AB1166 DETERMINANTS OF REPOSITORY CORTICOTROPIN INJECTION TREATMENT INITIATION FOR PATIENTS WITH RHEUMATOID ARTHRITIS IN A LARGE CLAIMS DATABASE

Abstract

Background: The treatment goal in rheumatoid arthritis (RA) is sustained remission and prevention of RA flares [1]. While targeted biologics have improved disease outcomes, almost one-third of patients (pts) discontinue treatment by 1 year and 50% by 2 years, with lack of efficacy as the most common reason [2]. Repository corticotropin injection (RCI) is a naturally sourced complex mixture of adrenocorticotropic hormone analogues and other pituitary peptides and is an agonist for all 5 melanocortin receptors (MCRs). Activation of MCRs by RCI has been shown to have direct and indirect anti-inflammatory and immunomodulatory effects. RCI is indicated for adjunctive therapy for short-term administration in RA flares or uncontrolled disease [3]. Objectives: To characterize RA pts that initiate RCI therapy and identify predictors of RCI initiation, compared to biologic disease-modifying antirheumatic drugs (DMARDs). Methods: This retrospective cohort study identified pts with ICD-9/10 diagnosis for RA over an 11-year period (2008-2018) in a large claims database (Truven MarketScan®). Adults with ≥1 claim for RCI (RCI cohort) or ≥1 RA-related biologic claim but no RCI (non-RCI cohort) were selected and characterized by demographics, disease severity (Claims-based Index for RA Severity, CIRAS), comorbidities (Charlson Comorbidity Index, CCI), treatment patterns, and healthcare resource utilization in the 12-month baseline (BL) period prior to their index date (i.e., the 1st RCI claim or last claim for biologic for non-RCI cohort). Predictors of RCI initiation were identified by multivariable logistic regression, controlling for demographics and BL characteristics. Results: A total of 393 pts initiated RCI therapy while 188,062 initiated biologic treatment with no RCI claims. At BL, cohorts were similar with respect to mean age (~56 years), gender (76-79% female), and insurance type (79-80% commercial). Cohorts differed by region, plan type, and index year. Compared to non-RCI patients, the RCI cohort had significantly higher CCI and CIRAS scores; higher use of traditional DMARDs (65.6% vs. 61.9%), corticosteroids (CS, 91.3% vs 68.8%), prescription nonsteroidal anti-inflammatory drugs (NSAIDs, 66.9% vs 58.5%), and opioids (67.7% vs 47.5%), but lower biologic use (45.8% vs. 87.7%) (all p<0.05). RCI pts had significantly higher mean number of inpatient, emergency room, office, and outpatient visits (all p<0.05). RCI therapy initiation was most significantly impacted by treatment patterns, including number of DMARDs, CS, and opioids tried in the previous year ([Figure 1][1]). Corticosteroid use was the strongest predictor of RCI initiation, especially extended use at any dose (OR≥2.6) and extended use of the highest doses (>15 mg/day, OR=8.5), present in 21% of the RCI cohort ([Figure 1][1]). Drug benefit generosity (proportion of out-of-pocket costs) was also associated with RCI initiation in any plan qualified as better than “below average” (OR=2.1-2.9). Anemia, renal disease, and Sjogren’s syndrome were also associated with higher odds of RCI initiation (OR=1.4-2.1). Conclusion: RA pts initiating RCI therapy were prescribed a greater number of traditional DMARDs, CS, and opioids in the previous 12 months compared to non-RCI pts, and have evidence of more severe disease and comorbidities. Extended and high dose CS use were the factors most associated with RCI initiation. References: [1]Smolen JS, et al. Ann Rheum Dis. 2017;76:960–977 [2]Strand V, et al.. Rheumatol Ther. 2017;4(2):489-502. [3]Acthar Gel (repository corticotropin injection; perscribing information). Mallinckrodt ARD LLC, Bedminster, NJ 07921 USA. 2019. ![Figure][2] Disclosure of Interests: Kyle Hayes Employee of: Mallinckrodt ARD, LLC, Mary Panaccio Employee of: Mallinckrodt Pharmaceuticals, Huanxue Zhou Consultant of: I am full time employee in KMK Consulting Inc. and providing consulting service to Mallinckrodt, Mohammed Fahim Consultant of: I am full time employee in KMK Consulting Inc. and providing consulting service to Mallinckrodt [1]: #F1 [2]: pending:yes