overall difference in safety risk was observed between patients with
and without previous exposure to biologics in ixekizumab psoriasis
information is for reference only and is not a treatment
recommendation. Safety and efficacy of ixekizumab in patients who
reported an allergic reaction with secukinumab have not been studied.
Decisions regarding the use of ixekizumab in patients who reported an
allergic reaction with secukinumab should be made at the discretion
of the prescribing physician using their best clinical judgment.
Label Information Related to Hypersensitivity
is contraindicated in patients with serious hypersensitivity to the
active substance or to any of the excipients listed in the Taltz
summary of product characteristics.2
hypersensitivity reactions, including some cases of anaphylaxis,
angioedema, urticaria and, rarely, late (10-14 days following
injection) serious hypersensitivity reactions including widespread
urticaria, dyspnea and high antibody titres have been reported. If
a serious hypersensitivity reaction occurs, administration of
ixekizumab should be discontinued immediately and appropriate therapy
Exposures to Secukinumab in a Study of Continuous Ixekizumab Q2W
(13/1227) patients enrolled in IXORA-P reported previous treatment
Patients who received secukinumab within a washout period of <5
months were excluded from the trial.4 It
is unknown whether any of these 13 patients previously experienced an
allergic reaction with secukinumab.
continous dosing schedule IXEQ2W is 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.2
Retrospective Review on Switching From Secukinumab to Ixekizumab
multicenter retrospective chart review in patients with plaque
psoriasis with prior exposure to secukinumab examined efficacy and
safety outcomes of subsequent treatment with ixekizumab. Inclusion
criteria included all consecutive patients who
18 years or older
moderate-to-severe plaque psoriasis, and
treated with ixekizumab therapy following discontinuation of
study was not sponsored by Lilly.
the 31 patients who met inclusion criteria, 10 experienced an AE to
secukinumab. Of those 10 patients, 5 (50%) experienced an AE to
ixekizumab. Conversely, of the 21 patients who did not experience an
AE to secukinumab, 6 (19.4) experienced an AE to ixekizumab.5
patients reported a postinjection systemic reaction and 1 patient
reported a dermatitic rash (peri-orbital) with ixekizumab. The
article did not specify whether these AEs were allergic reactions or
how many patients reported an allergic reaction with secukinumab.5
authors concluded that safety outcomes with secukinumab did not
correlate with ixekizumab safety outcomes.5
Trial Exclusion Criteria
was not yet marketed when the pivotal clinical trials of ixekizumab
for the treatment of PsO were initiated (UNCOVER-1, -2, and -3). In
these 3 pivotal trials, previous participation in any study
investigating other IL-17 antagonists was a criterion for exclusion.6
Brief descriptions of study designs are available at the end of this
response (see Appendix).
with previous exposure to IL-17 inhibitors were allowed to enroll in
IXORA-P, a study of continuous ixekizumab Q2W dosing in patients with
moderate-to-severe PsOs. Patients were excluded if they had
inadequate response to an IL-17 inhibitor.4
were excluded from pivotal phase 3 active PsA (SPIRIT-P1 and
SPIRIT-P2) trials if they had previous exposure to any IL-17
inhibitor or participated in any trial investigating other IL-17
were excluded from pivotal phase 3 AS/r-axSpA (COAST-V, COAST-W, and
COAST-X) trials if they had previous exposure to any IL-17 inhibitor
or participated in any trial investigating other IL-17 inhibitors.1
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Papp KA, Blauvelt A, Sullivan J, et al. Efficacy of ixekizumab in
patients previously treated with IL-17 inhibitors. Poster presented
at: 26th Meeting of the European Academy of Dermatology and
Venereology (EADV); September 13-17, 2017; Geneva, Switzerland.
Supplementary Appendix to: 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.
Georgakopoulos JR, Phung M, Ighani A, et al. Biologic switching
between interleukin 17A antagonists secukinumab and ixekizumab: a
12-week multicenter, retrospective study. J Eur Acad Dermatol
Venereol. 2019:33(1):e7-e8. https://dx.doi.org/10.1111/jdv.15100
Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab
in moderate-to-severe plaque psoriasis. N Engl J Med.
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
randomised, double-blind, placebo-controlled period of the SPIRIT-P2
phase 3 trial. Lancet. 2017;389(10086):P2317-P2327.
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.
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.
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, 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.
A study of ixekizumab (LY2439821) in participants with
nonradiographic axial spondyloarthritis (COAST-X). ClinicalTrials.gov
Updated August 27, 2019. Accessed November 1, 2019.
= ankylosing spondylitis/radiographic axial spondyloarthritis
= biologic disease-modifying antirheumatic drug
= Eli Lilly and Company
= nonradiographic axSpA
= psoriatic arthritis
= every 2 weeks
= tumor necrosis factor
Trials Brief 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
is a phase 3, 52-week double-blind trial in patients with
moderate-to-severe plaque psoriasis patients that examined the
efficacy and safety of continuous ixekizumab Q2W dosing over 52
(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 inhibitors, 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 an extension period to 52 weeks in patients
with active AS/r-axSpA who are naive to bDMARDs.11
is a phase 3, 16-week double-blind, placebo-controlled trial with an
extension period to 52 weeks in patients with active AS/r-axSpA and
an inadequate response or intolerance to 1 or 2 TNF inhibitors.12
is a phase 3, 52-week double-blind, placebo-controlled trial in
patients with nr-axSpA who are naive to bDMARDs.13