Bloostein Aliza, Caricchio Roberto
UMass Chan Medical School, Worcester, Massachusetts.
ACR Open Rheumatol. 2025 Apr;7(4):e70035. doi: 10.1002/acr2.70035.
Systemic lupus erythematosus (SLE), a chronic systemic autoimmune disease, has only three approved therapies, despite a rapidly expanding number of clinical trials. Trials in SLE struggle to recruit patients and fail to fully enroll. Rheumatoid arthritis (RA), another chronic autoimmune disease, has had more success in clinical trial enrollment. This article's goal is to analyze literature to compare patient perspectives on factors determining clinical trial participation in SLE and RA populations. A literature review regarding patient attitudes, perceptions, perspectives about, and barriers toward clinical trials was conducted. RA literature used more quantitative methods, whereas SLE literature used more qualitative methods. Literature revealed that patients with SLE and patients with RA reported similar factors motivating trial participation, such as altruism, personal benefit, and trust in physician, but patients with SLE were uniquely motivated by strong social networks. In terms of disadvantages to trial participation, patients with SLE and RA similarly reported fear of unknown interventions, complications, and side effects; only in the population of patients with SLE were fears of a disease flare and of not qualifying reported. SLE literature had a specific emphasis on factors influencing Black patient participation. This review informs steps for future research to better evaluate perceptions of clinical trials in patients with SLE and provides a framework for methods to increase SLE trial participation, including recognizing fear of changing treatment regimen as an explanation for the paucity of SLE trial participation, incorporating clinical trials as usual care for patients with SLE, and using less stringent inclusion and exclusion criteria for trials.
系统性红斑狼疮(SLE)是一种慢性全身性自身免疫性疾病,尽管临床试验数量迅速增加,但目前仅有三种获批疗法。SLE的临床试验在招募患者方面困难重重,且无法实现完全入组。类风湿性关节炎(RA)是另一种慢性自身免疫性疾病,其在临床试验入组方面较为成功。本文旨在分析文献,比较患者对决定SLE和RA患者参与临床试验的因素的看法。针对患者对临床试验的态度、认知、观点及障碍开展了一项文献综述。RA相关文献更多地采用定量研究方法,而SLE相关文献更多地采用定性研究方法。文献显示,SLE患者和RA患者报告的促使其参与试验的因素相似,如利他主义、个人受益以及对医生的信任,但强大的社交网络是SLE患者参与试验的独特动机。在参与试验的不利因素方面,SLE患者和RA患者同样报告了对未知干预措施、并发症和副作用的恐惧;只有SLE患者报告了对疾病发作和不符合条件的恐惧。SLE相关文献特别强调了影响黑人患者参与试验的因素。本综述为未来研究提供了方向,以便更好地评估SLE患者对临床试验的认知,并为提高SLE试验参与率提供了方法框架,包括认识到对改变治疗方案的恐惧是SLE试验参与率低的一个原因,将临床试验纳入SLE患者的常规治疗,以及在试验中使用不太严格的纳入和排除标准。