Comparison of clinical parameters and drug between patients treated with or without belimumab at first year and last follow-up
Factor . | First year . | Last follow-up . | ||||
---|---|---|---|---|---|---|
Standard therapy . | Belimumab . | P value . | Standard therapy . | Belimumab . | P value . | |
Number of patients | 112 | 112 | 112 | 112 | ||
Laboratory examination | ||||||
Serum creatinine, umol/L | 63.50 [51.75, 91.25] | 64.00 [55.00, 86.75] | 0.392 | 63.00 [54.75, 86.00] | 64.00 [54.00, 86.75] | 0.908 |
eGFR | 107.61 [79.65, 121.11] | 108.07 [78.26, 120.89] | 0.929 | 105.46 [80.61, 119.17] | 108.87 [78.80, 121.20] | 0.390 |
Serum albumin, g/L | 40.55 [36.48, 43.10] | 37.90 [33.48, 40.62] | <0.001 | 40.50 [36.93, 42.73] | 39.10 [35.70, 41.32] | 0.022 |
C3, g/L | 0.93 [0.78, 1.07] | 1.07 [0.89, 1.29] | <0.001 | 1.03 [0.85, 1.17] | 1.03 [0.80, 1.25] | 0.670 |
C4, g/L | 0.18 [0.13, 0.24] | 0.26 [0.19, 0.35] | <0.001 | 0.20 [0.14, 0.30] | 0.26 [0.19, 0.34] | 0.004 |
IgA, g/L | 2.54 [1.94, 3.25] | 2.00 [1.63, 2.77] | 0.001 | 2.47 [2.02, 3.18] | 1.94 [1.59, 2.67] | <0.001 |
IgG, g/L | 12.15 (4.01) | 10.12 (3.45) | <0.001 | 12.32 [10.04, 15.20] | 10.12 [7.96, 12.40] | <0.001 |
IgM, g/L | 0.73 [0.55, 1.09] | 0.58 [0.39, 0.85] | 0.002 | 0.78 [0.50, 1.06] | 0.55 [0.34, 0.84] | <0.001 |
Lupus anticoagulant | 1.15 [1.02, 1.44] | 1.12 [1.03, 1.29] | 0.375 | 1.15 [1.01, 1.33] | 1.16 [1.03, 1.32] | 0.819 |
Proteinuria, g/24h | 0.60 [0.18, 1.77] | 0.55 [0.17, 1.73] | 0.831 | 0.34 [0.13, 0.84] | 0.38 [0.17, 1.49] | 0.294 |
Urine WBC, WBC/ul | 9.00 [4.00, 23.00] | 11.59 [4.00, 39.00] | 0.402 | 13.29 [5.00, 48.61] | 9.00 [3.23, 29.01] | 0.015 |
Urine RBC, RBC/ul | 10.62 [3.50, 21.75] | 7.50 [3.38, 20.00] | 0.343 | 9.00 [4.00, 20.12] | 8.00 [3.00, 19.25] | 0.422 |
Positive ANA | 106 (94.6) | 101 (90.2) | 0.313 | 109 (97.3) | 97 (86.6) | 0.005 |
Positive anti-dsDNA | 50 (44.6) | 48 (42.9) | 0.893 | 53 (47.3) | 50 (44.6) | 0.789 |
Positive anti-Sm | 26 (23.2) | 24 (21.4) | 0.873 | 27 (24.1) | 15 (13.4) | 0.059 |
Positive anti-ssA | 71 (63.4) | 56 (50.0) | 0.059 | 74 (66.1) | 52 (46.4) | 0.005 |
Positive anti-ssB | 17 (15.2) | 13 (11.6) | 0.557 | 28 (25.0) | 14 (12.5) | 0.025 |
Therapy | ||||||
ATM (%) | 77 (68.8) | 71 (63.4) | 0.481 | 65 (58.0) | 61 (54.5) | 0.686 |
AZA (%) | 1 (0.9) | 0 (0.0) | 1.000 | 3 (2.7) | 1 (0.9) | 0.622 |
CNI (%) | 19 (17.0) | 34 (30.4) | 0.027 | 21 (18.8) | 32 (28.6) | 0.115 |
CTX (%) | 1 (0.9) | 5 (4.5) | 0.212 | 1 (0.9) | 3 (2.7) | 0.622 |
LEF (%) | 8 (7.1) | 6 (5.4) | 0.784 | 9 (8.0) | 6 (5.4) | 0.594 |
