safety and efficacy of ixekizumab in patients with eczema have not
been evaluated by Lilly.
were uncommonly reported adverse drug reactions (ADRs) according to
the Taltz summary of product characteristics.1
was not a specific criterion for exclusion from ixekizumab clinical
trials conducted in patients with moderate-to-severe plaque psoriasis
or PsA. In the psoriasis safety population from the 3 pivotal UNCOVER
clinical trials, MedDRA preferred term "eczema" was
reported as a
condition in 1 patient (0.0%), and
illness in 1 patient (0.0%).2
patients reported a preexisting condition or historical illness of
eczema in the 2 pivotal SPIRIT PsA trials.
of treatment-emergent eczema in the psoriasis and PsA clinical trials
as of 22-Feb-2017 data cutoff is provided in Table
the psoriasis clinical trial eczema AEs,
was considered a SAE, and
led to discontinuation.2
were no eczema SAEs or eczema AEs leading to discontinuation in the
PsA clinical trials as of the data cutoff.2
adverse events are defined as events that first occurred or worsened
in severity, relative to baseline, at any time during a clinical
study. The stated frequencies of adverse reactions represent the
proportion of individuals who experienced, at least once, a TEAE of
the type listed. Adverse events reported during the studies were not
necessarily caused by the therapy and the frequencies do not reflect
investigator assessment of causality.
1. Incidence of Eczema TEAEs in Psoriasis and Psoriatic Arthritis
Psoriasis Ixekizumab Exposures
Psoriatic Arthritis Ixekizumab Exposures
MedDRA = Medical Dictionary for Regulatory Activities; TEAE =
treatment-emergent adverse event.
Medications for Eczema Reported in Psoriasis Clinical Trials
7 ixekizumab registration clinical trials in psoriasis (including
phase 1, phase 2, and phase 3 studies), TEAEs were collected from a
total of 4209 patients exposed to ixekizumab as of 15-Apr-2015.
Eczema was reported as a TEAE in 92 patients in this data set.3
Of the 92 patients who reported treatment-emergent eczema, 58 (63%)
were reported to have received ≥1 concomitant medication.2
These concomitant medications received in patients who reported
eczema are summarized in Table 2
2. Concomitant Medications Provided for the Indication of
Treatment-Emergent Eczema across 7 Psoriasis Clinical Trials2
Medications for Indication of Eczema ab
corticosteroid, moderately potent
corticosteroid, potent, combination with antibiotic
corticosteroid, very potent
for systemic use
therapy was coded using WHO Drug Dictionary Version Jun13B2.
Concomitant medications listed reflect those reported as
eczema for indication in at least 4 patients. Values reflect
percentages of all patients who reported a concomitant medication for
Topical corticosteroids across potency classes were allowed
during the open label treatment period in the UNCOVER studies for any
indication for use.
Patients reported to have received ≥1 concomitant
medication for eczema indication.
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.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Strober B, Leonardi C, Papp KA, et al. Short- and long-term safety
outcomes with ixekizumab from 7 clinical trials in psoriasis:
etanercept comparisons and integrated data. J Am Acad Dermatol.
= Eli Lilly and Company
= Medical Dictionary for Regulatory Activities
= psoriatic arthritis
= serious adverse event
= treatment-emergent adverse event
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.