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Longitudinal Comparative Effectiveness & Safety of Biologics in Autoimmunity

纵向比较有效性

基本信息

批准号：
8531880
负责人：
JEFFREY R. CURTIS
金额：
$ 44.98万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2014-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8531880
关键词：
Longitudinal Comparative Effectiveness Safety Biologics

项目摘要

DESCRIPTION (PROVIDED BY APPLICANT): 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.

描述（由申请人提供）：尽管生物药物为降低类风湿性关节炎（RA）、银屑病关节炎（PsA）、强直性脊柱炎（AS）和炎症性肠病（IBD）的发病率提供了很大的希望，但从临床反应和严重不良事件（SAEs）的风险方面，更好地了解它们的相对有效性是至关重要的。由于头对头随机试验不太可能直接回答这些问题，本研究旨在帮助AHRQ、FDA、药品制造商、医生和患者确定生物药物的相对收益和风险。研究的具体目的：

项目成果

期刊论文数量（10）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

TNFi Cycling Versus Changing Mechanism of Action in TNFi-Experienced Patients: Result of the Corrona CERTAIN Comparative Effectiveness Study.

DOI：
10.1002/acr2.11337
发表时间：
2022-01
期刊：
ACR open rheumatology
影响因子：
3.4
作者：
Curtis JR;Kremer JM;Reed G;John AK;Pappas DA
通讯作者：
Pappas DA

Republished: The association between inflammatory markers, serum lipids and the risk of cardiovascular events in patients with rheumatoid arthritis.

重新发表：类风湿性关节炎患者炎症标志物、血脂与心血管事件风险之间的关联。

DOI：
10.1136/postgradmedj-2013-204715rep
发表时间：
2014
期刊：
Postgraduate medical journal
影响因子：
5.1
作者：
Zhang,Jie;Chen,Lang;Delzell,Elizabeth;Muntner,Paul;Hillegass,WilliamB;Safford,MonikaM;Millan,IrisYolandaNavarro;Crowson,CynthiaS;Curtis,JeffreyR
通讯作者：
Curtis,JeffreyR

Considerations in using registry and health plan data for studying pregnancy in rheumatic diseases.

使用登记和健康计划数据研究风湿病妊娠的考虑因素。