MMF (%) | 48 (42.9) | 47 (42.0) | 1.000 | 34 (30.4) | 43 (38.4) | 0.260 |
RAASi (%) | 46 (41.1) | 47 (42.0) | 1.000 | 28 (25.0) | 36 (32.1) | 0.301 |
Steroid (%) | 75 (67.0) | 68 (60.7) | 0.404 | 70 (62.5) | 61 (54.5) | 0.278 |
Dosage of steroid, mg/day | 5.00 [0.00, 10.00] | 5.00 [0.00, 10.00] | 0.269 | 5.00 [0.00, 8.12] | 4.38 [0.00, 8.12] | 0.643 |
Factor . | First year . | Last follow-up . | ||||
---|---|---|---|---|---|---|
Standard therapy . | Belimumab . | P value . | Standard therapy . | Belimumab . | P value . | |
Number of patients | 112 | 112 | 112 | 112 | ||
Laboratory examination | ||||||
Serum creatinine, umol/L | 63.50 [51.75, 91.25] | 64.00 [55.00, 86.75] | 0.392 | 63.00 [54.75, 86.00] | 64.00 [54.00, 86.75] | 0.908 |
eGFR | 107.61 [79.65, 121.11] | 108.07 [78.26, 120.89] | 0.929 | 105.46 [80.61, 119.17] | 108.87 [78.80, 121.20] | 0.390 |
Serum albumin, g/L | 40.55 [36.48, 43.10] | 37.90 [33.48, 40.62] | <0.001 | 40.50 [36.93, 42.73] | 39.10 [35.70, 41.32] | 0.022 |
C3, g/L | 0.93 [0.78, 1.07] | 1.07 [0.89, 1.29] | <0.001 | 1.03 [0.85, 1.17] | 1.03 [0.80, 1.25] | 0.670 |
C4, g/L | 0.18 [0.13, 0.24] | 0.26 [0.19, 0.35] | <0.001 | 0.20 [0.14, 0.30] | 0.26 [0.19, 0.34] | 0.004 |
IgA, g/L | 2.54 [1.94, 3.25] | 2.00 [1.63, 2.77] | 0.001 | 2.47 [2.02, 3.18] | 1.94 [1.59, 2.67] | <0.001 |
IgG, g/L | 12.15 (4.01) | 10.12 (3.45) | <0.001 | 12.32 [10.04, 15.20] | 10.12 [7.96, 12.40] | <0.001 |
IgM, g/L | 0.73 [0.55, 1.09] | 0.58 [0.39, 0.85] | 0.002 | 0.78 [0.50, 1.06] | 0.55 [0.34, 0.84] | <0.001 |
Lupus anticoagulant | 1.15 [1.02, 1.44] | 1.12 [1.03, 1.29] | 0.375 | 1.15 [1.01, 1.33] | 1.16 [1.03, 1.32] | 0.819 |
Proteinuria, g/24h | 0.60 [0.18, 1.77] | 0.55 [0.17, 1.73] | 0.831 | 0.34 [0.13, 0.84] | 0.38 [0.17, 1.49] | 0.294 |
Urine WBC, WBC/ul | 9.00 [4.00, 23.00] | 11.59 [4.00, 39.00] | 0.402 | 13.29 [5.00, 48.61] | 9.00 [3.23, 29.01] | 0.015 |
Urine RBC, RBC/ul | 10.62 [3.50, 21.75] | 7.50 [3.38, 20.00] | 0.343 | 9.00 [4.00, 20.12] | 8.00 [3.00, 19.25] | 0.422 |
Positive ANA | 106 (94.6) | 101 (90.2) | 0.313 | 109 (97.3) | 97 (86.6) | 0.005 |
Positive anti-dsDNA | 50 (44.6) | 48 (42.9) | 0.893 | 53 (47.3) | 50 (44.6) | 0.789 |
Positive anti-Sm | 26 (23.2) | 24 (21.4) | 0.873 | 27 (24.1) | 15 (13.4) | 0.059 |
Positive anti-ssA | 71 (63.4) | 56 (50.0) | 0.059 | 74 (66.1) | 52 (46.4) | 0.005 |
Positive anti-ssB | 17 (15.2) | 13 (11.6) | 0.557 | 28 (25.0) | 14 (12.5) | 0.025 |
Therapy | ||||||
ATM (%) | 77 (68.8) | 71 (63.4) | 0.481 | 65 (58.0) | 61 (54.5) | 0.686 |
AZA (%) | 1 (0.9) | 0 (0.0) | 1.000 | 3 (2.7) | 1 (0.9) | 0.622 |
