Label Information Related to Infections
is contraindicated in patients with clinically important active
infections (e.g. active tuberculosis).1
with ixekizumab is associated with an increased rate of infections
such as upper respiratory tract infection, oral candidiasis,
conjunctivitis, and tinea infections.1
should be used with caution in patients with clinically important
chronic infection or a history of recurrent infection. Patients
should be instructed to seek medical advice if signs or symptoms
suggestive of an infection occur. If an infection develops, monitor
carefully and discontinue ixekizumab if the patient is not responding
to standard therapy or the infection becomes serious. Ixekizumab
should not be resumed until the infection resolves.1
from Clinical Trials
Trial Exclusion Criteria
use of ixekizumab in patients with HCV has not been studied.
the pivotal phase 3 clinical trials for PsO, PsA, and axSpA
(including AS/r-axSpA and nr-axSpA), patients who had evidence of or
tested positive for HCV were excluded.2-7
positive test for HCV was defined as
for hepatitis C antibody, and
via a confirmatory test for HCV (for example, HCV polymerase chain
all ixekizumab exposures in PsO (N=6645; 17,902 PYs) as of March
2020, there was 1 (0.0%) reported case of hepatitis C and 1 (0.0%)
reported case of acute hepatitis C.8
all ixekizumab exposures in PsA (data from SPIRIT-P1, -P2, -P3, and
SPIRIT-H2H; N=1401; 2247.7 PYs) as of March 2020, there were no
cases of hepatitis C reported.8
all ixekizumab exposures in axSpA trials (including AS/r-axSpA and
nr-axSpA; N=932; 1849 PYs), as of March 2020, there were no cases of
hepatitis C reported.8
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and
UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in
moderate-to-severe plaque psoriasis. N Engl J Med.
Nash P, Kirkham B, Okada M, et al; SPIRIT-P2 Study Group. Ixekizumab
for the treatment of patients with active psoriatic arthritis and an
inadequate response to tumour necrosis factor inhibitors: results
from the 24-week randomised, double-blind, placebo-controlled period
of the SPIRIT-P2 phase 3 trial. Lancet.
Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study
Group. Ixekizumab, an interleukin-17A specific monoclonal antibody,
for the treatment of biologic-naive patients with active psoriatic
arthritis: results from the 24-week randomised, double-blind,
placebo-controlled and active (adalimumab)-controlled period of the
phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1):79-87.
Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group.
Efficacy and safety of ixekizumab in the treatment of radiographic
axial spondyloarthritis: sixteen-week results from a phase III
randomized, double-blind, placebo-controlled trial in patients with
prior inadequate response to or intolerance of tumor necrosis factor
inhibitors. Arthritis Rheumatol. 2019;71(4):599-611.
van der Heijde D, Cheng-Chung Wei J, Dougados M, et al; COAST-V
Study Group. Ixekizumab, an interleukin-17A antagonist in the
treatment of ankylosing spondylitis or radiographic axial
spondyloarthritis in patients previously untreated with biological
disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of
a phase 3 randomised, double-blind, active-controlled and
placebo-controlled trial. Lancet. 2018;392(10163):2441-2451.
Deodhar A, van der Heijde D, Gensler LS, et al; COAST-X Study Group.
Ixekizumab for patients with non-radiographic axial spondyloarthritis
(COAST-X): a randomised, placebo-controlled trial. Lancet.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
= ankylosing spondylitis/radiographic axial spondyloarthritis
= axial spondyloarthritis
= hepatitis C virus
= nonradiographic axial spondyloarthritis
= psoriatic arthritis