Figures & data
Figure 1. Disposition of study subjects.
a. A subject randomized to the EU-reference product group received the IP allocated to a subject in the AVT02 group due to a dosing error. Therefore, a total of 130 subjects actually received AVT02 and 129 subjects actually received EU-reference product. b. The 2 randomized subjects (1 each in the AVT02 and US-reference product groups) who did not receive the IP discontinued the study.
Table 1. Demographic and baseline characteristics (full analysis set)
Figure 2. Mean serum adalimumab concentrations over time by treatment (semi log; pharmacokinetic population).
Notes: Lower limit of quantification = 7.5 ng/mL.Concentrations reported as below the limit of quantification (<LLOQ) are set to zero for the calculation of summary statistics. Mean concentration values of zero are excluded from printing on log concentration scale.
Table 2. Summary of serum pharmacokinetic parameters for adalimumab by treatment (pharmacokinetic population)
Table 3. Overview of bioequivalence assessment of adalimumab primary pharmacokinetic parameters (pharmacokinetic population)
Table 4. Treatment-emergent adverse events (safety set)
Table 5. Summary of immunogenicity (immunogenicity population)
Supplemental material