Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Förekomst av hepatit B vid plackpsoriasis och psoriasisartrit i kliniska prövningar

Patienter som hade testats positivt för hepatit B eller som hade evidens på akut eller kronisk hepatit B-infektion exkluderades från de pivotala kliniska prövningarna av ixekizumab.

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

Psoriasis

Among all ixekizumab exposures in PsO (N=6091; PY=17,499.3), as of March 2019, 1 patient had a positive hepatitis HBV DNA test.3

Psoriatic Arthritis

Among all ixekizumab exposures in PsA (data from SPIRIT-P1, -P2, and -P3; N=1401; PY=2228.6), as of March 2019, 1 patient with a history of HBV had a positive HBV DNA test. Although the result was below the level of quantification, the patient discontinued from the study per protocol. Subsequent HBV DNA tests for the patient were negative.3,4

Axial Spondyloarthritis

Among all exposures in axSpA (N=929; 1336.2 PYs), as of April 2019, there were no TEAEs of hepatitis B.3

References

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

2. 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

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

4. Mease 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

Glossary

AE = adverse event

axSpA = axial spondyloarthritis

HBV = hepatitis B virus

PsA = psoriatic arthritis

PsO = psoriasis

PY = patient-years

TEAE = treatment-emergent adverse event

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.

Datum fӧr senaste ӧversyn 2020 M03 04


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