Taltz ® (ixekizumab)

Can Taltz® (ixekizumab) be used in patients with eczema?

The efficacy and safety of ixekizumab in patients with eczema has not been studied. The decision whether to prescribe ixekizumab in patients with eczema should be made at the discretion of the prescribing physician.

UK_cFAQ_IXE428_USE_IN_PATIENTS_WITH_ECZEMA_AND_TEAEs_PsO_PsA_axSpA
UK_cFAQ_IXE428_USE_IN_PATIENTS_WITH_ECZEMA_AND_TEAEs_PsO_PsA_axSpA
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Related Clinical Trial Exclusion Criteria

Eczema was not a specific criterion for exclusion from ixekizumab clinical trials conducted in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, or axial spondyloarthritis (including AS/r-axSpA and nr-axSpA).1-5

Preexisting Conditions of Eczema in Trials

In the psoriasis safety population from the 3 pivotal UNCOVER clinical trials, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term "eczema" was reported as a

  • preexisting condition in 1 patient (0.0%), and
  • historical illness in 1 patient (0.0%) in the ixekizumab treatment groups.6

No patients reported a preexisting condition or historical illness of eczema in the 2 pivotal SPIRIT psoriatic arthritis trials.6

In the axSpA safety population from the 3 pivotal COAST clinical trials, eczema was reported as a

  • preexisting condition in 3 patients (0.5%), and
  • historical illness in 1 patient (0.2%) in the ixekizumab treatment groups.6

Has eczema been reported with ixekizumab treatment?

Integrated Safety Data

Frequency of Eczematous Reactions Reported in Patients Exposed to Ixekizumab in Psoriasis, Psoriatic Arthritis, and axSpA Trials as of March 2020 shows the frequency of treatment-emergent eczematous reactions, reported as Medical Dictionary for Regulatory Activities (MedDRA) preferred terms including eczema and dermatitis, in patients exposed to ixekizumab during psoriasis, psoriatic arthritis, and axial spondyloarthritis trials as of March 2020.

Frequency of Eczematous Reactions Reported in Patients Exposed to Ixekizumab in Psoriasis, Psoriatic Arthritis, and axSpA Trials as of March 20206

MedDRA Preferred Term, n, (%)

All Psoriasis Ixekizumab Exposuresa
(N=6645)
n (%)

All Psoriatic Arthritis Ixekizumab Exposures
(N=1401)
n (%)

All axSpA Ixekizumab Exposures 
(N=932)
n (%)

Eczema

171 (2.6)b

15 (1.1)

17 (1.8)

Dermatitis

99 (1.5)c

4 (0.3)

10 (1.1)

Dyshidrotic eczema

33 (0.5)

2 (0.1)

4 (0.4)

Allergic dermatitis

27 (0.4)d

4 (0.3)

 5 (0.5)c

Atopic dermatitis

25 (0.4)c

5 (0.4)

2 (0.2)

Asteatotic eczema

19 (0.3)

0

0

Neurodermatitis

19 (0.3)

0

0

Hand dermatitis

17 (0.3)

0

2 (0.2)

Nummular eczema

7 (0.1)

0

0

Vesicular eczema

1 (0.0)

0

0

Abbreviations: axSpA = axial spondyloarthritis; MedDRA = Medical Dictionary for Regulatory Activities.

aIncludes data from trials conducted in adult and pediatric patients with psoriasis.

bThree events led to discontinuation of study drug and 1 event was considered serious.

cOne event led to discontinuation of study drug.

dTwo events led to discontinuation of study drug and 1 event was considered serious.

Treatment-Emergent Adverse Events of Eczema Reported During Placebo-Controlled Treatment Periods of Trials

Psoriasis Trials

Frequency of Eczematous Reactions Reported During the Placebo-Controlled Treatment Periods of UNCOVER-1, -2, and -3 Psoriasis Trials shows the frequency of treatment-emergent eczematous reactions, reported as MedDRA preferred terms including eczema and dermatitis, during the 12-week, placebo-controlled induction periods of the pivotal UNCOVER-1, -2, and -3 trials conducted in patients with plaque psoriasis.6

Frequency of Eczematous Reactions Reported During the Placebo-Controlled Treatment Periods of UNCOVER-1, -2, and -3 Psoriasis Trials6

MedDRA preferred term, n (%)

PBO
(N=791)

IXE Q4W
(N=1161)

IXE Q2W
(N=1167)

Eczema

0

3 (0.3)

3 (0.3)

Dermatitis

1 (0.1)

6 (0.5)

6 (0.5)

Dyshidrotic eczema

0

2 (0.2)

0

Allergic dermatitis

0

0

0

Atopic dermatitis

0

1 (0.1)

0

Asteatotic eczema

1 (0.1)

0

0

Neurodermatitis

0

0

1 (0.1)

Hand dermatitis

0

0

1 (0.1)

Nummular eczema

0

0

0

Vesicular eczema

0

0

0

 Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks following a 160-mg starting dose; IXE Q4W = ixekizumab 80 mg every 4 weeks following a 160-mg starting dose; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo.

