Metroplex Clinical Research Center, University of Texas Southwestern Medical Center , Dallas, TX, USA.
David Geffen School of Medicine, Division of Rheumatology, University of California Los Angeles , Los Angeles, CA, USA.
Expert Opin Drug Saf. 2020 Aug;19(8):935-944. doi: 10.1080/14740338.2020.1779219. Epub 2020 Jun 16.
Disease-modifying antirheumatic drugs (DMARDs) have significantly improved clinical symptoms and quality of life with reduced disease progression in many patients with rheumatoid arthritis (RA). Short-term glucocorticoid therapy is often used initially in combination with DMARDs, but some patients still have difficulty reaching treatment goals. Repository corticotropin injection (RCI, Acthar® Gel) is approved as adjunctive therapy for short-term administration in patients with continued RA disease activity.
To determine the safety of RCI in the treatment of RA, adverse events (AEs) from a recent clinical trial of RCI as an adjunctive therapy along with DMARDs and glucocorticoids (ClinicalTrials.gov identifier NCT02919761) were compared with AEs reported in randomized clinical trials of DMARDs and glucocorticoids alone. A systematic review of the literature yielded 4 articles describing the detailed safety results of DMARD/glucocorticoid combination therapy used in the treatment of RA for comparison.
There were no clinically significant differences between the AE profiles of RCI/DMARD/glucocorticoid treatment in the RCI clinical trial and those in the DMARD/glucocorticoid safety profile compiled from the reviewed clinical trials; this was supported by pharmacovigilance data. These results support the short-term safety of RCI as an adjunctive therapy for patients with persistently active RA.
在许多类风湿关节炎（RA）患者中，疾病修饰抗风湿药物（DMARDs）显著改善了临床症状和生活质量，减少了疾病进展。短期糖皮质激素治疗通常与 DMARDs 联合使用，但一些患者仍难以达到治疗目标。促皮质素储库制剂（RCI，Acthar® Gel）被批准为短期辅助治疗，用于持续存在 RA 疾病活动的患者。
为了确定 RCI 在治疗 RA 中的安全性，比较了 RCI 作为辅助治疗与 DMARDs 和糖皮质激素联合使用的近期临床试验（ClinicalTrials.gov 标识符 NCT02919761）中的不良反应（AE）与单独使用 DMARDs 和糖皮质激素的随机临床试验报告的 AE。对文献进行系统回顾，得到 4 篇描述用于治疗 RA 的 DMARD/糖皮质激素联合治疗详细安全性结果的文章，用于比较。
RCI 临床试验中 RCI/DMARD/糖皮质激素治疗的 AE 谱与从已审查临床试验中汇编的 DMARD/糖皮质激素安全性概况的 AE 谱之间没有临床显著差异；这得到了药物警戒数据的支持。这些结果支持 RCI 作为辅助治疗持续活动期 RA 患者的短期安全性。
