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Taltz ® (ixekizumab) injection
80 mg/mL
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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%).
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
Double-Blind Treatment Period |
Combined Treatment Periods |
||
Placebo |
Ixekizumab Q4W |
Total Ixekizumab |
|
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
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