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

Abstract

Purpose

Repository corticotropin injection (RCI) is indicated for a number of autoimmune-mediated 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 in-office 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.

Keywords:

• adrenocorticotropic hormone
• analogue
• ACTH
• immunomodulatory
• real-world patients

Acknowledgments

The authors thank the physicians who participated in this study. Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA, funded sponsorship of this study and the article processing charges. The authors thank Monica Nicosia, PhD, of Global Outcomes Group for medical writing assistance and Esther Tazartes, MS, of Global Outcomes Group for editorial assistance. This assistance was funded by Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.

Author Contributions

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript. All authors contributed to data analysis, drafting, and revising the article, take responsibility for the integrity of the work as a whole, and have given approval for the final version to be published. All authors had full access to all the data used in this study and take responsibility for the integrity of the data and accuracy of the data analysis.

Disclosure

Winnie W. Nelson and Mark L. Hanke were employees of Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA, at the time of this writing. Nancy Ho-Mahler is an employee of Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA. Beni Turner and Michael Eaddy are employees of Xcenda, Palm Harbor, FL, USA, which has received research funding from Mallinckrodt Pharmaceuticals for the conduct of this study. The authors report no other conflicts of interest in this work.