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SAT0101 A “Real-World” Characterization of Moderate-To-Severe Systemic Lupus Erythematosus
  1. V. Strand1,
  2. J. Johnson2,
  3. C. Vandeloo3,
  4. C. Galateanu3,
  5. S. Lobosco2
  1. 1Biopharmaceutical Consultant, Portola Valley, United States
  2. 2Adelphi Real World Ltd, Macclesfield, United Kingdom
  3. 3UCB Pharma, Brussels, Belgium


Background Systemic lupus erythematosus (SLE) is a chronic, multisystemic, inflammatory disease which impacts on physical functioning and Health-Related Quality of Life (HRQoL). Whilst SLE disease activity can be assessed by clinical measures, no consistent, standard criteria exist for the assessment of disease severity, which is a complex, multifaceted concept.

Objectives To characterize the patient group classified by physicians as having moderate-to-severe SLE, and to assess the burden of disease on these patients.

Methods Data were extracted from the Adelphi 2013 Lupus Disease-Specific Program, a multinational survey of clinical practice. Physicians completed Patient Record Forms (PRFs) and underwent face-to-face interviews; patients self-reported data including the EQ-5D, Work Productivity and Activity Impairment Index for SLE (WPAI-Lupus) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) in Patient Self-Completion Records (PSCs). Patient eligibility was determined by physicians; disease activity and severity were based on physician assessment. Data across countries were pooled.

Results Data were collected from rheumatologists in the USA (n=97), France (n=37) and Germany (n=35), including PRFs (550/200/207, respectively) and PSCs (303/109/149, respectively). Across countries, physician assessment of disease severity was predominantly based on affected organs and symptoms (considered to be of most importance by 45% and 35% of rheumatologists, respectively). Only 15% reported test results/clinical assessments as a determinate of SLE severity, with no single disease activity index widely used in clinical practice. Rather, 58% of rheumatologists reported using their own systematic assessment. Physician assessment of disease severity and disease activity were not strongly correlated: disease activity was controlled in 56.1% of patients classified as moderate-to-severe, and uncontrolled in 6.1% of mild patients. More patients with moderate-to-severe disease presented for the first time with greater disease severity and organ involvement (8% had cutaneous SLE), and a greater proportion flared per 12 month period (Table). Compared to mild disease, moderate-to-severe SLE was associated with a greater impact on HRQoL and work productivity and activity impairment (Table), which was comparable to rheumatic conditions including rheumatoid arthritis (RA) (for USA patients EQ-5D visual analogue scores across all SLE severities=72.7, RA=72.8; WPAI for all SLE severities=17.5%, RA=22.6%). In addition, fewer moderate-to-severe patients were employed, and a higher proportion required a care provider (Table).

Conclusions Data show that SLE severity is not consistently assessed or defined in clinical practice. Whilst symptoms and organ involvement are central to physician assessments of disease severity, measures used in clinical trials are not routinely adopted in daily practice. Furthermore, severity assessment is complex, with a limited correlation between assessments of severity, activity and control. Thus, there is a need for a simple, universal tool to accurately assess SLE disease severity and activity and to inform physician and patient decisions regarding treatment. This need is heightened by the finding that moderate-to-severe SLE is associated with a greater burden than mild disease.

Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.

Disclosure of Interest V. Strand Consultant for: UCB Pharma, J. Johnson: None declared, C. Vandeloo Employee of: UCB Pharma, C. Galateanu Employee of: UCB Pharma, S. Lobosco: None declared

DOI 10.1136/annrheumdis-2014-eular.1828

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