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 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 ≥ 60 kg (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. Injection sites may be alternated. If possible, areas of the skin that show psoriasis should be avoided as injection sites. The solution/the syringe 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 Double-Blind Treatment Periods of the Ixekizumab Clinical Trials

Psoriasis Clinical Trials

In the 12-week induction periods across clinical trials UNCOVER-1, -2, and -3, ISRs occurred significantly more frequently in patients treated with ixekizumab 80mg Q2W and ixekizumab 80mg Q4W than with placebo, but at a similar frequency to patients treated with etanercept (Table 1).2,3

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

Most ISRs (≥95%) were mild-to-moderate in severity. Of patients who reported an ISR, 0.2% discontinued ixekizumab due to ISR.3,4

Table 1. Injection Site Reactions Through Week 12 in UNCOVER-1, -2, and -32,3

Study

IXE Q2W

IXE Q4W

ETN

PBO

UNCOVER-1

N=433

N=432

N/A

N=431

Injection site reactions, n (%)a

69 (15.9)

52 (12.0)

N/A

13 (3.0)

UNCOVER-2 and -3 pooled

N=734

N=729

N=739

N=360

Injection site reactions, n (%)a

127 (17.3)

97 (13.3)

121 (16.4)

13 (3.6)

Abbreviations: ETN = etanercept; IXE = ixekizumab; N/A = not applicable; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.

a Term includes all injection-site reactions, including reaction, erythema, pain, pruritis, induration, urticaria, nodule, edema, rash, hypersensitivity, bruising, and swelling.

Psoriatic Arthritis Clinical Trials

Injection site reactions were reported in 18% (40/229) of patients treated with the recommended dosing regimen during the 24-week double-blind treatment period of SPIRIT-P1 and SPIRIT-P2. Injection site reactions were reported in 5% of patients in the placebo treatment group during the same treatment period.5,6

Most ISRs were mild-to-moderate in severity.7,8 Only 0.4% of patients discontinued ixekizumab due to ISRs, similar to the discontinuation rate for those patients receiving placebo (0.4%).6

The frequency of ISRs decreased over time (16.8% in the first 12 weeks and 1.7% during weeks 72 to 84; data cutoff September 15, 2016 for SPIRIT-P1 and September 30, 2016 for SPIRIT-P2).6

References

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

2. Gordon K, Blauvelt A, Langley RG, et al. Ixekizumab for treatment of moderate-to-severe plaque psoriasis: 12-week results from a phase 3 study (UNCOVER-1). Poster presented at: 23rd World Congress of Dermatology; June 8-13, 2015; Vancouver, Canada.

3. 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

4. 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

5. Mease PJ, Burmester G, Moriarty SR, et al. Safety of ixekizumab during 24 weeks of treatment in subjects with active psoriatic arthritis: Integrated safety analysis of two randomized, placebo controlled, phase 3 clinical trials. Poster presented at: 2017 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting; November 3-8, 2017; San Diego, CA.

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

7. 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

8. 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 randomized, 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

Glossary

ISR = injection site reaction

Q2W = every 2 weeks

Q4W = every 4 weeks

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: May 06, 2019

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