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Taltz ® (ixekizumab)
Can Taltz® (ixekizumab) 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. Blood creatinine and creatinine clearance TEAEs for each indication are provided.
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
Brief Descriptions of 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.
Among all ixekizumab exposures in PsO (N=6645 ; 17,902.0 PYs), as of March 2020
- blood creatinine increased was reported by 27 (0.4%) patients, and
- creatinine renal clearance decreased was reported by 3 (0.0%) patients.8
Among all ixekizumab exposures in PsA (N=1401; 2247.7 PYs) as of March 2020
- blood creatinine increased was reported by 4 (0.3%) patients, and
- no patients reported creatinine renal clearance decreased.8
Among all ixekizumab exposures in axSpA (N=932; 1792.2 PYs), as of March 2020
- 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
- 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).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) 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.10
1Taltz [Summary of Product Characteristics]. Eli Lilly Nederland B.V., The Netherlands.
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
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
9A 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
10A 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
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
Date of Last Review: February 03, 2020