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Taltz ® (ixekizumab)
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Risk of infection with Taltz® (ixekizumab)
Ixekizumab may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.
Table of contents
Information on infection in the Taltz label
Taltz is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).1
Treatment with Taltz is associated with an increased rate of infections such as
- upper respiratory tract infection,
- oral candidiasis,
- conjunctivitis, and
- tinea infections.1
Taltz should be used with caution in patients with clinically important chronic infection or a history of recurrent infection. 1
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.1
If an infection develops,
- patients should be carefully monitored and
- Taltz discontinued if
- the patient is not responding to standard therapy or if
- the infection becomes serious.1
Taltz 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
Ixekizumab clinical trial data on infections
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
Overall 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 2022. The proportion of patients with
- any infection was 62.5% [incidence rate (IR)=23.9 per 100 PYs of exposure]
- serious infections were 3.4% [IR=1.3 per 100 PYs of exposure]
- all Candida infections were 4.9% [IR=1.9 per 100 PYs of exposure], and
- opportunistic infections was 7.8% [IR=3.0 per 100 PYs of exposure].2,3
The IR of infections did not increase with longer ixekizumab exposure, up to 5 years.3-5
First 12 weeks of treatment (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.6
Infections |
IXE Q2W |
IXE Q4W |
PBO |
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.
Infections |
IXE Q2W |
IXE Q4W |
PBO |
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).
Psoriatic arthritis
Overall 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 2022. The proportion of patients with
First 24 weeks of treatment
In the 24-week, double-blind treatment periods of SPIRIT-P1 and SPIRIT-P2,
- a similar increase in risk of infection was seen in previous placebo-controlled trials in plaque psoriasis
- the most commonly reported infections in both trials were nasopharyngitis and upper respiratory tract infection (see Treatment-Emergent Infections Through Week 24 of SPIRIT-P1 and Treatment-Emergent Infections Through Week 24 of SPIRIT-P2)
- most infections were reported as mild-to-moderate in severity
- no cases of invasive fungal disease were reported in either trial, and
- no cases of active or reactivated TB were reported in either trial.11,12
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.
Infections |
SPIRIT-P1 |
||
IXE Q2W |
IXE Q4W |
PBO |
|
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.
Infections |
SPIRIT-P2 |
||
IXE Q2W |
IXE Q4W |
PBO |
|
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.
Axial Spondyloarthritis
Overall safety data
An integrated safety analysis was conducted from all ixekizumab axSpA exposures (N=932; PY=2097.7) across 4 axSpA trials (including AS/r-axSpA and nr-axSpA) as of March 2022. The proportion of patients with
- any infection was 57.9% [IR=25.7 per 100 PYs of exposure]
- serious infections were 2.5% [IR=1.1 per 100 PYs of exposure]
- all Candida infections were 2.8% [IR=1.2 per 100 PYs of exposure], and
- opportunistic infections were 3.0% [IR=1.3 per 100 PYs of exposure].2,3,13
The IR of infections decreased over time.2
First 16 weeks of treatment in AS/r-axSpA
In the 16-week double-blind treatment periods of COAST-V and COAST-W,
- the frequency of treatment-emergent infections was higher in the ixekizumab treatment groups vs placebo group (Treatment-Emergent Infections Through Week 16 of COAST-V and Treatment-Emergent Infections Through Week 16 of COAST-W), and
- most infections were mild-to-moderate in severity.14,15
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.15
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).15
None of these 3 events led to study discontinuation.15
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.15
Infections |
COAST-V |
|||
PBO |
ADA |
IXE Q2W |
IXE Q4W |
|
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.
Infections |
COAST-W |
||
PBO |
IXE Q2W |
IXE Q4W |
|
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 weeks of treatment in nr-axSpA
In COAST-X, most infections were mild-to-moderate in severity. 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).8,16
Infections |
PBO |
IXE Q4W |
IXE Q2W |
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.
3-Year Data From the COAST Program
The three-year long-term safety and efficacy data from the COAST program includes 1 year data from the originating studies (COAST-V, COAST-W, and COAST-X), and 2 year data from COAST-Y, long-term extension study.13
Of the adverse events of interest, infections were the most frequent, the majority of them were mild to moderate in severity. The safety profile of ixekizumab through 3 year from the COAST program was consistent with what has been previously reported with up to 2 years of exposure (Summary of Infections Through Week 156 of the COAST Program).13,17
Infections |
IXE Q2W |
IXE Q4W |
Infections overall |
309 (51.2) |
248 (54.6) |
Serious infections |
14 (2.3) |
9 (2) |
Herpes zoster |
6 (1) |
6 (1.3) |
Oral candidiasis |
2 (0.3) |
3 (0.7) |
Vulvovaginal candidiasis |
4 (2.1) |
3 (2.3) |
Skin candidiasis |
2 (0.3) |
0 |
Genital candidiasis |
1 (0.2) |
0 |
Esophageal candidiasis |
2 (0.3) |
2 (0.4) |
Abbreviations: IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks.
