Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Trombocytopeni

98 % av fallen av trombocytopeni var av grad 1. Personer med trombocytopeni som behandlats med ixekizumab förknippades inte med ökad förekomst av blödningar jämfört med placebo.

General Information

There is no contraindication, warning or precaution against using ixekizumab in patients with a history of thrombocytopenia.1

3 % of patients exposed to ixekizumab had a shift from a normal baseline platelet value to < 150,000 platelet cells/mm3 to ≥ 75,000 cells/mm3. Thrombocytopenia may persist, fluctuate or be transient.1

Ninety-eight percent of cases of thrombocytopenia were grade 1 (3% for IXEQ2W vs 1% for placebo; ≥75,000 cells/mm3 to <150,000 cells/mm3).1,2

Thrombocytopenia in subjects treated with ixekizumab was not associated with an increased rate of bleeding compared to subjects treated with placebo.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.1

This information is for reference only and is not a treatment recommendation. Decisions regarding the use of ixekizumab in patients with thrombocytopenia (or any medical condition) should be made at the discretion of the prescribing physician using their best clinical judgment.

Preexisting Thrombocytopenia in Ixekizumab Clinical Trials

 In the 3 pivotal phase 3 psoriasis clinical trials (UNCOVER -1, -2, and -3; N=2328) thrombocytopenia was reported as a preexisting condition in 3 (0.1%) patients and as a historical illness in 2 (0.1%) patients.

No patients reported thrombocytopenia as a preexisting condition or historical illness in the 2 pivotal phase 3 PsA (N=454) clinical trials (SPIRIT-P1 and SPIRIT-P2).2

Thrombocytopenia TEAEs

The term “thrombocytopenia” is a preferred term in the MedDRA. Treatment-emergent adverse events of “platelet count decreased” have also been included in this response.

No cases of thrombocytopenia resulted in an SAE. One TEAE of thrombocytopenia and 1 TEAE of platelet count decreased resulted in study drug discontinuation. There were no treatment-emergent bleeding events associated with thrombocytopenia grades 2, 3, or 4. Five ixekizumab treated patients had ≥1 treatment-emergent bleeding event associated with grade 1 thrombocytopenia, but none were serious or led to study discontinuation.2


Table 1. Incidence of Thrombocytopenia or Platelet Count Decreased TEAEs in Ixekizumab Clinical Trials2

TEAE

Psoriasis Clinical Trials

N=5730  PY=13479.0

n (%)

Psoriatic Arthritis Clinical Trials

N=1118  PY 1340.3

n (%)

All Thrombocytopenia TEAEs

20 (0.3)

3 (0.3)

Thrombocytopenia TEAEs leading to discontinuation

1 (0.0)

0

All Platelet count decreased TEAEs

9 (0.2)

4 (0.4)

Platelet count decreased TEAEs leading to discontinuation

1 (0.0)

0

Abbreviations: PY = patient-years of treatment; TEAE = treatment emergent adverse event.

References

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

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

Glossary

IXEQ2W = ixekizumab 80 mg every 2 weeks

MedDRA = Medical Dictionary for Regulatory Activities

PsA = psoriatic arthritis

SAE = serious adverse event

TEAE = treatment-emergent adverse event

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.

Datum fӧr senaste ӧversyn 2020 M01 16

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