as Adverse Drug Reaction
is not listed as adverse drug reaction in the Taltz summary of
Criteria in Ixekizumab Clinical Trials
Spondylitis/Radiographic Axial Spondyloarthritis Trials
with iritis were not explicitly excluded in the COAST-V and COAST-W
with iritis were not specifically excluded in the COAST-X study.4
specific exclusion criteria for iritis were included in the phase 3
psoriatic arthritis clinical trials. 5,6
specific exclusion criteria for iritis were included in the pivotal
phase 3 plaque psoriasis clinical trials.7
and TEAEs of Iritis in Ixekizumab Clinical Trials
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.
information is for reference only and is not a treatment
recommendation. Decisions regarding the use of ixekizumab in patients
with iritis (or any medical condition) should be made at the
discretion of the prescribing physician using their best clinical
Spondylitis/Radiographic Axial Spondyloarthritis Trials
was reported as a historical illness in 7 (1.9%) patients randomized
to ixekizumab through week 16 in COAST-V and COAST-W.6
Axial Spondyloarthritis Trial
was reported as a preexisting condition in 1 (0.5%) patient
randomized to ixekizumab in COAST-X.6
of Iritis in All Axial Spondyloarthritis Trials
all ixekizumab exposures axSpA trials (including AS/r-axSpA and
nr-axSpA) (N=929; 1336.2 PYs), as of April 2019, iritis was reported
as a TEAE in 6 patients.8
was not reported as preexisting or historical illness in any patient
randomized to ixekizumab through week 24 in SPIRIT-P1, SPIRIT-P2, or
TEAE of iritis was reported out of 1401 patients exposed to
ixekizumab across psoriatic arthritis clinical trials as of March
was not reported as a historical illness or preexisting condition in
any patient randomized to ixekizumab through week 12 (N=2328) in
UNCOVER -1, -2, and -3.6
(0.0%) TEAEs of iritis were reported out of 6091 patients exposed to
ixekizumab across plaque psoriasis trials (including phase 1, phase
2, and phase 3) as of March 21, 2019.6
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Deodhar 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.
van 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.
Deodhar 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.
Nash 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
randomized, double-blind, placebo-controlled period of the SPIRIT-P2
phase 3 trial. Lancet. 2017;389(10086):2317-2327.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab
in moderate-to-severe plaque psoriasis. N Engl J Med.
Genovese 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.
Mease 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.
A long-term efficacy and safety study of ixekizumab (LY2439821) in
participants with active psoriatic arthritis (SPIRIT P3).
identifier: NCT02584855. Updated November 15, 2019. Accessed
September 25, 2020.
A Long Term Extension Study of Ixekizumab (LY2439821) in
Participants With Axial Spondyloarthritis. ClinicalTrials.gov
identifier: NCT031129100. Updated May 3, 2019. Accessed June 24,
= ankylosing spondylitis/radiographic axial spondyloarthritis
= axial spondyloarthritis
= biologic disease-modifying antirheumatic drug
= exposure adjusted incidence rate
= Medical Dictionary for Regulatory Activities
= nonradiographic axial spondyloarthritis
= psoriatic arthritis
= every 2 weeks
= every 4 weeks
= treatment-emergent adverse event
= tumor necrosis factor
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.
Brief Clinical Trial Descriptions
-2, and -3 (N=3866) phase 3 trials in moderate-to-severe plaque
psoriasis were integrated to evaluate the safety of ixekizumab in
comparison to placebo up to 12 weeks after treatment initiation.
phase 3 trials examined the efficacy and safety of ixekizumab
compared with placebo and etanercept (UNCOVER-2 and -3) during
induction treatment and vs placebo in maintenance (UNCOVER-1 and
1. Induction (UNCOVER-1, -2, -3) and Maintenance (UNCOVER-1, -2)
Dosing Period Study Designs7
ETN = etanercept; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W =
ixekizumab 80 mg every 4 weeks; IXE Q12W = ixekizumab 80 mg every 12
weeks; PBO = placebo; R = randomization; sPGA = static Physician
ETN arm was not included in
(sPGA 0 or 1) to ixekizumab at week 12 were re-randomized to receive
IXE Q4W, IXE Q12W, or PBO.
to ETN at week 12 in UNCOVER-2 were switched to IXE Q4W (without a
160 mg starting dose) after a 4-week washout period.
to PBO at week 12 received a 160 mg starting dose of ixekizumab
followed by IXE Q4W.
line) = relapse (sPGA≥3).
is not represented in maintenance period design as the extension
period consisted of open-label treatment with IXE Q4W.
dosing schedules shown in Figure
1 are not consistent with the approved dosing
schedule for plaque psoriasis in the Taltz summary of product
characteristics. Please refer to the Taltz summary of product
characteristics for approved dosing.1
(N=417) is a phase 3, 24-week double-blind, placebo-controlled trial
with an active reference arm in patients with active PsA who are
naïve to bDMARDs with an extension period of up to 3 years.9
(N=363) is a phase 3, 24-week double-blind, placebo-controlled trial
in patients with active PsA and an inadequate response or
intolerance to TNF inhibitor, with an extension period of up to 3
(N=570) consists of a 36-week open-label period followed by a
randomized double-blind withdrawal period from week 36 to week 104.
This trial is being conducted in patients naïve to bDMARDs.10
is a phase 3, 16-week double-blind, placebo-controlled trial with an
active reference arm and a dose double-blind extension period to 52
weeks in patients with active AS/r-axSpA who are naive to bDMARDs.3
is a phase 3, 16-week double-blind, placebo-controlled trial with a
dose double-blind extension period to 52 weeks in patients with
active AS/r-axSpA and an inadequate response or intolerance to 1 or
2 TNF inhibitors.2
is a phase 3, 52-week double-blind, placebo-controlled trial in
patients with nr-axSpA who are naive to bDMARDs.4
is a phase 3, 104-week, long-term extension trial including a
double-blind, placebo-controlled 40-week randomized
withdrawal-retreatment period in patients with axial
spondyloarthritis who have completed the final study visit in
COAST-V, COAST-W, or COAST-X.11