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): Use in Patients with Lupus and TEAEs of Lupus in Psoriasis and Psoriatic Arthritis

The efficacy and safety of ixekizumab in patients with lupus have not been evaluated by Lilly.

Use in Psoriasis and Psoriatic Arthritis Patients with comorbid Lupus in clinical trials

Exclusion and Discontinuation Criteria Related to Lupus

In the ixekizumab phase 3 clinical trials in psoriasis and PsA, patients developing symptoms suggestive of a lupus-like syndrome and testing positive for antibodies against double-stranded DNA were required to discontinue from the studies.1,2

  • Rationale: In accordance with potential risks associated with immunosuppressive agents, a discontinuation rule for patients who develop symptoms suggestive of lupus-like syndrome and are positive for antibodies against double-stranded DNA was added to limit potential safety risks to these patients.2

Treatment-Emergent Adverse Events During Clinical Trials

In ixekizumab clinical trials, TEAEs were evaluated using MedDRA. This response includes TEAEs reported that include the term "lupus."2

Lupus-Related Treatment-Emergent Adverse Events

Psoriasis Trials

Within the overall safety database across 14 psoriasis trials as of March 21, 2019 (N=6091 patients exposed to ixekizumab accounting for 17499.3 PYs of exposure), there was 1 report of chronic cutaneous lupus erythematosus that led to study drug discontinuation.2

Psoriatic Arthritis Trials

Within the overall safety database across 4 PsA trials as of March 21, 2019 (N=1401 patients exposed to ixekizumab accounting for 2228.6 PYs of exposure), there were no TEAE reports of any of the MedDRA preferred terms containing the term "lupus."2

Anti-Double-Stranded DNA Antibodies

Screening and testing for double-stranded DNA antibody during ixekizumab trials were not routinely done.1,2 Within the overall safety database as of March 21, 2019 (for psoriasis and PsA) there were no TEAE reports of any MedDRA preferred term that included "double-stranded DNA antibody."2

Antinuclear Antibodies

Laboratory tests for antinuclear antibodies were not routinely performed in ixekizumab trials, although antinuclear antibody was listed in the study protocols as a hepatic monitoring test for treatment emergent abnormalities.1,2 Within the overall psoriasis safety database as of March 21, 2019 there was 1 TEAE report of "antinuclear antibody positive."2

Within the PsA database as of March 21, 2019, there were no reports of any MedDRA preferred term that included "antinuclear antibody."2

Post-Marketing Adverse Event Reporting Information

Adverse events related to lupus that have been reported to Lilly during postmarketing as of March 22, 2019 include 

  • cutaneous lupus erythematosus

  • lupus-like syndrome 

  • systemic lupus erythematosus, and

  • systemic lupus erythematosus rash.

These adverse events have been reported very rarely.2

Spontaneous reporting of adverse events can be highly variable and is not appropriately controlled clinical information on
which to base an assessment of whether a particular drug product caused an event. Spontaneous reporting is also limited in
usage due to bias in reporting, including incomplete information concerning the patient (that is, unknown medical history),
unknown concomitant medications and disease states, and under-reporting.

Therapeutic Indications

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.3

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.3

References

1. 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

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

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

Glossary

Lilly = Eli Lilly and Company

MedDRA = Medical Dictionary for Regulatory Activities

PsA = psoriatic arthritis

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: January 02, 2020

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