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Table 1 Patient demographics and disease characteristics by treatment groups

From: Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus

Patient demographic or disease characteristic Placebo (n = 13) Belimumab
   1.0 mg/kg (n = 15) 4.0 mg/kg (n = 14) 10 mg/kg (n = 14) 20 mg/kg (n = 14) All active (n = 57)
Sex (n [%])       
   Female 11 (85) 15 (100) 13 (93) 12 (86) 13 (93) 53 (93)
   Male 2 (15) 0 1 (7) 2 (14) 1 (7) 4 (7)
Race (n [%])       
   White 10 (77) 7 (47) 3 (21) 8 (57) 7 (50) 25 (44)
   African American 3 (23) 8 (53) 11 (79) 5 (36) 6 (43) 30 (53)
   Asian 0 0 0 1 (7) 1 (7) 2 (4)
Hispanic origin (n [%]) 4 (31) 2 (13) 1 (7) 5 (36) 1 (7) 9 (16)
Age (years; median [range]) 38 (30 to 58) 36 (22 to 56) 48.5 (23 to 62 37 (22 to 61) 38.5 (23 to 80) 39 (22 to 80)
Duration of SLE (years; median [range]) 5.3 (0.4 to 15.3) 3.4 (0.4 to 13) 8.7 (0.4 to 37.7) 6.3 (1.8 to 20.8) 8.0 (0.3 to 29.4) 6.9 (0.3 to 37.7)
SELENA SLEDAI score (median [range]) 4 (0 to 4) 2 (0 to 6) 0 (0 to 5) 2 (0 to 8) 2 (0 to 4) 2 (0 to 8)
ANA ≥1:40 at baseline (n [%]) 12 (92) 13 (87) 14 (86) 13 (93) 13 (93) 53 (93)
Anti-dsDNA antibody (IU/ml; median [range]) 9.5 (4.0 to 162.5) 6.0 (4.0 to 65.5) 4.5 (4.0 to 24.0) 27.0 (4.0 to 257.0) 5.0 (4.0 to 729.0) 6.5 (4.0 to 729.0)
Manifestations at the time of SLE diagnosis (n [%])       
   Antinuclear antibody 13 (100) 14 (93) 14 (100) 14 (100) 13 (93) 55 (97)
   Immunologic disorder 12 (92) 12 (80) 12 (86) 14 (100) 12 (86) 50 (88)
   Arthritis 12 (92) 14 (93) 11 (79) 12 (86) 12 (86) 49 (86)
   Hematologic disorder 7 (54) 14 (93) 9 (64) 7 (50) 8 (57) 38 (67)
   Malar rash 6 (46) 8 (53) 5 (36) 12 (86) 8 (57) 33 (58)
   Photosensitivity 7 (54) 7 (47) 6 (43) 9 (64) 8 (57) 30 (53)
   Serositis 6 (46) 4 (27) 8 (57) 7 (50) 8 (57) 27 (47)
   Oral ulcers 8 (62) 10 (67) 6 (43) 6 (43) 5 (36) 27 (47)
   Renal disorder 4 (31) 2 (13) 4 (29) 6 (43) 4 (29) 16 (28)
   Discoid rash 3 (23) 1 (7) 5 (36) 4 (29) 2 (14) 12 (21)
   Neurologic disorder 0 3 (20) 1 (7) 1 (7) 1 (7) 6 (11)
  1. ANA, antinuclear antibody; SLE, systemic lupus erythematosus; SELENA, Safety of Estrogens in Lupus Erythematosus National Assessment; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index.