FRI0293 Validation of the revised selena flare index in systemic lupus erythematosus

M. A. Petri, J. T. Merrill, R. Maciuca, J. C. Davis, W. Kennedy
2013 Annals of the Rheumatic Diseases  
BACKGROUND • Flare is one of the most commonly used outcome variables in SLE clinical trials. 1,2 • The SELENA flare index (SFI) has functioned well in clinical and clinical trial settings, 3 but has the limitation that it classifies only severe versus combined mild/moderate flares. • Since mild flares are often clinically insignificant, and it is useful to distinguish flares by organ system, a revision of the SELENA flare index 4 was carried out to define severe, moderate and mild flares
more » ... d mild flares separately, in terms of clinical and/or treatment variables, and by organ system. This revised SELENA flare index (SFI-R) is independent of SLEDAI. • The concordance between the SFI and the SFI-R flares was compared to the SFI used in the Phase 2 study of the efficacy and safety of rontalizumab (antiinterferon alpha) in SLE. 5 METHODS Study Design • SLE patients with moderate to severe active SLE were enrolled in ROSE for the evaluation of the safety and efficacy of rontalizumab, an anti-interferonalpha (anti-IFNa) IgG1 antibody.
doi:10.1136/annrheumdis-2013-eular.1420 fatcat:ajhweajjevbmhpg2ildo4pkpva