Table 1.
Patient characteristics and comparisons between patients who developed at least 1 renal flare and patients who did not from baseline through week 52
| Patient characteristics | All patients (N = 1844) | Renal flare (n = 136) | No renal flare (n = 1708) | P value |
|---|---|---|---|---|
| Demographics | ||||
| Age; mean (SD) | 38.6 (11.8) | 36.7 (11.7) | 38.7 (11.8) | 0.035a |
| Female sex; n (%) | 1769 (96.0) | 132 (97.1) | 1637 (95.8) | 0.642 |
| Ancestries; n (%) | ||||
| Asian | 396 (21.5) | 43 (31.6) | 353 (20.7) | 0.004a |
| Black/African American | 339 (18.4) | 24 (17.6) | 315 (18.4) | 0.908 |
| Indigenous Americanb | 243 (13.2) | 19 (14.0) | 224 (13.1) | 0.879 |
| White/Caucasian | 866 (47.0) | 50 (36.8) | 816 (47.8) | 0.017a |
| Clinical data at baseline | ||||
| SLE duration (yrs); median (IQR) | 4.1 (1.4–9.1); N = 1843 | 3.3 (1.2–8.1) | 4.2 (1.4–9.1); n = 1707 | 0.260 |
| Mean BMI (week 0–52); mean (SD) | 26.3 (6.4); N = 1793 | 25.2 (5.8); n = 126 | 26.3 (6.4); n = 1667 | 0.052 |
| SLEDAI-2K; mean (SD) | 9.6 (3.0) | 9.1 (3.2) | 9.5 (2.9) | 0.031a |
| Extra renal cSLEDAI-2K; mean (SD) | 7.2 (2.9) | 6.5 (3.0) | 7.3 (2.9) | < 0.001a |
| SDI score; median (IQR) | 0.0 (0.0–1.0); N = 1842 | 0.0 (0.0–1.0) | 0.0 (0.0–1.0); n = 1706 | 0.829 |
| SDI score ≥1; n (%) | 675 (36.6); N = 1842 | 49 (36.0) | 626 (36.7); n = 1706 | 0.950 |
| Serological profile at baseline | ||||
| Anti-dsDNA (+); n (%) | 1153 (62.5) | 101 (74.3) | 1052 (61.6) | 0.004a |
| Anti-Sm (+); n (%) | ||||
| at baseline | 348 (24.3); N = 1433 | 31 (33.3); n = 93 | 317 (23.7); n = 1340 | 0.048a |
| ever | 251 (24.5); N = 1435 | 31 (33.3); n = 93 | 320 (23.8); n = 1342 | 0.053 |
| Anti-RNP (+); n (%) | ||||
| at baseline | 206 (29.1); N = 709 | 20 (42.6); n = 47 | 186 (28.1); n = 662 | 0.052 |
| ever | 207 (29.1); N = 712 | 20 (41.7); n = 48 | 187 (28.2); n = 664 | 0.068 |
| Anti-ribosomal P (+); n (%) | ||||
| at baseline | 463 (28.6); N = 1617 | 41 (37.3); n = 110 | 422 (28.0); n = 1507 | 0.049a |
| ever | 463 (28.6); N = 1617 | 41 (37.3); n = 110 | 422 (28.0); n = 1507 | 0.049a |
| aPL (+); n (%) | ||||
| aCL | ||||
| aCL IgA | 34 (1.9); N = 1781 | 6 (4.5); n = 134 | 28 (1.7); n = 1647 | 0.053 |
| aCL IgG | 243 (13.6); N = 1784 | 28 (20.9); n = 134 | 215 (13.0); n = 1650 | 0.015a |
| aCL IgM | 182 (10.2); N = 1784 | 14 (10.4); n = 134 | 168 (10.2); n = 1650 | 1.000 |
| Anti-β2-GPI | ||||
| anti-β2-GPI IgA | 117 (16.4); N = 714 | 12 (25.0); n = 48 | 105 (15.8); n = 666 | 0.142 |
| anti-β2-GPI IgG | 23 (3.2); N=714 | 2 (4.2); n = 48 | 21 (3.2); n = 666 | 1.000 |
| anti-β2-GPI IgM | 49 (6.9); N = 714 | 3 (6.2); n = 48 | 46 (6.9); n = 666 | 1.000 |
| LAC | 134 (19.0); N = 706 | 5 (10.4); n = 48 | 129 (19.6); n = 658 | 0.169 |
| aPL (+) ever | 674 (37.7); N = 1788 | 58 (43.3); n = 134 | 616 (37.2); n = 1654 | 0.195 |
| BAFF (ng/ml); mean (SD) | 1.48 (1.04); N = 1617 | 1.40 (0.89); n = 116 | 1.49 (1.05); n = 1501 | 0.274 |
