Table 1.
Example anakinra dose and exposure values from published literature.
| Reference | Population | N | Dose | Route | AUC0-24h (mg/lxh) | Cmax (mg/l) |
|---|---|---|---|---|---|---|
| Yang B et al. (30) | PD HDx Normal GFR |
10 10 12 |
1 mg/kg | IV | 63.7
a
( ± 9.6) 64.2 a ( ± 14.9) 9.6 ( ± 1.4) |
15.6 ( ± 6.5) 14.5 ( ± 3.3) 22.4 ( ± 4.9) |
| Yang B 2003 (30) | GFR<30 | 12 | 100 mg | SC | 39.4 ( ± 4.3) | 2.2 ( ± 0.7) |
| Yang B et al. (38) | Adults | 7 | 100 mg | IV | 14.7 ( ± 3.4) | 32.2 ( ± 6.4) |
| Galea et al. (27) | Adults, SAH | 29 | 100-500 mg | IV | 34-102.8 (predicted) |
|
| Urien et al. (28) | Children | 87 | 2-10 mg/kg | SC | 9.6 | |
| Study 03-AR-0298 (39) | CAPS | 21 (17 Paed) | Initial: 1 mg/kg Month 3: 1.5 mg/kg Year 3: 3 mg/kg |
SC | 4.4 [1.8-6.9] 7.3 40.8 |
a
AUC0-48h,Target exposure based on pharmacokinetic/pharmacodynamic analysis. Concentration data expressed as mean (± standard deviation, SD) or median [range]. CAPS, cryopyrin-associated auto-inflammatory syndromes; HDx, haemodialysis; PD, peritoneal dialysis; SAH, subarachnoid haemorrhage.