Om du vill rapportera en biverkning gällande en av Lillys produkter, kontakta oss via e-post på DK_PHv@lilly.com eller på telefon +45 4526 6040. Har du ytterligare medicinska frågor gällande en av Lillys produkter, kontakta oss via länken ovan.
Taltz ® (ixekizumab) injektion
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
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.
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
Datum fӧr senaste ӧversyn 2020 M01 16