Repository corticotropin injection as adjunctive therapy in patients with rheumatoid arthritis who have failed previous therapies with at least three different modes of action

Abstract

ObjectiveMany 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.MethodIn 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.ResultsEight 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.ConclusionWhile 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.

Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial

“…The evidence for the clinical effectiveness of RCI in patients with RA was suggested in small open-label studies [19][20][21]. The current study was undertaken to confirm these findings in a larger population via a randomized, doubleblind, placebo-controlled withdrawal trial with an open-label run-in period.…”

“…1. All enrolled subjects received open-label RCI (1 ml, 80 U) subcutaneously twice weekly for 12 weeks (part 1), a dosage that previous studies suggest is effective [20,21]. Subjects were then assessed for treatment response using the DAS28-ESR, with thresholds of 2.6, 3.2, and 5.1 suggesting remission, LDA, and high disease activity, respectively [22,23].…”

Repository corticotropin injection in patients with rheumatoid arthritis resistant to biologic therapies

“…Our study reinforces the effectiveness of RCI treatment in patients with active RA. 20 Of the nine patients treated with RCI, five responded to 40 U daily for 1 week and did not need a dose increase (patients 2, 3, 6, 8, and 9). One patient in the 80 U group had clinically significant improvement (patient 5).…”

Melanocortin Regulation of Inflammation

“…Two patients have disease remission and three patients show low disease activity (117). Similarly, Gillis et al demonstrated that, after subcutaneous injection with RCI over 12 weeks, all six patients with refractory rheumatoid arthritis achieve significantly lower Disease Activity Score, decreased tender and swollen joint counts, and reduced physician global visual analog scale (118). In addition, significant improvement were also observed in terms of Health Assessment Questionnaire score (3/6), erythrocyte sedimentation rate (4/6), and C-reactive protein levels (4/6) (118).…”