• Ixekizumab product labeling does not contain a contraindication for use in patients with a malignancy or history of malignancy.1 However, the use of ixekizumab in this population has not been studied.
• Clinical Trial Exclusion Criteria:2-4
  • Active, or a history of malignant disease was an exclusion criterion in the pivotal psoriasis UNCOVER 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 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:2,4
  • 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.

• 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.5

• 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%).4

• 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.4

• No treatment-emergent lymphomas were reported in the 3 integrated PsA trial data cut described above based on MedDRA preferred terms.4

IR = incidence rate

MedDRA = Medical Dictionary for Regulatory Activities

NMSC = nonmelanoma skin cancer

PsA = psoriatic arthritis

PY = patient-years