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

Abstract

Kyle Hayes,1 Mary P Panaccio,1 Parul Houston,1 John Niewoehner,1 Mohammed Fahim,2 George J Wan,1 Bhavna Dhillon3 1Mallinckrodt Pharmaceuticals, Hampton, NJ, USA; 2KMK Consulting, Morristown, NJ, USA; 3United Rheumatology, Hauppauge, NY, USACorrespondence: Kyle HayesMallinckrodt Pharmaceuticals, Hampton, NJ, USATel [phone]Email [email protected]: Repository corticotropin injection (RCI; Acthar® Gel) is a naturally sourced mixture of adrenocorticotropic hormone analogs and other pituitary peptides that exerts anti-inflammatory and immunomodulatory properties via melanocortin receptors. RCI is approved as a short-term adjunctive therapy for rheumatoid arthritis (RA) and is typically used in patients with refractory RA. The objective of this study was to describe real-world outcomes of RA patients treated with RCI by retrospective analysis of an electronic medical records (EMR) database.Patients and Methods: EMR data were obtained from the United Rheumatology-Normal Integrated Community Evidence (UR-NICETM) data repository for patients who used RCI for the treatment of RA. Demographics, comorbidities, disease history, medications, and laboratory evaluations 365 days prior to and 365 days after initiation of RCI were examined.Results: The patient cohort was predominantly White females with a mean age of 60 years and high RA activity prior to RCI therapy. Clinical measures of disease severity indicated that patients had high RA activity before starting RCI therapy. Clinical Disease Activity Index (CDAI) scores were significantly reduced 365 days post-initiation of RCI. Swollen and tender joint counts and patient-reported outcomes, including Routine Assessment of Patient Index Data 3 (RAPID3), Physician Global Assessment, and patient assessment of pain severity were also significantly lower. The number of patients taking conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs), biologic (b) DMARDs, nonsteroidal anti-inflammatory drugs (NSAIDS), and opioids decreased, as did the number of drugs tried within each class for csDMARDs, bDMARDs, NSAIDs, and glucocorticoids.Conclusions: These findings suggest that RCI significantly improves clinical outcomes of RA and decreases the need for concomitant medications for up to 1 year following initiation of therapy. The study provides valuable insights into the use of RCI and management of these difficult-to-treat RA patients during routine clinical practice.Keywords: Acthar Gel, DMARDs, real-world evidence, rheumatoid arthritis, repository corticotropin injection, RCI, United Rheumatology database

Keywords

• acthar gel
• dmards
• real-world evidence
• rheumatoid arthritis
• repository corticotropin injection
• rci
• united rheumatology database