Table 3. Outcome Parameters of Responders During Follow-Upa,b.
| Parameters | Before treatment | Week 6 | Month 3 | Month 6 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Absolute | Difference (95% CI) | P value | Absolute | Difference (95% CI) | P value | Absolute | Difference (95% CI) | P value | ||
| Clinical status | ||||||||||
| Modified Rankin Scale, median (IQR) | 4 (3 to 5) | 4 (3 to 5) | 0.27 (−0.11 to 0.66) | .28 | 3 (2 to 4) | 0.47 (0.08 to 0.86) | .01 | 3 (2 to 4) | 0.78 (0.39 to 1.18) | <.001 |
| MoCA, median (IQR)a | 17 (3 to 26) | 17 (2 to 27.5) | −1.51 (−4.18 to 1.17) | .44 | 21 (8 to 26) | −2.15 (−4.7 to 0.4) | .12 | 22 (11 to 25) | −3.57 (−6.18 to −0.96) | .01 |
| MRI of the brain | ||||||||||
| T2 lesion load reduction, No./total No. (%) | NA | 5/21 (24) | −0.24 (−0.49 to 0.01) | .07 | 10/18 (56) | −0.29 (−0.56 to −0.02) | .03 | 9/19 (47) | 0.07 (−0.2 to 0.34) | .91 |
| T2 lesion load increase, No./total No. (%) | NA | 8/21 (38) | −0.38 (−0.61 to −0.15) | <.001 | 3/18 (17) | 0.25 (−0.0003 to 0.49) | .05 | 3/19 (16) | −0.002 (−0.25 to 0.25) | >.99 |
| Gd + enhancement present, No./total No. (%) | 9/21 (43) | 10/21 (52) | −0.05 (−0.19 to 0.09) | .8 | 8/18 (44) | 0.12 (−0.04 to 0.26) | .23 | 10/19 (47) | −0.11 (−0.26 to 0.04) | .22 |
| Cerebrospinal fluid | ||||||||||
| Cell count/μL, median (IQR) | 3 (1 to 8) | 2 (1 to 6) | 0.79 − 1.32 to 2.91 | .75 | 2 (1 to 4) | 1.79 (−0.36 to 3.95) | .14 | 2 (1 to 3) | 3.16 (0.97 to 5.36) | .01 |
| Total protein mg/dL, median (IQR) | 469 (415 to 573) | 500 (427 to 563) | 7.48 (−40.53 to 55.48) | .98 | 445 (393 to 555.5) | 22.94 (−25.17 to 71.05) | .59 | 459 (351 to 555) | 41.03 (−7.925 to 89.99) | .13 |
| Albumin ratio, median (IQR) | 7.68 (5.28 to 8.63) | 7.52 (6.25 to 9.40) | −0.09 (−1.140 to 0.97) | >.99 | 6.65 (5.14 to 8.84) | −0.04 (−1.11 to 1.04) | .99 | 6.50 (4.85 to 8.74) | 0.56 (−0.53 to 1.65) | .53 |
| Oligoclonal bands positive | 81 | 86 | −0.05 (−0.33 to 0.23) | .96 | 86 | −0,05 (−0.33 to 0.23) | .96 | 86 | −0.02 (−0.31 to 0.27) | >.99 |
| JCV load, copies/mL, median (IQR) | 1900 (500 to 8228) | 1000 (15 to 3000) | 2488 (−1052 to 6028) | .26 | 167 (0 to 983) | 4056 (449.7 to 7661) | .02 | 300 (0 to 1000) | 5057 (1387 to 8726) | .01 |
| JCV present, PCR positivity, No./total No. (%) | 20/22 (91) | 16/21 (76) | 0.19 (−0.06 to 0.45) | .21 | 13/20 (65) | 0.35 (0.09 to 0.60) | .01 | 10/19 (53) | 0.49 (0.23 to 0.76) | <.001 |
| tTau pg/mL, median (IQR) | 308 (196.5 to 588) | 264 (188 to 549) | −38.40 (−196.9 to 120.1) | .92 | 268 (181 to 344) | 133.3 (−25.56 to 292.2) | .13 | 208 (182.5 to 245) | 148.6 (−14.10 to 311.3) | .08 |
