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): How often do injection site reactions occur with Taltz treatment?

Injection site reactions were more frequently reported with ixekizumab treatment compared with placebo in clinical trials.

 Ixekizumab Label Information Related to Injection Site Reactions

Injection site reactions were very commonly (≥ 1/10) reported adverse drug reactions with ixekizumab treatment.1

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

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

Note that multiple, different dosing regimens, including unapproved doses, are included in this response. Please refer to the Taltz Summary of Product Characteristics for approved doses.

Injection Site Reactions in Psoriasis Clinical Trials

Integrated Data

Injection site reactions were reported as an adverse event in 15.2% (928/6091) [IR=5.3 per 100 PYs of exposure] of patients exposed to ixekizumab across 14 adult and pediatric psoriasis trials as of March 2019.2 Of these, the most commonly reported types of ISRs are shown in Table 1.

Table 1. Incidence of Injection Site Reactions in all Patients Exposed to Ixekizumab Across 14 Psoriasis Clinical Trials2,3

 

N=6091; 17,499.3 PYs of exposure
n (%) [IR]

Injection site reactions

928 (15.2) [5.3]

Injection site reaction (unspecified)

 603 (9.9) [3.4]

Injection site erythema

194 (3.2) [1.1]

Injection site pain

115 (1.9) [0.7]


Data From 12-Week, Double Blind, Placebo-Controlled Induction Period

Patients who reported an ISR of any type during psoriasis trials were given a follow-up form in order to collect additional information. Follow-up of patients who spontaneously reported an ISR of any type showed 51% reported pain, the majority (>90%) of which were categorized by the patient as mild-to-moderate.3

  • The majority of reported ISRs in UNCOVER-1, -2, and -3 occurred following the initial 160 mg starting dose.3 Median time to onset was 7 days for the first 160 mg dose. For those with multiple ISRs reported, subsequent doses had earlier median time to onset of 1.5 days for week 2 and 4 injections.4

  • The median duration of ISRs was 2 days.5

  • Generally, injection site pain was typically reported to occur during injection and erythema onset was delayed.4

  • Timing of ISRs varied depending on treatment group (ixekizumab 80 mg Q2W and Q4W dosing groups, etanercept, or placebo) and symptom reported.6

Injection Site Reactions in Psoriatic Arthritis Clinical Trials

Integrated Data

Injection site reactions were reported as an adverse event in 18.5% (259/1401) [IR=11.6 per 100 PYs of exposure] of patients exposed to ixekizumab across 4 psoriatic arthritis trials (SPIRIT-P1, SPIRIT-P2, SPIRIT-P3, and SPIRIT-H2H) as of March 2019.7 Of these, the most commonly reported types of ISRs are shown in Table 2.

Table 2. Incidence of Injection Site Reactions in all Patients Exposed to Ixekizumab Across 4 Psoriatic Arthritis Trials3,7

 

All Ixekizumab Exposures Across 4 Psoriatic Arthritis Trials
N=1401; 2228.6 PYs of exposure
n (%) [IR]

Injection site reactions

259 (18.5) [11.6]

Injection site reaction (unspecified)

156 (11.1) [7.0]

Injection site erythema

60 (4.3) [2.7]

Injection site pain 

21 (1.5) [0.9]

Abbreviations: IR = incidence rate per 100 patient-years of exposure; PY = patient-year.

Data From 24-Week Double-Blind Treatment Periods of SPIRIT-P1 and SPIRIT-P2 trials

Most ISRs (>95%) were mild-to-moderate in severity.3,8 Of patients who reported an ISR, 1.1% discontinued ixekizumab due to ISR.8,9

Patients who reported an ISR of any type during trials were given a follow-up form in order to collect additional information. Follow-up of patients who spontaneously reported an ISR of any type treated with ixekizumab 80 mg Q4W showed that 32.5% reported pain, the majority (>90%) of which were categorized by the patient as mild-to-moderate.3

Injection Site Reactions in Axial Spondyloarthritis Clinical Trials

Integrated Data

Injection site reactions were reported as an adverse event in 16.6% (154/929) [IR=11.5 per 100 PYs of exposure] of patients across 4 axSpA trials (including AS/r-axSpA and nr-axSpA trials) as of April 2019.7 Of these, the most commonly reported types of ISRs are shown in Table 3.

