Exclusion
Criteria Related to Herpes Zoster in the Ixekizumab Clinical Trials
In 3
phase 3 trials for psoriasis (UNCOVER-1, -2, and -3), 3 phase 3
trials for PsA (SPIRIT-P1, -P2, and –P3), and 3 phase 3
clinical trials for axSpA, including AS/r-axSpA and nr-axSpA
(COAST-V, COAST-W, and COAST-X), patients were excluded if they
currently
have or had a herpes zoster or any other clinically apparent
varicella-zoster virus infection within 12 weeks of baseline, or
had
any other active or recent infection within 4 weeks of baseline
that, in the opinion of the investigator, would pose an unacceptable
risk to the patient if participating in the study.1-6
Patients
With Comorbid Herpes Zoster
Comorbid
Herpes Zoster in the Psoriasis Clinical Trials
An
analysis of the efficacy and safety of ixekizumab with
moderate-to-severe PsO and comorbid herpes zoster has not been
conducted. In the 3 phase 3 ixekizumab clinical trials in patients
with PsO, 17 patients (0.7%) treated with ixekizumab had a historical
illness of herpes zoster.6
Comorbid
Herpes Zoster in the Psoriatic Arthritis Clinical Trials
An
analysis of the efficacy and safety of ixekizumab with
moderate-to-severe active PsA and comorbid herpes zoster has not been
conducted. In the 2 phase 3 ixekizumab clinical trials in patients
with PsA, SPIRIT-P1, and -P2, no patients treated with ixekizumab had
a historical illness of herpes zoster. In the phase 3 clinical trial
SPIRIT-P3, 3 (0.8%) patients had a historical illness of herpes
zoster.6
Comorbid
Herpes Zoster in the Axial Spondyloarthritis Clinical Trials
An
analysis of the efficacy and safety of ixekizumab with axSpA and
comorbid herpes zoster has not been conducted. In the 3 phase 3
ixekizumab clinical trials in patients with axSpA (including
AS/r-axSpA and nr-axSpA), 7 patients (1.2%) treated with ixekizumab
had a historical illness of herpes zoster.6
Ixekizumab
Label Information Related to Infections
Ixekizumab
is contraindicated in patients with clinically important active
infections (e.g. active tuberculosis).7
Treatment
with ixekizumab is associated with an increased rate of infections
such as upper respiratory tract infection, oral candidiasis,
conjunctivitis, and tinea infections.7
Ixekizumab
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.7
This
information is for reference only and is not a treatment
recommendation. Decisions regarding the use of ixekizumab in patients
with herpes zoster should be made at the discretion of the
prescribing physician using his or her best clinical judgment.
References
1.
Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab
in moderate-to-severe plaque psoriasis. N Engl J Med.
2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
2.
Nash P, Kirkham B, Okada M, et al. 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. 2017;389(10086):2317-2327.
http://dx.doi.org/10.1016/S0140-6736(17)31429-0
3.
van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. 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.
http://dx.doi.org/10.1016/s0140-6736(18)31946-9
4.
Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. 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.
http://dx.doi.org/10.1002/art.40753
5.
Deodhar A, van der Heijde D, Gensler LS, et al. Ixekizumab for
patients with non-radiographic axial spondyloarthritis (COAST-X): a
randomised, placebo-controlled trial. Lancet.
2020;395(10217):53-64.
http://dx.doi.org/10.1016/S0140-6736(19)32971-X
6.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
7.
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Glossary
AS/r-axSpA
= ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA
= axial spondyloarthritis
nr-axSpA
= nonradiographic axial spondyloarthritis
PsA
= psoriatic arthritis
PsO
= psoriasis