Psoriatic Arthritis Trials

Frequency of Eczematous Reactions Reported During the Placebo-Controlled Treatment Periods of SPIRIT-P1 and SPIRIT-P2 Psoriatic Arthritis Trials shows the frequency of treatment-emergent eczematous reactions, reported as MedDRA preferred terms including eczema and dermatitis, during the 24-week, placebo-controlled periods of the pivotal SPIRIT-P1 and SPIRIT-P2 trials conducted in patients with psoriatic arthritis.6

Frequency of Eczematous Reactions Reported During the Placebo-Controlled Treatment Periods of SPIRIT-P1 and SPIRIT-P2 Psoriatic Arthritis Trials6

MedDRA preferred term, n (%)

PBO
(N=224)

IXE Q4W
(N=229)

IXE Q2W
(N=225)

Eczema

0

0

3 (1.3)

Dermatitis

0

0

0

Dyshidrotic eczema

0

0

0

Allergic dermatitis

1 (0.4)

0

0

Atopic dermatitis

0

0

0

Asteatotic eczema

0

0

0

Neurodermatitis

0

0

0

Hand dermatitis

0

0

0

Nummular eczema

0

0

0

Vesicular eczema

0

0

0

 Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks following a 160-mg starting dose; IXE Q4W = ixekizumab 80 mg every 4 weeks following a 160-mg starting dose; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo. 

Axial Spondyloarthritis Trials

AS/r-axSpA Trials

Frequency of Eczematous Reactions Reported During the Placebo-Controlled Treatment Periods of COAST-V and COAST-W AS/r-axSpA Trials shows the frequency of treatment-emergent eczematous reactions, reported as MedDRA preferred terms including eczema and dermatitis, during the 16-week, placebo-controlled periods of the pivotal COAST-V and COAST-W trials conducted in patients with ankylosing spondylitis/radiographic axial spondyloarthritis.6

Frequency of Eczematous Reactions Reported During the Placebo-Controlled Treatment Periods of COAST-V and COAST-W AS/r-axSpA Trials6

MedDRA preferred term, n (%)

PBO
(N=190)

IXE Q4W
(N=195)

IXE Q2W
(N=181)

Eczema

0

2 (1.0)

2 (1.1)

Dermatitis

0

0

0

Dyshidrotic eczema

0

0

0

Allergic dermatitis

0

1 (0.5)

0

Atopic dermatitis

0

0

0

Asteatotic eczema

0

0

0

Neurodermatitis

0

0

0

Hand dermatitis

0

0

0

Nummular eczema

0

0

0

Vesicular eczema

0

0

0

 Abbreviations: AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo. 

Nonradiographic Axial Spondyloarthritis Trials

Frequency of Eczematous Reactions Reported During the Placebo-Controlled Treatment Period of COAST-X Nonradiographic Axial Spondyloarthritis Trial, Prior to any Switch to IXE Q2W Dosing shows the frequency of treatment-emergent eczematous reactions, reported as MedDRA preferred terms including eczema and dermatitis, during the 52-week, placebo-controlled period of the COAST-X trial conducted in patients with nonradiographic axial spondyloarthritis.6

Frequency of Eczematous Reactions Reported During the Placebo-Controlled Treatment Period of COAST-X Nonradiographic Axial Spondyloarthritis Trial, Prior to any Switch to IXE Q2W Dosing6

MedDRA preferred term, n (%)

PBO
(N=104)

IXE Q4W
(N=96)

IXE Q2W
(N=102)

Eczema

0

1 (1.0)

0

Dermatitis 

0

1 (1.0)

0

Dyshidrotic eczema

0

0

0

Allergic dermatitis

0

0

0

Atopic dermatitis

0

0

0

Asteatotic eczema

0

0

0

Neurodermatitis

0

0

0

Hand dermatitis

0

0

0

Nummular eczema

0

0

0

Vesicular eczema

0

0

0

 Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo.

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, 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

5Deodhar 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

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

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

axSpA =  axial spondyloarthritis  

MedDRA = Medical Dictionary for Regulatory Activities

nr-axSpA = nonradiographic axial spondyloarthritis 

Date of Last Review: July 29, 2021


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