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Taltz ® (ixekizumab) injection
80 mg/mL
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 hypersensitivity reactions with Taltz® (ixekizumab) in pediatric patients?
Ixekizumab is contraindicated in patients with known serious hypersensitivity to ixekizumab or to any of the excipients. In the all exposure population of IXORA-PEDS, 20 (10.2%) patients reported a nonanaphylactic allergic reaction/hypersensitivity TEAE.
Hypersensitivity-Related Label Information
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
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the ixekizumab group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in postmarketing use with ixekizumab. If a serious hypersensitivity reaction occurs, discontinue ixekizumab immediately and initiate appropriate therapy.3
Ixekizumab is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.3
Allergic Reaction/Hypersensitivity Treatment-Emergent Adverse Events in IXORA-PEDS
IXORA-PEDS: Allergic Reaction/Hypersensitivity Treatment-Emergent Adverse Events in the Double-Blind Treatment Period and Combined Treatment Periods provides a summary of allergic reaction/hypersensitivity treatment-emergent adverse events (TEAEs). The study reported no TEAEs of potential anaphylaxis.2
In the double-blind treatment period of IXORA-PEDS, 6 (5.2%) ixekizumab-treated patients and 1 (1.8%) patient in the placebo group reported an allergic reaction/hypersensitivity TEAE.1 No severe or serious allergic reaction/hypersensitivity adverse events (AEs) were reported. No patients discontinued study drug because of an allergic reaction/hypersensitivity AE.4
In the all ixekizumab exposure population through the 108-week final database lock, 20 (10.2%) patients reported a total of 22 allergic reaction/hypersensitivity TEAEs corresponding to an incidence rate of 5.8 per 100 patient-years of exposure. No allergic reaction/hypersensitivity serious AEs were reported. No patients discontinued study treatment because of an allergic reaction/hypersensitivity AE.2,4
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 for allergic reactions/hypersensitivities was 5.6 per 100 patient-years of exposure. These trials reported no confirmed events of anaphylaxis.5
|
12-Week Double-Blind Treatment Period |
Combined Treatment Periods |
|
|
Placebo |
Ixekizumab Q4W |
Total Ixekizumab |
Urticaria |
0 |
2 (1.7) |
5 (2.6) |
Bronchospasm |
0 |
1 (0.9) |
1 (0.5) |
Dermatitis atopic |
0 |
1 (0.9) |
5 (2.6) |
Eczema |
0 |
1 (0.9) |
2 (1.0) |
Rash maculopapular |
0 |
1 (0.9) |
1 (0.5) |
Rash pustular |
1 (1.8) |
0 |
0 |
Dermatitis |
0 |
0 |
2 (1.0) |
Drug eruption |
0 |
0 |
1 (0.5) |
Eye edema |
0 |
0 |
1 (0.5) |
Injection-related reaction |
0 |
0 |
1 (0.5) |
Rash |
0 |
0 |
1 (0.5) |
Skin reaction |
0 |
0 |
1 (0.5) |
Swelling of eyelid |
0 |
0 |
1 (0.5) |
Abbreviation: 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.
Enclosed Prescribing Information
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
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
3Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Griffiths 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