Table 1

Patient demographics and clinical characteristics at baseline

Placebo
(n=40)
Belimumab 10 mg/kg intravenous (n=53)
Age 5–11 years, n (%)3 (7.5)10 (18.9)
Age 12–17 years, n (%)37 (92.5)43 (81.1)
Female, n (%)39 (97.5)49 (92.5)
Weight, kg, median (IQR)53.30 (47.1 to 60.0)52.30 (38.7 to 67.0)
Age, years, median (IQR)15.0 (14.00 to 16.00)14.0 (12.00 to 15.00)
Disease duration, years (median, IQR)1.97 (1.30 to 3.57)1.48 (0.79 to 2.46)
SELENA-SLEDAI score, median (IQR)10.0 (8.00 to 12.00)10.0 (8.00 to 12.00)
SELENA-SLEDAI score, n (%)
 ≤1233 (84.6)43 (81.1)
 ≥136 (15.4)10 (18.9)
BILAG 1A or 2B domain score at baseline, n (%)29 (72.5)37 (69.8)
Physician’s Global Assessment of cSLE activity (PGA)*, median (IQR)1.3 (1.07 to 1.73)1.4 (1.05 to 1.50)
Parent-global of patient overall well-being†, median (IQR)5.0 (3.00 to 6.50)4.5 (2.50 to 6.50)
Proteinuria‡, mg/mg, median (IQR)0.12 (0.07 to 0.29)0.13 (0.08 to 0.21)
Anti-dsDNA antibody positive (≥30 IU/mL), n (%)27 (67.5)38 (71.7)
Low complement C3 (<90 mg/dL), n (%)12 (30.0)20 (37.7)
Low complement C4 (<10 mg/dL), n (%)15 (37.5)21 (39.6)
Anti-dsDNA antibody positive and low complement C3 or C4, n (%)17 (42.5)22 (41.5)
PedsQL physical functioning domain score§, median (IQR)64.1 (45.31 to 79.69)59.4 (43.75 to 78.13)
Medication usage; n (%)
 Any systemic corticosteroid¶38 (95.0)50 (94.3)
 Corticosteroid dose, mg/day, median (IQR)**10.00 (7.50 to 16.25)7.50 (5.00 to 10.00)
 Any immunosuppressant††27 (67.5)33 (62.3)
 Antimalarial‡‡31 (77.5)44 (83.0)
 NSAID§§12 (30.0)11 (20.8)
  • *Scale 0 to 3, a lower score indicates better patient well-being.

  • †Scale 0 to 10, a lower score indicates better patient well-being.

  • ‡Estimated by urinary protein/creatinine ratio.

  • §Scale 0 to 100.

  • ¶Corticosteroids (prednisone-equivalent) included: deflazacort, meprednisone, methylprednisolone, prednisolone, prednisone, prednisone acetate.

  • **Calculated for 40 placebo and 53 belimumab patients; 0.00 was imputed for those not receiving corticosteroids at baseline.

  • ††Immunosuppressants included: azathioprine, leflunomide, methotrexate, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, tacrolimus.

  • ‡‡Antimalarials included: chloroquine, hydroxychloroquine and hydroxychloroquine sulphate.

  • §§NSAIDs included: diclofenac, ibuprofen, loxoprofen sodium, meloxicam, naproxen, nimesulide.

  • BILAG, British Isles Lupus Assessment Group; cSLE, childhood-onset systemic lupus erythematosus; dsDNA, double-stranded DNA; NSAID, non-steroidal anti-inflammatory drug; Parent-global, Parent Global Assessment of patient overall well-being; PedsQL, Paediatric Quality of Life inventory generic core scale; PGA, Physician’s Global Assessment of cSLE activity; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index.