Although biologic medications offer much hope for reducing morbidity in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and inflammatory bowel disease (IBD), it is critical to better understand their comparative effectiveness, both in terms of clinical response as well as their risks for Serious Adverse Events (SAEs). Since head-to-head randomized trials are unlikely to be conducted that will directly answer these questions, this study is intended to help the AHRQ, the FDA, drug manufacturers, physicians, and patients identify the comparative benefits and risks of biologic medications.
The Specific Aims (SA) to study: SA1: Clinical effectiveness in arthritis. Among 2,500 RA and PsA patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA), a prospective cohort of people initiating biologic therapy, evaluate the comparative clinical effectiveness of currently approved and likely soon-to-be-approved anti-TNF medications compared to biologics with different mechanisms of action. SA2: Clinical effectiveness in IBD. Among more than 8,400 Medicare beneficiaries with IBD initiating biologic therapy, evaluate the comparative effectiveness of the currently approved anti-TNF medications (infliximab, adalimumab, certolizumab). The primary outcomes will include bowel resection and hospitalization. As a secondary outcome, we will examine short-term persistence on therapy without the need for corticosteroids or surgery. SA3: Safety of biologics, regardless of indication. Among more than 150,000 Medicare beneficiaries with RA, PsA, AS, and IBD who initiate biologic therapy, we will use national Medicare data to evaluate the comparative safety of currently and likely soon-to-be-approved anti-TNF medications compared to biologics with different mechanisms of action. In this collaboration between 2 CERTs and the CORRONA, we will use prospective data from a large cohort of RA and PsA patients and national Medicare data from 2006-2011. Our research team has demonstrated clinical and methodological expertise in the study of biologic therapies, clinical trials, drug safety, and the validation of adverse events that predicts high success for this multi-disciplinary collaborative endeavor. Although various biologic medications have excellent efficacy for chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and inflammatory bowel disease, their comparative effectiveness in terms of clinical response and safety are unknown. A collaboration between 2 CERTs and the Consortium of Rheumatology Researchers of North America (CORRONA) will gain an improved understanding of comparative effectiveness by evaluating clinical data from a prospective cohort study and through an analysis of national Medicare data from 2006-2011.

Public Health Relevance

Although various biologic medications have excellent efficacy for chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and inflammatory bowel disease, their comparative effectiveness in terms of clinical response and safety are unknown. A collaboration between 2 CERTs and the Consortium of Rheumatology Researchers of North America (CORRONA) will gain an improved understanding of comparative effectiveness by evaluating clinical data from a prospective cohort study and through an analysis of national Medicare data from 2006- 2011.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
5R01HS018517-03
Application #
8139292
Study Section
Health Care Quality and Effectiveness Research (HQER)
Program Officer
Baine, William
Project Start
2009-09-30
Project End
2014-09-29
Budget Start
2011-09-30
Budget End
2012-09-29
Support Year
3
Fiscal Year
2011
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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