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Taltz ® (ixekizumab) injection
80 mg/mLThis 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.
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
An integrated safety analysis of 15 adult and 1 pediatric psoriasis clinical trials as of March 19, 2020 (all patients exposed to ixekizumab (N=6645) accounting for 17,902 PY of exposure) assessed cumulative safety experience covering up to 5 years of exposure (Malignancies Reported in All Ixekizumab Exposures Across 16 Psoriasis Trials).17
|
All Ixekizumab Psoriasis Exposures Integrated Analysis Set |
Patients reporting ≥1 malignancy TEAE |
139 (2.1) [0.8] |
NMSCa |
54 (0.8) [0.3] |
Malignancies excluding NMSC |
92 (1.4) [0.5] |
Abbreviations: IR = incidence rate per 100 patient-years of exposure; NMSC = nonmelanoma skin cancer; PY = patient-years; TEAE = treatment-emergent adverse event.
aNo patients discontinued from the studies due to NMSC.
Malignancies excluding NMSC that were reported more than one time consisted of
Rates of malignancy did not increase over time during longer exposures to ixekizumab.17
An integrated safety analysis of 4 PsA clinical trials as of March 19, 2020 that included all patients exposed to ixekizumab (N=1401 accounting for 2247.7 PY of exposure) assessed cumulative safety experience covering up to 3 years of exposure (Malignancies Reported in All Ixekizumab Exposures Across 4 Psoriatic Arthritis Clinical Trials).16
|
All Ixekizumab Psoriatic Arthritis Exposures Integrated Analysis Set |
Patients reporting ≥1 malignancy TEAE |
15 (1.1) [0.7] |
NMSCa |
9 (0.6) [0.4] |
Malignancies excluding NMSC |
7 (0.5) [0.3] |
Abbreviations: IR = incidence rate per 100 patient-years of exposure; NMSC = nonmelanoma skin cancer; PY = patient-years; TEAE = treatment-emergent adverse event.
aOne patient with basal cell carcinoma discontinued from the study.
Of malignancies excluding NMSC, there was 1 case each of
Rates of malignancy did not increase over time during longer exposures to ixekizumab.8
An integrated safety analysis of 4 axSpA (including AS/r-axSpA and nr-axSpA) clinical trials as of March 19, 2020 that included all patients exposed to ixekizumab (N=932 accounting for 1849.0 PY of exposure) assessed cumulative safety experience covering up to 3 years of exposure (Malignancies Reported in All Ixekizumab Exposures Across 4 Axial Spondyloarthritis Trials).18
|
All Ixekizumab Axial Spondyloarthritis Exposures Integrated Analysis Set |
Patients Reporting ≥1 malignancy TEAE |
7 (0.8) [0.4] |
NMSC |
0 |
Malignancies excluding NMSC |
7 (0.8) [0.4] |
Abbreviations: IR = incidence rate per 100 patient-years of exposure; NMSC = nonmelanoma skin cancer; PY = patient-years; TEAE = treatment-emergent adverse event.
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.
2Alexandrescu DT, Riordan NH, Ichim TE, et al. On the missing link between inflammation and cancer. Dermatol Online J. 2011;17(1):10. http://escholarship.org/uc/item/0gf628ss
3Pouplard C, Brenaut E, Horreau C, et al. Risk of cancer in psoriasis: a systematic review and meta-analysis of epidemiological studies. J Eur Acad Dermatol Venereol. 2013;27(suppl 3):36-46. http://dx.doi.org/10.1111/jdv.12165
4Kimball AB, Schenfeld J, Accortt NA, et al. Cohort study of malignancies and hospitalized infectious events in treated and untreated patients with psoriasis and a general population in the United States. Br J Dermatol. 2015;173(5):1183-1190. http://dx.doi.org/10.1111/bjd.14068
5Geller S, Xu H, Lebwohl M, et al. Malignancy risk and recurrence with psoriasis and its treatments: a concise update. Am J Clin Dermatol. 2018;19(3):363-375. http://dx.doi.org/10.1007/s40257-017-0337-2
6Margolis D, Bilker W, Hennessy S, et al. The risk of malignancy associated with psoriasis. Arch Dermatol. 2001;137(6):778-783. http://www.ncbi.nlm.nih.gov/pubmed/11405770
7Strober B, Phillip S, Wilhelm S, et al. Safety and tolerability of ixekizumab: analysis of malignancies in 7 clinical studies of moderate-severe plaque psoriasis. Poster presented at: European Academy of Dermatology and Venereology 2015; October 7-11, 2015; Copenhagen, Denmark.
8Genovese MC, Mysler E, Tomita T, et al. Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials. Rheumatology (Oxford). Published online May 25, 2020. https://doi.org/10.1093/rheumatology/keaa189
9Deodhar 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
10Deodhar 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
11Gordon 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
12Langley RG, Papp K, Gooderham M, et al. 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
13Mease 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
14Nash 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 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
15van 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
16Data on file, Eli Lilly and Company and/or one of its subsidiaries.
17Griffiths CEM, Reich K, Gooderham M, et al. Long-term safety of ixekizumab in patients with moderate-to-severe psoriasis up to 5 years: pooled data from 16 clinical trials. Poster presented at: 29th Annual Meeting of the European Academy of Dermatology and Venereology (EADVirtual); October 29-31, 2020.
18Schwartzman S, Sandoval D, Kronbergs A, et al. Long-term safety profile of ixekizumab treatment on patients with axial spondyloarthritis. Poster presented at: American College of Rheumatology/ARP 2020 Annual Scientific Meeting (Virtual); November 5-9, 2020.
AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA = axial spondyloarthritis
NMSC = nonmelanoma skin cancer
nr-axSpA = nonradiographic axial spondyloarthritis
PsA = psoriatic arthritis
PY = patient-years
Date of Last Review: October 20, 2020
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