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
Lock2,3
|
|
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 (%)
|
|
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 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