Table 2.
Overview of PK Parameters of Dupilumab Following a Single SC Dose via the AI and the PFS‐S
| Parameter (Units) | |||
|---|---|---|---|
| Cmax (mg/L) Mean ± SD (Geometric Mean) | tmax (Day) Median (Min‐Max) | AUClast (mg • day/L) Mean ± SD (Geometric Mean) | |
|
Dupilumab 200 mg AI [test] (n = 64) |
21.7 ± 6.83 (20.5) |
3.00 (2.96–7.02) |
311 ± 118 a (284) |
|
Dupilumab200 mg PFS‐S [reference] (n = 64) |
20.3 ± 7.22 (18.9) |
3.00 (2.92‐7.06) |
284 ± 121 b (256) |
|
Geometric mean (ANOVA) ratio 200 mg AI versus 200 mg PFS‐S Point estimate (90%CI) |
1.08 (0.97–1.21) | 1.11 (0.96–1.28) | |
AI, autoinjector; ANOVA, analysis of variance; AUClast, area under the serum concentration–time curve until the last quantifiable concentration; Cmax, maximum serum concentration; PFS‐S, prefilled syringe with a needle shield; PK, pharmacokinetics; SC, subcutaneous; SD, standard deviation; tmax, time to maximum serum concentration.
n = 62 AUClast was not reported for 2 participants due to early discontinuation (missing samples at the last 3‐4 time points).
n = 63 AUClast was not reported for 1 participant due to missing samples on days 11 and 15.