CNI (%) | 19 (17.0) | 34 (30.4) | 0.027 | 21 (18.8) | 32 (28.6) | 0.115 |
CTX (%) | 1 (0.9) | 5 (4.5) | 0.212 | 1 (0.9) | 3 (2.7) | 0.622 |
LEF (%) | 8 (7.1) | 6 (5.4) | 0.784 | 9 (8.0) | 6 (5.4) | 0.594 |
MMF (%) | 48 (42.9) | 47 (42.0) | 1.000 | 34 (30.4) | 43 (38.4) | 0.260 |
RAASi (%) | 46 (41.1) | 47 (42.0) | 1.000 | 28 (25.0) | 36 (32.1) | 0.301 |
Steroid (%) | 75 (67.0) | 68 (60.7) | 0.404 | 70 (62.5) | 61 (54.5) | 0.278 |
Dosage of steroid, mg/day | 5.00 [0.00, 10.00] | 5.00 [0.00, 10.00] | 0.269 | 5.00 [0.00, 8.12] | 4.38 [0.00, 8.12] | 0.643 |
Values for numeric data are presented as mean (standard deviation) or median [interquartile range]; for categorical data, as count (percent).
ANA: antinuclear antibodies; ATM: hydroxychloroquine; AZA: azathioprine; C3: complement factor 3; C4: complement factor 4; CNI: calcineurin inhibitor; CTX: cyclophosphamide; dsDNA: double-stranded DNA; eGFR: estimated glomerular filtration rate; IgA: Immunoglobulin A; IgG: Immunoglobulin G; IgM: Immunoglobulin M; LEF: leflunomide; MMF: mycophenolate mofetil; RAASi: renin-angiotensin-aldosterone system inhibitors; RBC: red blood cells; ssA: Sjögren's-syndrome-related antigen A; ssB: Sjögren's-syndrome-related antigen B; WBC: white blood cells.
Comparison of clinical parameters and drug between patients treated with or without belimumab at first year and last follow-up
Factor . | First year . | Last follow-up . | ||||
---|---|---|---|---|---|---|
Standard therapy . | Belimumab . | P value . | Standard therapy . | Belimumab . | P value . | |
Number of patients | 112 | 112 | 112 | 112 | ||
Laboratory examination | ||||||
Serum creatinine, umol/L | 63.50 [51.75, 91.25] | 64.00 [55.00, 86.75] | 0.392 | 63.00 [54.75, 86.00] | 64.00 [54.00, 86.75] | 0.908 |
eGFR | 107.61 [79.65, 121.11] | 108.07 [78.26, 120.89] | 0.929 | 105.46 [80.61, 119.17] | 108.87 [78.80, 121.20] | 0.390 |
Serum albumin, g/L | 40.55 [36.48, 43.10] | 37.90 [33.48, 40.62] | <0.001 | 40.50 [36.93, 42.73] | 39.10 [35.70, 41.32] | 0.022 |
C3, g/L | 0.93 [0.78, 1.07] | 1.07 [0.89, 1.29] | <0.001 | 1.03 [0.85, 1.17] | 1.03 [0.80, 1.25] | 0.670 |
C4, g/L | 0.18 [0.13, 0.24] | 0.26 [0.19, 0.35] | <0.001 | 0.20 [0.14, 0.30] | 0.26 [0.19, 0.34] | 0.004 |
IgA, g/L | 2.54 [1.94, 3.25] | 2.00 [1.63, 2.77] | 0.001 | 2.47 [2.02, 3.18] | 1.94 [1.59, 2.67] | <0.001 |
IgG, g/L | 12.15 (4.01) | 10.12 (3.45) | <0.001 | 12.32 [10.04, 15.20] | 10.12 [7.96, 12.40] | <0.001 |
IgM, g/L | 0.73 [0.55, 1.09] | 0.58 [0.39, 0.85] | 0.002 | 0.78 [0.50, 1.06] | 0.55 [0.34, 0.84] | <0.001 |
