Flares in patients with Systemic Lupus Erythematosus (SLE)

Objective: Systemic lupus erythematosus (SLE) is characterised by relapses and remissions. This study describes the frequency, type and time to flare in a cohort of SLE patients. Methods: SLE patients with one or more “A” or “B” BILAG2004 systems meeting flare criteria (“new” or ”worse” items) and requiring an increase in immunosuppression were recruited from nine UK centres and assessed at baseline and monthly for nine months. Subsequent flares were defined as: severe (any “A” irrespective of number of “Bs”), moderate (≥2 “Bs” without any “As”) and mild (one “B”). Results: Of the 100 patients, 94% were female, 61% white Caucasians, mean age (SD) was 40.7 years (12.7) and mean disease duration (SD) 9.3 years (8.1). A total of 195 flares re-occurred in 76 patients over 781 monthly assessments (flare rate of 0.25/patient-month). There were 37 severe flares, 32 moderate flares and 126 mild flares. By month one, 22% had a mild/moderate/severe flare and 22% had a severe flare by 7 months. The median time to any “A” or “B” flare was 4 months. Severe/moderate flares tend to be in the system/s affected at baseline whereas mild flares can affect any system. Conclusion: In a population with active SLE we observed an ongoing rate of flares from early in the follow-up period with moderate-severe flares being due to an inability to fully control the disease. This real-world population study demonstrates the limitations of current treatments and provides a useful reference population from which to inform future clinical trial design