Ixekizumab Clinical Trial Criteria
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
Trial Exclusion Criteria:2-4
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).
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).
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
This is not an all-inclusive list of exclusion criteria, but rather
a list of those exclusion criteria related to malignancy.
Trial Discontinuation Criteria:2,4
clinical trial protocols required patients who developed a
malignancy to discontinue the studies.
were allowed to continue if they developed no more than 2 NMSC over
any 12-month period during the studies.
This is not an all-inclusive list of discontinuation criteria, but
rather discontinuation criteria related to malignancy.
Lymphoma in Psoriasis Clinical Trials
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
lymphomas reported in the 13 integrated psoriasis trial data cut
described above based on MedDRA preferred terms were
lymphoma (n=2, 0.0%)
large B-cell lymphoma (n=1, 0.0%)
disease (n=1, 0.0%)
disease mixed cellularity stage unspecified (n=1, 0.0%), and
lymphoma (n=1, 0.0%).4
Lymphoma in Psoriatic Arthritis Clinical Trials
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
treatment-emergent lymphomas were reported in the 3 integrated PsA
trial data cut described above based on MedDRA preferred terms.4
is indicated for the treatment of moderate to severe plaque psoriasis
in adults who are candidates for systemic therapy.1
alone or in combination with methotrexate, is indicated for the
treatment of active psoriatic arthritis in adult patients who have
responded inadequately to, or who are intolerant to one or more
disease-modifying anti-rheumatic drug (DMARD) therapies.1
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab
in moderate-to-severe plaque psoriasis. N Engl J Med.
Langley 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.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Griffiths 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.
= Medical Dictionary for Regulatory Activities
= nonmelanoma skin cancer
= psoriatic arthritis
medicine is subject to additional monitoring. This will allow quick
identification of new safety information. Healthcare professionals
are asked to report any suspected adverse reactions.