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): Tuberculosis

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

Ixekizumab Label Information

Ixekizumab must not be given to patients with active tuberculosis (TB). Consider anti-TB therapy prior to initiation of ixekizumab in patients with latent TB.1

Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).1

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

Tuberculosis Screening in Ixekizumab Clinical Trials

Patients were screened for TB using chest x-rays, PPD skin tests, or QFT.2,3

  • Patients who tested negative were retested yearly, with the exception of axSpA trials, in which no retesting for TB was required.2,3

  • Patients who 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.2,3

  • Patients who had evidence or suspicion of active TB were excluded from ixekizumab clinical trials.2,3

  • Patients who had household contact with a person with active TB were excluded, unless appropriate and documented prophylaxis for TB was given.3,4

Tuberculosis Treatment-Emergent Adverse Events From 14 Psoriasis Clinical Trials

An integrated safety analysis was conducted from all ixekizumab psoriasis exposures (N=6091; PY=17,499.3) across 14 plaque psoriasis clinical trials with data as of March 2019.5

  • The proportion of patients with any infections was 65.3% [IR=22.7 per 100 PYs of exposure].

  • The IR of serious infections was 1.3 per 100 PYs of exposure.

  • The IR of infections did not increase with longer ixekizumab exposure.

Of the 6091 patients, potential TB infection (using broad MedDRA-preferred terms) was reported in 59 (1.0%) patients (IR=0.3 per 100 PYs) of which

  • 43 (0.7%) had a positive Mycobacterium tuberculosis complex test, and

  • 17 (0.3%) had a positive tuberculin test.3

Opportunistic TB infection (using narrow MedDRA-preferred terms) was reported in 2 (0.0%) patients (pulmonary tuberculosis, n=1; tuberculosis, n=1).3

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

In an integrated analysis of 1401 patients (2228.6 PY) who received ixekizumab across 4 clinical trials in patients with PsA, 22 (1.6%) patients reported LTBI, which included cases positive for

  • tuberculin skin test

  • IFN-gamma release assay

  • history of TB, or

  • completed TB treatments.6

A total of 10 patients discontinued from ixekizumab PsA clinical trials due to positive TB tests. 6

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

In an integrated analysis of 929 patients (1336.2 PY) who received ixekizumab across 4 clinical trials in patients with AS/r-axSpA and nr-axSpA, 1 (0.1%) person reported LTBI as of April 2019.6

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 PYs).7

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.7

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.7

No cases of reactivation of TB were identified in this safety analysis.7

References

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

2. Riedl 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.

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

4. 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

5. 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.

6. Genovese 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

7. Mrowietz 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. Published online June 8, 2020. https://doi.org/10.1016/j.jaad.2020.06.012.

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

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: July 17, 2020

Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 8am - 4pm, excluding Bank Holidays

Or you can

Ask us a question Chat with Us If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a question