Lupus anticoagulant | 1.15 [1.02, 1.44] | 1.12 [1.03, 1.29] | 0.375 | 1.15 [1.01, 1.33] | 1.16 [1.03, 1.32] | 0.819 |
Proteinuria, g/24h | 0.60 [0.18, 1.77] | 0.55 [0.17, 1.73] | 0.831 | 0.34 [0.13, 0.84] | 0.38 [0.17, 1.49] | 0.294 |
Urine WBC, WBC/ul | 9.00 [4.00, 23.00] | 11.59 [4.00, 39.00] | 0.402 | 13.29 [5.00, 48.61] | 9.00 [3.23, 29.01] | 0.015 |
Urine RBC, RBC/ul | 10.62 [3.50, 21.75] | 7.50 [3.38, 20.00] | 0.343 | 9.00 [4.00, 20.12] | 8.00 [3.00, 19.25] | 0.422 |
Positive ANA | 106 (94.6) | 101 (90.2) | 0.313 | 109 (97.3) | 97 (86.6) | 0.005 |
Positive anti-dsDNA | 50 (44.6) | 48 (42.9) | 0.893 | 53 (47.3) | 50 (44.6) | 0.789 |
Positive anti-Sm | 26 (23.2) | 24 (21.4) | 0.873 | 27 (24.1) | 15 (13.4) | 0.059 |
Positive anti-ssA | 71 (63.4) | 56 (50.0) | 0.059 | 74 (66.1) | 52 (46.4) | 0.005 |
Positive anti-ssB | 17 (15.2) | 13 (11.6) | 0.557 | 28 (25.0) | 14 (12.5) | 0.025 |
Therapy | ||||||
ATM (%) | 77 (68.8) | 71 (63.4) | 0.481 | 65 (58.0) | 61 (54.5) | 0.686 |
AZA (%) | 1 (0.9) | 0 (0.0) | 1.000 | 3 (2.7) | 1 (0.9) | 0.622 |
CNI (%) | 19 (17.0) | 34 (30.4) | 0.027 | 21 (18.8) | 32 (28.6) | 0.115 |
CTX (%) | 1 (0.9) | 5 (4.5) | 0.212 | 1 (0.9) | 3 (2.7) | 0.622 |
LEF (%) | 8 (7.1) | 6 (5.4) | 0.784 | 9 (8.0) | 6 (5.4) | 0.594 |
MMF (%) | 48 (42.9) | 47 (42.0) | 1.000 | 34 (30.4) | 43 (38.4) | 0.260 |
RAASi (%) | 46 (41.1) | 47 (42.0) | 1.000 | 28 (25.0) | 36 (32.1) | 0.301 |
Steroid (%) | 75 (67.0) | 68 (60.7) | 0.404 | 70 (62.5) | 61 (54.5) | 0.278 |
Dosage of steroid, mg/day | 5.00 [0.00, 10.00] | 5.00 [0.00, 10.00] | 0.269 | 5.00 [0.00, 8.12] | 4.38 [0.00, 8.12] | 0.643 |
Factor . | First year . | Last follow-up . | ||||
---|---|---|---|---|---|---|
Standard therapy . | Belimumab . | P value . | Standard therapy . | Belimumab . | P value . | |
Number of patients | 112 | 112 | 112 | 112 | ||
Laboratory examination | ||||||
Serum creatinine, umol/L | 63.50 [51.75, 91.25] | 64.00 [55.00, 86.75] | 0.392 | 63.00 [54.75, 86.00] | 64.00 [54.00, 86.75] | 0.908 |
eGFR | 107.61 [79.65, 121.11] | 108.07 [78.26, 120.89] | 0.929 | 105.46 [80.61, 119.17] | 108.87 [78.80, 121.20] | 0.390 |
Serum albumin, g/L | 40.55 [36.48, 43.10] | 37.90 [33.48, 40.62] | <0.001 | 40.50 [36.93, 42.73] | 39.10 [35.70, 41.32] | 0.022 |
C3, g/L | 0.93 [0.78, 1.07] | 1.07 [0.89, 1.29] | <0.001 | 1.03 [0.85, 1.17] | 1.03 [0.80, 1.25] | 0.670 |
C4, g/L | 0.18 [0.13, 0.24] | 0.26 [0.19, 0.35] | <0.001 | 0.20 [0.14, 0.30] | 0.26 [0.19, 0.34] | 0.004 |
IgA, g/L | 2.54 [1.94, 3.25] | 2.00 [1.63, 2.77] | 0.001 | 2.47 [2.02, 3.18] | 1.94 [1.59, 2.67] | <0.001 |
