BCD020 rituximab bioanalog compared to standard treatment in juvenile systemic lupus erythematosus: The data of 12 months case-control study

Table 2 Characteristics of the patients (outcomes) at the end of the study, n (%)

Parameter	RTX (n = 19)	SOCT (n = 60)	P value
Laboratory features
ANA positivity	16 (84)	42 (70)	0.222
ANA level, titer, Me (25%; 75%)	640 (320; 2560)	640 (160; 2560)	0.849
Anti-dsDNA antibodies	3 (16)	26 (43)	0.079
Anti-dsDNA U/L (25%; 75%)	5.1 (0; 12.0)	7.4 (0.6; 57.4)	0.166
Low complement	3 (16)	25 (42)	0.098
Complement C3, g/L, Me (25%; 75%)	0.92 (0.8; 11)	1.07 (0.72; 1.4)	0.409
Complement C4, g/L, Me (25%; 75%)	0.19 (0.14; 0.27)	0.17 (0.12; 0.25)	0.594
Hemoglobine, g/L, Me (25%; 75%)	133 (127; 138)	124 (111; 133)	0.06
Platelets, 109/l, Me (25%; 75%)	276 (240; 306)	269 (215; 335)	0.712
WBC, 109/l, Me (25%; 75%)	4.9 (4.4; 5.8)	5.5 (4,5; 6.5)	0.252
ESR, mm/h, Me (25%; 75%)	6 (2; 20)	7 (2; 18)	0.365
SLE activity
SLEDAI onset score, Me (25; 75%)	3 (0; 4)	2 (0; 4)	0.599
SLEDAI onset, grade			0.804
0 grade	6 (32)	16 (26)
I grade	9 (47)	34 (57)
II grade	4 (21)	9 (15)
III grade	0 (0)	0 (0)
IV grade	0 (0)	1 (2)
Kidney involvement
Hematuria	6/8 (75)	4/17 (24)	0.015
Proteinuria	1/8 (13)	2/17 (12)	0.958
Active nephritis	1/8 (13)	5/17 (29)	0.356
Proteinuria, g/L, Me (25%; 75%)	0.07 (0; 0.1)	0 (0; 0.07)	0.209
Proteinuria, g/24 h, Me (25%; 75%)	0.15 (0.02; 0.3)	0 (0; 0.16)	0.066
Urea, mmol/L, Me (25%; 75%)	3.7 (3.1; 4.4)	3.84 (3.05; 4.66)	0.526
Creatinine, mmol/L, Me (25%; 75%)	0.06 (0.05; 0.07)	0.06 (0.05; 0.07)	0.78
Treatment
GCS, mg/kg, Me (25%; 75%)	0.1 (0.07; 0.15)	0.13 (0; 0.2)	0.569
Hydroxycholoquine	15 (78)	37 (62)	0.167
Mycophenolate mofetil	9 (47)	33 (55)	0.824
Azathioprine	2 (11)	4 (7)
Cyclophosphamide	3 (16)	9 (15)
Cyclosporinе	0 (0)	2 (3)
Methotrexate	1 (5)	7 (12)

Anti-dsDNA: Antibody against double-stained DNA; ANA: Antinuclear antibodies; ESR: Erythrocyte sedimentation rate; GCS: Glucocorticosteroids; SLEDAI: Systemic lupus erythematosus disease activity index; WBC: White blood cells.