Table 1.
Cynomolgus dosing and administration route groups.
Fig 1.
Mean serum and CSF I2S concentration-time profiles with 0.5 mg/kg idursulfase intravenous dose.
Error bars represent standard deviation.CM, cisterna magna; CSF, cerebrospinal fluid; I2S, iduronate-2-sulfatase; IT-L, intrathecal lumbar.
Table 2.
Comparisons of serum I2S pharmacokinetic parameters after 4 different idursulfase treatments.
Fig 2.
Mean intravenous and IT-L serum I2S concentration-time profiles.
Error bars represent standard deviation.I2S, iduronate-2-sulfatase; IT-L, intrathecal lumbar; IV, intravenous.
Table 3.
CSF pharmacokinetic parameters of idursulfase IV and IT at CM level.
Table 4.
CSF pharmacokinetic parameters of idursulfase IV and IT at lumbar level.
Fig 3.
Proportional relationship between idursulfase-IT dose and CSF I2S AUCinf and Cmax.
AUCinf, area under the serum concentration-time curve extrapolated to infinity; Cmax, maximum observed concentration; CSF, cerebrospinal fluid; I2S, iduronate-2-sulfatase.
Fig 4.
Mean CSF I2S concentration-time profiles.
After intravenous and IT-L dosing, mean CSF I2S concentration-time profiles were determinedwith CSF sampled at the CM level (A) and at the IT-L level (B). Error bars represent standard deviation. CSF, cerebrospinal fluid; I2S, iduronate-2-sulfatase; IT-L, intrathecal lumbar; IV, intravenous.
Table 5.
Bioavailability and exposure fraction (AUCinf) of I2S in the serum and CSF after IT-L dosing.