IgG, g/L | 12.15 (4.01) | 10.12 (3.45) | <0.001 | 12.32 [10.04, 15.20] | 10.12 [7.96, 12.40] | <0.001 |
IgM, g/L | 0.73 [0.55, 1.09] | 0.58 [0.39, 0.85] | 0.002 | 0.78 [0.50, 1.06] | 0.55 [0.34, 0.84] | <0.001 |
Lupus anticoagulant | 1.15 [1.02, 1.44] | 1.12 [1.03, 1.29] | 0.375 | 1.15 [1.01, 1.33] | 1.16 [1.03, 1.32] | 0.819 |
Proteinuria, g/24h | 0.60 [0.18, 1.77] | 0.55 [0.17, 1.73] | 0.831 | 0.34 [0.13, 0.84] | 0.38 [0.17, 1.49] | 0.294 |
Urine WBC, WBC/ul | 9.00 [4.00, 23.00] | 11.59 [4.00, 39.00] | 0.402 | 13.29 [5.00, 48.61] | 9.00 [3.23, 29.01] | 0.015 |
Urine RBC, RBC/ul | 10.62 [3.50, 21.75] | 7.50 [3.38, 20.00] | 0.343 | 9.00 [4.00, 20.12] | 8.00 [3.00, 19.25] | 0.422 |
Positive ANA | 106 (94.6) | 101 (90.2) | 0.313 | 109 (97.3) | 97 (86.6) | 0.005 |
Positive anti-dsDNA | 50 (44.6) | 48 (42.9) | 0.893 | 53 (47.3) | 50 (44.6) | 0.789 |
Positive anti-Sm | 26 (23.2) | 24 (21.4) | 0.873 | 27 (24.1) | 15 (13.4) | 0.059 |
Positive anti-ssA | 71 (63.4) | 56 (50.0) | 0.059 | 74 (66.1) | 52 (46.4) | 0.005 |
Positive anti-ssB | 17 (15.2) | 13 (11.6) | 0.557 | 28 (25.0) | 14 (12.5) | 0.025 |
Therapy | ||||||
ATM (%) | 77 (68.8) | 71 (63.4) | 0.481 | 65 (58.0) | 61 (54.5) | 0.686 |
AZA (%) | 1 (0.9) | 0 (0.0) | 1.000 | 3 (2.7) | 1 (0.9) | 0.622 |
CNI (%) | 19 (17.0) | 34 (30.4) | 0.027 | 21 (18.8) | 32 (28.6) | 0.115 |
CTX (%) | 1 (0.9) | 5 (4.5) | 0.212 | 1 (0.9) | 3 (2.7) | 0.622 |
LEF (%) | 8 (7.1) | 6 (5.4) | 0.784 | 9 (8.0) | 6 (5.4) | 0.594 |
MMF (%) | 48 (42.9) | 47 (42.0) | 1.000 | 34 (30.4) | 43 (38.4) | 0.260 |
RAASi (%) | 46 (41.1) | 47 (42.0) | 1.000 | 28 (25.0) | 36 (32.1) | 0.301 |
Steroid (%) | 75 (67.0) | 68 (60.7) | 0.404 | 70 (62.5) | 61 (54.5) | 0.278 |
Dosage of steroid, mg/day | 5.00 [0.00, 10.00] | 5.00 [0.00, 10.00] | 0.269 | 5.00 [0.00, 8.12] | 4.38 [0.00, 8.12] | 0.643 |
Values for numeric data are presented as mean (standard deviation) or median [interquartile range]; for categorical data, as count (percent).
ANA: antinuclear antibodies; ATM: hydroxychloroquine; AZA: azathioprine; C3: complement factor 3; C4: complement factor 4; CNI: calcineurin inhibitor; CTX: cyclophosphamide; dsDNA: double-stranded DNA; eGFR: estimated glomerular filtration rate; IgA: Immunoglobulin A; IgG: Immunoglobulin G; IgM: Immunoglobulin M; LEF: leflunomide; MMF: mycophenolate mofetil; RAASi: renin-angiotensin-aldosterone system inhibitors; RBC: red blood cells; ssA: Sjögren's-syndrome-related antigen A; ssB: Sjögren's-syndrome-related antigen B; WBC: white blood cells.
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