Table 3.
JCV load and STRATIFY JCV® of RRSM patients with the number of natalizumab infusions ranging from 4 to 12 (<12 months)
| Pt (n) | Pt JCV DNA+ (n)b | Pt JCV DNA− (n)b | Urine | Plasma | PBMC | RR (IC 95 %) p valued | |||
|---|---|---|---|---|---|---|---|---|---|
| JCV+ /JCV− | log10 gEq/mL (range)c | JCV+ /JCV− | log10 gEq/mL (range)c | JCV+/JCV− | log10 gEq/106 c (range)c | ||||
| STRATIFY JCV®a positive | |||||||||
| 13 | 5 | 8 | 12/15 | 5.33 (2–6.01) | 2/27 | 2.42 (1.61–2.69) | 3/26 | 1.95 (1–2.66) | 2.40 (1.52–3.80) p = 0.0012 |
| STRATIFY JCV®a negative | |||||||||
| 17 | 3 | 14 | 2/30 | 5.74 (3.77–6.04) | 1/33 | 1.86 | 1/33 | 1.11 | |
| Total (n) | 8/30 | 22/30 | 14/45 | 5.33 (2–6.04) | 3/60 | 1.86 (1.61– 2.69) | 4/59 | 1.53 (1–2.66) | |
| RR (IC 95 %) | 2.57 (1.61–4.09) | ||||||||
| p valued | p = 0.0006 | ||||||||
p = 0,0012: cases of JCV DNA in urine are statistically associated with a positive STRATIFY JCV® at t3 compared to cases of JCV DNA in plasma
p = 0,0006: statistical significant association between number of JCV DNA positive urine samples and positive STRATIFY JCV® at t3 compared to number of JCV DNA positive urine samples and a negative STRATIFY JCV® at t3
n number of patients, Pt patients
aSTRATIFY JCV®: 2-step virus-like particle-based enzyme-linked immunosorbent assay (ELISA) was performed t3, to detect specific anti-JC virus antibodies in serum
bPt JCV DNA+ and Pt JCV DNA−: number of patients with or without JCV DNA in at least 1 sample of plasma and/or PBMC and/or urine
cJCV loads values were expressed as median (range) of log10 genome equivalent (gEq)/mL in urine and in plasma, and as median (range) log10 gEq/106 cells in PBMCs (gEq/106 c)
dRelative risk (RR) and 95 % confidence interval (95 % CI) statistically significant with a p value <0.05 by χ 2 test