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

doi:10.5409/wjcp.v13.i1.89049

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Mar 9, 2024 (publication date) through Apr 30, 2024

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World Journal of Clinical Pediatrics

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Case Control Study

World J Clin Pediatr. Mar 9, 2024; 13(1): 89049
Published online Mar 9, 2024. doi: 10.5409/wjcp.v13.i1.89049

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.

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.

Table 3 Dynamics of the main indicators of the disease activity in studied groups

Reduction since the baseline of	Rituximab (n = 19)	SOCT (n = 60)	P value
Anti-dsDNA, U/L (25%; 75%)	-139.7 (106.4; 374.1)	-129.0 (81.0; 369.4)	0.75
Anti-dsDNA, U/L (25%; 75%)	-93.7 (93.1; 95.0)	-83.7 (63.2; 96.4)	0.29
SLEDAI, points	-19 (17; 23)	-10 (5.0; 15.5)	0.001
SLEDAI, %	86.9 (82.6; 100.0)	77.5 (60.0; 100.0)	0.147
Daily GCS dose, mg/kg	-0.8 (0.6; 0.9)	-0.57 (0.0; 1.0)	0.874
Daily GCS dose, %	-88 (85; 90)	-83.3 (66.7; 94.6)	0.525
Proteinuria, %	-96.7 (91.3; 100)	-100 (72.9; 100)	0.967
Daily proteinuria, g/24 h	-0.83 (0.27; 1.24)	-0.1 (0; 0.34)	0.031
Patients without active LN since BL, %	-7/8 (88)	-12/17 (71)	0.356

Anti-dsDNA: Antibody against double-stained DNA; BL: Baseline; GCS: Glucocorticosteroids; SLEDAI: Systemic lupus erythematosus disease activity index; LN: Lupus nephritis.

Citation: Kalashnikova E, Isupova E, Gaidar E, Sorokina L, Kaneva M, Masalova V, Dubko M, Kornishina T, Lubimova N, Kuchinskaya E, Chikova I, Raupov R, Kalashnikova O, Kostik M. BCD020 rituximab bioanalog compared to standard treatment in juvenile systemic lupus erythematosus: The data of 12 months case-control study. World J Clin Pediatr 2024; 13(1): 89049
URL: https://www.wjgnet.com/2219-2808/full/v13/i1/89049.htm
DOI: https://dx.doi.org/10.5409/wjcp.v13.i1.89049