Baseline demographic and clinical characteristics of the studies included in the efficacy comparison (mITT population)
| PLUTO20 | BLISS-5215 | BLISS-7617 | BLISS-NEA16 | EMBRACE19 | ||||||
| Placebo (n=40) | Belimumab 10 mg/kg intravenously (n=53) | Placebo (n=287) | Belimumab 10 mg/kg intravenously (n=290) | Placebo (n=275) | Belimumab 10 mg/kgintravenously (n=273) | Placebo (n=226) | Belimumab 10 mg/kgintravenously (n=451) | Placebo (n=149) | Belimumab 10 mg/kgintravenously (n=299) | |
| Age, years, mean (SD) | 14.8 (2.2) | 13.5 (2.6) | 36.2 (11.8) | 35.4 (10.8) | 40.0 (11.9) | 40.5 (11.1) | 31.7 (9.2) | 32.3 (9.7) | 39.3 (12.2) | 38.6 (11.1) |
| Female, n (%) | 39 (97.5) | 49 (92.5) | 270 (94.1) | 280 (96.6) | 252 (91.6) | 259 (94.9) | 210 (92.9) | 419 (92.9) | 144 (96.6) | 290 (97.0) |
| Race*, n (%) | ||||||||||
| White | 21 (52.5) | 27 (50.9) | 82 (28.6) | 71 (24.5) | 188 (68.4) | 189 (69.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Native American from North/Central/South America or Alaskan Native† | 11 (27.5) | 15 (28.3) | 89 (31.0) | 92 (31.7) | 36 (13.1) | 34 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Asian | 6 (15.0) | 8 (15.1) | 105 (36.6) | 116 (40.0) | 11 (4.0) | 11 (4.0) | 226 (100.0) | 451 (100.0) | 0 (0.0) | 0 (0.0) |
| Black African/American ancestry | 2 (5.0) | 3 (5.7) | 11 (3.8) | 11 (3.8) | 39 (14.2) | 39 (14.3) | 0 (0.0) | 0 (0.0) | 143 (96.0) | 293 (98.0) |
| Native Hawaiian or other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Multiracial | 0 (0.0) | 0 (0.0) | 1 (0.3) | 1 (0.3) | 2 (0.7) | 3 (1.1) | 0 (0.0) | 0 (0.0) | 6 (4.0) | 6 (2.0) |
| Ethnicity, n (%) | ||||||||||
| Hispanic or Latino | 17 (42.5) | 26 (49.1) | 143 (49.8) | 136 (46.9) | 55 (20.0) | 56 (20.5) | 1 (0.4) | 1 (0.2) | 73 (49.0) | 142 (47.5) |
| Non-Hispanic or non-Latino | 23 (57.5) | 27 (50.9) | 144 (50.2) | 154 (53.1) | 220 (80.0) | 217 (79.5) | 225 (99.6) | 450 (99.8) | 76 (51.0) | 157 (52.5) |
| SLE disease duration, years, mean (SD) | 2.7 (1.8) | 2.2 (2.0) | 5.9 (6.2) | 5.0 (5.1) | 7.4 (6.7) | 7.2 (7.5) | 6.0 (5.2) | 6.1 (5.0) | 6.9 (7.4) | 7.3 (7.1)‡ |
| SELENA-SLEDAI score, mean (SD) | 10.4 (3.6)§ | 10.3 (3.3) | 9.7 (3.6) | 10.0 (3.9) | 9.8 (4.0) | 9.5 (3.6) | 10.2 (4.1) | 9.8 (3.8) | 10.2 (2.9) | 9.9 (3.5) |
| Physician’s Global Assessment, mean (SD) | 1.4 (0.4) | 1.3 (0.4) | 1.4 (0.5) | 1.4 (0.5) | 1.5 (0.5) | 1.4 (0.5) | 1.6 (0.4)¶ | 1.6 (0.5)** | 1.5 (0.4) | 1.5 (0.5) |
| BILAG 1A or 2B, n (%) | 29 (72.5) | 37 (69.8) | 166 (57.8) | 172 (59.3) | 187 (68.0) | 160 (58.6) | 108 (47.8) | 204 (45.2) | 107 (71.8) | 215 (71.9) |
| Proteinuria, g/24 hours, mean (SD) | 0.5 (1.1) | 0.2 (0.2) | 0.6 (1.2) | 0.5 (0.9) | 0.4 (0.8) | 0.4 (0.7) | 1.0 (1.4) | 1.0 (1.3) | 0.6 (1.1) | 0.4 (0.9) |
*Patients who checked more than one race category were counted under individual race category according to the minority rule as well as the multiracial category.
†Included patients having origins in any of the original peoples of North and South America (including Central America) and who maintain tribal affiliation or community attachment.
‡n=298.
§n=39.
¶n=225.
**n=450.
BILAG, British Isles Lupus Assessment Group; mITT, modified intention-to-treat; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index; SLE, systemic lupus erythematosus.