General
Information
There
is no contraindication, warning or precaution against using
ixekizumab in patients with a history of thrombocytopenia.1
3 %
of patients exposed to ixekizumab had a shift from a normal baseline
platelet value to < 150,000 platelet cells/mm3
to ≥ 75,000 cells/mm3.
Thrombocytopenia may persist, fluctuate or be transient.1
Ninety-eight
percent of cases of thrombocytopenia were grade 1 (3% for IXEQ2W vs
1% for placebo; ≥75,000 cells/mm3
to <150,000 cells/mm3).1,2
Thrombocytopenia
in subjects treated with ixekizumab was not associated with an
increased rate of bleeding compared to subjects treated with
placebo.2
The
frequency of neutropenia and thrombocytopenia in psoriatic arthritis
and axial spondyloarthritis clinical studies is similar to that
observed in the plaque psoriasis studies.1
This
information is for reference only and is not a treatment
recommendation. Decisions regarding the use of ixekizumab in patients
with thrombocytopenia (or any medical condition) should be made at
the discretion of the prescribing physician using their best clinical
judgment.
Preexisting
Thrombocytopenia in Ixekizumab Clinical Trials
In
the 3 pivotal phase 3 psoriasis clinical trials (UNCOVER -1, -2, and
-3; N=2328) thrombocytopenia was reported as a preexisting condition
in 3 (0.1%) patients and as a historical illness in 2 (0.1%)
patients.
No
patients reported thrombocytopenia as a preexisting condition or
historical illness in the 2 pivotal phase 3 PsA (N=454) clinical
trials (SPIRIT-P1 and SPIRIT-P2).2
Thrombocytopenia
TEAEs
The
term “thrombocytopenia” is a preferred term in the
MedDRA. Treatment-emergent adverse events of “platelet count
decreased” have also been included in this response.
No
cases of thrombocytopenia resulted in an SAE. One TEAE of
thrombocytopenia and 1 TEAE of platelet count decreased resulted in
study drug discontinuation. There were no treatment-emergent bleeding
events associated with thrombocytopenia grades 2, 3, or 4. Five
ixekizumab treated patients had ≥1 treatment-emergent bleeding
event associated with grade 1 thrombocytopenia, but none were serious
or led to study discontinuation.2
Table
1. Incidence of Thrombocytopenia or Platelet Count Decreased TEAEs in
Ixekizumab Clinical Trials2
TEAE
|
Psoriasis
Clinical Trials
N=5730
PY=13479.0
n
(%)
|
Psoriatic
Arthritis Clinical Trials
N=1118
PY 1340.3
n
(%)
|
All
Thrombocytopenia TEAEs
|
20
(0.3)
|
3
(0.3)
|
Thrombocytopenia
TEAEs leading to discontinuation
|
1
(0.0)
|
0
|
All
Platelet count decreased TEAEs
|
9
(0.2)
|
4
(0.4)
|
Platelet
count decreased TEAEs leading to discontinuation
|
1
(0.0)
|
0
|
Abbreviations:
PY = patient-years of treatment; TEAE = treatment emergent adverse
event.
References
1.
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
2.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
IXEQ2W
= ixekizumab 80 mg every 2 weeks
MedDRA
= Medical Dictionary for Regulatory Activities
PsA
= psoriatic arthritis
SAE
= serious adverse event
TEAE
= treatment-emergent adverse event