Outcomes of a 12-month course of early and late rituximab BCD020 biosimilar administration in juvenile systemic lupus erythematosus: A retrospective study

Table 1 Baseline characteristics of systemic lupus erythematosus patients with early and late rituximab administration

Parameter	ERA, n = 16	LRA, n = 19	P value
ANA positivity	15 (94)	13 (68)	0.075
ANA level, titer, Me (25%; 75%)	1280 (1000; 2560)	320 (0; 5120)	0.077
Anti-dsDNA antibodies	9 (56)	12 (63)	0.678
Anti-dsDNA, mU/L, Me (25%; 75%)	19.0 (0; 81)	46 (6; 158)	0.231
Low complement	9/13 (69)	7/11 (64)	0.772
Complement C3, g/L, Me (25%; 75%)	0.57 (0.4; 0.8)	0.85 (0.7; 1.1)	0.059
Complement C4, g/L, Me (25%; 75%)	0.10 (0.06; 0.14)	0.19 (0.10; 0.24)	0.075
Hemoglobin, g/L, Me (25%; 75%)	108 (91; 131)	115 (108; 128)	0.578
Platelets, 109/L, Me (25%; 75%)	270 (140; 305)	246 (193; 273)	0.606
WBC, 109/L, Me (25%; 75%)	8.4 (5.7; 13.5)	5.1 (3.7; 8.3)	0.035
ESR, mm/h, Me (25%; 75%)	13 (5; 22)	12 (6; 22)	0.921
SLEDAI baseline, score, Me (25; 75%)	22 (15; 26)	10 (6; 16)	0.003
SLEDAI baseline, grade			0.074
0 grade	0 (0)	1 (5)
I grade	0 (0)	3 (16)
II grade	3 (19)	7 (37)
III grade	4 (25)	5 (26)
IV grade	9 (56)	3 (16)
Damage index, Me (25%; 75%)	1 (0; 1)	1 (0; 1)	0.616
Patients with active lupus nephritis	7 (44)	6 (32)	0.458
Proteinuria, g/24 h, Me (25%; 75%)	1.9 (0.5; 6.0)	0.4 (0; 3.8)	0.463
Urea, mmol/L, Me (25%; 75%)	5.8 (4.9; 8.5)	4.6 (3.7; 5.9)	0.077
Creatinine, mmol/L, Me (25%; 75%)	57 (52; 60)	62 (55; 75)	0.160
Corticosteroids, mg/kg, Me (25%; 75%)	1.0 (0.6; 1.0)	0.3 (0.2; 0.8)	0.027

Data are n (%). ANA: Antinuclear antibodies; dsDNA: Double-stained deoxyribonucleic acid; ERA: Early rituximab administration; ESR: Erythrocyte sedimentation rate; LRA: Late rituximab administration; SLEDAI: Systemic Lupus Erythematosus Disease Activity Index; WBC: White blood cells.

Table 2 Characteristics of systemic lupus erythematosus patients with early and late rituximab administration at the end of the study

Parameter	ERA, n = 16	LRA, n = 19	P value
ANA positivity	10 (63)	10 (53)	0.557
ANA level, titer, Me (25%; 75%)	320 (160; 3200)	400 (80; 2560)	0.620
Anti-dsDNA antibodies	1 (6)	5 (26)	0.112
Anti-dsDNA, mU/L, Me (25%; 75%)	5.3 (0; 12)	9 (0; 21)	0.451
Low complement	2/10 (20.0)	3/11 (27.3)	0.696
Complement C3, g/L, Me (25%; 75%)	0.91 (0.7; 1.2)	1.22 (0.9; 1,3)	0.185
Complement C4, g/L, Me (25%; 75%)	0.18 (0.1; 0.3)	0.19 (0.1; 0.3)	0.961
Hemoglobin, g/L, Me (25%; 75%)	133 (130; 139)	130 (110; 134)	0.092
Platelets, 109/L, Me (25%; 75%)	294 (267; 319)	232 (212; 260)	0.004
WBC, 109/L, Me (25%; 75%)	5.1 (4.5; 6.8)	5.2 (3.9; 6.1)	0.659
ESR, mm/h, Me (25%; 75%)	3 (2; 20)	7 (2; 16)	0.535
SLEDAI, score, Me (25; 75%)	2 (0; 4)	2 (0; 6)	1.0
SLEDAI score, grade			0.571
0 grade	5 (31)	7 (37)
I grade	9 (56)	7 (37)
II grade	2 (13)	4 (21)
III grade	0 (0)	0 (0)
IV grade	0 (0)	1 (5)
Damage index	1 (0; 1)	1 (0; 2)	0.874
Patients with active lupus nephritis	4/13 (31)	2 (11)	0.150
Proteinuria, g/24 h, Me (25%; 75%)	0.3 (0; 0.4)	0.07 (0;0.17)	0.427
Urea, mmol/L, Me (25%; 75%)	3.7 (3.0; 4.6)	3.7 (3.2; 4.7)	0.605
Creatinine, mmol/L, Me (25%; 75%)	57 (54; 67)	63 (58; 67)	0.187
Corticosteroids, mg/kg, Me (25%; 75%)	0.1 (0;08; 0.16)	0.1 (0.06; 0.2)	0.842
Patients with prednisolone ≤ 0.2 mg/kg	14 (88)	17 (90)	0.855
Time to prednisolone ≤ 0.2 mg/kg, years, Me (25%; 75%)	1.2 (0.9; 1.4)	2.8 (2.3; 4.0)	0.000001
Safety
Adverse events			0.707
Not reported	13 (82)	16 (84)
Serious adverse events	1 (6)	2 (11)
Frequent respiratory infections	1 (6)	0 (0)
Focal infections	1 (6)	1 (5)
Co-trimoxasol prophylaxis	9 (56)	9 (47)	0.716
Ig G level, g/L, Me (25%; 75%)	9.3 (4.1; 9.7)	8.3 (6.4;12.3)	0.676
Low Immunoglobulin	9/11 (82)	7/10 (70)	0.034
B-lymphocytes depletion	10/10 (100)	5/8 (63)	0.034
Intravenous immunoglobulin	8 (50)	7 (37)	0.433

Data are n (%). ANA: Antinuclear antibodies; dsDNA: Double-stained deoxyribonucleic acid; ERA: Early rituximab administration; ESR: Erythrocyte sedimentation rate; LRA: Late rituximab administration; SLEDAI: Systemic Lupus Erythematosus Disease Activity Index; WBC: White blood cells.