Andrew Concoff, MD: Repository Corticotropin Injection Gel for Rheumatoid Arthritis

Rheumatology Network interviewed Andrew Concoff, MD, Executive Vice President and Chief Value Medical Officer for United Rheumatology, to examine repository corticotropin injection (RCI) Acthar® gel. The gel significantly improves clinical outcomes for patients with rheumatoid arthritis (RA) and decreases the need for concomitant medications.

Rheumatology Network: Can you tell me a bit about the repository corticotropin injection gel works and your team’s initial interest in studying real-world outcomes for patients with RA?

Andrew Concoff, MD: Repository corticotropin injection (RCI) is a naturally sourced mixture of adrenocorticotropic hormone analogs and other pituitary peptides that exerts anti-inflammatory and immunomodulatory properties via melanocortin receptors. The phenotype of patients with rheumatoid arthritis that enroll in clinical trials is different from that seen in real-world clinical practice. Therefore, real-world evidence is needed to understand the patient journey in practices across the country. There exists a population of patients with rheumatoid arthritis, who despite treatment with traditional disease-modifying agents, languish in perpetual or moderate-high disease activity. Novel approaches are needed to better serve this population of patients who continue to be limited by their persistent rheumatoid arthritis activity.

RN: What was the study design your team utilized?

AC: This was a descriptive, non-interventional, US-based retrospective analysis of electronic medical record (EMR) data of patients who used RCI for the treatment of RA from the United Rheumatology-Normal Integrated Community Evidence (UR-NICETM) data repository was examined from the first prescription date for RCI treatment (RCI index date). Changes in clinical outcomes were determined by comparison of RA disease activity, symptoms, and patient-reported outcomes (PROs) prior to and following RCI initiation.

We should specifically mention that this study would not have been possible without the hard work and diligence of the data-contributing clinicians of United Rheumatology practices.

RN: What were the real-world outcomes for this patient population?

AC: We observed statistically significant reductions in clinical measures as well as PROs (RAPID3 and pain assessment). Findings of this study suggest that at least 1 dose of RCI can significantly improve clinical outcomes of RA and treatment patterns (by decreasing the need for concomitant medications) for up to 1 year following initiation of therapy.

RN: Why is this clinically significant?

AC: For clinicians, this study is a reminder that routine and consistent capture of a measure of disease activity as part of a treat-to-target strategy is vital to clearly identify whether a given patient is adequately treated on their current regimen. The treatment of those patients with high disease activity can be altered for better control. This study provides evidence that RCI is one option for addressing the needs of patients with high disease activity as the treatment resulted in statistically and clinically meaningful improvements in RA activity, and pain.

RN: Does your team plan on doing any further research on this topic?

AC: It is critically important that the rheumatology community find solutions for the patient populations in this study, namely, those who, despite the application of the remarkable treatment RA advances over the past 20 years, continue to languish in unacceptably high disease activity states with substantial disability. This retrospective study suggests one possible approach to improve that situation. The logical next step would be a prospective study to test the association found here to determine whether this therapeutic option delivers the relief and better disease control suggested by the associations we found.

RN: Is there anything else you’d like our audience to know?

AC: This study is an excellent example of the importance of the UR-NICE data repository to the understanding of the performance of a pharmaceutical in the real-world ecosystem of Clinical Rheumatology.