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): Treatment-Emergent Pustular Psoriasis in Clinical Trials

The numbers of patients with exposure to ixekizumab during clinical trials who reported a TEAE of pustular psoriasis are presented.

Treatment-Emergent Pustular Psoriasis in Clinical Trials

Treatment-emergent adverse events were defined as events that first occurred or worsened in severity, relative to baseline, at any time during a clinical trial. Adverse events reported during the trials were not necessarily caused by the therapy and the frequencies do not reflect investigator assessment of causality.

There are no MedDRA preferred terms that map specifically to palmoplantar pustular psoriasis or palmoplantar pustular rash. Therefore, it is unknown how many of the reports of pustular psoriasis and pustular rash involved the palms and soles.

All Ixekizumab Psoriasis Exposures

An integrated safety analysis of 16 psoriasis clinical trials as of March 2020 (all patients exposed to ixekizumab [N=6645] accounting for 17,902.0 PY of exposure) assessed cumulative safety experience covering up to 5 years duration of exposure. Of patients exposed to ixekizumab in these studies, 15 (0.2%) patients reported the MedDRA preferred term of "pustular psoriasis" (EAIR of 0.1 per 100 PYs). Of the 15 cases, 3 were considered to be serious, and 4 (0.1%) patients discontinued from the study due to the AE.1

There were 10 (0.2%) patients who experienced TEAEs that mapped to the MedDRA preferred term of “rash pustular” (EAIR of 0.1 per 100 PYs). The MedDRA preferred term of "pustule" was reported by 16 (0.2%) patients (EAIR of 0.1 per 100 PYs). The MedDRA preferred term of "palmoplantar pustulosis" was reported by 3 (0.0%) patients (EAIR of 0.0 per 100 PYs). None of these events were considered to be serious and no patients discontinued from the study due to an AE of "rash pustular," "pustule," or "palmoplantar pustulosis."1 

All Ixekizumab Psoriatic Arthritis Exposures

An integrated safety analysis of 4 PsA clinical trials as of March 2020 that included all patients exposed to ixekizumab (N=1401 accounting for 2247.7 PY of exposure) assessed cumulative safety experience covering up to 3 years duration of exposure. Of patients exposed to ixekizumab in these studies, 2 (0.1%) patients reported the MedDRA preferred term of "pustular psoriasis" (EAIR of 0.1 per 100 PYs). The TEAEs were not considered to be serious, and no patients discontinued from the study due to the AE.1

In addition, 1 (0.1%) patient experienced a TEAE that mapped to the MedDRA preferred term of “rash pustular” and 1 (0.1%) patient experienced "palmoplantar pustulosis" (EAIR of 0.0 per 100 PYs for each). The events were not considered to be serious and the patients did not discontinue from the study due to the AEs.1

All Ixekizumab Axial Spondyloarthritis Exposures

Across 4 axSpA trials (including AS/r-axSpA and nr-axSpA) as of March 2020 (N=932 accounting for 1849.0 PY of exposure to ixekizumab) covering up to 3 years duration of exposure, no patients reported the MedDRA preferred term of "pustular psoriasis."1

The MedDRA preferred term of "rash pustular" was reported by 2 (0.2%) patients (EAIR of 0.1 per 100 PYs). None of the events were considered to be serious, and 1 patient discontinued from the study due to the AE. "Pustule" was reported by 2 (0.2%) patients (EAIR of 0.1 per 100 PYs). The events were not considered to be serious and the patients did not discontinue from the study due to the AE.1

The MedDRA preferred term of "palmoplantar pustulosis" was reported by 3 (0.3%) patients (EAIR of 0.2 per 100 PYs). None of the events were considered to be serious, and no patients discontinued from the study due to the AE.1

References

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

Glossary

AE = adverse event

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

axSpA = axial spondyloarthritis

EAIR = exposure adjusted incidence rate

MedDRA = Medical Dictionary for Regulatory Activities

nr-axSpA = nonradiographic axial spondyloarthritis

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: April 15, 2020


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