Taltz® ▼ (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

Taltz® ▼ (ixekizumab): Use in Patients with Diabetes

Safety and efficacy of ixekizumab in patients with diabetes is undetermined because Lilly has not conducted studies of ixekizumab in this specific patient population.

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, or PsA. 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.1-3

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 Trials3


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.2,4

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 Trials3


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)

Therapeutic Indications

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.5

Ixekizumab, 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.5

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 randomized, 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. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4. 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

5. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

Lilly = Eli Lilly and Company 

PsA = psoriatic arthritis

This 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.

Date of Last Review: February 23, 2020

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