Table 3

Exploratory clinical outcomes from ROSE

End pointGroupIVSCPooled IV+SC
Placebo (n=41) (%)Rontalizumab (n=79) (%)Placebo (n=38) (%)Rontalizumab (n=77) (%)Placebo (N=79) (%)Rontalizumab (N=156) (%)Treatment difference*
(90% CI)
SELENA-SLEDAI flare by Week 24Overall78.067.173.763.275.965.2−11.1% (−20.9% to −1.2%)
ISM-High73.366.−8.9% (−20.5% to 2.6%)
ISM-Low90.970.661.537.575.054.5−20.5% (−41.0 to 1.6%)
Moderate or severe SFI-R flare by Week 24Overall52.544.347.437.750.041.0−9.1% (−20.0% to 1.9%)
ISM-High48.341.952.045.950.043.9−6.4% (−19.7% to 6.9%)
ISM-Low63.652.938.56.350.030.3−19.7% (−40.6% to 2.6%)
Prednisone ≤10 mg/day from Week 8–24Overall68.379.757.972.463.376.113.3% (3.1% to 23.5%)
ISM-High70.077.452.066.761.872.111.4% (−0.9% to 23.7%)
ISM-Low63.688.269.293.866.790.924.2% (1.8% to 44.7%)
  • *Treatment difference was adjusted for race/ethnicity and previous use of immunosuppressant agents (stratification factors), and cohort (IV vs SC) for the Overall and ISM-High comparisons. Absolute treatment difference reported for the ISM-Low group due to the low sample size.

  • IV, intravenous; ROSE, Rontalizumab in Systemic Lupus Erythematosus; SC, subcutaneous; SELENA–SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index; SFI-R, SELENA Flare Index.