Longitudinal Comparative Effectiveness & Safety of Biologics in Autoimmunity

描述(申请人提供)：尽管生物药物在降低类风湿性关节炎(RA)、牛皮癣关节炎(PSA)、强直性脊柱炎(AS)和炎症性肠病(IBD)的发病率方面有很大希望，但在临床反应和严重不良事件(SAE)风险方面更好地了解它们的比较有效性是至关重要的。由于不太可能进行直接回答这些问题的面对面随机试验，这项研究旨在帮助AHRQ、FDA、药品制造商、医生和患者确定生物药物的相对益处和风险。研究的具体目标(SA)： SA1：关节炎的临床疗效。在北美风湿病研究人员联合会(CORRONA)登记的2500名RA和PSA患者中，评估目前批准的和可能即将批准的抗肿瘤坏死因子药物与不同作用机制的生物制剂相比的临床疗效。 SA2：IBD的临床疗效。在8,400多名IBD开始生物治疗的医疗保险受益人中，评估目前批准的抗肿瘤坏死因子药物(英夫利昔单抗、阿达利单抗、certolizumab)的比较效果。主要结果将包括肠道切除和住院治疗。作为次要结果，我们将检查在不需要皮质类固醇或手术的情况下接受治疗的短期持久性。 SA3：生物制品的安全性，不分适应症。在启动生物治疗的150,000多名患有RA、PSA、AS和IBD的联邦医疗保险受益人中，我们将使用国家医疗保险数据来评估当前和可能即将批准的抗肿瘤坏死因子药物与不同作用机制的生物药物相比的相对安全性。 在2个CERT和CORRONA之间的合作中，我们将使用来自RA和PSA患者的大量队列的前瞻性数据以及2006-2011年的国家医疗保险数据。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，这预示着这项多学科合作努力将取得巨大成功。 尽管各种生物药物对类风湿性关节炎、银屑病关节炎、强直性脊柱炎、炎症性肠病等慢性炎症性疾病有很好的疗效，但它们在临床反应和安全性方面的比较效果尚不清楚。两个CERT和北美风湿病研究人员联盟(CORRONA)之间的合作将通过评估来自前瞻性队列研究的临床数据和对2006-2011年全国医疗保险数据的分析，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.