<p>Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis</p>

Abstract

Purpose: Repository corticotropin injection (RCI) is indicated for a number of autoimmunemediated diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis (DM)/polymyositis (PM). To better understand the practice patterns and outcomes of RCI in patients with RA, SLE, or DM/PM, we conducted a retrospective medical record analysis. Patients and Methods: Participating providers selected deidentified medical records of patients meeting the inclusion criteria (age ≥18 years; physician-reported diagnosis of RA, SLE, or DM/PM; initiation of treatment with RCI between 1/1/2011 and 2/15/2016; ≥3 inoffice visits with same site/provider). Collected data spanned 12 months before and after the first prescription date for RCI. Analyses included patient demographics and clinical history, RCI treatment patterns, and physician's impression of change. Results: Data from 54 patients with RA, 30 patients with SLE, and 8 patients with DM/ PM were analyzed. The most frequently reported reasons for initiating RCI were lack of efficacy with prior treatment, acute exacerbation of disease, and use as add-on to ongoing therapy. The most common initial RCI dosing, 80 U twice weekly, was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. The mean duration of treatment was 4.8, 6.5, and 6.8 months for RA, SLE, and DM/PM, respectively. Among the 57 patients with data on physician's impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of "improved," and the mean time to best impression of change was 3.4, 4.3, and 3.4 months for RA, SLE, and DM/PM, respectively. Conclusion: This study reports the real-world patient profile, use patterns, and outcomes of patients who used RCI for the treatment of RA, SLE, and DM/PM. These data can inform appropriate use and clinical expectations when using RCI.

Real-World Treatment Patterns and Outcomes from an Electronic Medical Records Database for Patients with Rheumatoid Arthritis Treated with Repository Corticotropin Injection

“…28 Additional real-world outcome studies show that osteoarthritis is a prevalent comorbidity in patients with RA treated with RCI. 15,29,30 In addition, the presence of more tender than swollen joints may reflect the coexistence of osteoarthritis in this patient population. 31 Clinical measures of disease severity, including CDAI and number of tender or swollen joints, indicated that patients had high RA activity prior to starting RCI therapy.…”

“…The RCI duration estimate (152±117 days) likely underestimates the total duration, as the time under treatment for the last prescription cannot be determined; however, our findings are consistent with other published reports characterizing the duration of RCI treatment in clinical practice in which the mean duration of treatment was 4.8 months. 29 Several recent publications support the use of RCI in patients for whom ACR-recommended RA therapies (glucocorticoids, csDMARDs, tsDMARDs, and bDMARDs) lack efficacy, for acute exacerbation of disease, or for use as an add-on therapy. 17,29,30,33 Retrospective analysis of patients with refractory RA demonstrated a significant improvement in physician impression of change after short-term RCI therapy.…”

“…29 Several recent publications support the use of RCI in patients for whom ACR-recommended RA therapies (glucocorticoids, csDMARDs, tsDMARDs, and bDMARDs) lack efficacy, for acute exacerbation of disease, or for use as an add-on therapy. 17,29,30,33 Retrospective analysis of patients with refractory RA demonstrated a significant improvement in physician impression of change after short-term RCI therapy. 29 In a similar real-world analysis of RCI use in patients with RA that did not adequately respond to standard-of-care therapies, patients experienced clinically-relevant reduction in disease activity and improved PROs.…”

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

“…Repository corticotropin injection (RCI; Acthar ® Gel, Mallinckrodt ARD LLC, Bedminster, NJ, USA)—a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides—is indicated for short-term administration in patients experiencing acute episodes or exacerbations of RA [ 15 ]. Evidence from previous studies suggests that in clinical practice, RCI is used primarily as late-line therapy to treat flares, as a bridge to new therapy, or as an add-on to prior therapy [ 16 , 17 ].…”

Cost-Effectiveness of Repository Corticotropin Injection versus Standard of Care for the Treatment of Active Rheumatoid Arthritis

“… 18 A retrospective chart review study reported that 78% of RA patients treated with RCI had an improvement based on physician assessment. 19 An observational administrative claims-based analysis of treatment patterns, healthcare utilization, and cost of RCI in patients with RA suggests a potential for a reduction in medical service use and associated costs with RCI by approximately 33%. 20 Together these data suggest a potential for improvement in patient’s health outcomes and an overall reduction in cost for disease management.…”