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

Table 1 The characteristics of the patients at the time of the start of the treatment, n (%)

Parameter	Rituximab (n = 19)	SOCT (n = 60)	P value
Demography
Sex, male	4 (21)	11 (18)	0.829
Onset age, years, Me (25%; 75%)	14 (12; 16)	12 (10; 14)	0.035
Clinical features
Skin involvement	18 (95)	50 (83)	0.257
Oral mucosa involvement	8 (58)	16 (27)	0.203
Alopecia	3 (16)	16 (27)	0.334
Arthritis	15 (78)	42 (70)	0.449
Pleurisy	6 (32)	8 (12)	0.070
Pericarditis	5 (26)	8 (12)	0.184
Ascitis	3 (16)	3 (5)	0.122
Myocarditis	2 (11)	7 (12)	0.856
CNS involvement	9 (47)	13 (22)	0.030
Splenomegaly	5 (26)	12 (20)	0.560
Hepatomegaly	9 (47)	14 (23)	0.045
Lymphadenopathy	8 (42)	10 (17)	0.022
Lung involvement	3 (16)	3 (5)	0.122
Palmar erythema	5 (26)	5 (8)	0.040
Livedo	3 (16)	5 (8)	0.348
Fever	11 (58)	32 (53)	0.728
Trombosis	1 (5)	3 (5)	0.964
MAS	4 (21)	1 (2)	0.003
Renal involvement
Nephritis	8 (42)	17 (28)	0.081
Kidney biopsy	3/8 (38)	7/17 (42)	0.670
Class of nephritis
I	0 (0)	0 (0)	0.700
II	0 (0)	0 (0)
III	1/3 (33)	3/7 (43)
IV	2/3 (67)	3/7 (43)
V	0 (0)	1/7 (14)
Hematuria	8/8 (100)	17/17 (100)	0.124
Proteinuria	8/8 (100)	17/17 (100)	0.487
Proteinuria, g/L, Me (25%; 75%)	0,31 (0; 0,93)	0,1 (0,0; 0,3)	0.154
Proteinuria, g/24 h, Me (25%; 75%)	0,49 (0,12; 1,2)	0,17 (0,0; 0,3)	0.046
Urea, mmol/L, Me (25%; 75%)	5,8 (4,8; 9,6)	4,2 (3,5; 5,5)	0.003
Creatinine, mcmol/L, Me (25%; 75%)	58 (52; 94)	59 (54; 70)	0.856
GFR, mL/1.73/m2	131 (72,0; 151)	130 (115; 147)	0.077
Decreased GFR	3 (16)	2 (3)	0.052
Dialysis	0 (0)	1 (2)	0.493
Laboratory features
ANA-positivity	19 (100)	52 (87)	0.094
ANA level, titer, Me (25%; 75%)	1920 (1280; 5120)	2560 (640; 10240)	0.859
Anti-dsDNA antibodies	15 (79)	43 (72)	0.532
Anti-dsDNA, U/L (25%; 75%)	102 (12; 150)	63 (14; 237)	0.975
Positive Coombs	11/16 (69)	15/34 (44)	0.104
Low complement	11/14 (79)	15/30 (50)	0.073
Complement C3, g/L, Me (25%; 75%)	0.64 (0.35; 1.0)	0.84 (0.74; 0.94)	0.170
Complement C4, g/L, Me (25%; 75%)	0.1 (0,05; 0,17)	0.12 (0,1; 0,24)	0.610
Anaemia	12 (63)	31/59 (52,5)	0.418
Hemoglobine, g/L, Me (25%; 75%)	111 (98; 129)	111 (100; 126)	0,865
Thrombocytopenia	9 (47)	18 (30)	0.118
Platelets, 109/L, Me (25%; 75%)	232 (189; 285)	269 (178; 328)	0.454
Leucopenia	11 (58)	23 (38)	0.134
WBC, 109/L, Me (25%; 75%)	5.3 (4.2; 11.1)	5.4 (4.2; 8.3)	0.526
Lymphopenia	6 (33)	6 (10)	0.023
ESR, mm/h, Me (25%; 75%)	21 (8; 31)	18 (5; 37)	0.766
C-reactive protein (CRP), mg/L, Me (25%; 75%)	0.7 (0; 2.0)	1.0 (0.2; 3.7)	0.841
SLE activity
SLEDAI onset score, Me (25; 75%)	22 (13; 26)	12 (9; 17)	0.002
SLEDAI onset, grade			0.005
0 grade	0 (0)	0 (0)
I grade	0 (0)	5 (8)
II grade	3 (16)	20 (33)
III grade	5 (26)	25 (42)
IV grade	11 (58)	10 (17)
Treatment
Intravenous corticosteroids	15 (79)	22 (37)	0.002
Corticosteroids, mg/kg, Me (25%; 75%)	1.0 (0.7; 1.0)	1.0 (0.4; 1.0)	0.854
Hydroxycholoquine	9 (47.4)	35/58 (60.3)	0.321
Non-biologic DMARDs	11 (58)	58 (97)	0.00001
Cyclophosphamide	5 (26)	23 (38)	0.340
Other DMARDs	6 (32)	37 (63)	0.054
Mycophenolate mofetil	2 (11)	20 (33)	0.630
Azathioprine	2 (11)	6 (10)
Cyclosporinе	0 (0)	2 (3)
Methotrexat	2 (11)	9 (15)

Anti-dsDNA: Antibody against double-stained DNA; ANA: Antinuclear antibodies; CNS: Central nervous system; DMARD: Disease-modifying anti-rheumatic drugs; ESR: Erythrocyte sedimentation rate; GFR: Glomerular filtration rate; MAS: Macrophage activation syndrome; Me: Median; SLEDAI: Systemic lupus erythematosus disease activity index; SOCT: Standard of care treatment; WBC: White blood cells.