Table 2

Clinical outcomes from ROSE

Primary end point: BILAG Index Response at Week 24
IVSCPooled IV+SC
GroupPlacebo (n=41)Rontalizumab (n=79)Placebo (n=38)Rontalizumab (n=77)Placebo (N=79)Rontalizumab (N=156)Treatment difference*
(90% CI)
Overall34.1%38.0%50.0%53.2%41.8%45.5%3.5% (−7.2 to 14.3%) p=0.60
ISM-High36.7% (11/30)40.3% (25/62)40.0% (10/25)45.9% (28/61)38.2% (21/55)43.1% (53/123)5.2% (−7.6 to 18.1%) p=0.51
ISM-Low27.3% (3/11)29.4% (5/17)69.2% (9/13)81.3% (13/16)50.0% (12/24)54.5% (18/33)4.5% (−17.7 to 26.5%) p=0.79
Key secondary end point: SRI-4 Response at Week 24
IVSCPooled IV+SC
Overall41.5%48.1%50.0%53.2%45.6%50.6%5.6% (−5.5 to 16.6%) p=0.41
ISM-High50.0% (15/30)41.9% (26/62)44.0% (11/25)47.5% (29/61)47.3% (26/55)44.7% (55/123)−2.3% (−15.5 to 10.9%) p=0.78
ISM-Low18.2% (2/11)70.6% (12/17)61.5% (8/13)75.0% (12/16)41.7% (10/24)72.7% (24/33)31.1% (8.9 to 51.0%) p=0.03
  • *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.

  • BILAG, British Isles Lupus Assessment Group; ISM, interferon signature metric; IV, intravenous; ROSE, Rontalizumab in Systemic Lupus Erythematosus; SC, subcutaneous; SRI, SLE response index.