Table 3.
Demographics and clinical characteristics of asymptomatic and symptomatic PML patients
Asymptomatic PML patients (n = 30) | Symptomatic PML patients1 (n = 342) | All PML patients (n = 372) | |
---|---|---|---|
Age at diagnosis, years | |||
Mean | 42.7 | 45.1 | 44.9 |
Median (range) | 43.5 (22–61) | 45.0 (14–73) | 45.0 (14–73) |
(n = 30) | (n = 337) | (n = 367) | |
Female, n (%) | 21 (70.0) | 242 (70.8) | 263 (70.7) |
Weight, kg | |||
Mean | 68.7 | 75.4 | 75.1 |
Median (range) | 65 (50–98) | 68 (46–163) | 68 (46–163) |
(n = 12) | (n = 142) | (n = 154) | |
Duration of MS at diagnosis, years | |||
Mean | 12.1 | 14.1 | 13.8 |
Median (range) | 12.0 (4–29) | 12.5 (1–51) | 12.0 (1–51) |
(n = 19) | (n = 120) | (n = 139) | |
Natalizumab exposure, months | |||
Mean | 40.6 | 39.8 | 39.9 |
Median (range) | 40.5 (24–94) | 40.0 (8–77) | 39.5 (8–94) |
(n = 30) | (n = 342) | (n = 372) | |
Prior IS use, yes, % | 23.3 | 28.1 | 27.7 |
EDSS score on natalizumab pre-PML | |||
Mean | 3.2 | 3.8 | 3.7 |
Median (range) | 3.0 (1–6.0) | 4.0 (0–8.5) | 3.5 (0–8.5) |
(n = 18) | (n = 172) | (n = 190) | |
KPS score on natalizumab pre-PML | |||
Mean | 85.0 | 80.2 | 80.6 |
Median (range) | 90.0 (60–100) | 80.0 (40–100) | 80.0 (40–100) |
(n = 10) | (n = 112) | (n = 122) | |
Time to PML diagnosis2, days | |||
Mean | 37.6 | 44.6 | NA |
Median (range) | 12 (0–168) | 28 (0–368) | |
(n = 30) | (n = 330) | ||
CSF JCV DNA3, copies/mL | |||
Mean | 277,000 | 185,000 | 192,000 |
Median (range) | 668 (12–4,970,000) | 510 (1–10,200,000) | 510 (1–10,200,000) |
(n = 24) | (n = 289) | (n = 313) | |
Geography, n (%) | |||
United States | 4 (13.3) | 123 (36.0) | 127 (34.1) |
Rest of world | 26 (86.7) | 219 (64.0) | 245 (65.9) |
CSF, cerebrospinal fluid; EDSS, Expanded Disability Status Scale; IS, immunosuppressant; JCV, JC virus; KPS, Karnofsky Performance Scale; MS, multiple sclerosis; NA, not applicable; PML, progressive multifocal leukoencephalopathy.
Two Crohn’s disease patients are included.
Time from first suspect MRI (for asymptomatic patients) or PML symptom (for symptomatic patients) to PML diagnosis date, defined as first positive JCV DNA in CSF or positive brain biopsy.
First positive test.