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Observational Study
. 2025 Jan 23;12(1):e001336.
doi: 10.1136/lupus-2024-001336.

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)

Martin Aringer  1 , Laurent Arnaud  2 , Richard A Furie  3 , Eric F Morand  4 , Christine Peschken  5 , Alberta Hoi  4 , Barnabas Desta  6 , Jonatan Hedberg  7 , Tina Grünfeld Eén  7 , Alessandro Sorrentino  8 , Danuta Kielar  8 , Raj Tummala  6 , Stephanie Chen  9 , Bo Ding  10
Affiliations
Observational Study

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)

Martin Aringer et al. Lupus Sci Med. .

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.

Keywords: Autoimmune Diseases; Epidemiology; Glucocorticoids; Lupus Erythematosus, Systemic; Therapeutics.

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Conflict of interest statement

Competing interests: MA has been an advisor or review panel member and has been a speaker for or been given honoraria from AbbVie/Abbott, AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, GSK, Novartis, Otsuka Pharma, Pfizer, Roche, Sanofi Aventis, and UCB; and has been a speaker for or been given honoraria from Chugai Pharma and Merck. LA has served as a consultant for AbbVie, Alexion, Alpine, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Grifols, Janssen, Kezar Life Sciences, LFB Biotechnologies, Medac, Novartis, Oséus, Pfizer, Roche-Chugai, and UCB; and has served as a consultant for and as an advisor or review panel member for AstraZeneca and GlaxoSmithKline. RAF has served as a consultant for Galapagos, IgM, Janssen, Servier, and Takeda; and has received grant or research support from Amgen and UCB; and has served as a consultant for and received grant or research support from AbbVie, AstraZeneca, Biogen, Bristol-Myers Squibb, Eli Lilly, EMD Serono, Genentech, and GlaxoSmithKline. EFM has served as a consultant for and received grant or research support from Biogen and UCB. CP has served as a consultant for and received grant or research support from AstraZeneca and GlaxoSmithKline; and has served as a consultant for and an advisor or review panel member for Roche. BDe, JH, TGE, DK, SC and BDi are employees of, and may own stock/stock options, in AstraZeneca. AS and RT are former employees of AstraZeneca and may own stock/stock options.

Figures

Figure 1
Figure 1. SPOCS study design and patient disposition. Other reasons for discontinuation consisted predominantly of issues related to the COVID-19 pandemic or patients moving or transferring to different centres or physicians. SPOCS, SLE Prospective Observational Cohort Study.
See this image and copyright information in PMC

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