Case Control Study
Copyright ©The Author(s) 2024.
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, male4 (21)11 (18)0.829
Onset age, years, Me (25%; 75%)14 (12; 16)12 (10; 14)0.035
Clinical features
Skin involvement18 (95)50 (83)0.257
Oral mucosa involvement8 (58)16 (27)0.203
Alopecia3 (16)16 (27)0.334
Arthritis15 (78)42 (70)0.449
Pleurisy6 (32)8 (12)0.070
Pericarditis5 (26)8 (12)0.184
Ascitis3 (16)3 (5)0.122
Myocarditis2 (11)7 (12)0.856
CNS involvement9 (47)13 (22)0.030
Splenomegaly5 (26)12 (20)0.560
Hepatomegaly9 (47)14 (23)0.045
Lymphadenopathy8 (42)10 (17)0.022
Lung involvement3 (16)3 (5)0.122
Palmar erythema5 (26)5 (8)0.040
Livedo3 (16)5 (8)0.348
Fever11 (58)32 (53)0.728
Trombosis1 (5)3 (5)0.964
MAS4 (21)1 (2)0.003
Renal involvement
Nephritis8 (42)17 (28)0.081
Kidney biopsy3/8 (38)7/17 (42)0.670
Class of nephritis
I0 (0)0 (0)
0.700
II0 (0)0 (0)
III1/3 (33)3/7 (43)
IV2/3 (67)3/7 (43)
V0 (0)1/7 (14)
Hematuria8/8 (100)17/17 (100)0.124
Proteinuria8/8 (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/m2131 (72,0; 151)130 (115; 147)0.077
Decreased GFR3 (16)2 (3)0.052
Dialysis0 (0)1 (2)0.493
Laboratory features
ANA-positivity19 (100)52 (87)0.094
ANA level, titer, Me (25%; 75%)1920 (1280; 5120)2560 (640; 10240)0.859
Anti-dsDNA antibodies15 (79)43 (72)0.532
Anti-dsDNA, U/L (25%; 75%)102 (12; 150)63 (14; 237)0.975
Positive Coombs11/16 (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
Anaemia12 (63)31/59 (52,5)0.418
Hemoglobine, g/L, Me (25%; 75%)111 (98; 129)111 (100; 126)0,865
Thrombocytopenia9 (47)18 (30)0.118
Platelets, 109/L, Me (25%; 75%)232 (189; 285)269 (178; 328)0.454
Leucopenia11 (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
Lymphopenia6 (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, grade0.005
0 grade0 (0)0 (0)
I grade0 (0)5 (8)
II grade3 (16)20 (33)
III grade5 (26)25 (42)
IV grade11 (58)10 (17)
Treatment
Intravenous corticosteroids15 (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
Hydroxycholoquine9 (47.4)35/58 (60.3)0.321
Non-biologic DMARDs11 (58)58 (97)0.00001
Cyclophosphamide5 (26)23 (38)0.340
Other DMARDs6 (32)37 (63)0.054
Mycophenolate mofetil2 (11)20 (33)0.630
Azathioprine2 (11)6 (10)
Cyclosporinе0 (0)2 (3)
Methotrexat2 (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 positivity16 (84)42 (70)0.222
ANA level, titer, Me (25%; 75%)640 (320; 2560)640 (160; 2560)0.849
Anti-dsDNA antibodies3 (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 complement3 (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, grade0.804
0 grade6 (32)16 (26)
I grade9 (47)34 (57)
II grade4 (21)9 (15)
III grade0 (0)0 (0)
IV grade0 (0)1 (2)
Kidney involvement
Hematuria6/8 (75)4/17 (24)0.015
Proteinuria1/8 (13)2/17 (12)0.958
Active nephritis1/8 (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
Hydroxycholoquine15 (78)37 (62)0.167
Mycophenolate mofetil9 (47)33 (55)0.824
Azathioprine2 (11)4 (7)
Cyclophosphamide3 (16)9 (15)
Cyclosporinе0 (0)2 (3)
Methotrexate1 (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.