CERobs Consulting LLC, Wrightsville Beach, NC, USA.
Mallinckrodt Pharmaceuticals Inc., Hampton, NJ, USA.
Adv Ther. 2022 Jul;39(7):3072-3087. doi: 10.1007/s12325-022-02176-4. Epub 2022 May 30.
Repository corticotropin injection (RCI; Acthar Gel) is approved by the US Food and Drug Administration (FDA) for use in 19 indications, including for the treatment of selected patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), symptomatic sarcoidosis, uveitis, and keratitis. Despite treatment with disease-modifying antirheumatic drugs, many patients with RA, SLE, and other chronic inflammatory rheumatic diseases continue to be affected by severe pain and fatigue, indicating a need for other therapies. To examine the clinical data regarding the impact of RCI treatment on pain and fatigue in selected populations, this review included English-language peer-reviewed publications of clinical trials of any size and cohort studies with more than 10 patients that included pain and/or fatigue based on patient-reported outcomes (PROs) and/or physician-assessed measures in adults following treatment with RCI for RA, SLE, symptomatic sarcoidosis, uveitis, or keratitis. Literature searches identified eight studies that met these criteria. Four studies (reported in five publications) were in patients with RA or SLE, two in patients with sarcoidosis, one in patients with uveitis, and one in patients with noninfectious keratitis. Across the different types of studies assessed (clinical trials, chart reviews, real-world evidence), the results were consistent with respect to the impact of RCI treatment on improving pain and fatigue. As summarized in this review, data from patient- and physician-reported outcome measures in eight studies demonstrate that, in addition to improving more traditional efficacy measures, RCI may also improve pain and fatigue in patients with RA, SLE, symptomatic sarcoidosis, uveitis, and noninfectious keratitis.
促肾上腺皮质激素注射液（RCI；Acthar Gel）已获得美国食品和药物管理局（FDA）批准，可用于 19 种适应症，包括治疗某些类风湿关节炎（RA）、系统性红斑狼疮（SLE）、症状性结节病、葡萄膜炎和角膜炎患者。尽管使用了改善病情的抗风湿药物，但许多 RA、SLE 和其他慢性炎症性风湿病患者仍受严重疼痛和疲劳的影响，表明需要其他治疗方法。为了研究 RCI 治疗对选定人群疼痛和疲劳的临床数据影响，本综述纳入了评估 RCI 治疗 RA、SLE、症状性结节病、葡萄膜炎或角膜炎患者疼痛和/或疲劳的任何大小的临床试验的英文同行评议出版物，以及纳入超过 10 名患者的队列研究，这些研究基于患者报告的结局（PROs）和/或医生评估的措施。文献检索确定了符合这些标准的八项研究。四项研究（报告了五项出版物）涉及 RA 或 SLE 患者，两项研究涉及结节病患者，一项研究涉及葡萄膜炎患者，一项研究涉及非感染性角膜炎患者。在评估的不同类型研究（临床试验、图表审查、真实世界证据）中，结果在 RCI 治疗对改善疼痛和疲劳的影响方面是一致的。正如本综述总结的那样，八项研究中患者和医生报告的结局测量数据表明，除了改善更传统的疗效指标外，RCI 还可能改善 RA、SLE、症状性结节病、葡萄膜炎和非感染性角膜炎患者的疼痛和疲劳。
