Taltz ® (ixekizumab) injection

80 mg/mL

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TALTZ® (ixekizumab): Injection Site Reactions in the Pediatric Psoriasis Clinical Trial

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%).

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US_cFAQ_IXE040_INJECTION_SITE_REACTIONS_PEDS
en-US

Injection Site Reactions 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.1

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.2

A summary of ISRs in IXORA-PEDS are provided in IXORA-PEDS: Injection Site Reactions in the Double-Blind Treatment Period and Combined Treatment Periods Through November 2019 Database Lock. A higher percentage of patients in the ixekizumab Q4W group reported at least 1 TEAE of ISRs compared with patients in the placebo group during the double-blind treatment period.1

In the double-blind treatment period of IXORA-PEDS, there were no severe or serious ISR AEs.  No patients discontinued study drug due to an ISR AE.1

In the all ixekizumab exposure population, as of the November 25, 2019 database lock, there were no SAEs due to ISRs and 1 ISR of injection site pain was severe. No patients discontinued study drug due to an ISR AE.1

Across 14 pooled psoriasis trials including 13 adult trials and IXORA-PEDS (N=6091, accounting for 17,499.3 PYs of total ixekizumab exposure), the IR of ISRs was 5.3 per 100 PYs of exposure.3

IXORA-PEDS: Injection Site Reactions in the Double-Blind Treatment Period and Combined Treatment Periods Through November 2019 Database Lock1,2


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 (%)

Injection site reactionsb

1 (1.8)

14 (12.2)

39 (19.9)

Injection site reaction

0

11 (9.6)

32 (16.3)

Injection site pain

1 (1.8)

5 (4.3)

7 (3.6)

Injection site erythema

0

2 (1.7)

5 (2.6)

Injection site hemorrhage

0

1 (0.9)

1 (0.5)

Injection site nodule

0

1 (0.9)

1 (0.5)

Injection site pruritus

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 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.

bHigh level MedDRA term.

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1Paller AS, Seyger MMA, Magariños GA, et al. Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Dermatol. Published online April 21, 2020. https://doi.org/10.1111/bjd.19147

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3Genovese MC, Kameda H, Rahman P, et al. Safety profile of ixekizumab in patients with moderate-to-severe plaque psoriasis and psoriatic arthritis: integrated analysis of 18 clinical trials. Poster presented at: American College of Rheumatology/ARP; November 8-13, 2019; Atlanta, GA.

Glossary

AE = adverse event

IR = incidence rate

ISR = injection site reaction

PY = patient-years

Q4W = every 4 weeks

SAE = serious adverse event

TEAE = treatment-emergent adverse event

Date of Last Review: March 26, 2020


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