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Taltz ® (ixekizumab)
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Candida infections with Taltz® (ixekizumab)
The Candida incidence rate is 1.9/ 100 patient-years (PY) for psoriasis, 2.0/ 100 PY for psoriatic arthritis, and 1.2/ 100 PY for axial spondyloarthritis, as of March 2022.
Table of contents
Candidiasis in psoriasis patients
- Incidence of candida infections from the UNCOVER phase 3 clinical trials
- All ixekizumab psoriasis exposures
Candidiasis in psoriatic arthritis patients
- Incidence of candida infections through week 24 from SPIRIT-P1 and SPIRIT-P2 phase 3 clinical trials
- All ixekizumab psoriatic arthritis exposures
Candidiasis in axial spondyloarthritis patients
- Incidence of candida infections through week 16 of AS/r-axSpA trials
- 52-week double-blind treatment period of nonradiographic axial spondyloarthritis trial
- All ixekizumab axial spondyloarthritis exposures
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 dosing.1
Candidiasis in psoriasis patients
Incidence of candida infections from the UNCOVER phase 3 clinical trials
In the UNCOVER clinical trials, Candida infections occurred in 1.4% of patients who received ixekizumab 80 mg every 2 weeks (Q2W) and in 0.6% of patients who received ixekizumab 80 mg every 4 weeks (Q4W) through week 12.2
Oral candidiasis occurred more frequently in the ixekizumab group than in the placebo group. In the first 12 weeks of treatment, dose-dependent oral candidiasis was observed with ixekizumab. Across the induction period (12 weeks), the exposure‑adjusted incidence rates of oral candidiasis were
- 0.6 per 100 PY in patients receiving ixekizumab Q4W
- 0.6 per 100 PY in patients receiving etanercept, and
- 0 per 100 PY in patients receiving placebo.2,3
Overall, Candida infections were localized and did not lead to discontinuation from study drug.3 In most cases, the infections were mild-to-moderate in severity, and resolved with standard oral or topical antifungal treatments.4,5 One patient who received ixekizumab 80 mg Q2W experienced a moderate skin Candida infection of the axilla and groin, which was treated with topical clotrimazole twice daily for 1 month, followed by a topical combination product containing isoconazole and corticosteroid for approximately 2 weeks. The patient continued treatment with ixekizumab.4
The exposure-adjusted incidence rate of Candida infections during weeks 0 through 60 was similar to the rate during weeks 0 to 12.2
In patients exposed to ixekizumab across the 3 pivotal UNCOVER trials (N=3736), the exposure-adjusted incidence rate for all Candida infections with ixekizumab was
- 3.7 per 100 PY for weeks 0 to 60 (n=128), and
- 6.0 per 100 PY for weeks 0 to 12 (n=16) (ixekizumab 80 mg Q2W only).2
Through week 60 of these trials, 2 patients had esophageal candidiasis confirmed by gastroscopy (both moderate severity) and neither patient discontinued from the study because of the infection.2
All ixekizumab psoriasis exposures
In a larger integrated analysis of data across 17 adult plaque psoriasis clinical trials as of March 2022 (N=6892; 18,025.7 PY of exposure), the incidence rate of Candida infections was 1.9 per 100 PY. All cases of Candida infections were localized; no systemic cases were observed.6,7
A total of 243 patients [3.5%; incidence rate (IR)=1.3 per PY] experienced a single Candida infection event, while recurrent infections (2 or more events) occurred in 1.3% of patients.7
Most Candida infections were mild (IR=0.8 per 100 PY) or moderate (IR=0.9 per 100 PY) in severity.7
The most common Candida infections were
- oral Candida (2.3%; IR=0.9 per 100 PY), and
- genital Candida (1.6%; IR=0.6 per 100 PY).7
In the psoriasis (PsO) cohort, 16 patients experienced a treatment-emergent adverse event (TEAE) of esophageal candidiasis (0.2%; IR=0.1 per 100 PY).7
Of these 16 patients,
- 2 patients experienced a serious adverse event, and
- 1 patient had discontinuation of ixekizumab.6-8
Among patients who experienced at least 1 event of treatment-emergent Candida infection,
- 63.5% did not use any antifungal medication
- 34.7% used topical antifungal therapy, and
- 1.5% used systemic antifungal therapy.7
The median (Q1-Q3) duration of Candida infections in the PsO cohort was 4.6 (1.6-14.3) weeks.7
Candidiasis in psoriatic arthritis patients
Incidence of candida infections through week 24 from SPIRIT-P1 and SPIRIT-P2 phase 3 clinical trials
In the SPIRIT-P1 and SPIRIT-P2 PsA trials, Candida infections occurred in 3.6% of patients who received ixekizumab 80 mg Q2W and in 1.7% of patients who received ixekizumab 80 mg Q4W through week 24.9
Candida infection occurred more frequently in patients who received ixekizumab than in patients who received placebo.9 Most Candida infections during the first 24 weeks of SPIRIT-P1 and SPIRIT-P2 were mild or moderate in severity. No patients discontinued from the studies because of Candida infections.8
All ixekizumab psoriatic arthritis exposures
In a larger integrated analysis of data across 4 PsA trials as of March 2022 (N=1401; 2247.7 PY of exposure), the incidence rate of Candida infections was 2.0 per 100 PY. All cases of Candida infection were localized. No cases of systemic candidiasis were reported.6
A total of 36 patients (2.6%; IR=1.6 per 100 PY) experienced a single Candida infection event, while recurrent infections (2 or more events) occurred in 0.6% of patients.7
Most Candida infections were mild (IR=1.5 per 100 PY) or moderate (IR=0.4 per 100 PY) in severity.7
The most common Candida infections were
- oral Candida (1.6%; IR=1.0 per 100 PY), and
- genital Candida (1.1%; IR=0.7 per 100 PY).7
In the PsA cohort, 2 patients experienced a TEAE of esophageal candidiasis (0.1%; IR=0.1 per 100 PY).7
Of these 2 patients,
- both were categorized as SAEs, and
