Taltz ® (ixekizumab) injektion

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Vilka är riskerna för depression och självmordsrelaterade biverkningar med Taltz® (ixekizumab)?

Analyser av data från kliniska prövningar med ixekizumab ger ingen evidens på ökad risk för depression eller suicidrelaterade incidenter kopplade till behandling med ixekizumab.

SE_cFAQ_IXE025_SUICIDE_RELATED_TEAEs_DEPRESSION_PsO_PsA_axSpA
SE_cFAQ_IXE025_SUICIDE_RELATED_TEAEs_DEPRESSION_PsO_PsA_axSpA
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What Are the Data on Depression or Suicidal Ideation and Behavior from the Ixekizumab Label and Clinical Trials?

Depression or Suicidal Ideation and Behaviour are not listed as adverse reactions in the Taltz summary of product characteristics.1

There was not any evidence of worsening of depression up to 60 weeks treatment with ixekizumab as assessed by the Quick Inventory of Depressive Symptomatology Self Report.1

Depression and Suicidal Ideation and Behavior in Psoriasis Clinical Trials

Treatment-Emergent Depression in the UNCOVER Clinical Trials

Depression was reported by 218 (3.3%) patients (IR=1.2 per 100 PY) across the psoriasis clinical development program (15 adult and 1 pediatric trials) including data for 6645 patients with 17,902 PY of exposure to ixekizumab as of March 19, 2020.

Suicidal Ideation and Behavior Incidence in the UNCOVER Clinical Trials

There were no completed suicides in 17,902 PY of exposure to ixekizumab (N=6645) across the psoriasis clinical development program (15 adult and 1 pediatric trials) as of March 19, 2020 data cutoff date,2 

The incidence of suicidal behavior and ideation events across the entire ixekizumab clinical development program was

  • consistent with the background incidence rates observed in patients with psoriasis, and
  • comparable across ixekizumab, placebo, and etanercept treatment groups.2-4

Suicidal ideation and self-injurious behavior AEs in the psoriasis clinical trials were

  • Suicide attempt 11 (0.2)
  • Suicidal ideation 6 (0.1)
  • Intentional overdose 1 (0.0)2

Data set: All PsO IXE, March 2020 database lock (16 Trials), all IXE exposures N=6645 n (%)2

Depression and Suicidal Ideation and Behavior in Psoriatic Arthritis Clinical Trials

Treatment-Emergent Depression in the SPIRIT Clinical Trials

Depression was reported by 37 (2.6%) patients (IR=1.6 per 100 PY ) across the PsA clinical development program (4 trials) including data for 1401 patients with 2247.7 PY of exposure to ixekizumab as of March 19, 2020.5

Suicidal Ideation and Behavior Incidence in the SPIRIT Clinical Trials

Suicidal ideation was reported by 1 (0.1%) patient (IR=0.0 per 100 PY) across the PsA clinical development program (4 trials) including data for 1401 patients with 2247.7 PY of exposure to ixekizumab as of March 19, 2020.2

There were no suicide attempts or completed suicides.2

Depression and Suicidal Ideation and Behavior in Ankylosing Spondylitis/Radiographic Axial Spondyloarthritis Clinical Trials

Treatment-Emergent Depression in the COAST Clinical Trials

Depression was reported by 18 (1.9%) patients (IR=1.0 per 100 PY) across the axSpA clinical development program (AS/r-axSpA and nr-axSpA trials) including data for 932 patients with 1792.2 PY of exposure to ixekizumab as of March 19, 2020.6

Suicidal Ideation and Behavior Incidence in the COAST Clinical Trials

Suicidal ideation was reported by 2 (0.2%) patients (IR=0.1 per 100 PY) across the axSpA clinical development program (AS/r-axSpA and nr-axSpA trials) including data for 932 patients with 1792.2 PY of exposure to ixekizumab as of March 19, 2020.2

There was 1 completed suicide (0.1% of total axSpA patient population) in the ixekizumab 80 mg Q2W treatment arm (N=98) in the 16-week double-blind treatment period of the COAST-W trial. This patient had a documented history of depression for about 1 year that was reported as mild at study entry. The blinded principal investigator judged the event as unrelated to the investigational product.7

Neuropsychiatric-Related Exclusion Criteria in Ixekizumab Clinical Trial Programs

Patients with comorbid depression were not excluded from the psoriasis, PsA, or axSpA clinical trials.7-11

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 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.9-12

References

1Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3Olivier 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

4Strober 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.e17. http://dx.doi.org/10.1016/j.jaad.2016.09.026

5Sesin C, Gallo G, Gellett AM, et al. Safety of ixekizumab in patients with psoriatic arthritis: an integrated analysis of 4 clinical trials. Poster presented at: European League Against Rheumatism Virtual Congress; June 2-5, 2021.

6Schwartzman S, Sandoval D, Kronbergs A, et al. Long-term safety profile of ixekizumab treatment on patients with axial spondyloarthritis. Poster presented at: Florida Society of Rheumatology 2021 Annual Meeting; July 9-11, 2021; Orlando, FL.

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

8Gordon 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

9Nash 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

10van 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

11Deodhar 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

12Griffiths CEM, Fava M, Miller AH, Russell J, 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

Glossary

AE = adverse event

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

axSpA = axial spondyloarthritis

IR = incidence rate

Lilly = Eli Lilly and Company

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

PY = patient-years

QIDS-SR16 = 16-item Quick Inventory of Depressive Symptomatology - Self-Report

Datum fӧr senaste ӧversyn 2020 M10 20


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