Taltz ® (ixekizumab)

How often do injection site reactions occur with Taltz® (ixekizumab) treatment?

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

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What were the Incidence and Risk of Injection Site Reactions in Psoriasis Clinical Trials?

The most commonly reported types of ISRs, as of March 19, 2020, are shown in Incidence of Injection Site Reactions in All Patients Exposed to Ixekizumab Across 16 Psoriasis Clinical Trials.

Incidence of Injection Site Reactions in All Patients Exposed to Ixekizumab Across 16 Psoriasis Clinical Trials1,2

 

N=6645; 17,902 PYs of Exposure
n (%) [IR]

Injection site reactions

1004 (15.1) [5.6]

Injection site reaction (unspecified)

656 (9.9) [3.7]

Injection site erythema

203 (3.1) [1.1]

Injection site pain

124 (1.9) [0.7]

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

Patients who reported an ISR of any type during psoriasis trials were given a follow-up form in order to collect additional information.1 

Follow-up of patients who spontaneously reported an ISR of any type showed 51% reported pain.1

The majority of reported ISRs in pivotal phase 3 psoriasis trials

  • occurred after the initial 160-mg starting dose,1 
  • were mild-to-moderate in severity,1
  • had a median time to onset of 7 days for the first 160-mg dose,
    • for those with multiple ISRs reported, subsequent doses had an earlier median time to onset of 1.5 days for week 2 and 4 injections),3
  • had a median duration of 2 days,4 
  • decreased over time,1 
  • was typically reported to occur during injection, and erythema onset was delayed3
  • varied in timing depending on treatment group and symptom reported,5 and
  • did not lead to discontinuation.1

The risk of ISRs was more common in subjects with a body weight <60 kg compared with the group with a body weight ≥60 kg6

What were the Incidence and Risk of Injection Site Reactions in Psoriatic Arthritis Clinical Trials?

Incidence of Injection Site Reactions in All Patients Exposed to Ixekizumab Across 4 Psoriatic Arthritis Trials (SPIRIT-P1, SPIRIT-P2, SPIRIT-P3, and SPIRIT-H2H)7,1

 

All Ixekizumab Exposures Across 4 Psoriatic Arthritis Trials
N=1401; 2247.7 PYs of Exposure
n (%) [IR]

Injection site reactions

260 (18.6) [11.6]

   Injection site reaction (unspecified)

156 (11.1) [6.9]

   Injection site erythema

60 (4.3) [2.7]

   Injection site pain 

22 (1.6) [1.0]

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

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.1

These ISRs

  • were mild-to-moderate in severity (>95%)1,8
  • led to discontinuation in 1.1% of patients8,9

The risk of ISRs was more common in subjects with a body weight <100 kg compared with the group with a body weight ≥100 kg6


What were the Incidence and Risk of Injection Site Reactions in Axial Spondyloarthritis Clinical Trials?

Incidence of Injection Site Reactions in All Patients Exposed to Ixekizumab Across 4 Axial Spondyloarthritis Trials (including AS/r-axSpA and nr-axSpA trials)1,10

 

All Ixekizumab Exposures Across 4 axSpA Trials
N=932; 1792.2 PYs of Exposure
n (%) [IR]

Injection site reactions 

155 (16.6) [8.6]

   Injection site reaction (unspecified)

92 (9.9) [5.1]

   Injection site erythema

33 (3.5) [1.8]

   Injection site swelling

16 (1.7) [0.9]

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

ISRs from the 16-week double-blind, placebo-controlled treatment periods of COAST-V and COAST-W AS/r-axSpA trials

  • were mild-to-moderate in severity (>95%)1,11,12
  • led to discontinuation in 1.1% of patients 11,12
  • had frequency and exposure-adjusted IR greater during the first 2 weeks of treatment compared with later 2-week intervals1
  • had a median duration of 2.8 days1

ISRs from the 52-week double-blind, placebo-controlled treatment periods of COAST-X nr-axSpA trial

  • were reported in 21.7% (43/198) of patients13
  • were mild-to-moderate in severity (>95%) 
  • led to discontinuation in 1.6% of patients13

In general, the ISRs were similar in subjects with a body weight <100 kg compared with the group with a body weight ≥100 kg.6

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Griffiths CEM, Reich K, Gooderham M, et al. Long-term safety of ixekizumab in patients with moderate-to-severe psoriasis up to 5 years: pooled data from 16 clinical trials. Poster presented at: 29th Annual Meeting of the European Academy of Dermatology and Venereology (EADVirtual); October 29-31, 2020.

3Shear 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

4Reich 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.

5Sheth 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.

6Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

7Sesin 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.

8Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study Group. 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

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

10Schwartzman 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.

11Deodhar 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

12van 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

13Deodhar 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

Glossary

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

Date of Last Review: October 19, 2020


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