Taltz ® (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

Is Taltz® (ixekizumab) Treatment Associated with a Risk of Infections?

Treatment with ixekizumab is associated with an increased rate of infections. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.

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UK_cFAQ_IXE317_INFECTIONS_PsO_PsA_axSpA
en-GB

What Does the Taltz Label Report on Infections?

Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).1

Treatment with ixekizumab is associated with an increased rate of infections such as

  • upper respiratory tract infection,
  • oral candidiasis,
  • conjunctivitis, and
  • tinea infections.1

Ixekizumab should be used with caution in patients with clinically important chronic infection or a history of recurrent infection. 1

If an infection develops,

  • patients should be carefully monitored and 
  • ixekizumab discontinued if
    • the patient is not responding to standard therapy or if
    • the infection becomes serious.1

Ixekizumab should not be resumed until the infection resolves.1

Please refer to the Taltz summary of product characteristics for the full list of adverse drug reactions.1

What Was Reported on Infections in the Ixekizumab Clinical Trials?

Note that multiple, different dosing regimens, including unapproved doses, are included in this response. Please refer to Taltz summary of product characteristics for full prescribing information.1

Psoriasis

Induction Period

Across the 12-week primary psoriasis placebo-controlled integrated analysis (UNCOVER-1, -2, and -3) (Treatment-Emergent Infections Through Week 12 Induction Period of UNCOVER-1, -2, and -3 and Serious Infections and Discontinuations due to Infection-Related Events Through Week 12 Induction Period of UNCOVER-1, -2, and -3),

  • most treatment-emergent infections were mild or moderate in severity, did not lead to treatment discontinuations, and were of 1 to 2 weeks duration
  • specific infection rates were overall comparable across treatment groups
  • serious infection incidence rates were low and similar across treatment groups, and 
  • in patients treated with ixekizumab during this period, there were no reports of
    • clinically active or reactivated TB
    • herpes zoster, or
    • invasive fungal infections.2
Treatment-Emergent Infectionsa Through Week 12 Induction Period of UNCOVER-1, -2, and -32-4

Infections

IXE Q2W
(N=1167)
n (%)

IXE Q4W
(N=1161)
n (%)

PBO
(N=791)
n (%)

Infections Overall

315 (27.0)b

318 (27.4)b

181 (22.9)

Upper respiratory tract infectionc

163 (14.0)

155 (13.4)

101 (12.8)

Tinea infections

17 (1.5)b

10 (0.9)b

1 (0.1)

Urinary tract infections

12 (1.0)

19 (1.6)

10 (1.3)

Bronchitis

12 (1.0)

15 (1.3)

7 (0.9)

Sinusitis

11 (0.9)

13 (1.1)

6 (0.8)

Rhinitis

9 (0.8)

10 (0.9)

0

Influenza

8 (0.7)

10 (0.9)

0

Conjunctivitis

8 (0.7)

1 (0.1)

3 (0.4)

Oral candidiasis

8 (0.7)b

2 (0.2)

0

Pharyngitis

6 (0.5)

14 (1.2)

7 (0.9)

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

aInfections that were reported in at least 10 patients from either dosing group or included in product labeling are listed.

bp<.05 vs PBO.

cUpper respiratory tract infections include nasopharyngitis and rhinovirus infection.

Serious Infections and Discontinuations due to Infection-Related Events Through Week 12 Induction Period of UNCOVER-1, -2, and -32

Infections

IXE Q2W
(N=1167)
n (%)

IXE Q4W
(N=1161)
n (%)

PBO
(N=791)
n (%)

Serious infections

5 (0.4)

8 (0.7)

3 (0.4)

Cellulitis

1 (0.1)

2 (0.2)

1 (0.1)

Appendicitis

2 (0.2)

0

0

Erysipelas

0

2 (0.2)

0

Abscess oral

1 (0.1)

0

0

Peritonitis

1 (0.1)

0

0

Bronchopneumonia

0

1 (0.1)

0

Pyelonephritis acute

0

1 (0.1)

0

Tonsillitis

0

1 (0.1)

0

Urinary tract infection

0

1 (0.1)

0

Urosepsis

0

1 (0.1)

0

Infectious mononucleosis

0

0

1 (0.1)

Skin bacterial infection

0

0

1 (0.1)

Discontinuations due to infection-related adverse events

4 (0.3)a

4 (0.3)b

2 (0.3)c

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

aAppendicitis (n=2), cellulitis (n=1), and osteomyelitis (n=1).

bCellulitis (n=1), bronchopneumonia (n=1), ear infection (n=1), and urosepsis (n=1).

cHerpes zoster (n=1) and tonsillitis (n=1).

