort study of Medicaid and Medicare beneficiaries with Inflammatory Bowel Disease (IBD) in the United States using administrative data. Medicaid data were from 2001-2005 and Medicare data were from 2006-2013.
Participants by arm
| Arm | Count |
|---|---|
| Anti-TNF - no Intervention Patients who are new users of anti-TNF therapy
No intervention: There is no intervention | 1,879 |
| Corticosteroids - no Intervention Patients initiating corticosteroids
No intervention: There is no intervention | 7,694 |
| Total | 9,573 |
Baseline characteristics
| Characteristic | Corticosteroids - no Intervention | Anti-TNF - no Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2856 Participants | 556 Participants | 3412 Participants |
| Age, Categorical Between 18 and 65 years | 4838 Participants | 1323 Participants | 6161 Participants |
| Age, Continuous | 53.2 years STANDARD_DEVIATION 18.8 | 50.1 years STANDARD_DEVIATION 17.7 | 52.6 years STANDARD_DEVIATION 18.6 |
| Region of Enrollment United States | 7694 participants | 1879 participants | 9573 participants |
| Sex: Female, Male Female | 4830 Participants | 1216 Participants | 6046 Participants |
| Sex: Female, Male Male | 2864 Participants | 663 Participants | 3527 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Patients treated with corticosteroids (CS) within the prior year and subsequently received either additional CS therapy meeting the definition of prolonged CS use or newly initiated anti-TNF therapy were included in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anti-TNF | Mortality Rate | 21.4 events per 1000 person-years |
| Steroids | Mortality Rate | 30.1 events per 1000 person-years |