Clinical and Economic Burden in Patients With Systemic Lupus Erythematosus During the First Year After Initiating Oral Corticosteroids: A Retrospective US Database Study.

Abstract

Objective: To characterize health care resource utilization (HCRU), health care costs, and adverse events (AEs) among patients with systemic lupus erythematosus (SLE) initiating oral corticosteroids (OCS) versus patients without OCS use.

Methods: In this retrospective cohort study (GSK Study 213061), eligible patients (aged ≥5 years at first OCS claim) with SLE from the IQVIA Real-World Data Adjudicated Claims-US database (January 2006 to July 2019) had continuous enrollment during the 6-month preindex (baseline) and 12-month postindex (observation) periods and one or more inpatient or emergency department SLE diagnosis codes or two or more outpatient SLE diagnosis codes during baseline. The "OCS-initiator cohort" comprised patients with one or more OCS pharmacy claims during the study period and no evidence of preindex OCS use and was classified into three exposure categories based on the number of 6-month periods of more than 5 mg/day of OCS use (0, 1, 2). The "no-OCS-use cohort" comprised patients without OCS claims, although patients may have received OCS prior to the study period. Clinical and economic outcomes were reported over the observation period.

Results: Adjusted health care costs differed significantly ($6542 [95% confidence interval (CI): $5761-$7368], $19,149 [95% CI: $16,954-$21,471], $28,985 [95% CI: $25,546-$32,885]). HCRU incidence rates were significantly greater for all OCS-initiator exposure categories (n = 16,216) versus the no-OCS-use cohort (n = 11,137; adjusted incidence rate ratios [95% CI]: 1.22 [1.19-1.24], 1.39 [1.34-1.43], 1.66 [1.60-1.73]). OCS-related AEs were experienced by 67.1% to 74.1% of patients with OCS initiation, most commonly affecting the immune system.

Conclusion: Within 12 months of OCS initiation, patients with SLE experienced substantial clinical and economic burden, which may imply a need to minimize OCS use.