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Taltz ® (ixekizumab)
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How frequent is depression with Taltz® (ixekizumab)?
Analyses of ixekizumab clinical trial data do not show evidence of increased risk of depression with ixekizumab treatment.
Table of contents
Were patients with depression excluded from the ixekizumab clinical trials?
Patients with comorbid depression were not excluded from the psoriasis, PsA, or axSpA clinical trials.1-5
Patients were excluded from the ixekizumab clinical trial programs if they had
- a score of 3 on Item 12 (thoughts of death or suicide) of the 16-item Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR16)
- a history of suicide attempt (limited to recent history within 30 days of screening or any time between screening and baseline in axSpA trials)
- presence of an uncontrolled neuropsychiatric disorder, or
- been clinically judged by the investigator to be at risk for suicide.2,3,5,6
In the UNCOVER psoriasis trials, of the 5101 screened, 8 (0.2%) patients were excluded for meeting at least 1 neuropsychiatric-related exclusion criterion.7
In the SPIRIT PsA trials, of the 1704 screened 5 (0.3%) patients were excluded based on QIDS-SR16 exclusion criterion.7
In the COAST-V and COAST-W AS/r-axSpA trials, of the 671 screened, 2 (0.3%) patients were excluded based on QIDS-SR16 exclusion criterion.7
In the COAST-X nr-axSpA trial, of the 436 screened, 1 (0.2%) patient was excluded based on QIDS-SR16 exclusion criteria.7
How frequent was depression in the ixekizumab clinical trials?
Note that multiple, different dosing regimens, including unapproved doses, are included in this response. Please refer to Taltz summary of product characteristics for full prescribing information.
Psoriasis
Psoriasis is associated with an increased risk of depression and suicide-related thoughts and behaviors, with higher severity of psoriasis associated with increased levels of depression.8-12
Depression Adverse Events Through Week 12 in Active- and Placebo-Controlled Psoriasis Clinical Trials: UNCOVER-1, -2, and -3, ITT Population lists depression adverse events (AEs) reported in the 12-week induction period of active- and placebo-controlled pooled clinical trials, such as UNCOVER-1, -2, and -3.
PBO |
ETNa |
IXE Q4W |
IXE Q2W |
|
Depression |
4 (0.5) |
3 (0.4) |
4 (0.3) |
4 (0.3) |
Abbreviations: ETN = etanercept; ITT = intent-to-treat; IXE = ixekizumab; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.
aData from UNCOVER-2 and -3 studies only.
An integrated safety analysis was conducted from all exposures of ixekizumab in adult patients with psoriasis (N=6892; 18,025.7 patient-years [PYs] of exposure) across 17 clinical trials with data up to March 2022. Depression was reported in 215 (3.1%) patients (incidence rate [IR] of 1.2 per 100 PYs of exposure).13,14
Psoriatic Arthritis
Depression Adverse Events Through Week 24 in Psoriatic Arthritis Clinical Trials: SPIRIT-P1, Safety Population and Depression Adverse Events Through Week 24 in Psoriatic Arthritis Clinical Trials: SPIRIT-P2, Safety Population list depression AEs reported in the 24-week double-blind treatment period of SPIRIT-P1 and -P2 studies.
SPIRIT-P1 |
||||
PBO |
ADA Q2Wa |
IXE Q2W |
IXE Q4W |
|
Depression |
0 |
1 (1.0) |
1 (1.0) |
2 (1.9) |
Abbreviations: ADA = adalimumab; IXE = ixekizumab; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.
aAdalimumab represents an active reference arm; the study was not powered to test equivalence or noninferiority of active treatment arms to each other, including adalimumab vs ixekizumab.
SPIRIT-P2 |
|||
PBO |
IXE Q2W |
IXE Q4W |
|
Depression |
3 (2.5) |
2 (1.6) |
2 (1.6) |
Abbreviations: IXE = ixekizumab; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.
Axial Spondyloarthritis
Depression Adverse Events Through Week 16 in AS/r-axSpA Clinical Trials: COAST-V, Safety Population and Depression Adverse Events Through Week 16 in AS/r-axSpA Clinical Trials: COAST-W, Safety Population list depression AEs reported in the 16-week double-blind treatment period of the COAST-V and COAST-W ankylosing spondylitis/radiographic axial spondyloarthritis (AS/r-axSpA) clinical trials.
