Gillis Theresa, Crane Megan, Hinkle Carly, Wei Nathan
Arthritis Treatment Center, Frederick, MD, USA.
Open Access Rheumatol. 2017 Jul 19;9:131-138. doi: 10.2147/OARRR.S131046. eCollection 2017.
Many types of treatment are available for patients with rheumatoid arthritis (RA), however, some patients fail to achieve remission. This report aims to determine the safety and efficacy of using repository corticotropin injection (RCI) as an adjunctive therapy in patients with RA refractory to at least three therapeutics with different mechanisms of action.
In this open-label, interventional, single-group study, patients received 80 U RCI twice weekly via subcutaneous injection over 12 weeks. Changes in the Ritchie-Camp Articular Index and health assessment questionnaire scores were monitored for changes from baseline measures.
Eight patients were enrolled and consisted of seven females and one male with an average age of 64.6 years and disease duration of 20.9 years. Use of RCI resulted in significant improvement in swollen and tender joint counts. The disease activity score 28 and the physician and patient visual analog scale scores were significantly reduced at treatment week 12. The reduction in health assessment questionnaire scores did not reach statistical significance after RCI treatment. Once RCI therapy was discontinued, all improvements in disease activity score 28, physician and patient visual analog scale, and tender and swollen joint counts achieved during treatment were lost by the week 16 follow-up visit.
While larger clinical trials are necessary to further confirm the efficacy of RCI in patients with refractory RA, the response of patients with refractory RA in this study suggests that RCI can be an effective add-on therapy for patients who have exhausted several classes of treatments. Furthermore, this study suggests that RCI has an alternative mode of action, compared to other available antirheumatic drugs.
类风湿关节炎(RA)患者有多种治疗方法可用,但部分患者无法实现病情缓解。本报告旨在确定使用长效促肾上腺皮质激素注射剂(RCI)作为辅助治疗手段,用于至少对三种作用机制不同的疗法均无效的RA患者时的安全性和有效性。
在这项开放标签、干预性单组研究中,患者在12周内每周两次皮下注射80单位RCI。监测里奇-坎普关节指数和健康评估问卷评分相对于基线测量值的变化。
共纳入8例患者,其中7例女性,1例男性,平均年龄64.6岁,病程20.9年。使用RCI后,肿胀和压痛关节计数显著改善。治疗第12周时,疾病活动评分28以及医生和患者视觉模拟量表评分显著降低。RCI治疗后,健康评估问卷评分的降低未达到统计学意义。一旦停止RCI治疗,在第16周随访时,治疗期间疾病活动评分28、医生和患者视觉模拟量表以及压痛和肿胀关节计数的所有改善均消失。
虽然需要更大规模的临床试验来进一步证实RCI对难治性RA患者的疗效,但本研究中难治性RA患者的反应表明,RCI对于已用尽几类治疗方法的患者可能是一种有效的附加治疗。此外,本研究表明,与其他可用的抗风湿药物相比,RCI具有不同的作用模式。