Patients with systemic lupus erythematosus (SLE) treated with oral corticosteroids (OCS) may experience significant financial burden, greater health care resource utilization (HCRU), and increased risk for treatment related adverse events (AEs) compared with patients not taking OCS, according to results of a retrospective cohort study published in ACR Open Rheumatology.
While OCS are considered part of standard treatment for SLE, their use is associated with increased risk for infection and AEs, as well as greater financial burden on the health care system and patients themselves. Investigators assessed HCRU, health care costs, and AEs among patients with SLE who initiated OCS.
Data were taken from the IQVIA Real-World Data Adjudicated Claims-US database. Patients with a diagnosis of SLE (according to medical chart codes or inpatient, outpatient, and emergency department claims data) aged at least 5 years at the time of diagnosis were included in the study.
Patients in the OCS-initiator cohort had at least 1 OCS pharmacy claim during the study period and no evidence of preindex OCS use. Based on the number of 6-month periods with more than 5 mg/day prednisone-equivalent OCS use, included patients were stratified into exposure categories 0, 1, or 2. Patients in the no-OCS-use cohort had no OCS claims during the study period. Outcomes were assessed over a 12-month follow-up period.
A total of 16,216 and 11,137 patients were included in the OCS-initiator and no-OCS-use cohorts, respectively. The majority of overall patients had mild SLE (OCS-initiator cohort, 56.1% vs no-OCS-use cohort, 66.1%) while a greater percentage of patients in the OCS-initiator cohort had moderate (32.4% vs 24.1%) or severe (11.6% vs 9.8%) SLE.
The investigators found significant adjusted cost differences between exposure categories 0 ($6542; 95% CI, $5761-$7368), 1 ($19,149; 95% CI, $16,954-$21,471) and 2 ($28,985; 95% CI, $25,546-$32,885). Among the OCS-initiator cohort, HCRU adjusted incidence rate ratios (IRRs) were significantly greater vs the no-OCS-use cohort (exposure category 0 IRR, 1.22; 95% CI, 1.19-1.24; exposure category 1 IRR, 1.39; 95% CI, 1.34-1.43; exposure category 2 IRR, 1.66; 95% CI, 1.60-1.73; all P <.01).
The OCS-initiator cohort experienced more OCS-related AEs (67.1%, 70.5%, and 74.1% for exposure categories 0, 1, and 2, respectively) vs the no-OCS-use cohort (56.3%). Statistically significant associations were observed for OCS-related AEs across all organ-domain groups, with the exception of dermatologic AEs among patients in exposure categories 0 or 2 and ophthalmologic AEs among those in exposure category 0.
Study limitations included the observational design, use of prescription claims data as indication of medication adherence, coding inaccuracies, and potential confounders. Additionally, direct causation between OCS exposure and AEs could not be determined.
The investigators concluded, “Taken altogether, the evidence that even low doses of OCS are associated with additional health care costs and HCRU supports the introduction of a lower prednisone-equivalent corticosteroid dose threshold in the treatment of SLE.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
DerSarkissian M, Gu YM, Duh MS, et al. Clinical and economic burden in patients with systemic lupus erythematosus during the first year after initiating oral corticosteroids: a retrospective US database study. ACR Open Rheumatol. 2023;5(6):318-328. doi:10.1002/acr2.11550