Outcomes of pregnancies from the tildrakizumab phase I–III clinical development programme.

Autor: Haycraft, K., DiRuggiero, D., Rozzo, S.J., Mendelsohn, A.M., Bhutani, T.
Předmět:
Zdroj: British Journal of Dermatology; Jul2020, Vol. 183 Issue 1, p184-186, 3p
Abstrakt: Dear Editor, Approximately 50% of patients with psoriasis are female, the majority of whom are of childbearing potential.[1] Tildrakizumab, a high-affinity, humanized, immunoglobulin (Ig)G1 , anti-interleukin-23p19 monoclonal antibody, demonstrated efficacy in treatment of moderate-to-severe chronic plaque psoriasis and was well tolerated in clinical studies.[[2]] IgG antibodies are actively transported across the placental barrier via placental Fc receptors, beginning at approximately gestational week 13.[4] The plasma half-life of tildrakizumab after subcutaneous administration is approximately 25 days;[5] therefore, tildrakizumab administered even in the first trimester may cross the placental barrier. The longest duration was for a patient whose last dose was on day 1196; this patient's full dose history was not reported (Table). These data are consistent with preclinical studies in pregnant cynomolgus monkeys, in which tildrakizumab showed no treatment-related adverse outcomes even at fetal serum concentrations many times higher than the week 16 steady-state serum concentrations observed in humans following treatment with tildrakizumab 100 mg, which ranged from 1-22 ± 0-94 g mL SP -1 sp to 1-47 ± 1-12 g mL SP -1 sp .[6] The present study adds to the existing evidence on the outcomes of biologic treatment of psoriasis during pregnancy. [Extracted from the article]
Databáze: Complementary Index