Postmarketing Reports of opportunistic infections
The following adverse reactions have been identified during post-approval use of ixekizumab. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to ixekizumab exposure.8
Infections:8
- bacterial, viral, and fungal opportunistic infections, including cryptococcal meningoencephalitis,
- esophageal and disseminated mucocutaneous candidiasis,
- pulmonary tuberculosis,
- toxoplasmosis,
- varicella zoster virus reactivation,
- cytomegalovirus colitis,
- pulmonary aspergillosis.
Cumulative reporting rates of opportunistic infections with ixekizumab exposure in the postmarketting setting since approval is provided in Postmarketing Cumulative Reporting Rates of Specific Opportunistic Infections Identified by the FDA.8
Opportunistic Infections Identified by FDA |
MedDRA Preferred Term |
Cumulative Reporting Rates (%)a |
Esophageal and disseminated mucocutaneous candidiasis |
Oesophageal candidiasis |
0.018b |
Mucocutaneous candidiasis |
0.002c |
|
Pulmonary tuberculosis |
Pulmonary tuberculosis |
0.001c |
Toxoplasmosis |
Toxoplasmosis |
0.001c |
Pulmonary aspergillosis |
Bronchopulmonary aspergillosis |
0.001c |
Cryptococcal meningoencephalitis |
Meningitis cryptococcal |
0.0003c |
Cytomegalovirus colitis |
Cytomegalovirus colitis |
0.0003c |
Varicella zoster virus reactivation (multidermatomal zoster and herpes zoster meningoencephalitis) |
Herpes zoster meningoencephalitis |
0.0003c |
Herpes zoster meningoradiculitis |
0.0003c |
|
Herpes zoster reactivation |
0.0003c |
Abbreviations: FDA = US Food and Drug Administration; MedDRA = Medical Dictionary for Regulatory Activities.
aCumulative reporting rates are calculated by dividing the count of events by the estimated number of patients exposed.
bRarely reported.
cVery rarely reported.
Postmarketing data do not necessarily represent the rate of occurrence of an adverse event (AE) in a treated population, but they represent a reporting rate of a particular AE to the company.
Spontaneous reporting of AEs can be highly variable and is not controlled clinical information on which to assess causality of a drug to an AE. Spontaneous reporting has limitations due to bias in reporting including incomplete information concerning the patient. In addition, the Global Patient Safety (GPS) spontaneous database may include reports of AEs for products that are available from a variety of manufacturers. When verification of product manufactured by Eli Lilly and Company is not obtainable, these cases are included in the spontaneous database.
References
1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland
2Deodhar A, Blauvelt A, Schwartzman S, et al. Long-term safety of ixekizumab in adult patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis. Poster presented at: American College of Rheumatology/ARP - 2022 Annual Scientific Meeting; November 10-14, 2022; Philadelphia, Pennsylvania.
3Deodhar A, Blauvelt A, Lebwohl M, et al. Long-term safety of Ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials. Arthritis Res Ther. 2024;26(1):49. https://doi.org/10.1186/s13075-023-03257-7
4Griffiths 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.
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. Dermatol Ther (Heidelb). 2022;12(6):1431-1446. https://doi.org/10.1007/s13555-022-00743-9
6Papp 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
7Gordon 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
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
9Genovese 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
10Deodhar AA, Combe B, Accioly AP, et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022;81(7):944-950. https://doi.org/10.1136/annrheumdis-2021-222027
11Mease 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
12Nash 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
13Deodhar A, Poddubnyy D, Rahman P, et al. Long-term safety and efficacy of ixekizumab in patients with axial spondyloarthritis: 3-year data from the COAST program. J Rheumatol. 2023;50(8):1020-1028. https://doi.org/10.3899/jrheum.221022
14Deodhar 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
15van 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
16Deodhar 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
17Braun J, Kiltz U, Deodhar A, et al. Efficacy and safety of ixekizumab treatment in patients with axial spondyloarthritis: 2-year results from COAST. RMD Open. 2022;8(2):e002165. http://dx.doi.org/10.1136/rmdopen-2021-002165
Date of Last Review: 16 September 2024