| pNfH pg/mL, median (range) | 1857 (1389 to 3437) | 1614 (1141 to 2489) | 1062 (−559.3 to 2684) | .31 | 1332 (810 to 2137) | 1929 (100.9 to 3756) | .04 | 788 (509 to 1293) | 1703 (−124.9 to 3530) | .08 |
| Virus-specific T cells | ||||||||||
| BKV/JCV-specific T cells detectable, No./total No. (%) | 7/20 (35) | 16/22 (73) | −0.43 (−0.68 to −0.18) | <.001 | 12/18 (66) | −0.24 (−0.51 to 0.02) | .09 | 11/18 (61) | −0.19 (−0.45 to 0.08) | .26 |
| BKV-specific T cells detectable, No./total No. (%) | 3/20 (15) | 11/22 (50) | −0.38 (−0.63 to −0.13) | <.001 | 8/18 (44) | −0.25 (−0.51 to 0.02) | .08 | 4/18 (22) | −0.02 (−0.29 to 0.24) | >.99 |
| JCV-specific T cells detectable, No./total No. (%) | 6/20 (30) | 16/22 (73) | −0.48 (−0.73 to −0.22) | <.001 | 12/18 (66) | −0.29(−0.57 to −0.02) | .03 | 11/18 (61) | .11 | |
| Blood leukocytesa | ||||||||||
| Leukocytes/μL, median (IQR) | 6500 (4075 to 8025) | 5700 (4300 to 7300) | −433.0 (−3078 to 2212) | .97 | 6000 (5100 to 8250) | 789.6 (−1741 to 3320) | .84 | 6850 (4775 to 7700) | 325.6 (−2254 to 2905) | .99 |
| Lymphocytes/μL, median (IQR) | 1038 (580.5 to 2071) | 912 (597.5 to 1812) | −683.7 (−3439 to 2071) | .91 | 1125 (512.5 to 2160) | 259.4 (−2328 to 2847) | .99 | 1036 (677 to 2618) | 1239 (−1430 to 3908) | .6 |
| CD4+ cells/μL, median (IQR) | 241 (132.5 to 526.5) | 287 (62 to 428) | −16.12 (−146.5 to 114.2) | .99 | 289 (99.5 to 588) | −93.17 (−209.7 to 23.41) | .15 | 321 (156 to 374.5) | −32.55 (−158.2 to 93.06) | .89 |
| CD8+ cells/μL, median (IQR) | 280 (153 to 1045) | 262 (119 to 500) | −34.45 (−207.9 to 139.0) | .95 | 416 (115 to 1347) | −36.42 (−191.5 to 118.7) | .92 | 392 (134.5 to 1218) | −46.30 (−213.5 to 120.9) | .87 |
| CD20+ cells/μL, median (IQR) | 70 (1.75 to 302) | 120 (35 to 178) | −937.4 (−3933 to 2058) | .83 | 162 (27.5 to 272) | 151.8 (−2527 to 2831) | .99 | 180 (41 to 466.5) | 1035 (−1852 to 3921) | .76 |
Abbreviations: BKV, BK polyomavirus; JCV, JC polyomavirus; MoCA, Montreal Cognitive Assessment; PCR, polymerase chain reaction; pNfH, phosphorylated neurofilament heavy chain; tTau, total tau protein.
SI conversion factor: To convert leukocytes and lymphocytes to ×109/L, multiply by 0.001.
a
Data not available for all patients. Difference (95% CI) as difference to pretreatment calculation (exception: magnetic resonance imaging of the brain as calculation of difference to previous time point).
b
Clinical and MRI parameters were compared to their pretreatment condition at different time points. Week 6 = median, 44 days (IQR, 41-49 days; minimum to maximum, 29-65 days), month 3 = median, 94 days (IQR, 84-101 days; minimum to maximum, 71-115 days), month 6 = median, 187 days (IQR, 179-195 days; minimum to maximum, 165-281 days).