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  1. Medical Information Right
  2. Immunology Right
  3. Taltz (ixekizumab) injection Right
  4. What is the incidence of injection site reactions with Taltz® (ixekizumab) in pediatric patients?
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Taltz ® (ixekizumab) injection

80 mg/mL

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

What is the incidence of injection site reactions with Taltz® (ixekizumab) in pediatric patients?

In the double-blind treatment period of IXORA-PEDS, a higher percentage of patients in the ixekizumab Q4W group (12.2%) reported at least 1 TEAE of ISR compared with patients in the placebo group (1.8%).

US_cFAQ_IXE040_INJECTION_SITE_REACTIONS_PEDS
US_cFAQ_IXE040_INJECTION_SITE_REACTIONS_PEDS
en-US

Injection Site Reactions in IXORA-PEDS

IXORA-PEDS was a 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.1,2

Prefilled syringes containing ixekizumab or placebo were used in IXORA-PEDS. The 20 and 40 mg lower doses were prepared by qualified study site personnel using a disposable syringe.3

IXORA-PEDS: Injection Site Reactions in the Double-Blind Treatment Period and Combined Treatment Periods Through the 108-Week Final Database Lock provides a summary of injection site reactions (ISRs) in IXORA-PEDS. A higher percentage of patients in the ixekizumab every 4 weeks (Q4W) group reported at least 1 treatment-emergent adverse event of ISR compared with patients in the placebo group during the double-blind treatment period.1

In the double-blind treatment period of IXORA-PEDS, no severe or serious injection site reaction (ISR) adverse events (AEs) were reported. No patients discontinued the study drug because of an ISR AE.1

In the combined treatment periods of IXORA-PEDS through the 108-week final database lock, there were no ISR serious adverse events and no patients discontinued study drug due to an ISR AE.2

Across 17 adult psoriasis trials (N=6892, accounting for 18,025.7 patient-years of total ixekizumab exposure) as of the March 19, 2021 database lock, the incidence rate of ISRs was 5.9 per 100 patient-years of exposure.4

IXORA-PEDS: Injection Site Reactions in the Double-Blind Treatment Period and Combined Treatment Periods Through the 108-Week Final Database Lock1-3


Double-Blind Treatment Period

Combined Treatment Periods
Through Week 108a
 

Placebo
(N=56)
n (%)

Ixekizumab Q4W
(N=115)
n (%)

Total Ixekizumab
(N=196)
n (%)

Injection site reactionsb

1 (1.8)

14 (12.2)

40 (20.4)

Injection site reaction

0

11 (9.6)

33 (16.8)

Injection site pain

1 (1.8)

5 (4.3)

7 (3.6)

Injection site erythema

0

2 (1.7)

5 (2.6)

Injection site pruritus

0

1 (0.9)

2 (1.0)

Injection site hemorrhage

0

1 (0.9)

1 (0.5)

Injection site nodule

0

1 (0.9)

1 (0.5)

Injection site swelling

0

0

1 (0.5)

Abbreviations: MedDRA = Medical Dictionary for Regulatory Activities; PY = patient-years; Q4W = every 4 weeks.

aAll patients who received at least 1 dose of ixekizumab in the induction, maintenance, and extension periods through the 108-week final database lock (342.81 total patient-years of exposure), including patients switched to ixekizumab from placebo or etanercept following the double-blind induction treatment period.

bHigh level MedDRA term.

Enclosed Prescribing Information

TALTZ® (ixekizumab) injection, for subcutaneous administration, Lilly

References

The published reference below is 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

2Paller AS, Seyger MMB, Magariños GA, et al; IXORA-PEDS Investigators. Long-term efficacy and safety of up to 108 weeks of ixekizumab in pediatric patients with moderate to severe plaque psoriasis: the IXORA-PEDS randomized clinical trial. JAMA Dermatol. Published online April 13, 2022. https://dx.doi.org/10.1001/jamadermatol.2022.0655

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

4Griffiths CEM, Gooderham M, Colombel JF, et al. Safety of ixekizumab in adult patients with moderate-to-severe psoriasis: data from 17 clinical trials with over 18,000 patient-years of exposure. Poster presented at: Annual Meeting of the American Academy of Dermatology (AAD); March 25-29, 2022; Boston, MA.

Date of Last Review: April 29, 2022

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