Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events
Abstract Introduction Psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) may confer an increased risk for cardiovascular (CV) disease, including major adverse cerebro-cardiovascular events (MACE), deep vein thrombosis (DVT), and pulmonary embolism (PE). Patients with the...
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Adis, Springer Healthcare
2025-01-01
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| Series: | Dermatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s13555-024-01323-9 |
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| author | Mark Lebwohl Atul Deodhar Sergio Schwartzman Carlo Salvarani Meghan Feely McDonald Natalia Bello Elsie L. Grace Elsa Inman Andris Kronbergs Marcus Ngantcha Proton Rahman Kim A. Papp Joseph F. Merola Alice B. Gottlieb Andrew Blauvelt |
| author_facet | Mark Lebwohl Atul Deodhar Sergio Schwartzman Carlo Salvarani Meghan Feely McDonald Natalia Bello Elsie L. Grace Elsa Inman Andris Kronbergs Marcus Ngantcha Proton Rahman Kim A. Papp Joseph F. Merola Alice B. Gottlieb Andrew Blauvelt |
| author_sort | Mark Lebwohl |
| collection | DOAJ |
| description | Abstract Introduction Psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) may confer an increased risk for cardiovascular (CV) disease, including major adverse cerebro-cardiovascular events (MACE), deep vein thrombosis (DVT), and pulmonary embolism (PE). Patients with these conditions are often exposed for extended time periods to biologics, such as ixekizumab (IXE). Therefore, understanding the risk of CV events, especially MACE, in patients with PsO, PsA, and axSpA exposed to IXE is important. Methods The incidence of MACE (i.e., adjudicated cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), DVT, and PE was assessed in adults who received ≥ 1 dose of IXE across 25 randomized clinical trials (17 PsO, 4 PsA, 4 axSpA). Rates of CV events were analyzed for pooled studies by indication and analyzed from treatment initiation up to the end of the study program. Exposure-adjusted incidence rates per 100 patient-years (IR/100 PY) are reported. Results This integrated safety analysis included 6892 patients with PsO, 1401 with PsA, and 932 with axSpA. The median duration of IXE exposure was 478.5 days (1.3 years) for patients with PsO, 504.5 days (1.4 years) for patients with PsA, and 981.0 days (2.7 years) for patients with axSpA. The incidence of adjudicated MACE was low (IR/100 PY: PsO = 0.5; PsA = 0.5; axSpA = 0.3) and stable over the treatment periods. The most common types of MACE reported were non-fatal myocardial infarction (IR/100 PY: PsO = 0.3; PsA = 0.3; axSpA = 0.3), followed by non-fatal stroke (IR/100 PY: PsO = 0.1; PsA = 0.2; axSpA = 0.0), and cardiovascular death (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.0). The incidences of DVT (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.1) and PE (IR/100 PY: PsO = 0.1; PsA = 0.0; axSpA = 0.0) were low. Conclusion This integrated safety analysis of 25 randomized clinical trials showed that the incidence of adjudicated MACE was low among adult patients with PsO, PsA, and axSpA and that the rates did not increase with increasing IXE exposure. Trial Registration The supplementary Table S1 provides a comprehensive list of clinical trials and their registration numbers. |
| format | Article |
| id | doaj-art-13357491c4b74d8d852507a31fc3f4a3 |
| institution | Kabale University |
| issn | 2193-8210 2190-9172 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Adis, Springer Healthcare |
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| series | Dermatology and Therapy |
