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Safety of Repository Corticotropin Injection as an Adjunctive Therapy for the Treatment of Rheumatoid Arthritis

Author

Expert Opin Drug Saf. 2020 Jun 16;1-10. doi: 10.1080/14740338.2020.1779219.Online ahead of print.

Roy Fleischmann 1, Daniel E Furst 2

Author Information

1 Metroplex Clinical Research Center, University of Texas Southwestern Medical Center , Dallas, TX, USA.

2 David Geffen School of Medicine, Division of Rheumatology, University of California Los Angeles , Los Angeles, CA, USA.

Abstract

Introduction: 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.

Areas covered: 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.

Expert opinion: 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.