Background demographics and disease characteristics
| n (%)† | Pooled safety analysis population* | BASE | ||||||
| Older adults (N=63) | Overall (N=4170) | Older adults (N=156) | Overall (N=4003) | |||||
| PBO N=27 | BEL N=36 | PBO N=1355 | BEL N=2815 | PBO N=82 | BEL N=74 | PBO N=2002 | BEL N=2001 | |
| Sex | ||||||||
| Female | 25 (92.6) | 33 (91.7) | 1268 (93.6) | 2661 (94.5) | 73 (89.0) | 68 (91.9) | 1853 (92.6) | 1848 (92.4) |
| Race‡ | ||||||||
| White | 18 (66.7) | 24 (66.7) | 516 (38.1) | 1100 (39.1) | 66 (80.5)§ | 58 (78.4)§ | 1090 (54.4) | 1096 (54.8) |
| Asian | 3 (11.1) | 1 (2.8) | 418 (30.8) | 836 (29.7) | 7 (8.5)§ | 8 (10.8)§ | 492 (24.6) | 483 (24.1) |
| Black African ancestry | 6 (22.2) | 5 (13.9) | 269 (19.9) | 568 (20.2) | 5 (6.1)§ | 4 (5.4)§ | 155 (7.7) | 175 (8.7) |
| American Indian/Alaska Native¶ | 0 (0.0) | 6 (16.7) | 149 (11.0) | 307 (10.9) | 4 (4.9)§ | 4 (5.4)§ | 257 (12.8) | 228 (11.4) |
| Multiracial | 0 (0.0) | 0 (0.0) | 15 (1.1) | 26 (0.9) | 0 (0.0)§ | 0 (0.0)§ | 14 (0.7) | 5 (0.2) |
| Missing | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0)§ | 0 (0.0)§ | 6 (0.3) | 14 (0.7) |
| Ethnicity | ||||||||
| Hispanic/Latino | 2 (7.4) | 12 (33.3) | 373 (27.5) | 765 (27.2) | 12 (14.6) | 13 (17.6) | 706 (35.3) | 708 (35.4) |
| Age (years) | ||||||||
| Mean | 68.3 | 67.9 | 37.8 | 37.5 | 70.2 | 69.6 | 40.8 | 40.4 |
| SD | 2.96 | 3.32 | 11.96 | 11.49 | 4.98 | 4.07 | 12.74 | 12.75 |
| Min, max | 65, 74 | 65, 77 | 18, 74 | 18, 77 | 65, 86 | 65, 83 | 18, 86 | 17, 83 |
| SLE disease duration (years)** | ||||||||
| Mean | 9.20 | 7.39 | 6.78 | 6.74 | 7.0 | 8.8 | 7.4†† | 7.4 |
| SD | 8.12 | 7.97 | 6.61 | 6.58 | 7.92 | 11.68 | 7.05 | 7.51 |
| SELENA-SLEDAI category | ||||||||
| ≤9 | 16 (59.3) | 23 (63.9) | 612 (45.2) | 1315 (46.7) | 64 (78.0) | 64 (86.5) | 1369 (68.4) | 1363 (68.1) |
| ≥10 | 11 (40.7) | 13 (36.1) | 743 (54.8) | 1500 (53.3) | 18 (22.0) | 10 (13.5) | 633 (31.6) | 638 (31.9) |
| SELENA-SLEDAI score‡‡ | ||||||||
| Mean | 8.7 | 8.3 | 10.0 | 9.9 | 7.3 | 6.3 | 7.9 | 7.8§§ |
| SD | 2.71 | 2.74 | 3.79 | 3.74 | 5.47 | 3.92 | 4.51 | 4.72 |
| SDI score | ||||||||
| n | 25 | 30 | 1242 | 2476 | 82 | 74 | 1999 | 1998 |
| Mean | 1.5 | 1.0 | 0.6 | 0.6 | 1.3 | 1.3 | 0.6 | 0.6 |
| SD | 1.61 | 1.64 | 1.12 | 1.08 | 1.94 | 1.61 | 1.17 | 1.16 |
| SLE medication use | ||||||||
| Glucocorticoid | 22 (81.5) | 28 (77.8) | 1184 (87.4) | 2404 (85.4) | 50 (61.0)§ | 41 (55.4)§ | 1646 (82.2) | 1667 (83.3) |
| Antimalarial | 18 (66.7) | 27 (75.0) | 956 (70.6) | 1934 (68.7) | 53 (64.6)§ | 48 (64.9)§ | 1451 (72.5) | 1491 (74.5) |
| IS | 8 (29.6) | 11 (30.6) | 712 (52.5) | 1443 (51.3) | 28 (34.1)§ | 27 (36.5)§ | 997 (49.8) | 1021 (51.0) |
| Average daily prednisone equivalent dose (mg/day) | ||||||||
| 0 | 5 (18.5) | 8 (22.2) | 171 (12.6) | 411 (14.6) | 33 (40.2)§ | 33 (44.6)§ | 363 (18.1) | 339 (16.9) |
| >0–≤7.5 | 6 (22.2) | 17 (47.2) | 351 (25.9) | 719 (25.5) | 19 (23.2)§ | 22 (29.7)§ | 649 (32.4) | 676 (33.8) |
| >7.5 | 16 (59.3) | 11 (30.6) | 833 (61.5) | 1685 (59.9) | 30 (36.6)§ | 19 (25.7)§ | 990 (49.5) | 986 (49.3) |
| Mean | 9.6 | 6.0 | 12.0 | 11.4 | 5.9§ | 5.3§ | 9.7 | 10.2 |
| SD | 8.84 | 4.75 | 9.68 | 9.56 | 7.52§ | 7.15§ | 10.79 | 11.93 |
*Pooled data from all studies except BASE.
†Unless stated otherwise.
‡Patients who checked more than one race category are counted under the individual category according to the minority rule as well as the multiracial category.
§Post hoc analyses.
¶A person having origins in any of the original peoples of North, Central or South America.
**Duration defined as (treatment start date−SLE diagnosis date+1).
††n=2001.
‡‡BASE: per screening SELENA-SLEDAI assessment.
§§n=2000.
BEL, belimumab; IS, immunosuppressant; PBO, placebo; SD, standard deviation; SDI, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index; SLE, systemic lupus erythematosus.