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Taltz ® (ixekizumab)
Taltz® (ixekizumab): Treatment-Emergent Adverse Events of Diabetes in Clinical Trials
Information on glucose related treatment-emergent adverse events in psoriasis, psoriatic arthritis, and axial spondyloarthritis clinical trials is provided.
UK_cFAQ_IXE409_Y2_USE_IN_PATIENTS_WITH_DIABETES_TEAEs_PsO_PsA_axSpA
en-GB
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 or elevated fasting serum glucose are not listed as adverse drug reactions in the Taltz Summary of Product Characteristics.1
Glucose Related TEAEs in Psoriasis Trials
Fasting serum glucose TEAEs were evaluated in the UNCOVER clinical trials during the double-blind treatment period through week 12 (including 2328 patients treated with ixekizumab 80 mg Q4W or Q2W and 791 patients treated with placebo) and through week 60.2 As shown in Percentage of Patients With Abnormal High Fasting Glucose Values at Week 12 (UNCOVER-1, -2, and -3) and Week 60 (UNCOVER-1 and -2), ixekizumab was not associated with abnormal glucose levels at 12 and 60 weeks.3 It should be noted that the patients in this group were not exclusively patients with diabetes.
Abbreviations: ETN = etanercept 50 mg twice weekly; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo.
aDefinition of abnormal high values varied according to age, gender, and race of patient. Ranges for fasting glucose were 66-365 mg/dL.
Fasting glucose measured at week 60 was comparable in patients treated with ixekizumab and those receiving placebo during the maintenance period (weeks 12-60 of UNCOVER-1 and -2). See Fasting Glucose Levels Through Week 12 and Through Week 60 of UNCOVER Clinical Trials in Psoriasis.
Week 12 (Induction Periods of UNCOVER-1, -2, and -3) |
Week 12 (Induction Periods of UNCOVER-1, -2, and -3) |
Week 12 (Induction Periods of UNCOVER-1, -2, and -3) |
Week 60 (Maintenance Period of UNCOVER-1 and -2) |
Week 60 (Maintenance Period of UNCOVER-1 and -2) |
|
Fasting glucose level, mg/dL |
PBO |
IXE Q4W |
IXE Q2W |
PBO |
IXE Q4W |
Mean Baseline (SD) |
103 (32) |
102 (31) |
101 (29) |
100 (21) |
101 (26) |
Mean Change from Baseline (SD) |
1.1 (27) |
1.7 (23) |
0.8 (22) |
0.7 (14) |
0.4 (21) |
Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo.
Ixekizumab treatment was not associated with clinically meaningful adverse changes of cardiovascular risk factors, including blood pressure, glucose control, or proatherogenic components of the lipid panel in the overall population during the induction (through week 12) and maintenance periods (through week 60).5 However, these analyses were not conducted specifically in patients with diabetes.
Note: The dosing schedule IXEQ4W during the first 12 weeks of treatment (induction phase) 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. 1
Glucose Related TEAEs in Psoriatic Arthritis Trials
Fasting serum glucose TEAEs were evaluated in the SPIRIT-P1 and SPIRIT-P2 trials during the double-blind treatment period through week 24, including 454 patients treated with ixekizumab 80 mg Q4W or Q2W and 224 patients treated with placebo.6
In the integrated 24-week placebo-controlled treatment periods of SPIRIT-P1 and SPIRIT-P2, treatment-emergent high fasting serum glucose (defined as a change from a fasting serum glucose value less than or equal to the ULN at baseline, to a value more than the ULN at any time during the treatment period) was reported in 3.8% of patients treated with ixekizumab 80 mg Q2W and 1.0% of patients treated with ixekizumab 80 mg Q4W compared with 3.8% of patients in the placebo group. It should be noted that these analyses were not conducted specifically in patients with diabetes.6
After 24 weeks, ixekizumab treatment compared with placebo was not associated with clinically meaningful adverse changes of CV risk factors in patients with PsA, including blood pressure, body weight, glucose control, or proatherogenic components of the lipid panel.6 However, these analyses were not conducted exclusively in patients with diabetes.
