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): Candidiasis

In clinical trials, oral candidiasis occurred more frequently in the ixekizumab group than in the placebo group.

General Information

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. If such an infection develops, monitor carefully and discontinue ixekizumab if the patient is not responding to standard therapy or the infection becomes serious. Ixekizumab should not be resumed until the infection resolves.1

In controlled studies, for up to 24 weeks, oral candidiasis was uncommonly reported (≥ 1/1.000 to < 1/100).1

Psoriasis

Incidence of Candida from UNCOVER Phase 3 Clinical Trials

The EAIR of Candida infections during weeks 0 through 60 was similar to the rate during weeks 0 to 12.2

In patients exposed ixekizumab across the 3 pivotal UNCOVER trials (N=3736), the EAIR 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) (IXE 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 due to their infection.2

All Ixekizumab Psoriasis Exposures

In a larger integrated analysis of data across 14 plaque psoriasis clinical trials as of March 2019 (N=6091; 17,499.3 PYs of exposure), the IR of oral candidiasis was 0.8 per 100 PYs.3 There were 13 cases of esophageal candidiasis reported, 2 of which were categorized as a SAE. There were no reports of deep organ or blood stream candidiasis noted in the safety analysis.4

Psoriatic Arthritis

Incidence of Candida Through Week 24 From SPIRIT-P1 and SPIRIT-P2 Phase 3 Clinical Trials

In the SPIRIT-P1 and SPIRIT-P2 psoriatic arthritis 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 24.5

Candida infection occurred more frequently in patients who received ixekizumab than in patients who received placebo.5 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 due to Candida  infections.4

One TEAE of esophageal candidiasis was reported as an SAE.4,6

Please note that the dosing schedule IXEQ2W mentioned above is not consistent with the approved dosing schedule for psoriatic arthritis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing. 1

All Ixekizumab Psoriatic Arthritis Exposures

In a larger integrated analysis of data across 4 psoriatic arthritis trials as of March 2019 (N=1401; 2228.6 PYs of exposure), the IR of oral candidiasis was 0.7 per 100 PYs.3 There were 2 cases of esophageal candidiasis reported, both of which were categorized as a SAE.4 There were no reports of deep organ or blood stream candidiasis noted in the safety analysis.4

References

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

2. Gordon KB, Blauvelt A, Papp KA, et al. 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

3. 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.

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

5. Combe 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

6. 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

Glossary

EAIR = exposure adjusted incidence rate

PsA = psoriatic arthritis

PY = patient-years

Q2W = every 2 weeks

Q4W = every 4 weeks

SAE = serious adverse event

TEAE = treatment-emergent adverse event

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: April 20, 2020

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