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)

Can Taltz® (ixekizumab) be used in patients with multiple sclerosis?

No data are available regarding the use of ixekizumab for the treatment of multiple sclerosis, as this use has not been studied by Lilly. Clinical trial exclusion criterion and TEAEs related to multiple sclerosis are summarized.

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What were the Clinical Trial Exclusion Criteria Related to Multiple Sclerosis?

Psoriasis Trials

Patients with presence or history of a demyelinating disorder were

  • excluded from UNCOVER-2 and -3 psoriasis trials1  
  • not specifically excluded from the UNCOVER-1 trial.2 

However, patients with significant neurologic disorders that, in the opinion of the investigator, posed an unacceptable risk to the patient if participating in the study or of interfering with the interpretation of data were excluded from the UNCOVER-1 trial.2 

Psoriatic Arthritis Trials

Patients with presence, personal history, or family history of a demyelinating disorder were

  • excluded from the SPIRIT-P1 psoriatic arthritis trial3
  • not specifically excluded from the SPIRIT-P2 trial.4

However, patients with significant neurologic disorders that, in the opinion of the investigator, posed an unacceptable risk to the patient if participating in the study or of interfering with the interpretation of data were excluded from the SPIRIT-P2 trial.4

Axial Spondyloarthritis Trials

Patients with presence, personal history, or family history (first-degree relative) of a demyelinating disorder were

  • excluded from the COAST-V AS/r-axSpA trial5
  • not specifically excluded from the COAST-W AS/r-axSpA or COAST-X nr-axSpA trials.6,7

However, patients with significant neurologic disorders that, in the opinion of the investigator, posed an unacceptable risk to the patient if participating in the study or of interfering with the interpretation of data were excluded from the COAST-W AS/r-axSpA or COAST-X nr-axSpA trial.6,7

Were Pre-existing Conditions of Multiple Sclerosis reported in Ixekizumab Trials?

No patients reported a pre-existing condition or historical illness of multiple sclerosis across the pivotal phase 3 trials in patients with PsO (UNCOVER-1, -2, and -3), PsA (SPIRIT-P1 and SPIRIT-P2), and axSpA (including AS/r-axSpA [COAST-V and COAST-W] and nr-axSpA [COAST-X]). 3

What is the Incidence of Multiple Sclerosis with Ixekizumab?

Multiple sclerosis is not listed as an adverse reaction in the Taltz summary of product characteristics.8

In an integrated analysis of safety data across 15 adult and 1 pediatric PsO clinical trials as of March 2020 (N=6645; 17,902 patient-years of exposure), 3 (0.0%) cases of multiple sclerosis were reported. All 3 events were categorized as a serious adverse event and 2 events led to discontinuation of ixekizumab.3

In an integrated analysis of safety data across 4 PsA clinical trials as of March 2020 (N=1401; 2247.7 patient-years of exposure), no cases of multiple sclerosis were reported.3

In an integrated analysis of safety data across 4 axSpA clinical trials as of March 2020 (N=932; 1792.2 patient-years of exposure), no cases of multiple sclerosis were reported.3

Reference

1Griffiths CEM, Reich K, Lebwohl M, et al; UNCOVER-2, UNCOVER-3 Investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541-551. https://doi.org/10.1016/S0140-6736(15)60125-8

2Gordon 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

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Nash 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

5van 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

6Deodhar 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

7Deodhar 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

8Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

Glossary

AS/r-axSpA = anchylosing spondylitis

AxSpA = axial spondyloarthritis 

Lilly = Eli Lilly and Company

MedDRA = Medical Dictionary for Regulatory Activities

nr-axSpA = non-radiographic axial spondyloarthritis  

PsA = psoriatic arthritis

PsO = plaque psoriasis

PY = patient-years

TEAE = treatment-emergent adverse event

Date of Last Review: August 31, 2021


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