Phoenix winnonlin professional version 6

All PK analyses were conducted on an evaluable PK population (i.e. patients who were compliant with the dosing regimen and the full PK sampling scheme or patients who had at least four of the five serum PK samples and were not missing the last PK sample on day 14). Serum ixekizumab concentration‐time data obtained from individual patients were analyzed using non‐compartmental PK methods (Phoenix WinNonlin Professional version 6.3; Pharsight Corporation, Mountain View, CA, USA). The PK parameters determined for ixekizumab included the maximum plasma concentration (C_max), time to maximum concentration (t_max) and the area under the curve (AUC_0‐tlast) where t_last is the time of the last sample (14 days ± 24 h). The C_max and AUC_0‐tlast were summarized as geometric means and 90% confidence intervals (CIs) for the PFS and autoinjector. The t_max was summarized and reported as median (minimum–maximum) number of days.

Noncompartmental PK parameters such as maximum plasma drug concentration (C_max), t_max, AUC_0‐t, AUC, t_1/2, CL/F, and percentage of AUC due to extrapolation from the time for the last quantifiable concentration to infinity (AUC%extrap) were calculated from the plasma concentration‐time data with Phoenix WinNonlin Professional Version 6.3 (Pharsight, a Certara company, St. Louis, Missouri). Actual sampling times were used in the calculations. Descriptive statistics (sample size, mean, standard deviation, coefficient of variation [CV%], geometric mean, geometric CV%, median, minimum, and maximum) were provided for concentrations at each time point and for all PK parameters.

Noncompartmental PK parameters, such as C_max, time to peak (maximum) plasma drug concentration (t_max), area under the plasma concentration–time curve calculated from time 0 to the last measurable concentration at time t (AUC_0–t), area under the plasma concentration–time curve from time 0 to infinity (AUC_0–∞), t_1/2, CL/F, apparent volume of distribution (Vz/F), and percentage of AUC_0–∞ due to extrapolation from the time for the last quantifiable concentration to infinity (AUC%extrap), were calculated from the plasma concentration–time data with Phoenix™ WinNonlin^® Professional Version 6.3 (Pharsight^®; Certara, St Louis, MO, USA). Actual sampling times were used in the calculations. Descriptive statistics (N, mean, standard deviation [SD], percentage of coefficient of variation [CV%], geometric mean, geometric CV%, median, minimum, and maximum) were provided for concentrations at each time point and for all PK parameters.