Effects of biologic and targeted therapies for rheumatoid arthritis on cancer outcomes

项目概要 类风湿性关节炎（RA）的治疗在过去二十年中发生了巨大变化， 开发调节免疫系统的新生物制剂和靶向疗法。人们普遍认为 这些药物不会增加患新癌症的风险，但是，它们对于 RA 患者的安全性 伴随癌症是有争议的，因为它们具有免疫调节潜力，可能会增加风险 癌症进展或复发，并导致其他不良事件（例如感染）的发生。 在复杂情况下的决策，例如需要治疗的 RA 和癌症患者的情况 面对不确定性，他们的关节炎可能具有挑战性。生物制剂和靶向 RA 的潜在影响 对癌症患者癌症进展和生存的治疗方法在很大程度上是未知的，排除了 开发可以帮助做出这些复杂决策的风险模型和工具。我们提出这项研究是为了填补 当前在几个领域的知识差距。首先，我们将对监控进行二次数据分析， 流行病学和最终结果 (SEER)、德克萨斯州癌症登记处 (TCR) 医疗保险链接文件、Optum Clinformatics 数据集市和德克萨斯大学 MD 安德森癌症中心电子健康记录。我们将检查 RA 合并癌症患者使用生物制剂和靶向疗法与生存的关系 跨越各种癌症类型。其次，使用相同的数据集，我们将评估其他安全结果，包括 严重感染、计划外住院和新的原发性恶性肿瘤。三、为了了解 为了满足 RA 合并癌症患者的信息需求，我们将对患者进行认知访谈 与这两种疾病一起评估他们对生物和靶向治疗的潜在危害和益处的信念 RA 的治疗方法及其偏好。最后，我们将采访风湿病学家和肿瘤学家 确定他们的信念和决策数据需求，以便为患有合并症的患者选择 RA 疗法 癌症。我们的最终目标是利用本研究获得的信息来开发风险预测模型并 决策工具，可以帮助 RA 和癌症患者及其医生做出明智的选择 风湿性关节炎治疗。这项研究的结果将对美国约 150 万人产生巨大影响 各州都有 RA，三分之一的男性和二分之一的女性在一生中会患上癌症，面临着 关于他们的治疗的复杂的治疗决定。这项提案的研究人员有着出色的跟踪记录 成功的观察研究记录和我们的初步数据证明了拟议的可行性 学习目标。从这项临床观察研究中获得的知识将为以下方面奠定基础： 设计一项未来的临床研究，评估治疗决策辅助。

PROJECT SUMMARY The treatment of rheumatoid arthritis (RA) has changed substantially in the last two decades with the development of new biologic and targeted therapies which modulate the immune system. It is well accepted that these agents do not increase risk of developing new cancers, however, their safety in patients with RA who have concomitant cancer is controversial given their immunomodulatory potential which could increase the risk of cancer progression or recurrence, and result in the development of other adverse events such as infections. Decision making in complex situations, as is the case for patients with RA and cancer who need treatment for their arthritis, can be challenging in the face of uncertainty. The potential effects of biologic and targeted RA therapies on cancer progression and survival in patients with cancer are largely unknown, precluding development of risk models and tools that can aid in these complex decisions. We are proposing this study to fill current gaps in knowledge in several areas. First, we will perform secondary data analyses of the Surveillance, Epidemiology and End Results (SEER), Texas Cancer Registry (TCR) Medicare linked files, Optum Clinformatics Data Mart, and The University of Texas MD Anderson Cancer Center electronic health records. We will examine the association of use of biologic and targeted therapies in patients with RA and concomitant cancer, with survival across various cancer types. Second, using the same datasets, we will evaluate other safety outcomes including serious infections, unplanned hospitalizations and new primary malignancies. Third, in order to understand the informational needs of patients with RA and concomitant cancer, we will conduct cognitive interviews of patients with both diseases to assess their beliefs with respect to the potential harms and benefits of biologic and targeted therapies for RA, and their preferences. Lastly, we will conduct interviews with rheumatologists and oncologists to ascertain their beliefs and decision-making data needs for choosing RA therapies in patients with concomitant cancer. Our ultimate goal is to use the information gained with this study to develop a risk prediction model and decision tool that can assist patients with RA and cancer, and their physicians, in making informed choices about RA treatment. Results of this study will have a great impact as approximately 1.5 million people in the United States have RA, and one in three men and one in two women will develop cancer over their lifetime, facing complex therapeutic decisions about their treatments. Investigators in this proposal have an excellent track record of successful observational studies and our preliminary data demonstrates the feasibility of the proposed study objectives. The knowledge gained from this clinical observational study will lay the groundwork needed to design a future clinical study evaluating a treatment decision-making aid.