Use of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: Supporting Shared Decision-Making Between Patients With Cancer and Clinicians.
Use of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: Supporting Shared Decision-Making Between Patients With Cancer and Clinicians.
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DOI：
10.1002/acr2.11552
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发表时间：
2023-06
影响因子：
3.4
通讯作者：
Barton, Jennifer L.
中科院分区：
文献类型：
--
作者：
Singh, Namrata;Grivas, Petros;Makris, Una E.;Suarez-Almazor, Maria E.;O'Hare, Ann M.;Barton, Jennifer L.
较新的疾病修饰抗风湿药物（DMARDs）有望改善生活质量并减少与类风湿性关节炎（RA）相关的残疾（1）。然而，由于担心恶性肿瘤风险可能增加，对使用这些药物的热情有所缓和（2），特别是对大量患有RA的人患有癌症或患癌症的风险增加（3）。美国食品和药物管理局（FDA）的黑框警告附加到这些代理人的风险，事件淋巴瘤与肿瘤坏死因子抑制剂（TNFi）的警告。然而，这是基于旧研究的结果（4）。最近的工作，包括对RA患者使用TNFi的多项大型人群研究的荟萃分析，未能发现接受这些药物的患者淋巴瘤风险增加（5，6）。尽管如此，FDA的警告无疑继续引起患者和临床医生对这些药物安全性的担忧。在这种情况下，如何治疗被诊断患有活动性或近期（诊断后5年内）癌症的RA患者提出了一个具有挑战性的临床难题。理论上，生物制剂和其他免疫抑制剂可能会增加恶性肿瘤的易感性，这可能使临床医生不愿意在活动性或近期癌症患者中使用这些治疗。较新的研究，虽然有限，挑战这些问题（7-10）。在迄今为止关于癌症复发风险的最大研究之一中，Dreyer等人使用丹麦生物学和癌症登记研究评估了RA患者和原发性癌症病史的死亡风险（7）。这些作者发现，生物DMARD不会增加第二次癌症诊断的风险;此外，观察到的死亡人数相对较少。该研究缺乏关于死亡原因的信息，因此无法评估癌症特异性死亡率。其他几项检查DMARD使用与癌症复发风险之间关系的研究没有报告显著的有害影响，尽管由于样本量小而受到限制，并且这些研究中的大多数患者都是长期癌症幸存者（10）。因此，关于DMARDs的使用如何影响活动性或近期诊断癌症患者的生存率的数据很少。此外，缺乏高质量的证据以及提示TNFi潜在危害的黑框警告如何影响了RA和伴随癌症（或病史或高风险）患者的护理尚不清楚。来自风湿病学国际工作组的建议表明，“类风湿性关节炎的治疗必须基于患者和风湿病学家之间的共同决定”（11），这种方法特别推荐给那些有当前或既往癌症史的RA患者，他们正在考虑使用这些药物（12）。共同决策（SDM）是一个过程，患者和临床医生在做出医疗决策时，根据每个患者的独特情况，价值观，目标，信念，期望和偏好，考虑所有可用治疗方案的风险和获益的最佳证据（13）。鉴于在这种情况下很少有数据可以指导SDM，显然迫切需要对患有RA的患者进行更严格的DMARD益处和危害研究。
Newer disease-modifying antirheumatic drugs (DMARDs) hold promise for improving quality of life and reducing disability related to rheumatoid arthritis (RA)(1). However, enthusiasm for the use of these agents has been tempered by concern for a potentially increased risk of malignancy (2), a particular concern for the substantial number of people with RA who have or are at an increased risk for developing cancer (3). A US Food and Drug Administration (FDA) black box warning attached to these agents cautions of the risk of incident lymphoma associated with tumor necrosis factor inhibitors (TNFi). However, this is based on the results of older studies (4). More recent work, including meta-analyses of multiple large population-based studies of the use of TNFi in patients with RA, has failed to find an increased risk of lymphoma among those receiving these agents (5, 6). Nonetheless, the FDA warning undoubtedly continues to raise concern in the minds of patients and clinicians regarding the safety of these agents. In this context, how to treat patients with RA diagnosed with an active or recent (within 5 years of diagnosis) cancer presents a challenging clinical conundrum. Theoretical concern that biologic and other immunosuppressive agents may increase susceptibility to malignancy may make clinicians reluctant to use these therapies in patients with an active or recent cancer. Newer studies, though limited, challenge these concerns (7–10). In one of the largest studies to date on the risk of recurrent cancer, Dreyer et al assessed the risk of mortality in patients with RA and a history of a primary cancer using the Danish biological and cancer registries (7). These authors found that biologic DMARDs did not increase the risk of a second cancer diagnosis; further, the number of deaths observed was relatively small. The study lacked information on the cause of death, so it could not evaluate cancer-specific mortality. Several other studies examining the relationship between DMARD use and the risk of recurrent cancer have not reported significant harmful impacts, although they were limited because of small sample sizes, and a majority of patients included in these studies were long-term cancer survivors (10). Therefore, the data on how use of DMARDs impacts survival in patients with active or recently diagnosed cancer are sparse. Also, how the absence of high-quality evidence, as well as the black box warning suggesting potential harm with TNFi, has shaped the care of patients with RA and concomitant (or history of or high risk for) cancer is not known. Recommendations from an international task force in rheumatology suggest that “the treatment of rheumatoid arthritis must be based on a shared decision between patient and rheumatologist”(11), and this approach is specifically recommended for patients with RA who have a current or prior history of cancer who are contemplating use of these agents (12). Shared decision-making (SDM) is a process whereby both the patient and the clinician consider the best available evidence of risks and benefits across all available treatment options in the context of each patient’s unique circumstances, values, goals, beliefs, expectations, and preferences when making medical decisions (13). Given that few data exist to guide SDM in this context, there is clearly a critical need for more rigorous research on the benefits and harms of DMARDs in people with RA who have an
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