Short
Summary
Low
grade neutropenia has been commonly observed in patients receiving
ixekizumab. However, neutropenia ≥ grade 3 (<1,000 cells/mm3)
has been observed infrequently in patients receiving ixekizumab.1
In
general, neutropenia
was
transient
did
not require discontinuation of ixekizumab, and
was
not associated with an increased frequency of infections.1
Information
from the Label
Neutropenia
was an uncommonly (≥ 1/1,000 to < 1/100) reported
adverse reaction in the ixekizumab clinical trials.2
In
plaque psoriasis studies, 9 % of patients receiving ixekizumab
developed neutropenia. In most cases, the blood neutrophil count was
≥ 1,000 cells/mm3.
Such levels of neutropenia may persist, fluctuate or be transient.
0.1 % of patients receiving ixekizumab developed a neutrophil count <
1,000 cells/mm3.
In general, neutropenia did not require discontinuation of
ixekizumab.2
The
frequency of neutropenia in psoriatic arthritis clinical studies is
similar to that observed in the plaque psoriasis studies.2
Clinical
Trial Laboratory Assessment Results
Psoriasis
An
integrated safety analysis was conducted from all ixekizumab PsO
exposures (N=6091; PY=17,499.3 PYs) across 14 plaque PsO clinical
trials with data up to March 21, 2019.3
The MedDRA-preferred term "neutropenia" was reported in 54
(0.9%) patients (IR=0.3 per 100 PYs of exposure).1
Psoriatic
Arthritis
An
integrated safety analysis was conducted from all ixekizumab PsA
exposures (N=1401; PY=2228.6 PYs) across 4 PsA clinical trials with
data up to March 21, 2019.3
The MedDRA-preferred term "neutropenia" was reported in 29
(2.1%) patients (IR=1.3 per 100 PYs of exposure).1
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2.
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
3.
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
IR =
incidence rate
PsA
= psoriatic arthritis
PsO
= psoriasis
PY =
patient-years
▼ This
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.