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
not require discontinuation of ixekizumab, and
not associated with an increased frequency of infections.1
Label Information Related to Neutropenia
was an uncommonly (≥ 1/1,000 to < 1/100) reported
adverse reaction in the ixekizumab clinical trials.2
plaque psoriasis studies,
of patients receiving ixekizumab developed neutropenia.
cases, the blood neutrophil count was ≥1,000 cells/mm3.
Such levels of neutropenia may persist, fluctuate or be transient.
of patients receiving ixekizumab developed a neutrophil count <1,000
general, neutropenia did not require discontinuation of ixekizumab.2
frequency of neutropenia and thrombocytopenia in psoriatic arthritis
and axial spondyloarthritis clinical studies is similar to that
observed in the plaque psoriasis studies.2
Trial Laboratory Assessment Results
integrated safety analysis was conducted from all ixekizumab adult
and pediatric PsO exposures (N=6645; PY=17,902 PYs) across 16 plaque
PsO clinical trials with data up to March 19, 2020. The
MedDRA-preferred term "neutropenia" was reported in 57
(0.9%) patients (IR=0.3 per 100 PYs of exposure).1
integrated safety analysis was conducted from all ixekizumab PsA
exposures (N=1401; PY=2247.7) across 4 PsA clinical trials with data
up to March 19, 2020.3
The MedDRA-preferred term "neutropenia" was reported in 29
(2.1%) patients (IR=1.3 per 100 PYs of exposure).1
integrated safety analysis was conducted from all ixekizumab axSpA
exposures (N=932; PY=1849) across 4 axSpA (including AS/r-axSpA and
nr-axSpA) trials with data up to March 19, 2020. Neutropenia grade ≥1
was reported in 156 (16.7%) patients (IR=8.4 per 100 PYs of
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
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.
Schwartzman S, Sandoval D, Kronbergs A, et al. Long-term safety
profile of ixekizumab treatment on patients with axial
spondyloarthritis. Poster presented at: American College of
Rheumatology/ARP 2020 Annual Scientific Meeting (Virtual); November
= ankylosing spondylitis/radiographic axial spondyloarthritis
= axial spondyloarthritis
= nonradiographic axial spondyloarthritis
= psoriatic arthritis