Taltz ® (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

How often did hypersensitivity reactions occur in pediatric psoriasis with Taltz® (ixekizumab) treatment?

In the all exposure population of IXORA-PEDS, 16 (8.2%) patients reported a nonanaphylactic allergic reaction/hypersensitivity treatment-emergent adverse event.

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Hypersensitivity-Related Label Information

Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported.  If a serious hypersensitivity reaction occurs, administration of ixekizumab should be discontinued immediately and appropriate therapy initiated.1

Ixekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients (Sodium citrate, Citric acid Anhydrous, Sodium chloride, Polysorbate 80, Water for injections).1

Allergic Reaction/Hypersensitivity Treatment-Emergent Adverse Events in IXORA-PEDS

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.2

A summary of allergic reaction/hypersensitivity TEAEs are provided in IXORA-PEDS: Allergic Reaction/Hypersensitivity Treatment-Emergent Adverse Events in the Double-Blind Treatment Period and Combined Treatment Periods. All TEAEs were nonanaphylactic in nature.3

In the double-blind treatment period of IXORA-PEDS, 6 (5.2%) ixekizumab-treated patients and 1 (1.8%) patient in the placebo arm reported an allergic reaction/hypersensitivity TEAE. There were no severe or serious allergic reaction/hypersensitivity AEs.  No patients discontinued study drug due to an allergic reaction/hypersensitivity AE.3

In the all ixekizumab exposure population, as of the November 25, 2019 database lock, 16 (8.2%) patients reported a total of 17 allergic reaction/hypersensitivity TEAEs. There were no allergic reaction/hypersensitivity SAEs. No patients discontinued study treatment due to an allergic reaction/hypersensitivity AE.3

Across 14 pooled psoriasis trials including 13 adult trials and IXORA-PEDS (N=6091, accounting for 17,499.3 PYs of total ixekizumab exposure),

  • there were no confirmed cases of anaphylaxis, and
  • the IR of hypersensitivity was 5.1 per 100 PYs.3
IXORA-PEDS: Allergic Reaction/Hypersensitivity Treatment-Emergent Adverse Events in the Double-Blind Treatment Period and Combined Treatment Periods3

 

12-Week Double-Blind Treatment Period

Combined Treatment Periods
Through November 25, 2019a 

 

Placebo
N=56
n (%)

Ixekizumab Q4W
N=115
n (%)

Total Ixekizumab
N=196
n (%)

Urticaria

0

2 (1.7)

3 (1.5)

Bronchospasm

0

1 (0.9)

1 (0.5)

Dermatitis atopic

0

1 (0.9)

4 (2.0)

Eczema

0

1 (0.9)

1 (0.5)

Rash maculo-papular

0

1 (0.9)

1 (0.5)

Rash pustular

1 (1.8)

0

0

Dermatitis

0

0

1 (0.5)

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)

Abbreviations: PY = patient-years; Q4W = every 4 weeks.

aIncludes induction, maintenance, and extension periods through the 48-week database lock (253.9 total PY of ixekizumab exposure), including patients switched to ixekizumab from placebo or etanercept following the double-blind induction treatment period.

References

1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

2Paller 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. Abstract presented at: 28th Annual Meeting of the European Academy of Dermatology and Venereology (EADV Virtual); October 9-13, 2019; Madrid, Spain.

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

Glossary

AE = adverse event

IR = incidence rate

PY = patient-years

SAE = serious adverse event

TEAE = treatment-emergent adverse event

Date of Last Review: February 27, 2020


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