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): Incidence of Injection Site Reactions

Injection site reactions were very commonly reported.

Short Summary

  • The most frequent injection site reactions observed were erythema and pain. These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of ixekizumab.1

  • Ixekizumab is contraindicated in patients with serious hypersensitivity to the active substance or to any of the excipients.1

Information from the Label

Adverse Reactions of Injection Site Reactions

In the adult plaque psoriasis studies, injection site reactions were more common in subjects with a body weight <60 kg compared with the group with a body weight ≥60kg (25% vs. 14% for the combined Q2W and Q4W groups).1

In the psoriatic arthritis studies, injection site reactions were more common in subjects with a body weight <100 kg compared with the group with a body weight ≥100 kg (24% vs. 13% for the combined Q2W and Q4W groups).1

In the axial spondyloarthritis studies, injection site reactions were similar in subjects with a body weight <100 kg compared with the group with a body weight ≥100 kg (14% vs. 9% for the combined Q2W and Q4W groups).1

The increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in an increase in discontinuations in either the plaque psoriasis, or the psoriatic arthritis or the axial spondyloarthritis studies.1

Method of Administration

Ixekizumab is for subcutaneous injection.1

  • Injection sites may be alternated.1

  • If possible, areas of the skin that show psoriasis should be avoided as injection sites.1

The solution/the syringe/pen must not be shaken.1

After proper training in subcutaneous injection technique, patients may self-inject ixekizumab if a healthcare professional determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Comprehensive instructions for administration are given in the package leaflet and the user manual.1

Incidence of Injection Site Reactions in the Placebo-Controlled Treatment Periods of the Ixekizumab Clinical Trials

Note: Dosing schedules are mentioned in this response that are not consistent with the approved dosing schedule in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing. 1

Psoriasis Clinical Trials

Most ISRs (≥95%) were mild-to-moderate in severity. Of patients who reported an ISR, 0.2% discontinued ixekizumab due to ISR.2,3

The most commonly reported types of ISRs during the 12-week induction periods of UNCOVER-1, -2, and -3 for the ixekizumab 80 mg Q2W and Q4W dosing groups and placebo are shown in Table 1.

Table 1. Frequency of Injection Site Reactions During 12-Week Induction Periods of UNCOVER-1, -2, and -3 Psoriasis Trials4,5


IXE Q2W
N=1167 
n (%)

IXE Q4W
N=1161
n (%)

PBO
N=791
n (%)

Injection site reaction (unspecified)

117 (10.0)a

89 (7.7)a

9 (1.1)

Injection site erythema

52 (4.5)a

32 (2.8)a

2 (0.3)

Injection site pain

28 (2.4)

17 (1.5)

14 (1.8)

Abbreviations: IXE Q2W= ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo. 

a p<.001 vs PBO.

Psoriatic Arthritis Clinical Trials

Most ISRs (>95%) were mild-to-moderate in severity.5,6 Of patients who reported an ISR, 1.1% discontinued ixekizumab due to ISR.6,7

The most commonly reported types of ISRs during the 24-week placebo-controlled periods of SPIRIT-P1 and SPIRIT-P2 for the ixekizumab 80 mg Q2W and Q4W dosing groups and placebo are shown in Table 2.

Table 2. Frequency of Injection Site Reactions During 24-Week Placebo-Controlled Periods of SPIRIT-P1 and SPIRIT-P2 Psoriatic Arthritis Trials5


IXE Q2W
N=225
n (%)

IXE Q4W
N=229
n (%)

PBO
N=224
n (%)

Injection site reaction (unspecified)

32 (14.2)a

22 (9.6)a

1 (0.4)

Injection site erythema

17 (7.6)a

9 (3.9)b

0

Injection site hypersensitivity 

6 (2.7)c

1 (0.4)

0

Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo.

a p<.001 vs PBO.

b p<.005 vs PBO.

c p<.05 vs PBO.

Axial Spondyloarthritis Trials

AS/r-axSpA Trials

Most ISRs (>95%) were mild-to-moderate in severity.5,8,9 Of patients who reported an ISR, 1.1% discontinued ixekizumab due to ISR.8,9

The most commonly reported types of ISRs during the 16-week placebo-controlled periods of COAST-V and COAST-W for the ixekizumab 80 mg Q2W and Q4W dosing groups and placebo are shown in Table 3.

Table 3. Frequency of Injection Site Reactions During 16-Week Placebo-Controlled Periods of COAST-V and COAST-W AS/r-axSpA Trials5

 

IXE Q2W
N=181
n (%)

IXE Q4W 
N=195
n (%)

PBO
N=190
n (%)

Injection site reaction (unspecified)

15 (8.3)

3 (1.5)

3 (1.6)

Injection site pain

5 (2.8)

4 (2.1)

4 (2.1)

Injection site erythema

4 (2.2)

3 (1.5)

1 (0.5)

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; PBO = placebo.

nr-axSpA Trials

Most ISRs (>95%) were mild-to-moderate in severity. Of patients who reported ISR, 1.6% discontinued due to ISR.10

The most commonly reported types of ISRs during the 52-week placebo-controlled period of COAST-X for the ixekizumab 80 mg Q2W and Q4W dosing groups and placebo are shown in Table 4 .

Table 4. Incidence of Injection Site Reactions During 52-week Placebo-Controlled Period of COAST-X Clinical nr-axSpA Triala,5


IXE Q2W
N=102
n (%)

IXE Q4W
N=96
n (%)

PBO
N=104
n (%)

Injection site reaction (unspecified)

17 (16.7)b

11 (11.5)

4 (3.8)

Injection site erythema

4 (3.9)

3 (3.1)

1 (1.0)

Injection site swelling

2 (2.0)

2 (2.1)

0

Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo; TEAE = treatment-emergent adverse event. 

a TEAEs were summarized using the safety population, defined as all patients who received at least 1 dose of the trial drug, per the assigned treatment. TEAEs were summarized before any switch to open-label ixekizumab.

b p<.001 vs PBO.

References

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

2. Griffiths CEM, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541-551. http://dx.doi.org/10.1016/S0140-6736(15)60125-8

3. 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

4. Shear NH, Paul C, Blauvelt A, et al. Safety and tolerability of ixekizumab: integrated analysis of injection-site reactions from 11 clinical trials. J Drugs Dermatol. 2018;17(2):200-206. http://jddonline.com/articles/dermatology/S1545961618P0200X

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

6. 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

7. 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 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

8. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. 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

9. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. 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

10. Deodhar A, van der Heijde D, Gensler LS, et al. 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

ISR = injection site reaction

nr-axSpA = nonradiographic axial spondyloarthritis

Q2W = every 2 weeks

Q4W = every 4 weeks

Date of Last Review: September 25, 2020


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