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Taltz ® (ixekizumab) injection
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Taltz® (ixekizumab) be used in patients with a malignancy or history of malignancy?
Ixekizumab has not been studied in patients with a malignancy or history of malignancy.
Ixekizumab Use in Patients With Malignancies or History of Malignancies
Ixekizumab product labeling does not contain a contraindication for use in patients with a malignancy or history of malignancy. However, the use of ixekizumab in this population has not been studied.1
Clinical Trial Malignancy Exclusion Criteria
- Active, or a history of malignant disease was an exclusion criterion in the pivotal psoriasis UNCOVER clinical trials and in the pivotal psoriatic arthritis (PsA) SPIRIT clinical trials (history of malignant disease within 5 years prior to baseline for SPIRIT-P2 and later trials, including IXORA psoriasis studies, SPIRIT-H2H in PsA, and axial spondyloarthritis trials).
- Patients were excluded if they had current or a history of lymphoproliferative disease, or signs or symptoms of lymphoproliferative disease (limited to within 5 years of baseline for later trials).
- Patients with successfully treated basal-cell carcinoma (no more than 3), squamous-cell carcinoma of the skin, or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline were allowed to participate in the pivotal psoriasis and PsA studies.
- Note: This is not an all-inclusive list of exclusion criteria, but rather a list of those exclusion criteria related to malignancy.2-8
Clinical Trial Malignancy Discontinuation Criteria
- The clinical trial protocols required patients who developed a malignancy to discontinue from the studies .
- Patients were allowed to continue in the study if they developed no more than 2 nonmelanoma skin cancers over any 12-month period during the studies.
- Note: This is not an all-inclusive list of discontinuation criteria, but rather discontinuation criteria related to malignancy.4,9
Enclosed Prescribing Information
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 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
3Deodhar 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
4Gordon 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
5Langley RG, Papp K, Gooderham M, et al; IXORA-P Investigators. Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P). Br J Dermatol. 2018;178(6):1315-1323. http://dx.doi.org/10.1111/bjd.16426
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
7Nash 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
8van 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
9Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: October 20, 2020