Integrated Safety Data

An integrated safety analysis was conducted from all ixekizumab adult psoriasis exposures (N=6892; 18,025.7 patient-years [PYs]) across 17 adult plaque psoriasis clinical trials as of March 19, 2021. The proportion of patients with

  • any infection was 62.5% [incidence rate (IR)=23.9 per 100 PYs of exposure]
  • serious infection was 3.4% [IR=1.3 per 100 PYs of exposure]
  • all Candida infections was 4.9% [IR=1.9 per 100 PYs of exposure], and 
  • opportunistic infections was 4.6% [IR=1.8 per 100 PYs of exposure].5

The IR of infections did not increase with longer ixekizumab exposure, up to 5 years.6

Psoriatic Arthritis

24-Week Double-Blinded Treatment Period

In the 24-week, double-blind treatment periods of SPIRIT-P1 and SPIRIT-P2,

In the 24-week, double-blind treatment period of SPIRIT-P1, the incidence of treatment-emergent infections was similar between patients treated with ixekizumab vs placebo. 

  • Three serious infection-related adverse events (herpes zoster involving eyelid, esophageal candidiasis, and gastroenteritis) were reported in patients treated with ixekizumab. All 3 events resolved with treatment and did not lead to study discontinuation.

In the 24-week, double-blind treatment period of SPIRIT-P2, the incidence of treatment-emergent infections was numerically higher in patients treated with ixekizumab vs placebo.

  • The most common infections occurred at similar percentages in patients treated with ixekizumab and those treated with placebo. Three serious infection-related adverse events (abscess jaw, anal abscess, and perirectal abscess) were reported in patients treated with ixekizumab.
    • None of these 3 events led to study discontinuation.7,8
Treatment-Emergent Infections Through Week 24 of SPIRIT-P14,7

Infections

SPIRIT-P1

IXE Q2W
(N=102)
n (%)

IXE Q4W
(N=107)
n (%)

PBO
(N=106)
n (%)

Treatment-emergent infections, n (%)a

24 (23.5)

30 (28.0)

27 (25.5)

Nasopharyngitis

3 (2.9)

7 (6.5)

5 (4.7)

URTI

3 (2.9)

5 (4.7)

7 (6.6)

Bronchitis

3 (2.9)

3 (2.8)

3 (2.8)

Serious infection

2 (2.0)

1 (0.9)

0

Discontinuations due to infection-related adverse events

0

0

0

Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo; URTI = upper respiratory tract infection. 

aSpecific infections reported by >5 patients treated with ixekizumab from either clinical trial are listed.

Treatment-Emergent Infections Through Week 24 of SPIRIT-P24,8

Infections

SPIRIT-P2

IXE Q2W
(N=123)
n (%)

IXE Q4W
(N=122)
n (%)

PBO
(N=118)
n (%)

Treatment-emergent infections, n (%)a

47 (38.2)

47 (38.5)

35 (29.7)

Nasopharyngitis

4 (3.3)

8 (6.6)

4 (3.4)

URTI

12 (9.8)

11 (9.0)

9 (7.6)

Bronchitis

4 (3.3)

1 (0.8)

4 (3.4)

Serious infection

3 (2.0)

0

0

Discontinuations due to infection-related adverse events

1 (0.8)b

2 (1.6)b

1 (0.8)b

Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo; URTI = upper respiratory tract infection. 

aSpecific infections reported by >5 patients treated with ixekizumab from either clinical trial are listed.

bFolliculitis.

Integrated Safety Data

An integrated safety analysis was conducted from all ixekizumab psoriatic arthritis exposures (N=1401; 2247.7 PYs) across 4 psoriatic arthritis clinical trials as of March 19, 2021. The proportion of patients with 

  • any infection was 54.2% [IR=33.8 per 100 PYs of exposure]
  • serious infection was 2.0% [IR=1.2 per 100 PYs of exposure]
  • all Candida infections was 3.2% [IR=2.0 per 100 PYs of exposure], and 
  • opportunistic infections was 2.9% [1.8 per 100 PYs of exposure].9

The IR of infections decreased over time.10

Axial Spondyloarthritis

16-week Double-Blinded Treatment Period of AS/r-axSpA Trials

In the 16-week double-blinded treatment periods of COAST-V and COAST-W,

  • the frequency of treatment-emergent infections was higher in the ixekizumab treatment groups vs placebo group
  • most infections were mild-to-moderate in severity, and
  • five infection-related SAEs were reported, and none led to study discontinuation.11,12

In the 16-week, double-blind treatment period of COAST-V, the frequency of treatment-emergent infections was higher in the active treatment groups (ixekizumab and adalimumab) compared with placebo. The frequency of infections was similar between all active treatment groups (including both ixekizumab dosing groups and adalimumab). COAST-V was not powered to compare adalimumab with ixekizumab, adalimumab was used as an active reference.12

Three infection-related serious adverse events (SAEs) that were reported include

  • gastroenteritis (ixekizumab dosed every 2 weeks group)
  • urinary tract infection (ixekizumab dosed every 4 weeks group), and
  • appendicitis (adalimumab group).12

None of these 3 events led to study discontinuation.12

In the 16-week, double-blind treatment period of COAST-W, the frequency of treatment-emergent infections was higher for ixekizumab than for placebo. Two SAEs (peritonitis and pharyngitis) were reported in the ixekizumab dosed every 4 weeks group. Neither event led to study discontinuation.12

Treatment-Emergent Infections Through Week 16 of COAST-V4,12

Infections

COAST-V

PBO
(N=86)
n (%)

