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Taltz ® (ixekizumab) injektion
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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
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,
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
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 PsA exposures (N=1401; PY=2247.7) across 4 PsA clinical trials with data up to March 19, 2020.3 The MedDRA-preferred term "neutropenia" was reported in 29 (2.1%) patients (IR=1.3 per 100 PYs of exposure).1
An integrated safety analysis was conducted from all ixekizumab axSpA exposures (N=932; PY=1849) 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=8.4 per 100 PYs of exposure).4
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.
4. Schwartzman 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
Datum fӧr senaste ӧversyn 2020 M10 16