Background
Methods
Study population
Specimen collection and handling
Chart Abstraction
Clinical findings | At time of enrollment (N =32) |
---|---|
Female (%) | 26 (81.3%) |
Age (years) | 16.0 |
Weight (kg) | 61.5 +/- 20.35 |
Ethnicity (%) | |
African American | 9 (28%) |
Caucasian | 12 (37.5%) |
Hispanic/Other | 11 (34.3%) |
Age at diagnosis of SLE (years) | 13.67 |
Age at enrollment (years) | 16.0 |
Duration of SLE (Months) | 22.9 +/- 20.51 |
New onset SLE (%) | 4 (12.5) |
Lupus nephritis WHO* (%) | |
I | 4 (12.5) |
II | 2 (6.3) |
III | 1 (3.1) |
III/V | 1 (3.1) |
IV | 11 (34.4) |
V | 4 (12.5) |
No renal biopsy | 9 (28.1) |
H/O antiphospholipid syndrome | 1 |
H/O neuropsychiatric manifestation/CNS Lupus | 6 |
H/O Vasculitis | 4 |
H/O Arthritis | 25 |
H/O Serositis | 3 |
H/O Pulmonary hemorrhage | 1 |
H/O Cytopenia | 22 |
H/O Raynaud’s phenomeonoN | 3 |
H/O Positive anti-double stranded DNA | 22 |
Positive ANA | 32 |
Ribonuceloprotein | 21 |
Laboratory findings | At time of enrollment [mean] |
Hemoglobin (g/dl) | 12.40 |
White blood counT (X 109/L) | 5.75 |
Platelet count (X 109/L) | 255 |
Serum creatinine (mg/dl) | 0.64 |
Complement 3 (g/dl) | 110 |
Complement 4 (g/dl) | 19 |
CD3 | 1004 |
CD19 | 0 |
IGG | 820 |
IGA | 128 |
IGM | 29 |
Urinalysis | |
Hematuria (%) | 5 (15.6) |
Proteinuria (%) | 6 (18.75) |
Normal (%) | 21 (65.6) |
Extraction and Purification of DNA from Plasma and Urine
Real-time polymerase chain reaction (RT-PCR)
Statistics
Results
Patient | At enrollment | 3 months | 6 months | 9 months | 12 months | |||||
---|---|---|---|---|---|---|---|---|---|---|
Urine | Blood | Urine | Blood | Urine | Blood | Urine | Blood | Urine | Blood | |
1 | Negative | Negative | Negative | Negative | Negative |
Positive
15.6
| Negative | Negative | n/a | n/a |
2 | Negative | Negative | Negative | Negative | Negative | Negative | n/a | Negative | n/a | Negative |
3 | Negative | Negative | Negative | Negative | n/a |
Positive
30.9
| Negative | Negative | Negative | Negative |
4 | Negative | Negative | Negative | Negative |
Positive
0.03
|
Positive
2.65
| Negative | Negative | Negative | Negative |
b 5 | Negative | Negative | Negative | Negative |
Positive
1.04×10
4
|
Positive
0.68
|
Positive
1.86×10
4
| Negative |
Positive
1.76×10
3
| Negative |
6 | Negative | Negative |
Positive
527
| Negative | Negative |
Positive
4.5
| n/a | n/a | Negative | Negative |
7 | Negative | Negative | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a |
8 | Negative | Negative |
Positive
1.60
| Negative | Negative | Negative | n/a | n/a | Negative | Negative |
b 9 | Negative |
Positive
1.5x10
6
| Negative | Negative | Negative |
Positive
4.3
| Negative | Negative | Negative | Negative |
10 | Negative | Negative | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a |
11 | Negative | Negative | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a |
b 12 | Negative | Negative | n/a | Negative | n/a | n/a | n/a | n/a | n/a | n/a |
b 13 | Negative | Negative |
Positive
563
| n/a | Negative | Negative | n/a | n/a | n/a | n/a |
b 14 | Negative | Negative | Negative | Negative | Negative | Negative | n/a | n/a | n/a | n/a |
c 15 | Negative | Negative | n/a | n/a | n/a | n/a | Negative | Negative | n/a | n/a |
16 | Negative | Negative | n/a | n/a | n/a | n/a | n/a | n/a | Negative | Negative |
17 | Negative | Negative | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a |
18 | Negative | Negative | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a |
b 19 | Negative | Negative | Negative | Negative | Negative | Negative | n/a | n/a | Negative | Negative |
20 | Negative | Negative | Negative | n/a | Negative | Negative | Negative | n/a | n/a | n/a |
21 | Negative | Negative | n/a | n/a | Negative | Negative | n/a | n/a | n/a | n/a |
22 | Negative | Negative | Negative |
Positive
26.5
| Negative | Negative | Negative | Negative | n/a | n/a |