| spelling | doaj-art-13357491c4b74d8d852507a31fc3f4a32025-02-02T12:09:40ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722025-01-0115116118810.1007/s13555-024-01323-9Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular EventsMark Lebwohl0Atul Deodhar1Sergio Schwartzman2Carlo Salvarani3Meghan Feely McDonald4Natalia Bello5Elsie L. Grace6Elsa Inman7Andris Kronbergs8Marcus Ngantcha9Proton Rahman10Kim A. Papp11Joseph F. Merola12Alice B. Gottlieb13Andrew Blauvelt14Mount Sinai HospitalOregon Health and Science University72nd Street Medical AssociatesSOC Reumatologia, Azienda USL-IRCCSMount Sinai HospitalEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanyMemorial University of NewfoundlandAlliance Clinical Trials and Probity Medical Research, Waterloo, Division of Dermatology, Temerty School of Medicine, The University of TorontoDivision of Rheumatology, Department of Dermatology and Department of Medicine, UT Southwestern Medical CenterDepartment of Dermatology, Icahn School of Medicine at Mount SinaiBlauvelt Consulting, LLCAbstract Introduction Psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) may confer an increased risk for cardiovascular (CV) disease, including major adverse cerebro-cardiovascular events (MACE), deep vein thrombosis (DVT), and pulmonary embolism (PE). Patients with these conditions are often exposed for extended time periods to biologics, such as ixekizumab (IXE). Therefore, understanding the risk of CV events, especially MACE, in patients with PsO, PsA, and axSpA exposed to IXE is important. Methods The incidence of MACE (i.e., adjudicated cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), DVT, and PE was assessed in adults who received ≥ 1 dose of IXE across 25 randomized clinical trials (17 PsO, 4 PsA, 4 axSpA). Rates of CV events were analyzed for pooled studies by indication and analyzed from treatment initiation up to the end of the study program. Exposure-adjusted incidence rates per 100 patient-years (IR/100 PY) are reported. Results This integrated safety analysis included 6892 patients with PsO, 1401 with PsA, and 932 with axSpA. The median duration of IXE exposure was 478.5 days (1.3 years) for patients with PsO, 504.5 days (1.4 years) for patients with PsA, and 981.0 days (2.7 years) for patients with axSpA. The incidence of adjudicated MACE was low (IR/100 PY: PsO = 0.5; PsA = 0.5; axSpA = 0.3) and stable over the treatment periods. The most common types of MACE reported were non-fatal myocardial infarction (IR/100 PY: PsO = 0.3; PsA = 0.3; axSpA = 0.3), followed by non-fatal stroke (IR/100 PY: PsO = 0.1; PsA = 0.2; axSpA = 0.0), and cardiovascular death (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.0). The incidences of DVT (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.1) and PE (IR/100 PY: PsO = 0.1; PsA = 0.0; axSpA = 0.0) were low. Conclusion This integrated safety analysis of 25 randomized clinical trials showed that the incidence of adjudicated MACE was low among adult patients with PsO, PsA, and axSpA and that the rates did not increase with increasing IXE exposure. Trial Registration The supplementary Table S1 provides a comprehensive list of clinical trials and their registration numbers.https://doi.org/10.1007/s13555-024-01323-9Axial spondyloarthritisCerebro-cardiovascularIxekizumabLong-term safetyMACEPsoriasis |
| spellingShingle | Mark Lebwohl Atul Deodhar Sergio Schwartzman Carlo Salvarani Meghan Feely McDonald Natalia Bello Elsie L. Grace Elsa Inman Andris Kronbergs Marcus Ngantcha Proton Rahman Kim A. Papp Joseph F. Merola Alice B. Gottlieb Andrew Blauvelt Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events Dermatology and Therapy Axial spondyloarthritis Cerebro-cardiovascular Ixekizumab Long-term safety MACE Psoriasis |
| title | Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events |
| title_full | Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events |
| title_fullStr | Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events |
| title_full_unstemmed | Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events |
| title_short | Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events |
| title_sort | long term safety of ixekizumab treatment in patients with psoriasis psoriatic arthritis or axial spondyloarthritis a post hoc analysis of cerebro cardiovascular events |
| topic | Axial spondyloarthritis Cerebro-cardiovascular Ixekizumab Long-term safety MACE Psoriasis |
| url | https://doi.org/10.1007/s13555-024-01323-9 |
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