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)

What is the Dosing of Taltz® (ixekizumab) in Patients with Renal Impairment?

We can not provide dose recommendations, because ixekizumab has not been studied in patients with renal impairment.

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Is Ixekizumab Renally Eliminated?

Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the pharmakokinetics of ixekizumab have not been conducted.

  • Renal elimination of intact ixekizumab, an IgG MAb, is expected to be low and of minor importance.1

Were Patients with Renal Impairment Excluded From the Ixekizumab Clinical Trials?

Patients were excluded from the ixekizumab clinical trials if they had

  • a renal disorder with that study participation poses an unacceptable risk to the patient or interfering with the data interpretation, or
  • clinical laboratory test results outside the normal reference range that were considered clinically significant.2-7

What was the Limit for the Serum Creatinine Level to Exclude Patients From the Trials? 

Patients who had a serum creatinine >2.0 mg/dL at screening were specifically excluded from the plaque psoriasis (PsO) and psoriatic arthritis (PsA) clinical trials.2,5,6

What was the Incidence of Renal Adverse Events in the Ixekizumab Clinical Trials?

Plaque Psoriasis

  • 27 (0.4%) patients reported blood creatinine increased, and
  • 3 (0.0%) patients reported creatinine renal clearance decreased

among all ixekizumab exposures in PsO (N=6645 ; 17,902.0 patient years (PYs), as of March 2020.

Psoriatic Arthritis

  • 4 (0.3%) patients reported blood creatinine increased, and
  • 0 patients reported creatinine renal clearance decreased

among all ixekizumab exposures in PsA (N=1401; 2247.7 PYs) as of March 2020.

Axial Spondyloarthritis

  • 1 (0.1%) patient reported blood creatinine increased, and
  • 1 (0.1%) patient reported creatinine renal clearance decreased

among all ixekizumab exposures in axial spondyloarthritis (axSpA) (N=932; 1792.2 PYs), as of March 2020.

Clinical Trial Descriptions is provided at the end of this response. 

References

1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

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

3Deodhar 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

4van 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

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

6Mease 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

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

8A long-term efficacy and safety study of ixekizumab (LY2439821) in participants with active psoriatic arthritis (SPIRIT P3). ClinicalTrials.gov identifier: NCT02584855. Updated November 15, 2019. Accessed May 25, 2021. https://www.clinicaltrials.gov/ct2/show/NCT02584855

9A 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

Appendix

Clinical Trial Descriptions

Plaque Psoriasis

  • UNCOVER-1, -2, and -3 (N=3866) phase 3 trials, conducted in patients with moderate-to-severe plaque psoriasis, were integrated to evaluate the safety of ixekizumab up to 12 weeks after treatment initiation in comparison to placebo. The phase 3 trials examined efficacy and safety of ixekizumab compared with placebo and etanercept (UNCOVER-2 and -3) during induction dosing period and vs placebo during maintenance period (UNCOVER-1 and -2).

Psoriatic Arthritis

  • SPIRIT-P1 (N=417) is a phase 3, 24-week double-blind, placebo-controlled trial with an active reference arm in patients with active PsA who are naïve to bDMARDs with an extension period of up to 3 years.6
  • SPIRIT-P2 (N=363) is a phase 3, 24-week double-blind, placebo-controlled trial in patients with active PsA and an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitor, with an extension period of up to 3 years.5
  • SPIRIT-P3 (N=570) consists of a 36-week open-label period followed by a randomized double-blind withdrawal period from week 36 to 104. This trial is being conducted in patients naïve to bDMARDs.8

Axial Spondyloarthritis

  • 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.4
  • COAST-W (N=316) was a phase 3, 16-week double-blind, placebo-controlled trial with a dose-double blind extension period to 52 weeks, conducted in patients with active AS/r-axSpA and an inadequate response or intolerance to 1 or 2 TNF inhibitors.3
  • 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.7
  • 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, is conducted in patients with axial spondyloarthritis who have completed the final study visit in COAST-V, COAST-W, or COAST-X.9

Date of Last Review: February 03, 2020


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