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Taltz ® (ixekizumab)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk
Comorbid tuberculosis and Taltz® (ixekizumab)
Do not administer ixekizumab to patients with active tuberculosis (TB) infection. Consider Anti-TB therapy prior to initiation of Taltz in patients with latent TB.
Content overview
Summary of information regarding TB infection
Tuberculosis screening in ixekizumab clinical trials
Treatment-emergent adverse events of tuberculosis from ixekizumab clinical trials
Summary of information regarding TB infection
Taltz is contraindicated in patients with active tuberculosis. 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
Below, you will find additional information about tuberculosis screening and tuberculosis as a treatment-emergent adverse event in ixekizumab clinical trials.
Tuberculosis screening in ixekizumab clinical trials
Patients were screened for TB using chest x-rays, purified protein derivative skin tests, or QuantiFERON®-TB Gold.2,3 Patients who
- tested negative were retested yearly, with the exception of axSpA trials, in which no retesting for TB was required
- tested positive for TB but had no evidence of TB infection were allowed to participate in the trial if they received at least 4 weeks of appropriate LTBI therapy, with the completion of the therapy during the course of the study
- had evidence or suspicion of active TB were excluded from ixekizumab clinical trials, and
- had household contact with a person with active TB were excluded, unless appropriate and documented prophylaxis for TB was given.2-4
Treatment-emergent adverse events of tuberculosis from ixekizumab clinical trials
17 Psoriasis clinical trials
In an integrated safety analysis of all ixekizumab adult psoriasis exposures (N=6892; 18,025.7 patient-years [PYs] of exposure) across 17 plaque psoriasis trials as of March 2022, latent TB was reported in 106 (1.5%) patients (incidence rate [IR]=0.6 per 100 PYs). There were no confirmed cases of TB reactivation reported.5-7
A positive TB test led to discontinuation of study drug in 67 patients. Among them, 1 case was reported as TB by the investigator (occurred in a patient who was previously treated for latent TB, but without symptoms and treated with isoniazid, so did not indicate active disease). There was 1 case of pulmonary TB. This patient had a diagnosis of active tuberculosis, and it was not considered a reactivation.8
There were no existing latent TB cases that presented any sign of active TB disease, and there were no fatal cases due to TB.5
4 Psoriatic arthritis clinical trials
In an integrated safety analysis of all ixekizumab PsA exposures (N=1401; 2247.7 PYs of exposure) across 4 PsA trials as of March 2022, latent TB was reported in 35 (2.5%) patients (IR=1.6 per 100 PYs). No confirmed cases of TB reactivation were reported.6,7
Upon annual TB testing, 35 patients who were originally negative at entry in the trials had a positive TB test (2.5%, IR=1.6 per 100 PYs). A positive TB test led to discontinuation in 10 patients according to protocols. The remaining 25 patients who did not discontinue the trial received treatment for latent TB infection prior to resuming study drug.9
Most new cases of latent TB occurred in patients from countries at high risk of TB.9
Data revealed no existing latent TB cases who presented any signs of active TB disease. No cases of latent TB resulted in death.9
4 Axial spondyloarthritis clinical trials
In an integrated safety analysis of all ixekizumab axSpA (including ankylosing spondylitis/radiographic axial spondyloarthritis [AS/r-axSpA] and nonradiographic axial spondyloarthritis [nr-axSpA]) exposures (N=932; 2097.7 PYs of exposure) across 4 axSpA trials as of March 2022, latent TB was reported in 2 (0.2%) patients (IR=0.1 per 100 PYs).6,7 No confirmed cases of TB reactivation were reported.6,7,10
References
1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland [UK]
2Riedl E, Winkler S, Xu W, et al. No reactivation of tuberculosis in psoriasis patients with latent tuberculosis infection while on ixekizumab treatment: a report from 11 clinical studies. Abstract presented at: 27th Congress of the European Academy of Dermatology and Venereology; September 12-16, 2018; Paris, France.
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4Gordon 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
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
6Deodhar 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.
7Deodhar 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
8Griffiths 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
9Deodhar 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
10Deodhar 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
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Date of Last Review: 29 March 2024