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.
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.
|Charles-Schoeman, Christina; Yin Lee, Yuen; Shahbazian, Ani et al. (2017) Improvement of High-Density Lipoprotein Function in Patients With Early Rheumatoid Arthritis Treated With Methotrexate Monotherapy or Combination Therapies in a Randomized Controlled Trial. Arthritis Rheumatol 69:46-57|
|Charles-Schoeman, Christina; Wang, Xiaoyan; Lee, Yuen Yin et al. (2016) Association of Triple Therapy With Improvement in Cholesterol Profiles Over Two-Year Followup in the Treatment of Early Aggressive Rheumatoid Arthritis Trial. Arthritis Rheumatol 68:577-86|
|Herrinton, Lisa J; Harrold, Leslie; Salman, Craig et al. (2016) Population Variations in Rheumatoid Arthritis Treatment and Outcomes, Northern California, 1998-2009. Perm J 20:4-12|
|Navarro-Millán, Iris; Yang, Shuo; DuVall, Scott L et al. (2016) Association of hyperlipidaemia, inflammation and serological status and coronary heart disease among patients with rheumatoid arthritis: data from the National Veterans Health Administration. Ann Rheum Dis 75:341-7|
|Pappas, Dimitrios A; John, Ani; Curtis, Jeffrey R et al. (2016) Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry. Rheumatol Ther 3:103-115|
|Mamtani, Ronac; Clark, Amy S; Scott, Frank I et al. (2016) Association Between Breast Cancer Recurrence and Immunosuppression in Rheumatoid Arthritis and Inflammatory Bowel Disease: A Cohort Study. Arthritis Rheumatol 68:2403-11|
|Curtis, Jeffrey R; Harrold, Leslie R; Asgari, Maryam M et al. (2016) Diagnostic Prevalence of Ankylosing Spondylitis Using Computerized Health Care Data, 1996 to 2009: Underrecognition in a US Health Care Setting. Perm J 20:4-10|
|Park, Jin Kyun; Yang, Ji Ae; Ahn, Eun Young et al. (2016) Survival rates of cancer patients with and without rheumatic disease: a retrospective cohort analysis. BMC Cancer 16:381|
|Colantonio, Lisandro D; Kent, Shia T; Kilgore, Meredith L et al. (2016) Agreement between Medicare pharmacy claims, self-report, and medication inventory for assessing lipid-lowering medication use. Pharmacoepidemiol Drug Saf 25:827-35|
|Yun, Huifeng; Yang, Shuo; Chen, Lang et al. (2016) Risk of Herpes Zoster in Autoimmune and Inflammatory Diseases: Implications for Vaccination. Arthritis Rheumatol 68:2328-37|
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