Taltz ® (ixekizumab) injection

80 mg/mL

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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. Information on treatment-emergent malignancies is available.

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Summary of Ixekizumab Malignancy Information

  • Nonclinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of ixekizumab.1
  • Psoriasis may be associated with an increased risk of malignancy.2-4 Geller et al summarized the baseline malignancy risk in patients with psoriasis as well as the risk of malignancy with psoriasis treatments.5
    • The overall rates of malignancies reported in ixekizumab studies in psoriasis were consistent with the incidence rates reported in observational studies of patients with psoriasis.6,7
  • Rates of malignancy did not increase over time with longer exposures to ixekizumab in the psoriasis, PsA, or axSpA (including AS/r-axSpA and nr-axSpA) clinical trial programs.8

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 Exclusion Criteria

  • Active, or a history of malignant disease was an exclusion criterion in the pivotal psoriasis UNCOVER clinical trials and in the pivotal 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 axSpA 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.9-15

Clinical Trial Discontinuation Criteria 

  • The clinical trial protocols required patients who developed a malignancy to discontinue the studies.
  • Patients were allowed to continue in the study if they developed no more than 2 NMSC 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.11,16

Treatment-Emergent Malignancies in Clinical Trials

All Ixekizumab Psoriasis Exposures

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

Malignancies Reported in All Ixekizumab Exposures Across 16 Psoriasis Trials16,17

 

All Ixekizumab Psoriasis Exposures Integrated Analysis Set
N=6645; 17,902 PY of Exposure
n (%) [IR]

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

  • prostate cancer (n=12)
  • squamous cell carcinoma (n=7)
  • invasive ductal breast carcinoma (n=5)
  • colon cancer (n=4)
  • lung cancer metastatic (n=3)
  • rectal adenocarcinoma (n=3)
  • B-cell lymphoma (n=2)
  • breast cancer (n=2)
  • intraductal proliferative breast lesion (n=2)
  • invasive breast carcinoma (n=2) 
  • invasive lobular breast carcinoma (n=2), and
  • renal cell carcinoma (n=2).16

Rates of malignancy did not increase over time during longer exposures to ixekizumab.17

All Ixekizumab Psoriatic Arthritis Exposures

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

Malignancies Reported in All Ixekizumab Exposures Across 4 Psoriatic Arthritis Clinical Trials16

 

All Ixekizumab Psoriatic Arthritis Exposures Integrated Analysis Set
N=1401; 2247.7 PY of Exposure
n (%) [IR]

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 

  • prostate cancer 
  • breast cancer 
  • gastrointestinal stromal tumor 
  • invasive ductal breast carcinoma 
  • malignant melanoma in situ 
  • metastatic renal cell carcinoma, and
  • papillary thyroid cancer.16

Rates of malignancy did not increase over time during longer exposures to ixekizumab.8

All Ixekizumab Axial Spondyloarthritis Clinical Trials

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

Malignancies Reported in All Ixekizumab Exposures Across 4 Axial Spondyloarthritis Trials16,18

 

All Ixekizumab Axial Spondyloarthritis Exposures Integrated Analysis Set
N=932; 1849.0 PY of Exposure
n (%) [IR]

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.

Of malignancies excluding NMSC, there was 1 case each of 

  • abdominal neoplasm
  • acute promyelocytic leukemia 
  • chronic lymphocytic leukemia 
  • anal cancer 
  • breast cancer 
  • bladder cancer, and
  • ovarian cancer.16,18

    References

    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.

    Glossary

    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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