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)

Taltz® (ixekizumab): General Safety Information in the Pediatric Psoriasis Clinical Trial

The safety profile in IXORA-PEDS was generally consistent with that seen in adults with moderate-to-severe plaque psoriasis.

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Ixekizumab Label Information Related to Safety

Contraindications

Ixekizumab is contraindicated in patients with serious hypersensitivity to the active substance or to any of the excipients.1

Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).1

Warnings and Precautions

Treatment with ixekizumab is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections.1

Ixekizumab should be used with caution in patients with clinically important chronic infection or a history of recurrent infection. 1

Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.1

If an infection develops,

  • patients should be carefully monitored and 
  • ixekizumab discontinued if
    • the patient is not responding to standard therapy or if
    • the infection becomes serious.1

Ixekizumab should not be resumed until the infection resolves.1

Ixekizumab must not be given to patients with active tuberculosis (TB).1

  • Anti-TB therapy prior to initiation of ixekizumab in patients with latent TB should be considered.1

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

Cases of new or exacerbations of inflammatory bowel disease have been reported with ixekizumab. Ixekizumab is not recommended in patients with inflammatory bowel disease.1

If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, ixekizumab should be discontinued and appropriate medical management should be initiated.1

Ixekizumab should not be used with live vaccines. No data are available on the response to live vaccines; there are insufficient data on response to inactive vaccines.1

Adverse Drug Reactions

List of adverse reactions in clinical studies and postmarketing reports1

System organ class

Frequency

Adverse reaction

Infections and infestations

 

Very common

Upper respiratory tract infection

Common

Tinea infection, Herpes simplex (mucocutaneous)

Uncommon

Influenza, Rhinitis, Oral candidiasis, Conjunctivitis, Cellulitis 

Blood and lymphatic system disorders

Uncommon

Neutropenia, Thrombocytopenia

Immune system disorders

Uncommon

Angioedema

Rare

Anaphylaxis

Respiratory, thoracic and mediastinal disorders

Common

Oropharyngeal pain

Gastrointestinal disorders

Common

Nausea

Uncommon

Inflammatory bowel disease

Skin and subcutaneous disorders

Uncommon

Urticaria, Rash, Eczema,  

General disorders and administration site conditions

Very common

Injection site reactionsa

aSee section description of selected adverse reactions

Paediatric Population

The safety profile observed in children with plaque psoriasis treated with ixekizumab every 4 weeks is consistent with the safety profile in adult patients with plaque psoriasis with the exception of the frequencies of

  • conjunctivitis,
  • influenza, and
  • urticaria

which were common.1

Inflammatory bowel disease was also more frequent in paediatric patients, although it was still uncommon. In the paediatric clinical study, Crohn’s disease occurred in

  • 0.9% of patients in the ixekizumab group and
  • 0% of patients in the placebo group

during the 12‑week, placebo-controlled period.

Crohn’s disease occurred in a total of 4 ixekizumab treated subjects (2.0%) during the combined placebo-controlled and maintenance periods of the paediatric clinical study.1

Treatment-Emergent Adverse Events Reported in the Double-Blind Treatment Period of IXORA-PEDS

The most common TEAEs (occurring in ≥5% of ixekizumab-treated patients) were

  • nasopharyngitis (11.3%)
  • headache (10.4%)
  • injection site reaction (9.6%)
  • nausea (5.2%), and
  • abdominal pain (5.2%).2,3

An overview of AEs and AEs of special interest reported during the double-blind treatment period of IXORA-PEDS are summarized in IXORA-PEDS: Adverse Events in the 12-Week, Double-Blind Treatment Period .

IXORA-PEDS: Adverse Events in the 12-Week, Double-Blind Treatment Period 2,4

 

Placebo
N=56
n (%)

Ixekizumab Q4W
N=115
n (%)

TEAE overall

25 (45)

64 (56)

TEAE by severitya

Mild

16 (29)

47 (41)

Moderate

9 (16)

17 (15)

Severe

0

0

Death

0

0

Serious AE

0

1 (1)b

Discontinuation due to AEs

1 (2)c

0

Infections

14 (25)

37 (32)

Serious Infections

0

0

Opportunistic Infections

0

0

Injection-site reactions

1 (2)

14 (12)

Allergic reactions/hypersensitivity

1 (2)

6 (5)

Potential anaphylaxis

0

0

Cytopenia

0

1 (1)

Hepatic

0

0

Malignancies

0

0

Depression

0

1 (1)

Interstitial Lung Disease

0

0

Inflammatory Bowel Disease (adjudicated)

0

1 (1)

Crohn's Disease

0

1 (1)

Ulcerative Colitis

0

0

Abbreviations: AE = adverse event; Q4W = every 4 weeks; TEAE = treatment-emergent adverse event.

aPatients with multiple occurrences of the same event are counted under the highest severity.

bAccidental overdose of antihistamine.

cGuttate psoriasis.

Treatment-Emergent Adverse Events in the Combined Treatment Periods of IXORA-PEDS

The safety overview of ixekizumab in the IXORA-PEDS trial through the November 2019 database lock is summarized in IXORA-PEDS: Adverse Events in the Combined Treatment Periods Through the 48-Week Interim Database Lock. The combined treatment periods consists of all patients exposed to ixekizumab in the induction, maintenance, and extension periods of IXORA-PEDS through the 48-week interim database lock (253.9 total PY of exposure), including patients switched to ixekizumab from placebo or etanercept following the double-blind induction treatment period.4

IXORA-PEDS: Adverse Events in the Combined Treatment Periods Through the 48-Week Interim Database Lock2,4

 

Total Ixekizumaba
N=196
n (%)

TEAE overall

161 (82)

TEAE by severityb

Mild

80 (41)

Moderate

72 (37)

Severe

9 (5)

Death

0

Serious AE

13 (7)

Discontinuation due to AEs

3 (2)c

Infections

129 (66)

Serious Infections

2 (1)d

Opportunistic Infections

0

Injection-site reactions

39 (20)

Allergic reactions/hypersensitivity

16 (8)

Potential anaphylaxis

0

Cytopenia

3 (2)

Hepatic

4 (2)

Malignancies

0

Depression

6 (3)

Interstitial Lung Disease

0

Inflammatory Bowel Disease (adjudicated)

4 (2)

Crohn's Disease

4 (2)

Ulcerative Colitis

0

Abbreviations: AE = adverse event; PY = patient-years; TEAE = treatment-emergent adverse event.

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

bPatients with multiple occurrences of the same event are counted under the highest severity.

cCrohn's disease, n=2; Pityriasis rubra pilaris, n=1.

dOne each of acute otitis media and tonsillitis.

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.

4Paller 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

Glossary

AE = adverse event

CD = Crohn's disease

IBD = inflammatory bowel disease

PY = patient-years

TB = tuberculosis

TEAE = treatment-emergent adverse event

UC = ulcerative colitis

Date of Last Review: May 14, 2020


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