| Low C3 levels; n (%) | 732 (39.7) | 70 (51.5) | 662 (38.8) | 0.005a |
| Low C4 levels; n (%) | 686 (37.2) | 64 (47.1) | 622 (36.4) | 0.017a |
| Renal markers at baseline | ||||
| Serum albumin (g/l); mean (SD) | 41.51 (3.70) | 40.91 (4.00) | 41.56 (3.67) | 0.045a |
| Serum creatinine (μmol/l); mean (SD) | 66.55 (14.21) | 67.14 (18.09) | 66.51 (13.86) | 0.259 |
| eGFR (ml/min); mean (SD) | 113.32 (35.3); N = 1843 | 111.81 (37.3) | 113.44 (35.1); n = 1707 | 0.732 |
| UPCR (mg/mg); mean (SD) | 0.12 (0.07) | 0.13 (0.08) | 0.12 (0.07) | 0.134 |
| Medications | ||||
| Prednisone equivalent dose during follow-up (mg/d); mean (SD) | 9.95 (7.86) | 12.67 (9.26) | 9.73 (7.70) | < 0.001a |
| Treatment at baseline; n (%) | N = 1633 | n = 118 | n = 1515 | |
| Antimalarial agentsC | 1258 (68.2) | 89 (65.4) | 1169 (68.4) | 0.530 |
| Immunosuppressants | ||||
| Azathioprine | 352 (19.1) | 22 (16.2) | 330 (19.3) | 0.433 |
| Methotrexate | 278 (15.1) | 11 (8.1) | 267 (15.6) | 0.025a |
| Mycophenolic acid | 151 (8.2) | 24 (17.6) | 127 (7.4) | < 0.001a |
| Oral cyclophosphamide | 21 (1.1) | 6 (4.4) | 15 (0.9) | 0.001a |
| Tacrolimus | 40 (2.2) | 2 (1.5) | 38 (2.2) | 0.783 |
| Cyclosporine | 53 (2.9) | 4 (2.9) | 49 (2.9) | 1.000 |
| Leflunomide | 43 (2.3) | 6 (4.4) | 37 (2.2) | 0.169 |
| Trial intervention; n (%) | ||||
| Placebo | 588 (31.9) | 57 (41.9) | 531 (31.1) | 0.012a |
| Belimumab | 1256 (68.1) | 79 (58.1) | 1177 (68.9) | 0.012a |
| IV 1 mg/kg | 311 (16.9) | 13 (9.6) | 298 (17.4) | 0.025a |
| IV 10 mg/kg | 602 (32.6) | 48 (35.3) | 554 (32.4) | 0.556 |
| SC 200 mg | 343 (18.6) | 18 (13.2) | 325 (19.0) | 0.120 |
| Belimumab approved dose; n (%) | 945 (61.6); N = 1533 | 66 (53.7); n = 123 | 879 (62.3); n = 1410 | 0.071 |
(+), positive levels; aCL, anticardiolipin antibodies; anti-β2-GPI, anti-β2-glycoprotein I antibodies; anti-dsDNA, anti-double-stranded DNA antibodies; anti-RNP, anti-ribonucleoprotein antibodies; anti-Sm, anti-Smith antibodies; aPL, antiphospholipid antibodies; BAFF, B cell activating factor belonging to the TNF ligand family; BMI, body mass index; C3, complement component 3; C4, complement component 4; cSLEDAI-2K, clinical SLEDAI-2K; eGFR, estimated glomerular filtration rate; Ig, immunoglobulin; IQR, interquartile range; IV, intravenous; LAC, lupus anticoagulant; SC, subcutaneous; SDI, Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index; SLE, systemic lupus erythematosus; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; UPCR, urinary protein-to-creatinine ratio.
Data are presented as numbers (%) or means (SD). In case of nonnormal distributions, the medians (interquartile range) are indicated. In case of missing values, numbers of patients with available data are indicated.
Statistically significant P values.
Alaska Native or American Indian from North, South or Central America.
Hydroxychloroquine, chloroquine, mepacrine, mepacrine hydrochloride or quinine sulfate.