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Taltz ® (ixekizumab)
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Taltz® (ixekizumab) use in renal impairment
No formal trial of the effect of renal impairment on the pharmacokinetics of ixekizumab was conducted.
Summary
Ixekizumab is a monoclonal antibody and is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous immunoglobulins.1
Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the PK of ixekizumab have not been conducted.1
- 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.
Taltz has not been studied in patients with renal or hepatic impairment. No dose recommendations can be made.1
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 psoriasis and psoriatic arthritis clinical trials specifically excluded patients who had a serum creatinine greater than 2.0 mg/dL at screening.2,5,6
Psoriasis
Among all adult patients exposed to ixekizumab in psoriasis trials (N=6892; 18,025.7 PYs), as of March 19, 2021,
- blood creatinine increase was reported in 27 (0.4%) patients
- creatinine clearance increase was reported in 14 patients (0.2%), and
- creatinine clearance decrease was reported in 4 (0.1%) patients.8
Psoriatic Arthritis
Among all ixekizumab exposures in psoriatic arthritis (N=1401; 2247.7 PYs) as of March 19, 2021,
- blood creatinine increase was reported in 4 (0.3%) patients
- creatinine clearance increase was reported in 2 (0.1%), and
- no patients reported creatinine clearance decreased.8
Axial Spondyloarthritis
Among all ixekizumab exposures in axSpA (N=932; 2096.2 PYs), as of March 19, 2021,
- blood creatinine increase was reported in 2 (0.2%) patients, and
- creatinine clearance decrease was reported in 1 (0.1%) patient.8
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
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 19 May 2022