Taltz® (ixekizumab): How often did injection site reactions occur in the pediatric psoriasis clinical trial?

 Ixekizumab Label Information Related to Injection Site Reactions

Injection site reactions were very commonly (≥ 1/10) reported adverse drug reactions with ixekizumab treatment.¹

The most frequent injection site reactions observed were erythema and pain. These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of ixekizumab.¹

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

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.²

Prefilled syringes containing ixekizumab or placebo were used in IXORA-PEDS. The lower doses were prepared by qualified study site personnel using a disposable syringe.³

A summary of ISRs in IXORA-PEDS are provided in  . 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.²

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.²

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.²

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.⁴

Table 1. IXORA-PEDS: Injection Site Reactions in the Double-Blind Treatment Period and Combined Treatment Periods Through November 2019 Database Lock^2,3

Abbreviations: MedDRA = Medical Dictionary for Regulatory Activities; PY = patient-years; Q4W = every 4 weeks.

^a All 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.

^b High level MedDRA term.

References

1. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Paller AS, Seyger MMB, Magariños GA, et al. 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

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

4. Genovese 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