Patient Characteristics and Indicators of Treatment Initiation with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis: A Claims Database Analysis

Abstract

Repository corticotropin injection (RCI) is indicated as adjunctive, short-term therapy in selected patients with RA. To characterize RCI users and identify predictors of RCI initiation in RA, we compared preindex characteristics, treatment patterns, comorbidities, healthcare resource utilization (HCRU), and costs for patients who had initiated RCI treatment (RCI cohort) versus patients with no RCI claims and ≥ 1 targeted synthetic or biologic disease-modifying antirheumatic drugs (ts/bDMARD) claim (non-RCI ts/bDMARD cohort). We analyzed pharmacy and medical claims data from a large commercial and Medicare supplemental administrative database. Inclusion criteria were age ≥ 18 years, ≥ 1 inpatient or ≥ 2 outpatient claims with RA diagnosis (January 1, 2007–December 31, 2018), and 12-month continuous medical and pharmacy coverage preindex. Results from baseline cohort comparisons informed multiple logistic regression analysis. Compared with the non-RCI ts/bDMARD cohort ( n = 162,065), the RCI cohort ( n = 350) had a greater proportion of patients with higher Charlson comorbidity index (CCI) scores; higher mean claims-based index of RA severity and CCI scores; greater frequency of almost all comorbidities; higher use of nontraditional DMARDs, glucocorticoids, and opioids; higher all-cause HCRU; and higher medical and total costs. By multivariable analysis, the most significant predictors of RCI initiation were intermittent glucocorticoid use at any dose (odds ratio [OR] 1.67), extended-use glucocorticoids at medium (OR 2.03) and high doses (OR 2.99), nontraditional DMARD use (OR 2.09), anemia (OR 1.39), and renal disease (OR 2.45). Before RCI initiation, patients had more severe RA, higher comorbidity burden, greater use of glucocorticoids and opioids, and higher HCRU compared with non-RCI initiators. The most significant predictors for starting RCI in patients with RA were intermittent use of glucocorticoids at any dose, extended-use high-dose glucocorticoids, use of nontraditional DMARDs, and comorbid anemia and renal disease. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-020-00272-x.

Real-world treatment patterns for repository corticotropin injection in patients with rheumatoid arthritis

“… 20 Another analysis of a rheumatology electronic medical record (EMR) database reported significant improvements in RA disease activity, functional status and pain with a decreased need for concomitant medications for up to 1 year following initiation of RCI therapy. 21 The benefit–risk profile of RCI is consistent across well-controlled clinical trials, 4 open-label studies 1 , 13 – 15 and a retrospective analysis. 20 The current study provides additional supportive real-world rheumatology practice data on disease-assessment and prescribing patterns, dosing, clinical effectiveness and tolerability, which are important for understanding performance in patients with complex disease in clinical practice.…”

“…Rheumatoid arthritis (RA) is an autoimmune disease that causes synovial inflammation and progressive joint damage. 1 There is a large unmet need for patients with refractory RA who display persistently high RA disease activity or flares despite treatment with standard-of-care therapies. 1 Real-world evidence is necessary to support the effectiveness of RA drugs in a clinical setting and to identify appropriate patient populations who are likely to experience a clinical response to such treatments.…”

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

“…28 Additional real-world outcome studies show that osteoarthritis is a prevalent comorbidity in patients with RA treated with RCI. 15,29,30 In addition, the presence of more tender than swollen joints may reflect the coexistence of osteoarthritis in this patient population. 31 Clinical measures of disease severity, including CDAI and number of tender or swollen joints, indicated that patients had high RA activity prior to starting RCI therapy.…”

“…RCI is used in patients experiencing acute episodes or exacerbations of RA, as a late-line therapy to treat RA flares, as a bridge to new therapy, or as an add-on to prior therapy. 6 , 15 Multiple published studies of RCI use in patients with refractory RA support its efficacy and safety including patient-reported improvements in pain, fatigue, and work productivity; 16−20 however, there remains a need for real-world evidence for the use of RCI to treat RA. Namely, data on prescribing patterns, dosing, efficacy, and tolerability are limited.…”

Post Hoc Analysis of Predictors of Clinical Response to Repository Corticotropin Injection in Persistently Active Rheumatoid Arthritis

“…Despite numerous available DMARDs, in the majority of patients, LDA is not achieved or maintained over a prolonged period [6,7]. An estimated 6% of patients with moderate to severe RA (approximately 30,000-34,000 US patients) do not respond to DMARDs [8][9][10]. Failure to achieve LDA and possibly remission can lead to irreversible joint damage [6].…”