Taltz ® (ixekizumab) injection

80 mg/mL

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TALTZⓇ (ixekizumab): Tuberculosis in Psoriasis, Psoriatic Arthritis, and Axial Spondyloarthritis Clinical Trials

Do not administer ixekizumab to patients with active TB infection. Initiate treatment of latent TB prior to administering ixekizumab.

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Summary and General Information

Evaluate patients for 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

Integrated data from clinical trials of ixekizumab in psoriasis, PsA, and axSpA showed no confirmed cases of TB reactivation.4,5

Tuberculosis Screening in Ixekizumab Clinical Trials

Patients were screened for TB using chest x-rays, PPD skin tests, or QFT.6,7 Patients who

  • tested negative were retested yearly, with the exception of axSpA trials, in which no retesting for TB was required6,7
  • 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 study6,7
  • had evidence or suspicion of active TB were excluded from ixekizumab clinical trials,6,7 and
  • Patients who had household contact with a person with active TB were excluded, unless appropriate and documented prophylaxis for TB was given.7,8

Tuberculosis Treatment-Emergent Adverse Events From 16 Psoriasis Clinical Trials

In an integrated safety analysis of all ixekizumab adult and pediatric psoriasis exposures (N=6645; PY=17,902.0) across 16 plaque psoriasis trials as of March 19, 2020, potential TB infection (using broad MedDRA-preferred terms) was reported in 59 (0.9%) patients (IR=0.3 per 100 PYs), of which

  • 42 (0.6%) had a positive Mycobacterium tuberculosis complex test, and
  • 17 (0.3%) had a positive tuberculin test.7

Opportunistic TB infection (using narrow MedDRA-preferred terms) was reported in 2 (0.0%) patients (pulmonary TB, n=1; TB, n=1).7

Tuberculosis Treatment-Emergent Adverse Events From 4 Psoriatic Arthritis Clinical Trials

In an integrated safety analysis of all ixekizumab PsA exposures (N=1401; PY=2247.7) across 4 PsA trials as of March 19, 2020, potential TB infection (using broad MedDRA-preferred terms) was reported in 7 (0.5%) patients (IR=0.3 per 100 PYs), of which

  • 5 (0.4%) had a positive tuberculin test, and
  • 2 (0.1%) had a positive Mycobacterium tuberculosis complex test.7

Tuberculosis Treatment-Emergent Adverse Events From 4 Axial Spondyloarthritis Clinical Trials

In an integrated analysis of 932 patients (1849.0 PY) who received ixekizumab across 4 trials in patients with AS/r-axSpA and nr-axSpA as of March 19, 2020, no cases of TB were reported.9

Post Hoc Analysis of Integrated Safety Data in Psoriasis and Psoriatic Arthritis Clinical Trials

A post hoc analysis of integrated safety data from 16 clinical trials in patients with psoriasis and PsA evaluated the incidence of treatment-emergent LTBI in patients who received ixekizumab. The analysis included data from 13 psoriasis clinical trials (N=5898; 16,313 PY) and 3 PsA clinical trials (N=1118; 1822 PY).5

Of the 5898 patients from the psoriasis clinical trials included in the analysis, 101 (1.7%) developed treatment-emergent LTBI. A total of 36 patients continued in the study, and 30 of those patients received LTBI treatment.5

Of the 1118 patients from the PsA clinical trials included in the analysis, 32 (2.9%) developed treatment-emergent LTBI. A total of 12 patients continued in the study, and 7 of those patients received LTBI treatment.5

No cases of reactivation of TB were identified in this safety analysis.5

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; 2021.

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. 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

4Genovese 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). Published online May 25, 2020. https://doi.org/10.1093/rheumatology/keaa189

5Mrowietz U, Riedl E, Winkler S, et al. No reactivation of tuberculosis in patients with latent tuberculosis infection receiving ixekizumab: a report from 16 clinical studies of patients with psoriasis or psoriatic arthritis. J Am Acad Dermatol. 2020;83(5):1436-1439. https://doi.org/10.1016/j.jaad.2020.06.012

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

9Schwartzman S, Sandoval D, Kronbergs A, et al. Long-term safety profile of ixekizumab treatment on patients with axial spondyloarthritis. Abstract presented at: American College of Rheumatology/ARP 2020 Annual Scientific Meeting (Virtual); November 5-9, 2020.

Glossary

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

axSpA = axial spondyloarthritis

IR = incidence rate

LTBI = latent tuberculosis infection

MedDRA = Medical Dictionary for Regulatory Activities

nr-axSpA = nonradiographic axial spondyloarthritis

PPD = purified protein derivative skin test 

PsA = psoriatic arthritis

PY = patient-years

QFT = QuantiFERON®-TB Gold

TB = tuberculosis

Date of Last Review: November 02, 2020


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