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FRI0381 Association of Disease Activity and Severity with Steroid-Containing Standard-Of-Care Regimens in Sle: Interim Results from the Prospective Observational SESAME Study
  1. I. Saulescu1,
  2. F. Furtunescu1,
  3. A. Perna2,
  4. S. Mihalcea3,
  5. W. Tł ustochowicz4,
  6. M. Majdan5,
  7. E. Kiss6,
  8. R. Ionescu1
  1. 1Carol Davila University of Medicine and Pharmacy, Bucharest, Romania
  2. 2GlaxoSmithKline, London, United Kingdom
  3. 3GlaxoSmithKline, Bucharest, Romania
  4. 4Military Institut of Medicine, Warsaw
  5. 5Department of Rheumatology and Systemic Connective Tissue Disorders, Medical University of Lublin, Lublin, Poland
  6. 6National Institute of Rheumatology and Physiology, Budapest, Hungary


Background Systemic lupus erythematosus (SLE) is an idiopathic autoimmune condition that impacts quality of life and life expectancy, and is associated with significant co-morbidity. Factors related to both the disease and subsequent treatments contribute to the clinical presentation of SLE. Steroid regimens are the cornerstone of treatment, but high doses and cumulative exposure have been associated with significant toxicity.

Objectives The SESAME study was a prospective observational study compiling real-life experiences from a large cohort of European patients to investigate the medical, economic and social burden of SLE. Here we report data on treatment regimen and SLE severity at patient inclusion.

Methods Consecutive SLE patients (N=737) were enrolled at 19 specialized lupus centres (Romania=11, Poland=6, Hungary=2) after providing informed consent and followed for 12 months (BEL115014). SLE activity and damage were assessed by SELENA-SLEDAI and SLICC/ACR damage indices. In the event of a disease flare, the SELENA-SLEDAI Flare Index was included. Severe disease was defined as: 1) having at least one of the major organ systems (renal, neurological, cardiovascular or respiratory) activelly involved (symptomatic or biologically active) at enrolment AND 2) requiring >7.5 mg/day corticosteroids (prednisone equivalent dose) and/or immunosuppressant(s) (including biological drugs).

Results The mean ± standard deviation (SD) disease duration was 8.0±7.7 years. The mean ± SD SELENA-SLEDAI and SLICC/ACR scores were 6.4±7.8 and 1.1±1.6, respectively. Damage was found even in the non-severe subgroup. The proportion of patients with at least one organ system damaged was significantly higher in patients with severe disease (n=255) compared to non-severe disease (n=482; 47.1% vs 34.2%; p<0.001). The proportion of patients experiencing a flare at inclusion was 2.9 times higher in patients with severe disease compared to non-severe disease (42.4% vs 14.7%; p<0.001). Oral and/or injectable corticosteroids were prescribed to 577 (78.3%) patients. Mean ± SD daily prednisone-equivalent dose (only for patients with oral corticosteroids) was 12.7±11.2 mg/day and found to be higher in patients with severe disease compared with non-severe disease (17.0±14.5 vs 9.8±6.9 mg/day; p<0.001). Corticosteroid-free regimens were prescribed to 142 (19.3%) of patients, and were 4.1 times less common in patients with severe disease compared with non-severe disease (6.3% vs 26.1%; p<0.001).

Conclusions 78.3% of patients in the SESAME cohort were receiving a steroid regimen for SLE at inclusion. Higher doses of steroids were prescribed to patients with severe disease compared with non-severe disease. However, mean daily prednisone-equivalent dose was also high (>7.5 mg/day) in non-severe patients, reflecting a caution to adjust steroid regimens according to disease activity. Persistent high doses of cortisone might explain the presence of damage in 34.2% of the patients with non-severe SLE.


  1. Duru N, et al. Ann Rheum Dis 2013;72:1905–13.

Disclosure of Interest None declared

DOI 10.1136/annrheumdis-2014-eular.5013

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