Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data
Secukinumab, a selective interleukin (IL)-17A inhibitor, is approved for use in adult and paediatric psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The aim of this study was to report the long-term safety of secukinumab in pooled data from 28 cli...
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| Format: | Article |
| Language: | English |
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Medical Journals Sweden
2022-04-01
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| Series: | Acta Dermato-Venereologica |
| Subjects: | |
| Online Access: | https://medicaljournalssweden.se/actadv/article/view/563 |
| _version_ | 1818047615613272064 |
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| author | Alice B. Gottlieb Atul Deodhar Iain B. Mcinnes Xenofon Baraliakos Kristian Reich Stefan Schreiber Weibin Bao Kwaku Marfo Hanno B. Richards Luminita Pricop Abhijit Shete Vivek Trivedi Deborah Keefe Charis C. Papavassilis Piotr Jagiello Philemon Papanastasiou Philip J. Mease Mark Lebwohl |
| author_facet | Alice B. Gottlieb Atul Deodhar Iain B. Mcinnes Xenofon Baraliakos Kristian Reich Stefan Schreiber Weibin Bao Kwaku Marfo Hanno B. Richards Luminita Pricop Abhijit Shete Vivek Trivedi Deborah Keefe Charis C. Papavassilis Piotr Jagiello Philemon Papanastasiou Philip J. Mease Mark Lebwohl |
| author_sort | Alice B. Gottlieb |
| collection | DOAJ |
| description | Secukinumab, a selective interleukin (IL)-17A inhibitor, is approved for use in adult and paediatric psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The aim of this study was to report the long-term safety of secukinumab in pooled data from 28 clinical trials and a post-marketing safety surveillance in psoriasis, psoriatic arthritis and ankylosing spondylitis patients. Analyses included 12,637 secukinumab-treated patients, corresponding to 15,063, 5,985 and 3,527 patient-years of exposure in psoriasis, psoriatic arthritis and ankylosing spondylitis patients, respectively. Incidences of serious adverse events were low, with no identifiable patterns across indications. Active tuberculosis or latent tuberculosis infections were rare. The incidence of opportunistic infections was < 0.2/100 patient-years, the incidence of malignancy was ≤ 1/100 patient-years, and the incidence of major adverse cardiovascular events was < 0.7/100 patient-years, with no apparent increases over time. Secukinumab demonstrated a favourable safety profile for up to 5 years of treatment across the 3 indications, and no new safety signals were identified.
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| first_indexed | 2024-12-10T10:08:36Z |
| format | Article |
| id | doaj.art-df7f9d86b24a460b8b32d03dd5d1cb7c |
| institution | Directory Open Access Journal |
| issn | 0001-5555 1651-2057 |
| language | English |
| last_indexed | 2024-12-10T10:08:36Z |
| publishDate | 2022-04-01 |
| publisher | Medical Journals Sweden |
| record_format | Article |
| series | Acta Dermato-Venereologica |
| spelling | doaj.art-df7f9d86b24a460b8b32d03dd5d1cb7c2022-12-22T01:53:12ZengMedical Journals SwedenActa Dermato-Venereologica0001-55551651-20572022-04-0110210.2340/actadv.v102.563Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance DataAlice B. Gottlieb0Atul Deodhar1Iain B. Mcinnes2Xenofon Baraliakos3Kristian Reich4Stefan Schreiber5Weibin Bao6Kwaku Marfo7Hanno B. Richards8Luminita Pricop9Abhijit Shete10Vivek Trivedi11Deborah Keefe12Charis C. Papavassilis13Piotr Jagiello14Philemon Papanastasiou15Philip J. Mease16Mark Lebwohl17Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, USADivision of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USAInstitute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UKRheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, GermanyTranslational Research in Inflammatory Skin Disease, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of Medicine I, University Hospital Schleswig-Holstein, Kiel, GermanyNovartis Pharmaceuticals Corporation, East Hanover, USNovartis Pharma AG, Basel, SwitzerlandNovartis Pharma AG, Basel, SwitzerlandNovartis Pharmaceuticals Corporation, East Hanover, USNovartis Pharma AG, Basel, SwitzerlandNovartis Pharmaceuticals Corporation, East Hanover, USNovartis Pharmaceuticals Corporation, East Hanover, USNovartis Pharma AG, Basel, SwitzerlandNovartis Pharma AG, Basel, SwitzerlandNovartis Pharma AG, Basel, SwitzerlandSwedish Medical Center and University of Washington, Seattle, USMount Sinai Hospital, New York, USSecukinumab, a selective interleukin (IL)-17A inhibitor, is approved for use in adult and paediatric psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The aim of this study was to report the long-term safety of secukinumab in pooled data from 28 clinical trials and a post-marketing safety surveillance in psoriasis, psoriatic arthritis and ankylosing spondylitis patients. Analyses included 12,637 secukinumab-treated patients, corresponding to 15,063, 5,985 and 3,527 patient-years of exposure in psoriasis, psoriatic arthritis and ankylosing spondylitis patients, respectively. Incidences of serious adverse events were low, with no identifiable patterns across indications. Active tuberculosis or latent tuberculosis infections were rare. The incidence of opportunistic infections was < 0.2/100 patient-years, the incidence of malignancy was ≤ 1/100 patient-years, and the incidence of major adverse cardiovascular events was < 0.7/100 patient-years, with no apparent increases over time. Secukinumab demonstrated a favourable safety profile for up to 5 years of treatment across the 3 indications, and no new safety signals were identified. https://medicaljournalssweden.se/actadv/article/view/563Ankylosing spondylitisbiologicsinterleukinpsoriasispsoriatic arthritissafety |
| spellingShingle | Alice B. Gottlieb Atul Deodhar Iain B. Mcinnes Xenofon Baraliakos Kristian Reich Stefan Schreiber Weibin Bao Kwaku Marfo Hanno B. Richards Luminita Pricop Abhijit Shete Vivek Trivedi Deborah Keefe Charis C. Papavassilis Piotr Jagiello Philemon Papanastasiou Philip J. Mease Mark Lebwohl Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data Acta Dermato-Venereologica Ankylosing spondylitis biologics interleukin psoriasis psoriatic arthritis safety |
| title | Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data |
| title_full | Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data |
| title_fullStr | Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data |
| title_full_unstemmed | Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data |
| title_short | Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data |
| title_sort | long term safety of secukinumab over five years in patients with moderate to severe plaque psoriasis psoriatic arthritis and ankylosing spondylitis update on integrated pooled clinical trial and post marketing surveillance data |
| topic | Ankylosing spondylitis biologics interleukin psoriasis psoriatic arthritis safety |
| url | https://medicaljournalssweden.se/actadv/article/view/563 |
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