Longitudinal Comparative Effectiveness & Safety of Biologics in Autoimmunity

描述（申请人提供）：尽管生物制剂药物对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）的发病率有很大希望，但更好地了解其临床反应和严重不良事件（SAE）风险方面的比较有效性至关重要。由于不太可能进行直接回答这些问题的头对头随机试验，因此本研究旨在帮助AHRQ，FDA，药物制造商，医生和患者确定生物药物的比较益处和风险。研究的具体目标（SA）： SA 1：关节炎的临床有效性。在2,500名RA和PsA患者中，北美风湿病研究者联盟（CORRONA）是一个前瞻性队列，由开始生物治疗的人组成，评估目前批准和可能即将批准的抗TNF药物与具有不同作用机制的生物制剂相比的临床有效性。 SA 2：IBD的临床有效性。在超过8，400名IBD开始生物治疗的医疗保险受益人中，评估目前批准的抗TNF药物（英夫利昔单抗，阿达木单抗，赛妥珠单抗）的比较有效性。主要结局将包括肠切除术和住院治疗。作为次要结果，我们将检查短期持续治疗而不需要皮质类固醇或手术。 SA 3：生物制剂的安全性，无论适应症如何。在超过150，000名开始生物治疗的RA，PsA，AS和IBD的医疗保险受益人中，我们将使用国家医疗保险数据来评估目前和可能即将批准的抗TNF药物与具有不同作用机制的生物制剂相比的比较安全性。 在2个CERT和CORRONA之间的合作中，我们将使用来自2006-2011年RA和PsA患者大队列的前瞻性数据和国家医疗保险数据。我们的研究团队在生物疗法研究、临床试验、药物安全性和不良事件验证方面展示了临床和方法学专业知识，这些知识预测了这种多学科合作奋进的高度成功。 虽然各种生物药物对慢性炎症性疾病（如类风湿性关节炎、银屑病关节炎、强直性脊柱炎和炎症性肠病）具有良好的疗效，但其在临床反应和安全性方面的比较有效性尚不清楚。两个CERT和北美流变学研究者联盟（CORRONA）之间的合作将通过评估前瞻性队列研究的临床数据和通过分析2006-2011年的国家医疗保险数据来更好地了解比较有效性。

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.