Background/Purpose: Systemic lupus erythematosus (SLE) therapies include non-steroidal anti-inflammatory drugs, antimalarials, systemic immunosuppressants, and biologics with corticosteroids as necessary. The majority of these current therapies are only partially effective in disease control. Despite treatment, patients may experience flares of disease activity, which can lead to progressive end-organ damage. Severe flares may require intensive immunosuppression, including with high-dose corticosteroids, with risk including end-organ damage. The objective was to understand the unmet need in SLE by quantifying use of high-dose (≥40mg/day) corticosteroids and determining factors associated with its use.

Methods: This study utilized the Truven Marketscan® commercial claims database. Patients were indexed on first use of antimalarial, oral immunosuppressant or biologic during 2012-2013 (first use determined based on no claims for the 3 drug classes during the 1-year pre-index). Included patients had 2 recorded SLE diagnoses, were 18-50 years of age and had continuous medical and prescription enrollment from baseline through the 2-year follow-up. Patients with other pre-specified autoimmune disorders or cancers during the study period (baseline through follow-up) were excluded. During follow-up, fill of at least 1 high-dose corticosteroid prescription was assessed and associative logistic regression modeling performed.

Results: 1,401 patients (93% female; mean age 38.4 years) met the study criteria; 79% were indexed on an antimalarial, 15% on an oral immunosuppressive, 1% on a biologic and 5% on a combination of at least 2 of the aforementioned classes. 16% patients received a diagnosis code for nephritis or chronic kidney disease (CKD), 3% for myocarditis or pericarditis, and 13% for thrombocytopenia or leukopenia.  During baseline, 56% of patients had at least 1 visit to a rheumatologist and 13% filled at least 1 high-dose corticosteroid prescription.  During follow-up, 22% of patients had at least 1 high-dose corticosteroid prescription. Factors significantly associated (p<0.05) with high-dose corticosteroids during follow-up included: baseline rheumatologist visit (OR=0.62; 95% CI=0.47-0.82), number of SLE medication classes received during follow-up (OR=1.85, 95% CI=1.36-2.51), receipt of high dose corticosteroid during baseline (OR=5.21, 95% CI=3.60-7.53), nephritis or CKD (OR=1.85, 95% CI=1.29-2.64), myocarditis/pericarditis (OR=3.38, 95% CI=1.75-6.55), and thrombocytopenia/leukopenia (OR=1.70, 95% CI=1.17-2.48).

Conclusion: A number of baseline factors were associated with high-dose corticosteroid treatment during the follow-up period; one notable factor is the high percentage of patients using high-dose corticosteroids (≥40 mg/day). This indicates that important subsets of patients experience inadequate disease control with current therapies. This study reveals high-dose corticosteroid use is prevalent in SLE management broadly, underscoring the unmet need in this population.