Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events.
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
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引用次数: 0
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.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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