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)

Taltz® ▼ (ixekizumab): Can it be used in patients with renal impairment? Is a dose adjustment recommended?

Ixekizumab has not been studied in patients with renal impairment. No dose recommendations can be made.

Ixekizumab Label Information Related to Renal Impairment

Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the PK of ixekizumab have not been conducted. Renal elimination of intact ixekizumab, an IgG MAb, is expected to be low and of minor importance; similarly, IgG MAbs are mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence clearance of ixekizumab.1

Ixekizumab has not been studied in patients with renal or hepatic impairment. No dose recommendations can be made.1

Please refer to Taltz summary of product characteristics for full prescribing information.

Clinical Trial Data

Study exclusion criteria for all clinical trials included

  • having a renal disorder that, in the opinion of the investigator, poses an unacceptable risk to the patient if participating in the study or of interfering with the interpretation of data, or

  • having clinical laboratory test results at screening that are outside the normal reference range for the population and are considered clinically significant.2-7

The PsO and PsA clinical trials specifically excluded patients who had a serum creatinine >2.0 mg/dL at screening.2,5,6

Brief descriptions of the pivotal clinical trials for moderate-to-severe PsO, PsA, and axSpA are provided at the end of this response. 

Note that data from multiple, different dosing regimens, including unapproved doses, are included in this response.

Psoriasis

Among all ixekizumab exposures in PsO (N=6091; 17,499.3 PYs), as of March 21, 2019

  • blood creatinine increased was reported by 26 (0.4%) patients, and

  • creatinine renal clearance decreased was reported by 3 (0.0%) patients.8

Psoriatic Arthritis

Among all ixekizumab exposures in PsA (N=1401; 2228.6 PYs) as of March 21, 2019

  • blood creatinine increased was reported by 4 (0.3%) patients, and

  • no patients reported creatinine renal clearance decreased.8

Axial Spondyloarthritis

Among all ixekizumab exposures in axSpA (N=929; 1336.2 PYs), as of April 2019

  • blood creatinine increased was reported by 1 (0.1%) patient, and

  • creatinine renal clearance decreased was reported by 1 (0.1%) patient.8

Brief Descriptions of Clinical Trials

Psoriasis Trials

  • UNCOVER-1, -2, and -3 (N=3866) phase 3 trials in moderate-to-severe plaque psoriasis were integrated to evaluate the safety of ixekizumab in comparison to placebo up to 12 weeks after treatment initiation.

  • The phase 3 trials examined the efficacy and safety of ixekizumab compared with placebo and etanercept (UNCOVER-2 and -3) during induction treatment and vs placebo in maintenance (UNCOVER-1 and -2).2

Psoriatic Arthritis Trials

  • 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 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.9

Axial Spondyloarthritis Trials

  • COAST-V (N=341) is a phase 3, 16-week double-blind, placebo-controlled trial with an active reference arm and a dose-double blind extension period to 52 weeks in patients with active AS/r-axSpA who are naive to bDMARDs.4

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

  • COAST-X (N=303) is a phase 3, 52-week double-blind, placebo-controlled trial in patients with nr-axSpA who are naive to bDMARDs.7

  • COAST-Y (N=750) is a phase 3, 104-week, long-term extension trial including a double-blind, placebo-controlled 40-week randomized withdrawal-retreatment period in patients with axial spondyloarthritis who have completed the final study visit in COAST-V, COAST-W, or COAST-X.10

Therapeutic Indications

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1

Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.1

Ixekizumab is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.1

Ixekizumab is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).1

References

1. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Gordon KB, Blauvelt A, Papp KA, et al. 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

3. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. 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

4. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. 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

5. Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomized, 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

6. Mease PJ, van der Heijde D, Ritchlin CT, et al. 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

7. Deodhar A, van der Heijde D, Gensler LS, et al. 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

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

9. A long-term efficacy and safety study of ixekizumab (LY2439821) in participants with active psoriatic arthritis (SPIRIT P3). ClinicalTrials.gov identifier: NCT02584855. Updated November 6, 2018. Accessed March 13, 2019. https://www.clinicaltrials.gov/ct2/show/NCT02584855?term=SPIRIT-P3&rank=1.

10. A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis. ClinicalTrials.gov identifier: NCT031129100. Updated May 3, 2019. Accessed June 24, 2019. https://www.clinicaltrials.gov/ct2/show/NCT03129100

Glossary

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

axSpA = axial spondyloarthritis

bDMARD = biologic disease-modifying antirheumatic drug

nr-axSpA = nonradiographic axial spondyloarthritis

PK = pharmacokinetics

PsA = psoriatic arthritis

PsO = psoriasis

PY = patient-years

TEAE = treatment-emergent adverse event

TNF = tumor necrosis factor

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: February 03, 2020

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