- no patients discontinued ixekizumab due to a Candida infection.6-8
Among patients who experienced at least 1 event of treatment-emergent Candida infection,
- 77.8% did not use any antifungal medication
- 22.2% used topical antifungal therapy, and
- none of the patients used systemic antifungal therapy.7
The median (Q1-Q3) duration of Candida infections in the PsA cohort was 3.4 (1.3-10.1) weeks.7
Candidiasis in axial spondyloarthritis patients
Incidence of candida infections through week 16 of AS/r-axSpA trials
In the 16-week, double-blind treatment period of COAST-V, no cases of Candida infections were reported in ixekizumab or placebo groups. One case of skin Candida infection was reported in the adalimumab active reference arm.11
In the 16-week, double-blind treatment period of COAST-W, 2 Candida infections were reported in the ixekizumab Q2W study arm (1 esophageal and 1 genital candidiasis). No infections were reported in the placebo group.12
52-week double-blind treatment period of nonradiographic axial spondyloarthritis trial
No cases of oral candidiasis were reported in either ixekizumab treatment group in COAST-X through week 52. One case of oral candidiasis was reported in a patient in the placebo group.13
All ixekizumab axial spondyloarthritis exposures
In an integrated safety analysis across 4 axial spondyloarthritis trials (including ankylosing spondylitis/radiographic axial spondyloarthritis and nonradiographic axial spondyloarthritis) (N=932; 2097.7 PY of exposure to ixekizumab) with data as of March 2022, the incidence rate of Candida infection was 1.2 per 100 PY. All cases of Candida infection were localized. No cases of systemic candidiasis were reported.6
A total of 22 patients (2.4%; IR=1.0 per 100 PY) experienced a single Candida infection event, while recurrent infections (2 or more events) occurred in 0.4% of patients.7
Most Candida infections were mild (IR=0.8 per 100 PY) or moderate (IR=0.5 per 100 PY) in severity.7
The most common Candida infections were
- genital Candida (1.3%; IR=0.6 per 100 PY), and
- oral Candida (0.9%; IR=0.4 per 100 PY).
In the axial spondyloarthritis (axSpA) cohort, 5 patients experienced a TEAE of esophageal candidiasis (0.5%; IR=0.2 per 100 PY).7
Of these 5 patients,
- none were categorized as SAEs, and
- 1 patient discontinued ixekizumab due to esophageal candidiasis.6-8
Among patients who experienced at least 1 event of treatment-emergent Candida infection,
- 80.8% did not use any antifungal medication
- 11.5% used topical antifungal therapy, and
- 7.7% used systemic antifungal therapy.7
The median (Q1-Q3) duration of Candida infections in the axSpA cohort was 3.1 (1.1-8.6) weeks.7
Candida auris
Candida auris (C. auris) was first reported in the United States in 2016. On March 20th of, 2023, the Centers for Disease Control and Prevention (CDC) issued a press release on C. auris. C. auris has been deemed as an urgent antimicrobial resistance threat because it is often resistant to multiple antifungal drugs, spreads quickly in healthcare facilities, and can cause severe infections.14
In an integrated safety analysis across 25 ixekizumab clinical trials with data as of March 2022 (including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis/radiographic axial spondyloarthritis and nonradiographic axial spondyloarthritis) and spontaneous reporting database of adverse events with data as of March 2023, C. auris has not been reported.8
Some of the potential limitations for diagnosing C. auris are
- lack of microbial culture results in some patients to confirm clinical diagnoses, or
- disparity of experience between dermatologists and rheumatologists in diagnosing cutaneous fungal infections.7
Taltz label information related to infections
Treatment with ixekizumab is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections.1
For complete information, please refer to the Taltz Summary of Product Characteristics, in particular the sections1:
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.8 Undesirable effects
References
1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland [UK]
2Gordon 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
3Strober B, Leonardi C, Papp KA, et al. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: etanercept comparisons and integrated data. J Am Acad Dermatol. 2017;76(3);432-440.e17. http://dx.doi.org/10.1016/j.jaad.2016.09.026
4Griffiths CEM, Reich K, Lebwohl M, et al; UNCOVER-2, UNCOVER-3 Investigators. 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. https://doi.org/10.1016/S0140-6736(15)60125-8
5Papp 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
6Deodhar 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
7Schwartzman S, Puig L, Cohen AD, et al. Treatment-emergent Candida infections in patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis treated with ixekizumab: an integrated safety analysis of 25 clinical studies. Expert Opin Drug Saf. 2024;23(10):1347-1357. https://doi.org/10.1080/14740338.2024.2399092
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
9Combe B, Rahman P, Kameda H, et al. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020;22(1):14. http://dx.doi.org/10.1186/s13075-020-2099-0
10Mease 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
11van 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
12Deodhar 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
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
14Increasing Threat of Spread of Antimicrobial-resistant Fungus in Healthcare Facilities. Press release. Centers for Disease Control and Prevention (CDC); March 20, 2023. Accessed June 16, 2023. https://www.cdc.gov/media/releases/2023/p0320-cauris.html#:~:text=CDC%20has%20deemed%20C.,infections%20with%20high%20death%20rates
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Date of Last Review: 26 May 2026