Tildrakizumab, a novel anti-IL-23 monoclonal antibody, is unaffected by ethnic variability in Caucasian, Chinese, and Japanese subjects.

Article Details

Citation
Copy to clipboard

Zandvliet A, Glasgow S, Horowitz A, Montgomery D, Marjason J, Mehta A, Xu C, van Vugt M, Khalilieh S

Tildrakizumab, a novel anti-IL-23 monoclonal antibody, is unaffected by ethnic variability in Caucasian, Chinese, and Japanese subjects.

Int J Clin Pharmacol Ther. 2015 Feb;53(2):139-46. doi: 10.5414/CP202176.

PubMed ID
25546162 [ View in PubMed
]
Abstract

OBJECTIVE: To evaluate the effect of ethnicity on the pharmacokinetics (PK) of tildrakizumab, a novel anti-IL-23 monoclonal antibody for the treatment of psoriasis. MATERIALS AND METHODS: This was an open-label, 2-part study in healthy adult subjects. In part 1, Japanese subjects and matched Caucasian and Chinese subjects (to Japanese) were assigned to 1 of 3 cohorts and administered tildrakizumab 50, 200, or 400 mg subcutaneously (SC). In part 2, Japanese subjects received tildrakizumab 10 mg/kg IV. Pre- and post-treatment antidrug antibodies were assessed. Safety and tolerability were assessed throughout the study. RESULTS: 59 subjects were enrolled; 53 in part 1 and 6 in part 2. Overall geometric mean AUCinfinity was 6.15, 6.05, and 6.32 dayxmug/mL/mg in Japanese, Caucasian, and Chinese subjects, respectively, after administration of a single SC dose. Bioavailability was ~92%. Six out of 58 evaluable subjects were positive for post-treatment ADA; 2 of these positive subjects had reduced tildrakizumab exposure. Most AEs were mild in intensity and the most frequent treatment-related AEs were injection site hematoma (15%), injection site pain (10%), and injection site erythema (8%). CONCLUSIONS: The pharmacokinetics of tildrakizumab were similar in Japanese, Caucasian, and Chinese subjects. Tildrakizumab exposure increased proportionally with dose in the range of 50-400 mg. A single SC dose of 50, 200, and 400 mg or a single IV dose of 10 mg/kg was generally well tolerated.

DrugBank Data that Cites this Article

Drugs