Real-world treatment patterns and clinical characteristics in patients with moderate-to-severe systemic lupus erythematosus: an analysis of the SLE Prospective Observational Cohort Study (SPOCS).

Abstract

Objectives: Systemic lupus erythematosus (SLE) is a disease with heterogeneous treatment patterns largely based on organ involvement and disease severity. The SLE Prospective Observational Cohort Study (SPOCS) collected data worldwide over 3 years from patients with moderate-to-severe SLE. We report real-world patterns of medication use in patients enrolled in SPOCS.

Methods: Data were collected at study entry; patients were followed twice annually according to local practice. Disease activity (SLE Disease Activity Index 2000 (SLEDAI-2K)), average oral glucocorticoid dose and use of other treatments-specifically antimalarials, biologics and immunosuppressants-were measured over time. Subgroup analyses were stratified by baseline interferon gene signature (IFNGS) status and disease activity (SLEDAI-2K) status.

Results: Patient demographics and baseline characteristics were similar among subgroups; the majority of patients were on antimalarials (n=670; 81.1%), followed by glucocorticoids (n=537; 65.0%), immunosuppressants (n=453; 54.8%) and biologics (n=175; 21.2%). In the overall population, median (IQR) SLEDAI-2K scores decreased within 12 months (baseline: 8.0 (6.0-12.0); 12 months: 4.0 (2.0-8.0)) and remained stable thereafter. The mean (SD) daily oral glucocorticoid dose increased by 6 months (baseline: 6.0 (7.09); 6 months: 9.8 (8.67)) and remained stable thereafter. The proportion of patients who were on glucocorticoid doses >5 mg/day ranged from ~20% to 33% throughout the study. In subgroup analyses, patients with high IFNGS and high disease activity state (HDAS) at baseline used more immunosuppressants and glucocorticoids compared with those with low IFNGS and non-HDAS at baseline.

Conclusions: These findings underscore that SLE therapy is still often unable to reach goals as recommended by the European Alliance of Associations for Rheumatology, both with regard to glucocorticoid use and disease activity, suggesting that there is an unmet need for new treatment options for patients with SLE.

Trial registration number: NCT03189875; 16 June 2017.