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): Hepatitis B Events in Plaque Psoriasis and Psoriatic Arthritis Clinical Trials

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.

Information from the Label

Ixekizumab is contraindicated in patients with clinically important active 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

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.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

Therapeutic Indications

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1

Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.1

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

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.

Date of Last Review: March 04, 2020

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