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Taltz ® (ixekizumab)
Taltz® (ixekizumab): Neutropenia in Psoriasis, Psoriatic Arthritis, and Axial Spondyloarthritis
The majority of cases of neutropenia reported with ixekizumab were either grade 1 or grade 2.
Short Answer 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
Ixekizumab Label Information Related to Neutropenia
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/mm3.2
In general, neutropenia did not require discontinuation of ixekizumab.2
The frequency of neutropenia and thrombocytopenia in psoriatic arthritis and axial spondyloarthritis clinical studies is similar to that observed in the plaque psoriasis studies.2
Clinical Trial Laboratory Assessment Results
An integrated safety analysis was conducted from all ixekizumab adult and pediatric PsO exposures (N=6645; PY=17,902 PYs) across 16 plaque PsO clinical trials with data up to March 19, 2020. The MedDRA-preferred term "neutropenia" was reported in 57 (0.9%) patients (IR=0.3 per 100 PYs of exposure).1
An integrated safety analysis was conducted from all ixekizumab axSpA exposures (N=932; PY=1792.2) across 4 axSpA (including AS/r-axSpA and nr-axSpA) trials with data up to March 19, 2020. Neutropenia grade ≥1 was reported in 156 (16.7%) patients (IR=8.7 per 100 PYs of exposure).4
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Taltz [Summary of Product Characteristics]. Eli Lilly Nederland B.V., The Netherlands.
3Genovese 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.
4Schwartzman S, Sandoval D, Kronbergs A, et al. Long-term safety profile of ixekizumab treatment on patients with axial spondyloarthritis. Poster presented at: American College of Rheumatology/ARP 2020 Annual Scientific Meeting (Virtual); November 5-9, 2020.
AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA = axial spondyloarthritis
IR = incidence rate
nr-axSpA = nonradiographic axial spondyloarthritis
PsA = psoriatic arthritis
PsO = psoriasis
PY = patient-years
Date of Last Review: October 16, 2020