Exploratory clinical outcomes from ROSE
| End point | Group | IV | SC | Pooled 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 24 | Overall | 78.0 | 67.1 | 73.7 | 63.2 | 75.9 | 65.2 | −11.1% (−20.9% to −1.2%) |
| ISM-High | 73.3 | 66.1 | 80.0 | 70.0 | 76.4 | 68.0 | −8.9% (−20.5% to 2.6%) | |
| ISM-Low | 90.9 | 70.6 | 61.5 | 37.5 | 75.0 | 54.5 | −20.5% (−41.0 to 1.6%) | |
| Moderate or severe SFI-R flare by Week 24 | Overall | 52.5 | 44.3 | 47.4 | 37.7 | 50.0 | 41.0 | −9.1% (−20.0% to 1.9%) |
| ISM-High | 48.3 | 41.9 | 52.0 | 45.9 | 50.0 | 43.9 | −6.4% (−19.7% to 6.9%) | |
| ISM-Low | 63.6 | 52.9 | 38.5 | 6.3 | 50.0 | 30.3 | −19.7% (−40.6% to 2.6%) | |
| Prednisone ≤10 mg/day from Week 8–24 | Overall | 68.3 | 79.7 | 57.9 | 72.4 | 63.3 | 76.1 | 13.3% (3.1% to 23.5%) |
| ISM-High | 70.0 | 77.4 | 52.0 | 66.7 | 61.8 | 72.1 | 11.4% (−0.9% to 23.7%) | |
| ISM-Low | 63.6 | 88.2 | 69.2 | 93.8 | 66.7 | 90.9 | 24.2% (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.