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)

Long-Term Safety Results of Taltz® (ixekizumab) in Axial Spondyloarthritis

Up to 116 weeks, most TEAEs were mild-to-moderate in severity and the frequencies were similar across all ixekizumab dosing regimens.

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Detailed Long-Term Safety Data from the Integrated Analysis of Axial Spondyloarthritis Trials

Overview

The safety analysis in this response includes data from all patients who received at least 1 dose of ixekizumab at week 0 of the originating trials COAST-V, COAST-W, and COAST-X and up to week 64 of the long-term extension trial COAST-Y. The analysis evaluated the safety of ixekizumab in 932 patients accounting for 1598.9 PYs of exposure.

Overall, 779 patients (83.6%; IR 48.7 per 100 PYs) reported at least one TEAE. Of these events,

  • 307 (32.9%; IR 19.2) were mild
  • 383 (41.1%; IR 24.0) were moderate, and
  • 89 (9.5%; IR, 5.6) were severe.1

A total of 85 patients (9.1%; IR 5.3 per 100 PYs) reported at least 1 SAE and 60 patients (6.4%; IR 3.8 per 100 PYs) discontinued from the study due to an AE.1

Three reported deaths in patients who received ixekizumab were due to

  • suicide (the patient had a prior history of mild depression, and the suicide was not considered to be related to study drug by the investigator)1,2
  • murder, and
  • sepsis (reported in a patient with a history of chronic renal failure and atrial fibrillation).1

Other Adverse Events of Special Interest

Adverse Events of Special Interest in the Long-Term Integrated Safety Analysis of axSpA Trials (COAST-V, -W, -X, and -Y), presents IRs of AEs of special interest in the long-term integrated safety analysis from axSpA trials COAST-V, -W, -X, and -Y.

Adverse Events of Special Interest in the Long-Term Integrated Safety Analysis of axSpA Trials (COAST-V, -W, -X, and -Y)1,a

Adverse Event

Number of Events
(N=932; PY=1598.8)

%, (IR)

Infections

510

54.7 (31.9)

Serious infections

20

2.1 (1.3)

Injection site reactions

156

16.7 (9.8)

Hypersensitivity/allergic reactions

83

8.9 (5.2)

Potential anaphylaxis

1

 0.1 (0.1)

Cerebrocardiovascular eventsb

14

1.5 (0.9)

MACE (adjudicated)

2

0.2 (0.1)

Anterior uveitis

52

5.6 (3.3)

Malignancies

7

0.8 (0.4)

Depression

17

1.8 (1.1)

Cytopenias

26

2.8 (1.6)

Neutropenia

12

1.3 (0.8)

IBD (adjudicated)

15c

1.6 (0.9)

Crohn's disease

6

0.6 (0.4)

Ulcerative colitis

9

1.0 (0.6)

Abbreviations: axSpA = axial spondyloarthritis; IBD = inflammatory bowel disease; IR = incidence rate per 100 patient-years; MACE = major adverse cerebrocardiovascular events; PY = patient-years.

aIncludes data from all patients who received at least 1 dose of ixekizumab since week 0 of the originating trials COAST-V, COAST-W, and COAST-X up to week 64 of a long-term extension trial COAST-Y.

bMACE cases include confirmed cases of vascular death (including cardiovascular and cerebrovascular deaths and excluding hemorrhagic deaths outside of the central nervous system), nonfatal myocardial infarction, and nonfatal stroke.

cTwo additional cases of IBD occurred, 1 case during the long-term extension period of COAST-Y (weeks 64-104) and 1 case during the posttreatment follow-up period.

The section Appendix: Clinical Trial Brief Descriptions  provides brief descriptions of the axSpA clinical trials. 

References

1Braun J, Kiltz U, Deodhar A, et al. Long-term treatment with ixekizumab in patients with axial spondyloarthritis: 2-year results from COAST-Y. Poster presented at: European League Against Rheumatism Virtual Congress; June 2-5, 2021.

2Deodhar 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

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, 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

5A long term extension study of ixekizumab (LY2439821) in participants with axial spondyloarthritis. ClinicalTrials.gov identifier: NCT03129100. Updated June 18, 2021. Accessed July 13, 2021. https://www.clinicaltrials.gov/ct2/show/NCT03129100

6Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

Glossary

AE = adverse event

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

axSpA = axial spondyloarthritis

bDMARD = biologic disease-modifying antirheumatic drug

IR = incidence rate

nr-axSpA = nonradiographic axial spondyloarthritis

PY = patient-years

Q2W = every 2 weeks

Q4W = every 4 weeks

SAE = serious adverse event

TEAE = treatment-emergent adverse event

TNF = tumor necrosis factor

Appendix: Clinical Trial Brief Descriptions 

COAST-V (N=341) was a phase 3, 16-week double-blind, placebo-controlled trial with an active reference arm and a dose double-blind extension period of 52 weeks, conducted in patients with active AS/r-axSpA who were naïve to bDMARDs.3

COAST-W (N=316) was a phase 3, 16-week double-blind, placebo-controlled trial with a dose double-blind extension period of 52 weeks, conducted in patients with active AS/r‑axSpA and an inadequate response or intolerance to 1 or 2 TNF inhibitors.2

COAST-X (N=303) was a phase 3, 52-week double-blind, placebo-controlled trial, conducted in patients with nr-axSpA who were naïve to bDMARDs.4

COAST-Y (N=773) is a phase 3, 104-week, long-term extension trial including a double-blind, placebo-controlled 40-week randomized withdrawal-retreatment period, conducted in patients with axial spondyloarthritis who have completed the final study visit in COAST-V, COAST-W, or COAST-X.5

The dosing schedule IXEQ2W is not consistent with the approved dosing schedule for axial spondyloarthritis. Please refer to the Taltz summary of product characteristics for approved dosing.6

Date of Last Review: May 21, 2021


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