Note: The dosing schedule IXEQ2W is not consistent with the approved dosing schedule for psoriatic arthritis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing.1
Glucose Related TEAEs in Axial Spondyloarthritis Trials
AS/r-axSpA Trials
Fasting serum glucose TEAEs were evaluated in the COAST-V and COAST-W trials during the double-blind treatment period through week 16, including 376 patients treated with ixekizumab 80 mg Q4W or Q2W and 191 patients treated with placebo.7,8
In the integrated 16-week placebo-controlled treatment periods of COAST-V and COAST-W, treatment-emergent high fasting serum glucose (defined as a change from a fasting serum glucose value less than or equal to the ULN at baseline, to a value more than the ULN at any time during the treatment period) was reported in 12.6% of patients treated with ixekizumab 80 mg Q2W and 15.4% of patients treated with ixekizumab 80 mg Q4W compared with 9.9% of patients in the placebo group. It should be noted that these analyses were not conducted specifically in patients with diabetes.6
Non-radiographic Axial Spondyloarthritis Trials
Fasting serum glucose TEAEs were evaluated in the COAST-X trial during the double-blind treatment period through week 52, including 198 patients treated with ixekizumab 80 mg Q4W or Q2W and 105 patients treated with placebo.9
In the 52-week placebo-controlled treatment period of COAST-X, treatment-emergent high fasting serum glucose (defined as a change from a fasting serum glucose value less than or equal to the ULN at baseline, to a value more than the ULN at any time during the treatment period) was reported in 6.2% of patients treated with ixekizumab 80 mg Q2W and 10.6% of patients treated with ixekizumab 80 mg Q4W compared with 7.1% of patients in the placebo group. It should be noted that these analyses were not conducted specifically in patients with diabetes.6
Note: The dosing schedule IXEQ2W is not consistent with the approved dosing schedule for axial spondyloarthritis. Please refer to the Taltz summary of product characteristics for approved dosing.1
References
1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland
2Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. 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
3Wu JJ, Egeberg A, Solomon JA, et al. Ixekizumab treatment shows a neutral impact on the glucose and lipid profile of patients with moderate-to-severe psoriasis: results from UNCOVER-1, -2, and -3. Poster presented at: 75th Annual Meeting of the American Academy of Dermatology; March 3-7, 2017; Orlando, FL. https://www.aad.org/eposters/Submissions/getFile.aspx?id=4662&type=sub
4Egeberg A, Wu JJ, Korman N, et al. Ixekizumab treatment shows a neutral impact on cardiovascular parameters in patients with moderate-to-severe plaque psoriasis: results from UNCOVER-1, UNCOVER-2, and UNCOVER-3. J Am Acad Dermatol. 2018;79(1):104-109. http://dx.doi.org/10.1016/j.jaad.2018.02.074
5Strober B, Leonardi C, Papp KA, et al. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: etanercept comparisons and integrated data. J Am Acad Dermatol. 2017;76(3):432-440. https://doi.org/10.1016/j.jaad.2016.09.026
6Data on file, Eli Lilly and Company and/or one of its subsidiaries.
7Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. 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
8van der Heijde D, Cheng-Chung Wei J, Dougados M, et al; COAST-V Study Group. 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
9Deodhar A, van der Heijde D, Gensler LS, et al; COAST-X Study Group. 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
Glossary
AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA = axial spondyloarthritis
CV = cardiovascular
Lilly = Eli Lilly and Company
nr-axSpA = nonradiographic axial spondyloarthritis
PsA = psoriatic arthritis
Q2W = every 2 weeks
Q4W = every 4 weeks
TEAE = treatment-emergent adverse event
ULN = upper limit of normal
Date of Last Review: February 23, 2020
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