Table 3. Incidence of Injection Site Reactions in all Patients Exposed to Ixekizumab Across 4 Axial Spondyloarthritis Trials3,7

 

All Ixekizumab Exposures Across 4 axSpA Trials
N=929; 1336.2 PYs of Exposure
n (%) [IR]

Injection site reactions 

154 (16.6) [11.5]

Injection site reaction (unspecified)

91 (9.8) [6.8]

Injection site erythema

33 (3.6) [2.5]

Injection site swelling

15 (1.6) [1.1]

Abbreviations: axSpA = axial spondyloarthritis; IR = incidence rate per 100 patient-years; PY = patient-year.

In patients exposed to ixekizumab across 4 axSpA trials (including AS/r-axSpA and nr-axSpA) as of April 2019, the most common preferred terms of ISRs (n [IRs/100 PY]) were

  • unspecified ISR (92 [5.9/100 PY])

  • injection-site erythema (33 [2.1/100 PY]), and

  • injection-site swelling (16 [1.0/100 PY]).3

Data From 16-Week Double-Blind, Placebo-Controlled Treatment Periods of COAST-V and COAST-W AS/r-axSpA Trials

Most ISRs (>95%) were mild-to-moderate in severity.3,10,11 Of patients who reported an ISR, 1.1% discontinued ixekizumab due to ISR.10,11

  • The frequency and exposure adjusted IR was greater during the first 2 weeks of treatment compared with later 2-week intervals.3

  • The median duration of ISRs was 2.8 days.3

Data from 52-week Double-Blind, Placebo-Controlled Treatment Period of COAST-X nr-axSpA Trial

Injection site reactions were reported in 21.7% (43/198) of patients with nr-axSpA treated with ixekizumab during the 52-week double-blind treatment period of COAST-X.12

Most ISRs (>95%) were mild-to-moderate in severity. Of patients who reported ISR, 1.6% discontinued due to ISR.12

References

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

2. Genovese MC, Kameda H, Rahman P, et al. Safety profile of ixekizumab in patients with moderate-to-severe plaque psoriasis and psoriatic arthritis: integrated analysis of 18 clinical trials. Poster presented at: American College of Rheumatology/ARP; November 8-13, 2019; Atlanta, GA.

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

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. Reich K, Leonardi C, Ohtsuki M, et al. Safety and tolerability of ixekizumab: integrated analysis of injection-site reactions in patients with moderate-to-severe psoriasis treated with ixekizumab compared with placebo or etanercept from three phase 3 trials. Poster presented at: 25th European Academy of Dermatology and Venereology Congress; September 28-October 2, 2016; Vienna, Austria.

6. Sheth P, Muram T, Lin C, et al. Patient Perspectives on Injection Site Reactions in 2 Phase 3 Trials of Ixekizumab Versus Etanercept and Placebo in Psoriasis. Poster presented at: 77th Annual Meeting of the American Academy of Dermatology; March 1-15, 2019; Washington, D.C.

7. Genovese MC, Mysler E, Tomita T, et al. Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials. Rheumatology (Oxford). Published online May 25, 2020. https://doi.org/10.1093/rheumatology/keaa189

8. 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

9. 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

10. 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

11. 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

12. 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 = ankylosing spondylitis

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

axSpA = axial spondyloarthritis

IR = incidence rate

ISR = injection site reaction

nr-axSpA = nonradiographic axial spondyloarthritis

PY = patient-years

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: June 04, 2020

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