Taltz ® (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

Treatment-Emergent Herpes Zoster Infections in Taltz® (ixekizumab) Clinical Trials

Herpes zoster infection has been reported with ixekizumab treatment in patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis.

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Herpes Zoster in the Ixekizumab Clinical Development Program

Summary 

Among all ixekizumab exposures as of March 2020, herpes zoster was reported as a TEAE in 

  • 112 patients (1.7%; 0.6 EAIR), in 16 PsO clinical trials (N=6645; 17,902 PY), 
  • 16 patients (1.1%; 0.7 EAIR), across 4 PsA clinical trials (N=1401; 2247.7 PY), and
  • 12 patients (1.3%; 0.7 EAIR), across 4 axSpA clinical trials (including AS/r-axSpA and nr-axSpA) (N=932; 1792.2 PY).1

More information on TEAEs of Herpes Zoster in ixekizumab clinical trials are included in the sections

Ixekizumab details on the label information are available in the section What is Stated on Infections in the Ixekizumab Label Information?.

Note that multiple, different dosing regimens, including unapproved doses, are included in this response. Please refer to the Taltz Summary of Product Characteristics for approved dosing.2

Treatment-Emergent Adverse Events of Herpes Zoster in Ixekizumab Clinical Trials

Psoriasis

12-Week Induction Period of UNCOVER-1, -2, and -3

Primary Placebo-Controlled Dataset

The primary PsO placebo-controlled dataset includes patients with PsO from 3 phase 3 studies (UNCOVER-1, -2, and -3) who were randomized to receive

  • ixekizumab 80 mg Q4W (n=1161)
  • ixekizumab 80 mg Q2W (n=1167), or
  • placebo (n=791).1,3

During the induction period, herpes zoster was reported as a TEAE by

  • 0 patients treated with ixekizumab, and
  • 2 patients (0.3%) treated with placebo.1,3
Placebo and Active-Controlled Dataset

The primary PsO placebo- and active-controlled dataset evaluated safety data through the induction period and includes patients from UNCOVER-2 and -3 who were randomized to receive

  • ixekizumab 80 mg Q4W (n=729)
  • ixekizumab 80 mg Q2W (n=734)
  • etanercept (n=739), or
  • placebo (n=360).1,3

Herpes zoster was reported as a TEAE in

  • 1 patient (0.1%) treated with etanercept, and
  • 0 patients who received either ixekizumab or placebo.1

Maintenance Period of UNCOVER-1 and -2

The PsO maintenance dataset evaluated safety after the induction period from weeks 12 through 60 and includes patients from UNCOVER-1 and -2 who were randomized to receive

  • ixekizumab 80 mg Q4W (n=416)
  • ixekizumab 80 mg Q12W (n=408), or
  • placebo (n=402).1,3

Herpes zoster was reported as a TEAE in

  • 1 patient (0.2%) treated with ixekizumab 80 mg Q4W
  • 1 patient (0.2%) treated with ixekizumab 80 mg Q12W, and
  • 1 patient (0.2%) treated with placebo.1

Integrated Data

Among all ixekizumab exposures in 16 PsO clinical trials (N=6645; 17,902 PY) through March 2020, herpes zoster was reported as a TEAE in 112 patients (1.7%; 0.6 EAIR). One case (0%) of herpes zoster infection was categorized as an SAE, and no events led to discontinuation of study drug.1

Psoriatic Arthritis

24-Week Double-Blind Period of SPIRIT-P1 and -P2

In the 24-week double-blind period of SPIRIT-P1, one patient who received ixekizumab Q2W had a TEAE of herpes zoster that involved the eyelid, and it was classified as an SAE.4 No patients reported a TEAE of herpes zoster during the 24-week double-blind period of SPIRIT-P2.5

Integrated Data

Among all ixekizumab exposures across 4 PsA clinical trials (N=1401; 2247.7 PY) as of March 2020, herpes zoster was reported as a TEAE in 16 patients (1.1%; 0.7 EAIR). One case (0.1%) of herpes zoster infection was categorized as an SAE, and no events led to discontinuation of study drug.1

Axial Spondyloarthritis

16-Week Double-Blind Period of COAST-V and -W

No patients reported a TEAE of herpes zoster during the 16-week double-blind period of COAST-V.6 In the COAST-W trial, 1 patient (0.9%) who received ixekizumab Q4W had a TEAE of herpes zoster during the double-blind period.7

52-Week Double-Blind Period of COAST-X

In the 52-week double-blind period of COAST-X, 2 patients (2%) who received ixekizumab Q4W and 1 patient (1%) who received placebo had a TEAE of herpes zoster.8

Integrated Data

Among all ixekizumab exposures across 4 axSpA clinical trials (including AS/r-axSpA and nr-axSpA) (N=932; 1792.2 PY) as of March 2020, herpes zoster was reported as a TEAE in 12 patients (1.3%; 0.7 EAIR). No cases of herpes zoster infection were categorized as an SAE, and no events led to discontinuation of study drug.1

What is Stated on Infections in the Ixekizumab Label Information?

Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).2

Treatment with ixekizumab is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections.2

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.2

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Taltz [Summary of Product Characteristics]. Eli Lilly Nederland B.V., The Netherlands.

3Strober B, Leonardi C, Papp KA, et al. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: etanercept comparisons and integrated data. J Am Acad Dermatol. 2017;76(3):432-440.e17. http://dx.doi.org/10.1016/j.jaad.2016.09.026

4Mease 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. http://dx.doi.org/10.1136/annrheumdis-2016-209709

5Nash 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

6van 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

7Deodhar 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

8Deodhar 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

Glossary

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

axSpA = axial spondyloarthritis

EAIR = exposure adjusted incidence rate

MedDRA = Medical Dictionary for Regulatory Activities

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

PsO = psoriasis

PY = patient-years

Q2W = every 2 weeks

Q4W = every 4 weeks

Q12W = every 12 weeks

SAE = serious adverse event

TEAE = treatment-emergent adverse event

Date of Last Review: April 22, 2021


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