Taltz ® (ixekizumab) injection

80 mg/mL

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TALTZ® (ixekizumab): Pharmacokinetics in Pediatric Psoriasis

Observed PK trough concentrations at week 12 in pediatric patients is comparable to the adult ixekizumab Q4W observed trough concentrations at week 12.

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 psoriasis patients (6 to <18 years of age) 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 at week 12, respectively (Observed Ixekizumab Trough Concentrations at Week 12). There were limited PK data in patients weighing <25 kg.2

Observed PK trough concentrations at week 12 in pediatric patients is comparable to the adult ixekizumab Q4W observed trough concentrations at week 12.3

Observed Ixekizumab Trough Concentrations at Week 122,3

Treatment Group

Arithmetic Mean (SD)

<25 kg

NAa

25-50 kg

3.9 (2.4)

>50 kg

3.8 (2.2)

Adults 80 mg Q4W

3.5 (2.2)

Abbreviations: NA = not applicable; PK = pharmacokinetics; 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

1Paller AS, Seyger MMB, Magariños GA, et al. Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in pediatric patients with moderate-to-severe plaque psoriasis. Talk presented at: 28th Annual Meeting of the European Academy of Dermatology and Venereology; October 9-13, 2019; Madrid, Spain.

2Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

PK = pharmacokinetics

Q4W = every 4 weeks

Date of Last Review: January 06, 2020


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