Table 2 Reveglucosidase alfa mean (range) PK parameters in LOPD subjectsa
From: A study on the safety and efficacy of reveglucosidase alfa in patients with late-onset Pompe disease
| Â | 5Â mg/kg | 10Â mg/kg | 20Â mg/kg | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Â | Day 1 | Week 12 | Week 24 | Day 1 | Week 12 | Week 24 | Day 1 | Week 12 | Week 24 |
Mean PK parameter | (n = 3) | (n = 3) | (n = 3) | (n = 3) | (n = 3) | (n = 3) | (n = 10) | (n = 9) | (n = 9) |
Cmax (range), ng/mL | 28,172 (16072–38,300) | 28,829 (20072–38,300) | 14,117 (3084–30,901) | 80,873 (41225–124,800) | 49,843 (3235–76,825) | 55,187 (3451–100,440) | 112,974 (59912–250,500) | 87,182 (25197–171,780) | 126,196 (53246–218,400) |
AUC0-inf (range), ng·h/mL | 32,004 (19865–43,524) | 34,411 (21470–44,478) | 22,343 (4587–52,228) | 109,655 (58114–143,692) | 90,439 (25777–135,436) | 129561b(95030–164,092) | 294,648 (157200–684,264) | 261,255 (90854–417,087) | 361,068 (109285–597,203) |
Vz (range), mL/kg | 66.3 (46.0–105) | 58.7 (38.5–90.6) | 499 (42.3–1083) | 98.4 (55.9–121) | 442 (42.8–1154) | 44.2b(31.8–57.0) | 76.6 (20.8–177) | 95.5 (29.8–180) | 92.2 (12.8–273) |
CL (range), mL/h·kg | 173 (115–252) | 160 (112–233) | 558 (95.7–1090) | 107 (69.6–172) | 184 (73.8–388) | 83.1b(60.9–105) | 84.9 (29.2–127) | 101 (48.0–220) | 73.5 (33.5–183) |
Half-life (range), hours | 0.261 (0.217–0.289) | 0.250 (0.237–0.270) | 0.507 (0.306–0.688) | 0.701 (0.475–1.07) | 1.20 (0.327–2.06) | 0.367b(0.361–0.373) | 0.723 (0.310–2.22) | 0.715 (0.343–1.47) | 0.767 (0.259–1.65) |