Adherence to Acthar Gel (RCI) and Outcomes in Patients with Membranous Nephropathy: A Claims Database Analysis

Kyle Hayes,1 Mohammed Fahim,2 Feng Sheng Hu,2 Mary P Panaccio,1 George J Wan1 1Mallinckrodt Pharmaceuticals, Bridgewater, NJ, USA; 2KMK Consulting, Morristown, NJ, USACorrespondence: George J Wan, Mallinckrodt Pharmaceuticals, 440 Route 22 East, Bridgewater, NJ, USA, Email [email protected]: To describe real-world patient characteristics and outcomes after initiation of Acthar Gel (repository corticotropin injection, RCI) in the management of nephrotic syndrome (NS). This real-world study characterized patients with membranous nephropathy (MN) who initiated RCI therapy and evaluated the impact of higher versus lower adherence to RCI on NS-related outcomes, healthcare resource utilization, and medical costs.Patients and Methods: We retrospectively analyzed data from the Integrated Dataverse from Symphony Health database. Adult (≥ 18 years) patients were included if they had ≥ 1 inpatient or ≥ 2 outpatient claims for an NS and MN diagnosis (January 1, 2016-December 31, 2022); ≥ 1 prescription claim for RCI; and continuous eligibility ≥ 12 months before and ≥ 12 months following and including the index date. Patients with ≥ 2 RCI claims and a calculated proportion of days covered (PDC) were included. Those with a PDC above the sample mean were classified as “above-average” adherence and those below the mean as “below-average” adherence in that period.Results: The analyzed population comprised 28 patients with below-average and 34 with above-average RCI adherence. The above-average adherence cohort showed a noticeable reduction compared with the below-average adherence cohort in corticosteroid use, extended corticosteroid use, opioid use, NS-related renal biopsy procedures, all-cause and NS-related inpatient hospitalizations, and NS-related office visits. From baseline to follow-up, inpatient hospitalization rates were similar in the below-average adherence cohort for all-cause (50.0% vs 53.6%) and NS-related (35.7% vs 28.6%) admissions but markedly lower in the above-average cohort for all-cause (50.0% vs 23.5%) and NS-related (41.2% vs 8.8%) hospitalizations. Despite similar baseline medical costs, all-cause ($131,306 vs $50,048) and NS-related costs ($111,743 vs $29,868) were noticeably higher at follow-up in the below-average adherence cohort than the above-average adherence cohort.Conclusion: This real-world study shows that greater adherence to RCI during treatment improves overall outcomes studied.Plain Language Summary: What do you need to know?Membranous nephropathy (MN) is a kidney disease that can lead to nephrotic syndrome (NS), causing swelling, high cholesterol, and protein loss in the urine. Some people with NS do not respond to common treatments like corticosteroids or calcineurin inhibitors. Acthar Gel (repository corticotropin injection, RCI) is a prescription drug used for people with NS and other conditions.Why did we do this study?We wanted to see how well RCI works for adults with MN and whether taking it as prescribed can improve health outcomes and reduce medical costs.How did we do this study?We studied anonymous health insurance claims records from 62 adults with MN treated with RCI from 2016 to 2022. We divided patients into two groups based on medication adherence (how consistently they took RCI). One group had above-average adherence, and the other had below-average adherence. We compared health outcomes and healthcare use between the groups.What did we find?People who took RCI more regularly had better outcomes than those who did not. They used fewer corticosteroids, had fewer hospital visits and kidney procedures (like biopsies), used less opioid medication, and had lower overall healthcare costs.What do the findings mean?RCI may be a treatment option for adults with MN who do not respond to standard therapies. Taking RCI as prescribed can reduce symptoms and reduce the need for other medical care. Treatment adherence is important for achieving the best health results.Keywords: Acthar® Gel, nephrotic syndrome, membranous nephropathy, repository corticotropin injection