Taltz ® (ixekizumab) injection

80 mg/mL

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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.

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Prescribing Information

Plaque Psoriasis

The incidences of treatment-emergent neutropenia from the prescribing information are listed in Neutropenia Grade 1, Grade 2, > Grade 3 Through Week 12 of UNCOVER Psoriasis Clinical Trials and Neutropenia Incidence Weeks 0 Through 60 of UNCOVER Psoriasis Clinical Trials. These data are from the UNCOVER clinical trials that were conducted in adult patients with moderate-to-severe plaque PsO.1

  • The majority of cases of neutropenia were either grade 1 or grade 2.1
  • In subjects treated with ixekizumab, the incidence rate of neutropenia during weeks 13 to 60 was lower than the incidence rate during weeks 0 to 12.1
  • Neutropenia in the ixekizumab group was not associated with an increased rate of infection compared to the placebo group.1
Neutropenia Grade 1, Grade 2, > Grade 3 Through Week 12 of UNCOVER Psoriasis Clinical Trials1

Neutropenia

Ixekizumab Q2W

Placebo

Grade 1a

7%

3%

Grade 2b

2%

0.3%

Grade ≥3c

0.2%d

0.1%e

Abbreviation: Q2W = ixekizumab 80 mg every 2 weeks following a 160-mg starting dose.

aGrade 1 neutropenia defined as >1500 to <2000 cells/mm3.

bGrade 2 neutropenia defined as >1000 to <1500 cells/mm3.

cGrade >3 neutropenia defined as <1,000 cells/mm3.

dCorresponds to 0.007 events per subject-year of follow-up.

eCorresponds to 0.006 events per subject-year of follow-up.

Neutropenia Incidence Weeks 0 Through 60 of UNCOVER Psoriasis Clinical Trials1

Neutropenia

Ixekizumab

Placebo

All Grades

11%a

3%b

aCorresponds to 0.24 events per subject-year of follow-up.

bCorresponds to 0.14 events per subject-year of follow-up.

Psoriatic Arthritis

Overall, the safety profile observed in patients with PsA treated with ixekizumab Q4W is consistent with the safety profile in patients with plaque PsO with the exception of the frequencies of influenza and conjunctivitis.1

Ankylosing Spondylitis

Overall, the safety profile observed in patients with AS/r-axSpA treated with ixekizumab Q4W is consistent with the safety profile in patients with plaque PsO.1

Non-radiographic Axial Spondyloarthritis

Overall, the safety profile observed in patients with nr-axSpA treated with ixekizumab 80 mg Q4W up to week 16 is consistent with the previous experience of ixekizumab in other indications.1

Clinical Trial Treatment-Emergent Adverse Event 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).2

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).2

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

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

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: Florida Society of Rheumatology 2021 Annual Meeting; July 9-11, 2021; Orlando, FL.

Glossary

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

axSpA = axial spondyloarthritis

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

PsO = psoriasis

PY = patient-years

Q4W = every 4 weeks

TEAE = treatment-emergent adverse event

Date of Last Review: November 05, 2020


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