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): Neutropenia

The majority of cases of neutropenia reported with ixekizumab were either grade 1 or grade 2.

Short Summary

Low grade neutropenia has been commonly observed in patients receiving ixekizumab. However, neutropenia ≥ grade 3 (<1,000 cells/mm3) has been observed infrequently in patients receiving ixekizumab.1

In general, neutropenia

  • was transient

  • did not require discontinuation of ixekizumab, and

  • was not associated with an increased frequency of infections.1

Information from the Label

Neutropenia was an uncommonly (≥ 1/1,000 to < 1/100) reported adverse reaction in the ixekizumab clinical trials.2

In plaque psoriasis studies, 9 % of patients receiving ixekizumab developed neutropenia. In most cases, the blood neutrophil count was ≥ 1,000 cells/mm3. Such levels of neutropenia may persist, fluctuate or be transient. 0.1 % of patients receiving ixekizumab developed a neutrophil count < 1,000 cells/mm3. In general, neutropenia did not require discontinuation of ixekizumab.2

The frequency of neutropenia in psoriatic arthritis clinical studies is similar to that observed in the plaque psoriasis studies.2

Clinical Trial Laboratory Assessment Results

Psoriasis

An integrated safety analysis was conducted from all ixekizumab PsO exposures (N=6091; PY=17,499.3 PYs) across 14 plaque PsO clinical trials with data up to March 21, 2019.3 The MedDRA-preferred term "neutropenia" was reported in 54 (0.9%) patients (IR=0.3 per 100 PYs of exposure).1

Psoriatic Arthritis

An integrated safety analysis was conducted from all ixekizumab PsA exposures (N=1401; PY=2228.6 PYs) across 4 PsA clinical trials with data up to March 21, 2019.3 The MedDRA-preferred term "neutropenia" was reported in 29 (2.1%) patients (IR=1.3 per 100 PYs of exposure).1

References

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

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

3. Genovese MC, Kameda H, Rahman P, et al. Safety profile of ixekizumab in patients with moderate-to-severe plaque psoriasis and psoriatic arthritis: integrated analysis of 18 clinical trials. Poster presented at: American College of Rheumatology/ARP; November 8-13, 2019; Atlanta, GA.

Glossary

IR = incidence rate

PsA = psoriatic arthritis

PsO = psoriasis

PY = patient-years

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 17, 2020

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