Taltz ® (ixekizumab) injektion

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Taltz® (ixekizumab): Hur ofta inträffade reaktioner på injektionsstället hos barn?

I den dubbelblinda behandlingsperioden för IXORA-PEDS rapporterade en högre andel patienter i ixekizumab Q4W-gruppen (12,2%) minst 1 biverkning av typen reaktioner vid injektionsstället jämfört med patienter i placebogruppen (1,8%).

 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 Table 1. 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 Lock2,3


12- Week Double-Blind Treatment Period

Combined Treatment Periods
Through November 25, 2019
a 

 

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.

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 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

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

Datum fӧr senaste ӧversyn 2020 M01 08


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