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Taltz ® (ixekizumab) injection
80 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the incidence of tuberculosis with Taltz® (ixekizumab)?
Do not administer Taltz (ixekizumab) to patients with active tuberculosis (TB) infection. Initiate treatment of latent TB prior to administering ixekizumab.
Summary and General Information
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ixekizumab. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering ixekizumab. Consider anti-TB therapy prior to initiating ixekizumab in patients with history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ixekizumab should be monitored closely for signs and symptoms of active TB during and after treatment.1
Reactivation of latent TB has been reported with the use of other immunosuppressive agents.2,3
Tuberculosis Screening in Ixekizumab Clinical Trials
Patients were screened for TB using chest x-rays, purified protein derivative skin tests, or QuantiFERON®-TB Gold.6,7 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.6-8
Tuberculosis Treatment-Emergent Adverse Events From 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).9 There were no confirmed cases of TB reactivation reported.9,10
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.11
There were no existing latent TB cases that presented any sign of active TB disease, and there were no fatal cases due to TB.9
Tuberculosis Treatment-Emergent Adverse Events From 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.10
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.12
Most new cases of latent TB occurred in patients from countries at high risk of TB.12
Data revealed no existing latent TB cases who presented any signs of active TB disease. No cases of latent TB resulted in death.12
Tuberculosis Treatment-Emergent Adverse Events From 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). No confirmed cases of TB reactivation were reported.10
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
2Fallahi-Sichani M, Flynn JL, Linderman JJ, Kirschner DE. Differential risk of tuberculosis reactivation among anti-TNF therapies is due to drug binding kinetics and permeability. J Immunol. 2012;188(7):3169-3178. http://dx.doi.org/10.4049/jimmunol.1103298
3Xie X, Li F, Chen JW, Wang J. Risk of tuberculosis infection in anti-TNF-α biological therapy: from bench to bedside. J Microbiol Immunol Infect. 2014;47(4):268-274. http://dx.doi.org/10.1016/j.jmii.2013.03.005
4Griffiths 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.
5Schwartzman 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.
6Riedl 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.
7Data on file, Eli Lilly and Company and/or one of its subsidiaries.
8Gordon 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
9Griffiths 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
10Deodhar 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.
11Griffiths 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). Published online May 27, 2022. http://dx.doi.org/10.1007/s13555-022-00743-9
12Deodhar 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
Date of Last Review: November 11, 2022