Taltz® (ixekizumab): Can it be used in patients with diabetes?

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

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

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

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

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