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

Abstract

IntroductionAlthough synthetic and biologic disease-modifying antirheumatic drugs are available, many patients with rheumatoid arthritis have a difficult-to-control disease and need other treatment options. Repository corticotropin injection (RCI) may alleviate symptoms and exacerbations in patients with refractory disease.MethodsNine patients with refractory rheumatoid arthritis were included in this study. Patients were maintained on their baseline therapies with a minimum of 7.5 mg prednisone daily. RCI was given daily at 40 U for 7 days. Patients who had an adequate disease response were given 40 U twice weekly through Week 12. For patients who had inadequate disease response, the dose was increased to 80 U daily for 7 days, followed by 80 U twice weekly through Week 12.ResultsThe primary endpoint was >1.2 point reduction in the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) at Week 12. Secondary endpoints were improvements in Health Assessment Questionnaire-Disease Index and Functional Assessment of Chronic Illness Therapy scores. Six of the nine patients met the primary endpoint. The average change in DAS28-CRP from baseline to Week 12 was numerically greater with 40 U than with 80 U RCI. Functional Assessment of Chronic Illness Therapy and Health Assessment Questionnaire-Disease Index improved as early as Week 1, and the improvements remained throughout treatment.ConclusionThere was no association between cortisol levels and low-dose RCI response. No serious adverse events occurred. RCI produced a clinically meaningful reduction in markers of disease activity, improved health-related quality of life, and a favorable safety profile. The response rate to RCI was substantial and shows promise in this difficult-to-treat population.

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.…”

Patient Characteristics and Indicators of Treatment Initiation with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis: A Claims Database Analysis

“…In addition to the mechanistic understanding of RCI efficacy, there is significant clinical evidence supporting the use of RCI treatment in patients with refractory RA following standard treatment recommended by current guidelines. The safety and effectiveness of RCI therapy in RA has been shown in small single-arm studies [ 35 – 37 ] and in a two-part multicenter, randomized, placebo-controlled withdrawal trial in 259 patients with active RA [defined as Disease Activity Score with 28 joint count and erythrocyte sedimentation rate (DAS28-ESR) > 3.2] despite treatment with a glucocorticoid and one or two DMARDs, including biologic DMARDs [ 18 , 38 ]. In the first part of the latter trial, all patients received twice-weekly open-label RCI for 12 weeks, at which point patients who achieved low disease activity (LDA; defined as DAS28-ESR < 3.2) were randomized to 12 more weeks of RCI or matching placebo [ 18 ].…”

Real-world treatment patterns for repository corticotropin injection in patients with rheumatoid arthritis

“… 4 , 12 – 19 Patients with RA receiving RCI therapy experienced a reduction in swollen joint count (SJC) and tender joint count (TJC) as well as improved physical function and health-related quality of life. 13 , 15 , 20 Patients with RA or systemic lupus erythematosus who received RCI had lower rates of hospitalization, emergency department visits and outpatient services. 17 , 19 …”