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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): Were Hepatitis B Events reported in Clinical Trials?
Information about hepatitis B events with ixekizumab treatment in psoriasis, psoriatic arthritis, and axial spondyloarthritis clinical trials is provided.
Ixekizumab Label Information Related to Infections
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 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
Hepatitis B is not listed as adverse reaction in the Taltz summary of product characteristics.1
Clinical Trial Exclusion Criteria
Patients who had tested positive for hepatitis B, or who had evidence of acute or chronic hepatitis B infection, were excluded from the pivotal ixekizumab clinical trials.2,3
Hepatitis B Events in Clinical Trials
Analyses of hepatic-related AEs did not demonstrate clinically important adverse effects related to ixekizumab treatment in patients with PsO or PsA. Longer-term exposure with ixekizumab was not associated with an increased risk of hepatic-related AEs. There were no clinically meaningful differences in the frequency of hepatic-related TEAEs (narrow terms) across treatment groups in the axSpA clinical studies.3
Among all ixekizumab exposures in adult and pediatric PsO trials (N=6645; PY=17,902), as of March 2020, 1 patient had a positive hepatitis B virus DNA test.3
Among all ixekizumab exposures in PsA (data from SPIRIT-P1, -P2, -P3, and SPIRIT-H2H; N=1401; PY=2247.7), as of March 2020, 1 patient with a history of hepatitis B virus had a positive hepatitis B virus DNA test. Although the result was below the level of quantification, the patient discontinued from the study per protocol. Subsequent hepatitis B virus DNA tests for the patient were negative.3,4
Among all ixekizumab exposures in axSpA (including AS/r-axSpA and nr-axSpA trials) (N=932; 1792.2 PYs), as of March 2020, 1 patient had a positive hepatitis B virus DNA test.3
1Taltz [Summary of Product Characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Gordon 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
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4Mease P, Roussou E, Burmester GR, et al. Safety of ixekizumab in patients with psoriatic arthritis: results from a pooled analysis of three clinical trials. Arthritis Care Res (Hoboken). 2019;71(3):367-378. http://dx.doi.org/doi:10.1002/acr.23738