b 23 | Negative | Negative |
Positive
2.47
|
Positive
2.84
| n/a | n/a | n/a | n/a | Negative | Negative |
24 | Negative | Negative | Negative | Negative | Negative | Negative | n/a | n/a | n/a | n/a |
25 | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative |
c 26 |
Positive
0.07
| Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative |
c 27 | Negative |
Positive
33.5
| Negative | n/a | n/a | n/a | n/a | n/a | n/a | n/a |
28 | Negative | Negative | Negative | Negative | Negative | Negative | n/a | n/a | n/a | n/a |
29 | Negative | Negative | n/a | n/a | n/a | n/a | Negative | Negative | n/a | n/a |
30 | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative |
31 | Negative | Negative | Negative | n/a | n/a | n/a | Negative | Negative | n/a | n/a |
32 | Negative | Negative | Negative | Negative | n/a | n/a | n/a | n/a | n/a | n/a |
Positive BKV/Total Samples (%) | 1/32 (3.1%) | 2/32 (6.2%) | 4/22 (18.1%) | 2/19 (10.5%) | 2/18 (11.1%) | 6/19 (31.5%) | 1/13 (7.6%) | 0/13 (0%) | 1/12 (8.3%) | 0/13 (0%) |
Clinical history | Presence of Bk viruria or viremia (N = 12) | Absence of BK viruria or viremia (N = 20) |
P-value |
---|---|---|---|
Median | Median | ||
Age | 15 | 16 | 0.08 |
Female | 9 | 17 | 0.65 |
Male | 3 | 3 | |
Race | 0.79 | ||
Caucasian | 4 | 8 | |
African American | 3 | 6 | |
Other | 5 | 6 | |
SLE WHO Class | 0.75 | ||
I | 2 | 2 | |
II | 1 | 1 | |
III | 0 | 1 | |
III/IV | 1 | 0 | |
IV | 3 | 8 | |
V | 2 | 2 | |
No renal biopsy | 3 | 6 | |
Duration of SLE | 21 | 21 | 0.89 |
Laboratory findings | |||
Serum creatinine | 0.61 | 0.66 | 0.33 |
Hematuria | 1 | 2 | 1.0 |
Proteinuria | 2 | 4 | 1.0 |
Hemoglobin | 12.45 | 12.25 | 0.56 |
Platelet count | 269.5 | 243 | 0.77 |
WBC Count | 5.05 | 5.95 | 0.89 |
C3 | 106 | 113 | 0.77 |
C4 | 18 | 19 | 0.88 |
CD3 | 982 | 1087 | 0.44 |
CD19 | 0 | 0 | 0.23 |
IGG | 796 | 866 | 0.80 |
IGA | 86 | 143 | 0.21 |
IGM | 30 | 29 | 0.88 |
Medication history | |||
Exposure to any biologic a
| 11 | 16 | 0.62 |
1 Biologic | 10 | 13 | |
2 Biologics | 0 | 2 | |
3 OR more biologics | 1 | 1 | |
Exposure to IVIG | 5 | 6 | 0.70 |
Exposure to hydroxychloroquine | 12 | 9 | 0.0016 b
|
Exposure to MMF | 9 | 17 | 0.65 |
Exposure to cyclophosphamide | 3 | 11 | 0.15 |
Exposure to rituximab | 10 | 15 | 0.68 |
Exposure to steroids | 12 | 20 | 1.0 |
Type of biologic exposure | No. of patients [N = 32 (%)] | Overall cumulative dose (grams) [median, range] | Cumulative dose/body weight (mg/kg) [median, range] | # of doses [median, range] | Length of exposure since diagnosis in days [median, range] |
Abatacept | 4 (12.5) | 15.3 (3.6–26.2) | 231.6 (108–375) | 21 (8–28) | 540.5 (169–732) |
Adalimumab | 1 (3.1) | 480 | 10.2 | 12 | 159 |
Belimumab | 3 (9.3) | 3.9 (1–5.3) | 75.5 (18.7–78.1) | 8 (2–8) | 176 (16–235) |
Infliximab | 2 (6.25) | 4.7 | 91.8 | 11.5 | 299 |
Rituximab | 29 (90.6) | 5.0 (1.8–9.9) | 89.1 (18–192.1) | 8 (2–12) | 503 (96-12,226) |
Tocilizumab | 2 (6.25) | 3.4 | 57.9 | 8 | 196.5 |
Ivig (g/kg) | 12 (37.5) | 263.5 (1–14,193) | 6.85 (1–39.8) | 11.5 (1–47) | 241.5 (1-1462) |
Ever received Non-biologics | No. Of patients [N = 32 (%)] | Overall cumulative dose (grams) [median, range] | Cumulative dose/body weight (mg/kg) [median, range] | # of doses [median, range] | Length of exposure since diagnosis in days [median, range] |
Azathioprine | 2 | 37.7 | 790.6 | N/A | 496 |
Cyclophosphamide | 15 (46.8) | 7.1 (4.3–12.7) | 94.6 (40.3–295) | 6 | 148 (84-1152) |
Hydroxy-chloroquine | 25 (78.1) | N/A | N/A | N/A | 536 (72–2801) |
Methotrexate | 4 (12.5) | 1.2 (0.5–2.3) | 20.3 (11.9–42.7) | N/A | 354 (224–1167) |
Mycophenolate | 28 (87.5) | 1109 (128–6751) | 23,680 (1950–400,720) | N/A | 921.5 (38-2261) |
Prednisone | 30 (93.7) | 6.1 (0.1–25.4) | 95.35 (2.3–542.4) | N/A | 525.5 (5-3987) |
Solu-medrol | 32 (100) | 10.4 (3–60) | 158.9 (41–1272) | 16 (3–60) | 547.5 (1-1788) |