Taltz® (Ixekizumab)

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Ixekizumab: Treatment-Emergent Lymphoma in Psoriasis and Psoriatic Arthritis Clinical Trials

Malignant disease was an exclusion criterion in ixekizumab clinical trials. Treatment-emergent lymphomas are summarized.

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The information contained in this letter may not completely match the current local labeling for IXEKIZUMAB. Please see local labeling approved in your country.

Malignancy-Related Ixekizumab Clinical Trial Criteria

  • 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.
  • Clinical Trial Exclusion Criteria:1-5
    • 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 and SPIRIT-H2H in PsA).
    • 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.
  • Clinical Trial Discontinuation Criteria:1,5
    • The clinical trial protocols required patients who developed a malignancy to discontinue the studies.
    • Patients were allowed to continue 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.

Treatment-Emergent Lymphoma in Psoriasis Clinical Trials

  • Across 13 pooled psoriasis trials (N=5898, accounting for 17,003.4 PYs of total ixekizumab exposure as of September 2018 database lock), the IR of malignancies was 0.8 per 100 PYs of exposure.6
  • Treatment-emergent lymphomas reported in the 13 integrated psoriasis trial data cut described above based on MedDRA preferred terms were
    • B-cell lymphoma (n=2, 0.0%)
    • diffuse large B-cell lymphoma (n=1, 0.0%)
    • Hodgkin's disease (n=1, 0.0%) 
    • Hodgkin's disease mixed cellularity stage unspecified (n=1, 0.0%), and
    • Non-Hodgkin's lymphoma (n=1, 0.0%).5

Treatment-Emergent Lymphoma in Psoriatic Arthritis Clinical Trials

  • Across 3 pooled PsA trials (N=1118, accounting for 1937.7 PYs of total ixekizumab exposure as of September 2018 database lock), the IR of malignancies was 0.8 per 100 PYs of exposure.5
  • No treatment-emergent lymphomas were reported in the 3 integrated PsA trial data cut described above based on MedDRA preferred terms.5

References

1Gordon 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

2Mease 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

3Nash 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

4Langley 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

5Data on file, Eli Lilly and Company and/or one of its subsidiaries.

6Griffiths C, Blauvelt A, Reich K, et al. Long-term safety of ixekizumab in patients with moderate-to-severe psoriasis: results from more than 17,000 patient-years of exposure. Poster presented at: 6th Congress of the Skin Inflammation & Psoriasis International Network; April 25-27, 2019; Paris, France.

Glossary

IR = incidence rate

MedDRA = Medical Dictionary for Regulatory Activities

NMSC = nonmelanoma skin cancer

PsA = psoriatic arthritis

PY = patient-years

Fecha de la última revisión: 2019 M05 16


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