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

项目总结 类风湿性关节炎(RA)的治疗在过去的二十年里发生了很大的变化， 开发调节免疫系统的新的生物和靶向疗法。人们普遍认为 然而，这些药物不会增加发生新癌症的风险，然而，它们在RA患者中的安全性是 伴发癌症是有争议的，因为它们的免疫调节潜力可能会增加风险 可能导致癌症进展或复发，并导致其他不良事件的发展，如感染。 在复杂情况下的决策，就像RA和癌症患者需要治疗的情况一样 他们的关节炎，在面对不确定性时可能是具有挑战性的。生物性和靶向性类风湿关节炎的潜在作用 对于癌症患者的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 开发可帮助做出这些复杂决策的风险模型和工具。我们建议这项研究填补 目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，光学临床信息学 数据集市和德克萨斯大学MD安德森癌症中心的电子健康记录。我们将研究 类风湿关节炎及其伴发癌症患者使用生物和靶向治疗与生存率的关系 横跨各种癌症类型。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恶性肿瘤。第三，为了理解 关于类风湿关节炎及其伴随癌症患者的信息需求，我们将对患者进行认知访谈 对这两种疾病进行评估，评估他们对生物和靶向治疗的潜在危害和好处的信念 类风湿性关节炎的治疗方法和他们的喜好。最后，我们将采访风湿科医生和肿瘤学家。 了解伴发类风湿性关节炎患者选择类风湿关节炎治疗的信念和决策数据需求 癌症。我们的最终目标是利用通过这项研究获得的信息来开发风险预测模型和 一种决策工具，可以帮助RA和癌症患者及其医生在知情的情况下做出选择 RA治疗。这项研究的结果将产生重大影响，因为美国约有150万人 各州有类风湿性关节炎，三分之一的男性和每两名女性中有一人会在一生中患上癌症，面临 关于他们的治疗的复杂的治疗决定。这项提案中的调查人员有一个很好的跟踪 成功的观测研究记录和我们的初步数据证明了建议的可行性。 研究目标。从这项临床观察性研究中获得的知识将奠定必要的基础 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.