ADA
(N=90)
n (%)

IXE Q2W
(N=83)
n (%)

IXE Q4W
(N=81)
n (%)

Treatment-emergent infections

13 (15)

19 (21)

17 (20)

16 (20)

Nasopharyngitis

6 (7)

6 (7)

5 (6)

6 (7)

URTI

4 (5)

2 (2)

4 (5)

7 (9)

Candida (genital)

0

0

0

0

Candida (esophageal)

0

0

0

0

Candida (skin)

0

1 (1)

0

0

Herpes zoster

0

0

0

0

Reactivated TB

0

0

0

0

Serious Infection

0

1 (1)

1 (1)

1 (1)

Discontinuations due to infection-related AEs

0

0

1 (1)a

0

Abbreviations: ADA = adalimumab 40 mg every 2 weeks; AE = adverse event; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = Placebo; TB = tuberculosis; URTI = upper respiratory tract infection.

aInfectious diarrhea.

Treatment-Emergent Infections Through Week 16 of COAST-W4,11

Infections

COAST-W

PBO
(N=104)
n (%)

IXE Q2W
(N=98)
n (%)

IXE Q4W
(N=114)
n (%)

Treatment-emergent infections

10 (9.6)

23 (23.5)

34 (29.8)

Nasopharyngitis

2 (2)

4 (4)

5 (4)

URTI

3 (3)

4 (4)

9 (8)

Candida (genital)

0

1 (1)

0

Candida (esophageal)

0

1 (1)

0

Candida (skin)

0

0

0

Herpes zoster

0

0

1 (1)

Reactivated TB

0

0

0

Serious Infection

0

0

2 (2)

Discontinuations due to infection-related AEs

0

0

2 (2)a

Abbreviations: ADA = adalimumab 40 mg every 2 weeks; AE = adverse event; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = Placebo; TB = tuberculosis; URTI = upper respiratory tract infection.

aDiverticulitis and peritonitis.

52-week Double-Blinded Treatment Period of nr-axSpA Trial

In COAST-X, most infections were mild-to-moderate in severity, and the most common infections were nasopharyngitis and upper respiratory tract infection (Summary of Infections From the COAST-X Safety Population During the 52-Week Double-Blind Treatment Period of COAST-X).4,13

Summary of Infections From the COAST-X Safety Populationa During the 52-Week Double-Blind Treatment Period of COAST-X4,13

Infections

PBO
(N=104)
n (%)

IXE Q4W
(N=96)
n (%)

IXE Q2W
(N=102)
n (%)

Infections Overall

30 (29)

38 (40)

43 (42)

Mild

24 (23)

20 (21)

29 (28)

Moderate 

6 (6)

17 (18)

13 (13)

Severe

0 (1)

1 (1)

1 (1)

Most common infections

Nasopharyngitis

8 (8)

18 (19)

16 (16)

URTI

4 (4)

4 (4)

6 (6)

Discontinuation due to infection

0

0

0

Serious infections

0

1 (1)b

0

Opportunistic infections

Oral candidiasis

1 (1)

0

0

Herpes zoster

1 (1)

2 (2)

0

Reactivated TB

0

0

0

Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo; TB = tuberculosis; URTI = upper respiratory tract infection.

aSafety population defined as all patients who received at least one dose of study drug.

bErysipelas.

Integrated Safety Data

An integrated safety analysis was conducted from all ixekizumab axSpA exposures (N=932; PY=2096.2) across 4 axSpA trials (including AS/r-axSpA and nr-axSpA) as of March 19, 2021. The proportion of patients with

  • any infection was 57.9% [IR=25.8 per 100 PYs of exposure]
  • serious infections was 2.5% [IR=1.1 per 100 PYs of exposure]
  • all Candida infections was 2.8% [IR=1.2 per 100 PYs of exposure], and 
  • opportunistic infections was 1.8% [IR=0.8 per 100 PYs of exposure].9

The IR of infections decreased over time.14

References

1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

2Papp KA, Bachelez H, Blauvelt A, et al. Infections from seven clinical trials of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriasis. Br J Dermatol. 2017;177(6):1537-1551. http://dx.doi.org/10.1111/bjd.15723

3Gordon 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

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5Griffiths CEM, Gooderham M, Colombel JF, et al. Safety of ixekizumab in adult patients with moderate-to-severe psoriasis: data from 17 clinical trials with over 18,000 patient-years of exposure. Poster presented at: Annual Meeting of the American Academy of Dermatology (AAD); March 25-29, 2022; Boston, MA.

6Griffiths 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.

7Mease 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

8Nash 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

9Schwartzman S, Deodhar A, Combe B, et al. Safety profile of ixekizumab for the treatment of psoriatic arthritis and axial spondyloarthritis up to 3 years: an updated integrated safety analysis. Poster presented at: Annual Meeting of the America College of Rheumatology (ACR Convergence Virtual); November 1-10, 2021.

10Genovese 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). 2020;59(12):3834-3844. https://doi.org/10.1093/rheumatology/keaa189

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

14Schwartzman 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.

Date of Last Review: 15 March 2022


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