General
Information
This
information is for reference only and is not a treatment
recommendation. Safety and efficacy of ixekizumab in patients with
diabetes is undetermined because Lilly has not conducted
studies of ixekizumab in this specific patient population. Decisions
regarding the use of ixekizumab in patients with diabetes should be
made at the discretion of the prescribing physician using their best
clinical judgment.
Diabetes
was not a specific criteria for exclusion from ixekizumab clinical
trials conducted in patients with plaque psoriasis, PsA, or axSpA
(including AS/r-axSpA and nr-axSpA trials). Exclusion criteria
included the presence of significant uncontrolled endocrine disorders
that, in the opinion of the investigator, posed an unacceptable risk
to the patient if participating in the study or of interfering with
the interpretation of data.1-6
Preexisting
Diabetes in Psoriasis Trials
UNCOVER-1,
-2, and -3, 3 multicenter, randomized, double-blind,
placebo-controlled trials enrolled a total of 3119 subjects ≥18
years with moderate-to-severe plaque psoriasis.1
Table
1 summarizes the
patients enrolled in the UNCOVER-1, -2, and -3 trials with a history
of preexisting diabetes.
Table
1. Preexisting Diabetes Reported in Psoriasis Clinical Trials6
|
N=3119
|
Preexisting
Condition, n (%)
|
--
|
Diabetes
mellitus type 2
|
287
(9.2)
|
Diabetes
mellitus (type unspecified)
|
63
(2.0)
|
Diabetes
mellitus type 1
|
27
(0.9)
|
Preexisting
Diabetes in Psoriatic Arthritis Trials
SPIRIT-P1
and SPIRIT-P2, 2 multicenter, randomized, double-blind,
placebo-controlled trials enrolled a total of 678 subjects ≥18
years with active psoriatic arthritis.2,7
Table
2 summarizes
the patients enrolled in SPIRIT-P1 and SPIRIT-P2 with a history of
preexisting diabetes.
Table
2. Preexisting Diabetes Reported in Psoriatic Arthritis Clinical
Trials6
|
N=678
|
Preexisting
condition, n (%)
|
--
|
Diabetes
mellitus type 2
|
21
(3.1)
|
Diabetes
mellitus (type unspecified)
|
15
(2.2)
|
Diabetes
mellitus type 1
|
1
(0.1)
|
Preexisting
Diabetes in Axial Spondyloarthritis Trials
Ankylosing
Spondylitis/Radiographic Axial Spondyloarthritis Trials
COAST-V
and COAST-W, 2 multicenter, randomized, double-blind,
placebo-controlled trials enrolled a total of 657 patients ≥18
years with active AS/r-axSpA.3,4
Table
3 summarizes the patients
enrolled in COAST-V and COAST-W with a history of preexisting
diabetes.
Table
3. Preexisting Diabetes Reported in AS/r-axSpA Trials6
|
N=566
|
Preexisting
condition, n (%)
|
--
|
Type
2 diabetes mellitus
|
28
(4.9)
|
Type
1 diabetes mellitus
|
1
(0.2)
|
Type
2 diabetes mellitus requiring insulin
|
6
(1.1)
|
Abbreviation:
AS/r-axSpA = ankylosing spondylitis/radiographic axial
spondyloarthritis.
Non-radiographic
Axial Spondyloarthritis Trials
A
multicenter, randomized, double-blind, placebo-controlled trial,
COAST-X, enrolled a total of 303 patients ≥18 years with active
nr-axSpA.5
Table
3 summarizes the patients
enrolled in COAST-V and COAST-W with a history of pre-existing
diabetes.
Table
4. Pre-existing Diabetes Reported in Non-radiographic Axial
Spondyloarthritis Trials6
|
N=303
|
Pre-existing
condition, n (%)
|
--
|
Type
2 diabetes mellitus
|
6
(2.0)
|
Type
1 diabetes mellitus
|
1
(0.3)
|
Type
2 diabetes mellitus requiring insulin
|
3
(1.0)
|
References
1.
Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab
in moderate-to-severe plaque psoriasis. N Engl J Med.
2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
2.
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):2317-2327.
http://dx.doi.org/10.1016/S0140-6736(17)31429-0
3.
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.
2018;392(10163):2441-2451.
http://dx.doi.org/10.1016/s0140-6736(18)31946-9
4.
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.
http://dx.doi.org/10.1002/art.40753
5.
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.
2020;395(10217):53-64.
http://dx.doi.org/10.1016/S0140-6736(19)32971-X
6.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
7.
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.
http://dx.doi.org/10.1136/annrheumdis-2016-209709
Glossary
AS/r-axSpA
= ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA
= axial spondyloarthritis
Lilly
= Eli Lilly and Company
nr-axSpA
= nonradiographic axial spondyloarthritis
PsA
= psoriatic arthritis