Baseline characteristics of BLISS-52 and BLISS-76 SRI responders and non-responders
| Responders (n=761) | Non-responders (n=923) | All patients (n=1684) | |
|---|---|---|---|
| Demographics | |||
| Women, n (%) | 718 (94.3) | 867 (93.9) | 1585 (94.1) |
| Mean age±SD, y | 37.3±11.4 | 38.2±11.6 | 37.8±11.5 |
| Treatment assignment, n/N (%) | |||
| Placebo | 218/562 (38.8) | 344/562 (61.2) | NA |
| Belimumab 1 mg/kg | 258/559 (46.2) | 301/559 (53.8) | NA |
| Belimumab 10 mg/kg | 285/563 (50.6) | 278/563 (49.4) | NA |
| Baseline SLE characteristics | |||
| Mean SELENA-SLEDAI score±SD | 10.5±3.4§ | 9.1±3.9 | 9.7±3.8 |
| ≥10, n (%) | 483 (63.5)§ | 395 (42.8) | 878 (52.1) |
| BILAG scores, n (%) | |||
| ≥1 A or 2 B | 493 (64.8)+ | 531 (57.5) | 1024 (60.8) |
| ≥1 A | 125 (16.4) | 138 (15.0) | 263 (15.6) |
| ≥1 B | 714 (93.8)§ | 812 (88.0) | 1526 (90.6) |
| No A or B | 47 (6.2)§ | 111 (12.0) | 158 (9.4) |
| Mean PGA score±SD | 1.5±0.5+ | 1.4±0.5 | 1.4±0.5 |
| Mean SLICC damage index±SD | 0.7±1.1+ | 0.9±1.3 | 0.8±1.2 |
| Mean proteinuria±SD, g/24 h | 0.44±0.84 | 0.53±0.99 | 0.49±0.93 |
| Anti-dsDNA ≥30 IU/mL, n (%) | 517 (67.9)# | 651 (70.5) | 1168 (69.4) |
| ANA ≥1:80, n (%) | 696 (91.5) | 870 (94.2) | 1566 (93.0) |
| Mean IgG±SD, g/L | 16.6±6.0 | 16.4±6.2 | 16.5±6.1 |
| >16.2 g/L, n (%) | 358 (47.0) | 386 (41.8) | 744 (44.2) |
| Low C3 (<90 mg/dL), n (%) | 311 (40.9)# | 447 (48.4) | 758 (45.0) |
| Low C4 (<16 mg/dL), n (%) | 395 (51.9)§ | 549 (59.5) | 944 (56.1) |
| Corticosteroid use, n (%) | 668 (87.8) | 785 (85.0) | 1453 (86.3) |
| >7.5 mg/d, n (%) | 471 (61.9)+ | 505 (54.7) | 976 (58.0) |
| Immunosuppressant use, n (%) | 323 (42.4)§ | 497 (53.8) | 820 (48.7) |
| Baseline HRQoL | |||
| Mean SF-36 PCS±SD | 39.6±9.2* | 38.6±10.0 | 39.1±9.7 |
| Mean SF-36 MCS±SD | 40.6±10.9 | 41.0±11.6 | 40.8±11.3 |
| Mean FACIT-Fatigue score±SD | 30.9±11.5* | 29.4±12.1 | 30.1±11.9 |
*p<0.05; +p<0.01; #p<0.001; §p<0.0001 (note: p values represent comparison between responders and non-responders from the likelihood ratio test for categorical data and from the t-test for continuous variables).
ANA, antinuclear antibody; anti-dsDNA, antidouble-stranded DNA; BILAG, British Isles Lupus Assessment Group; C, complement; FACIT, Functional Assessment of Chronic Illness Therapy; HRQoL, health-related quality of life; IgG, immunoglobulin-G; MCS, Mental Component Summary; NA, not applicable; PCS, Physical Component Summary; PGA, Physician's Global Assessment; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index; SF-36, Medical Outcomes Survey Short Form; SLE, Systemic Lupus Erythematosus; SLICC, Systemic Lupus International Collaborating Clinics; SRI, SLE Responder Index.