Taltz ® (ixekizumab) injection

80 mg/mL

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How does the pharmacokinetics of Taltz® (ixekizumab) in pediatric patients compare with adult patients?

Observed pharmacokinetic trough concentrations at week 12 in pediatric patients is comparable with trough concentrations at week 12 observed in adult patients treated with ixekizumab every 4 weeks.

US_cFAQ_IXE034_PHARMACOKINETICS_PEDS
US_cFAQ_IXE034_PHARMACOKINETICS_PEDS
en-US

IXORA-PEDS: Pharmacokinetics

IXORA-PEDS is an ongoing, multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the efficacy and safety of ixekizumab in pediatric patients aged 6 to <18 years with moderate-to-severe plaque psoriasis.1

Ixekizumab Trough Concentrations at Week 12

Pediatric patients with psoriasis aged 6 to <18 years were administered ixekizumab at the recommended pediatric dosing regimen for 12 weeks. Patients weighing >50 kg and 25 to 50 kg had a mean±SD steady-state trough concentration of 3.8±2.2 μg/mL and 3.9±2.4 μg/mL, respectively at week 12 (Observed Ixekizumab Trough Concentrations at Week 12). Limited pharmacokinetic data were available in patients weighing <25 kg.2

Observed pharmacokinetic trough concentrations at week 12 in pediatric patients is comparable with the observed trough concentrations at week 12 in adult patients treated with ixekizumab every 4 weeks.3,4

Observed Ixekizumab Trough Concentrations at Week 122,4

Treatment Group

Arithmetic Mean (SD), μg/mL

<25 kg body weight

NAa

25-50 kg body weight

3.9 (2.4)

>50 kg body weight

3.8 (2.2)

Adults 80 mg Q4W

3.5 (2.2)

Abbreviations: NA = not applicable; PK = pharmacokinetic; Q4W = every 4 weeks.

aOnly 2 patients in the <25 kg group had PK samples at week 12 so an arithmetic mean was not calculated.

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1Paller AS, Seyger MMB, Magariños GA, et al; IXORA-PEDS Study Group. Efficacy and safety of ixekizumab in a phase III, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Dermatol. 2020;183(2):231-241. https://doi.org/10.1111/bjd.19147

2Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.

3Jackson K, Chua L, Velez de Mendizabal N, et al; IXORA-PEDS Study Group. Population pharmacokinetic and exposure-efficacy analysis of ixekizumab in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Clin Pharmacol. Published online August 10, 2021. https://dx.doi.org/10.1111/bcp.15034

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: August 16, 2021


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