Pharmacokinetics and immunogenicity
The maximal mean serum concentration of brazikumab (209 μg/mL) was observed after the end of the second infusion of 700 mg at week 4. Trough levels during the SC administration open-label period (determined at 24 and 112 weeks) were generally comparable (mean values ranging from 14.5 to 22.4 μg/mL) and similar to the mean pre-dose concentration at week 12 (16.7 μg/mL) at the end of the IV induction period. Trough serum concentrations at week 24 and 112 in patients who had initially received 700 mg IV doses during the induction period were similar to those who initially received placebo (15.1 μg/mL vs 14.5 μg/mL, and 22.4 μg/mL vs 18.3 μg/mL, respectively) (Fig. Individual serum concentration–time profiles of brazikumab. IV, intravenous; Q4W, every 4 weeks; SC, subcutaneous