Taltz ® (ixekizumab) injektion

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Taltz® (ixekizumab): Tuberkulos i kliniska prövningar med psoriasis, psoriasisartrit och Axial spondyloartrit

Integrerade data från kliniska prövningar av ixekizumab vid psoriasis, PsA och axSpA visade inga bekräftade fall av TB-reaktivering.

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en-GB

Summary

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

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

Reactivation of LTBI 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

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 or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If 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.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
  • 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 (1792.2 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

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

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

Datum fӧr senaste ӧversyn 2020 M11 02


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