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Background Organ system involvement in systemic lupus erythematosus (SLE) is highly variable. Better understanding of the symptom and organ involvement patterns in patients with SLE may facilitate making more accurate prognoses and individualized management decisions. This analysis aimed to categorize patients with SLE into clusters according to their organ system involvement. Methods This was a secondary, descriptive analysis (208683) that utilized survey data collected from adult patients with SLE and their physicians, enrolled in the 2015 Adelphi Real World Disease Specific Programme (US and Europe) (205086). Latent class modeling based on current organ involvement was used to generate clusters of patients with similar manifestations; characteristics of each cluster were compared using the chi-square test for categorical variables and Kruskal-Wallis test for ordered/numeric outcomes. Results Overall, 1376 patients (n=1196 [87.0%] female; mean [standard deviation (SD)]) age, 42.1 [13.6] years) were included in the analysis. Four patient clusters were generated: Cluster 1 (n=250, 18.2%), lowest overall organ burden (predominantly mucocutaneous); Cluster 2 (n=670, 48.7%), joint and skin SLE (predominantly mucocutaneous and musculoskeletal) with limited renal/hematologic involvement; Cluster 3 (n=150, 10.9%), highest frequency of renal/hematologic involvement; Cluster 4 (n=306, 22.2%), highest frequency of mucocutaneous, musculoskeletal, constitutional, cardiorespiratory and neuropsychiatric involvement, but without renal involvement. Key results are summarized in the table 1. Significant between-cluster differences were observed for disease severity (p Conclusions This analysis provides important insights on potential clinically meaningful subsets of SLE (per organ system involvement) using real-world evidence. The highest disease burden was observed in Clusters 3 and 4, confirming the extensive impact of SLE irrespective of renal involvement. Limitations included the absence of serological findings or disease activity indices for cluster formation or comparison. Funding Source(s): Study funded by GlaxoSmithKline; ownership of data retained by Adelphi Real World.

Background Despite recent advances in the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN), understanding of their pathogenesis and the interrelation between disease states remains incomplete. A pragmatic review (GSK study LS3178) was conducted to map disease severity and progression of renal involvement in SLE, focusing on: LN development among patients with SLE, within-LN progression, and progression to end-stage renal disease (ESRD). Methods A keyword based literature search was conducted using PubMed, Google and Google Scholar and supplemented with a bibliography search relevant to the focus area. The following publications were screened and prioritized for inclusion: high quality; published after 2010; addressed a topic of focus or an information gap; data were from the USA or Europe. High-quality pre-2010 and non-USA/Europe publications were permitted. Results Overall, 248 citations were identified (keyword based search, n=117; bibliography search, n=131). Following full text screening, 144 publications were considered relevant to the review and 26 were selected for inclusion (21 primary studies, 3 narrative reviews and 2 systematic literature reviews). An overview of the results is provided in the Figure. This review identified that 726% of patients had LN at the time of SLE diagnosis, and 3148% of patients with SLE developed LN in the disease course, most (8090%) within 5 years of diagnosis. Class IV nephritis was the most common LN class found at first (3560%) and repeat (3563%) biopsy and had the worst prognosis. Histological transformation from one LN class to another was reported in 4076% of patients, most commonly in patients with nonproliferative lesions in the first biopsy. Overall, the proportion of patients who subsequently developed ESRD was 36% (SLE) and 428% (LN). Limited data existed for time to progression within LN and from SLE/LN to ESRD, and for renal signs present before LN diagnosis. Conclusions This review highlights risk factors for developing LN and progressing from SLE/LN to ESRD. Male patients, patients of non white ethnicities, and patients of a younger age at SLE diagnosis had the highest risk for developing LN and progressing from SLE/LN to ESRD. Of the renal parameters, elevated serum creatinine was identified as the best predictor of worsening disease state. A higher risk of worse outcomes is seen in the earlier SLE/LN disease stages, demonstrating the importance of early diagnosis and the need for effective disease modifying treatments for SLE and LN. Funding Source(s): Study funded by GSK.