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

Abstract

Purpose

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-NICE^TM) 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

Abbreviations

ACR, American College of Rheumatology; b, biologic; BMI, body mass index; CDAI, Clinical Disease Activity Index; cs, conventional synthetic; DAS28-ESR, Disease Activity Score 28 joint count with ESR; DMARD, disease-modifying antirheumatic drug; EMR, electronic medical record; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; MCR, melanocortin receptor; NSAID, nonsteroidal anti-inflammatory drug; nt, nontraditional; PRO, patient-reported outcome; RA, rheumatoid arthritis; RAPID3, Routine Assessment of Patient Index Data 3; RCI, repository corticotropin injection; ts, targeted synthetic; UR-NICE^TM, United Rheumatology-Normal Integrated Community Evidence^TM; VAS, visual analogue scale.

Compliance with Ethics Guidelines

The management of study data conformed to all applicable Health Insurance Portability and Accountability Act rules. All data were de-identified throughout the study to preserve patient anonymity and confidentiality. This observational study was conducted under the research exception provisions of the Privacy Rule, 45 CFR 164.514(e), and was exempt from Institutional Review Board informed consent requirements.

Acknowledgments

Professional writing and editorial support were provided by MedLogix Communications, LLC, Itasca, Illinois, under the direction of the authors and were funded by Mallinckrodt Pharmaceuticals. We thank Sung-Woo Ahn for assistance with data analysis.

Disclosure

KH, GJW, and JN are employees of Mallinckrodt Pharmaceuticals. PH and MP are paid independent consultants for Mallinckrodt Pharmaceuticals. MF is an employee at KMK consulting and a paid analyst for Mallinckrodt Pharmaceuticals. BD is an employee of United Rheumatology. The authors report no other conflicts of interest in this work.