Results of the ILLUMINATE and BLISS trials†
| ILLUMINATE-1 | ILLUMINATE-2 | BLISS 52 | BLISS 76 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Outcome measure | Analysis | PBO | TAB 120 mg Q2W | TAB 120 mg Q4W | PBO | TAB 120 mg Q2W | TAB 120 mg Q4W | PBO | BEL 10 mg/kg | PBO | BEL 10 mg/kg |
| SRI-5 | Original | 29.3 | 31.8 (NS) | 35.2 (0.052) | 27.7 (NS) | 38.4 (0.002) | 34.8 (0.051) | Not available | Not available | 20.4 | 32.6 (<0.001) |
| Modified‡ | 29.8 | 34.1 (NS) | 37.0 (0.021) | NA | NA | NA | NA | NA | NA | NA | |
| SRI-4 | Original | Not available | Not available | Not available | 37.8 (NS) | 49.2 (<0.05) | 44.9 (NS) | 44 | 58 (0.0006) | 33.5 | 43.2 (<0.05) |
| Modified‡ | 39.8 | 47.2 (<0.05) | 47.4 (<0.005) | NA | NA | NA | NA | NA | NA | NA | |
†Figures are percentage of patients achieving the target; figures between brackets are p values, with significant differences indicated in bold.
‡In the modified analyses performed for ILLUMINATE-1, patients in whom antimalarials and/or immunosuppressants were tapered were not considered as de facto non-responders.
BEL, belimumab; NA, not applicable; NS, not significant; PBO, placebo; SRI, SLE responder index; TAB, tabalumab.