COAST-V |
||||
PBO |
ADA Q2Wa |
IXE Q2W |
IXE Q4W |
|
Depression |
0 |
1 (1.0) |
0 |
0 |
Abbreviations: ADA = adalimumab; AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis; IXE = ixekizumab; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.
aAdalimumab represents an active reference arm; the study was not powered to test equivalence or noninferiority of active treatment arms to each other, including adalimumab vs ixekizumab.
COAST-W |
|||
PBO |
IXE Q2W |
IXE Q4W |
|
Depression |
5 (4.8) |
2 (2.0) |
0 |
Abbreviations: AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis; IXE = ixekizumab; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.
Depression Adverse Events Through Week 52 in COAST-X Trial in nr-axSpA Patients, Safety Population lists depression AEs reported in the 52-week double-blind treatment period of the COAST-X nonradiographic axial spondyloarthritis (nr-axSpA) clinical trial.
|
PBO |
IXE Q4W |
IXE Q2W |
Depressiona |
0 |
0 |
4 (3.9) |
Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo; TEAE = treatment-emergent adverse event.
aOne patient with preexisting anxiety in the IXE Q2W arm discontinued study drug due to a TEAE of suicidal ideation after switching to open-label ixekizumab.
Depression Adverse Events Through Week 156 of the COAST Program in Axial Spondyloarthritis Patients, Safety Population lists depression AEs reported in the 156-week safety data from the COAST program.
|
IXE Q4W |
IXE Q2W |
Total IXEa |
Depression |
6 (1.3) |
13 (2.2) |
19 (2) |
Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks.
a126 patients who switched from IXE Q4W to IXE Q2W were included in both the IXE Q4W and IXE Q2W columns.
References
1Gordon 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
2Nash P, Kirkham B, Okada M, et al; SPIRIT-P2 Study Group. 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
3van 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
4Deodhar 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
5Deodhar 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
6Griffiths CEM, Fava M, Miller AH, et al. Impact of ixekizumab treatment on depressive symptoms and systemic inflammation in patients with moderate-to-severe psoriasis: an integrated analysis of three phase 3 clinical studies. Psychother Psychosom. 2017;86(5):260-267. http://dx.doi.org/10.1159/000479163
7Data on file, Eli Lilly and Company and/or one of its subsidiaries.
8Gelfand JM, Troxel AB, Lewis JD, et al. The risk of mortality in patients with psoriasis: results from a population-based study. Arch Dermatol. 2007;143(12):1493-1499. http://dx.doi.org/10.1001/archderm.143.12.1493
9Olivier C, Robert PD, Daihung D, et al. The risk of depression, anxiety, and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol. 2010;146(8):891-895. http://dx.doi.org/10.1001/archdermatol.2010.186
10Yeung H, Takeshita J, Mehta NN, et al. Psoriasis severity and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 2013;149(10):1173-1179. http://dx.doi.org/10.1001/jamadermatol.2013.5015
11Armstrong A, Robertson A, Edson-Heredia E, et al. Association of psoriasis severity with health-related quality of life, depression, and work productivity. Poster presented at: 73rd Annual Meeting of the American Academy of Dermatology; March 20-24, 2015; San Francisco, CA.
12Griffiths CEM, Gooderham M, Colombel JF, et al. Safety of ixekizumab in adult patients with moderate-to-severe psoriasis: data from 17 clinical trials with over 18,000 patient-years of exposure. Dermatol Ther (Heidelb). 2022;12(6):1431-1446. https://doi.org/10.1007/s13555-022-00743-9
13Deodhar A, Blauvelt A, Schwartzman S, et al. Long-term safety of ixekizumab in adult patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis. Poster presented at: American College of Rheumatology/ARP - 2022 Annual Scientific Meeting; November 10-14, 2022; Philadelphia, Pennsylvania.
14Deodhar A, Blauvelt A, Lebwohl M, et al. Long-term safety of Ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials. Arthritis Res Ther. 2024;26(1):49. https://doi.org/10.1186/s13075-023-03257-7
15Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study Group. 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
16Nash P, Kirkham B, Okada M, et al. A phase 3 study of the efficacy and safety of ixekizumab in patients with active psoriatic arthritis and inadequate response to tumour necrosis factor inhibitor(s). Poster presented at: 2017 European League Against Rheumatism; June 14-17, 2017; Madrid, Spain.
17Deodhar A, Poddubnyy D, Rahman P, et al. Long-term safety and efficacy of ixekizumab in patients with axial spondyloarthritis: 3-year data from the COAST program. J Rheum. Published online March 1, 2023. https://www.jrheum.org/content/early/2023/02/23/jrheum.221022.long
Date of Last Review: 29 March 2024