Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® (ixekizumab): Neutropeni vid psoriasis, psoriasisartrit och axiell spondyloartrit

De flesta fall av neutropeni som rapporterats med ixekizumab var antingen grad 1 eller grad 2.

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en-GB

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

Psoriasis

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

Psoriatic Arthritis

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

Axial Spondyloarthritis

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

References

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.

Glossary

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


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