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Taltz ® (ixekizumab)
Can Patients with Herpes Zoster Use Taltz® (ixekizumab)?
This answer provides relevant information to consider when using ixekizumab in patients with herpes zoster.
What are the Exclusion Criteria Related to Herpes Zoster in the Pivotal Ixekizumab Clinical Trials?
In 3 pivotal phase 3 trials for PsO (UNCOVER-1, -2, and -3), 2 pivotal phase 3 trials for PsA (SPIRIT-P1 and -P2), and 3 pivotal 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 infection 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
Comorbid Herpes Zoster in the Psoriatic Arthritis Clinical Trials
Efficacy and safety of ixekizumab has not been analyzed in patients with active PsA and comorbid herpes zoster infection.6
In the SPIRIT-P1 and -P2 phase 3 ixekizumab clinical trials in patients with PsA, no patients treated with ixekizumab had a historical illness of herpes zoster.6
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
Efficacy and safety of ixekizumab has not been analyzed in patients with active axSpA and comorbid herpes zoster infection.6
In the 3 COAST 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
What is Stated on Infections in the Ixekizumab Label Information?
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. 7
If an infection develops,
- patients should be carefully monitored and
- ixekizumab discontinued if
- the patient is not responding to standard therapy or if
- the infection becomes serious.7
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.
1Gordon 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. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
2Nash 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. 2017;389(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0
3van 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. http://dx.doi.org/10.1016/s0140-6736(18)31946-9
4Deodhar 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. http://dx.doi.org/10.1002/art.40753
5Deodhar 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. 2020;395(10217):53-64. http://dx.doi.org/10.1016/S0140-6736(19)32971-X
6Data on file, Eli Lilly and Company and/or one of its subsidiaries.
7Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland
AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA = axial spondyloarthritis
nr-axSpA = nonradiographic axial spondyloarthritis
PsA = psoriatic arthritis
PsO = psoriasis
Date of Last Review: April 22, 2021