Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis

Long-term safety data are critical for evaluating therapies for psoriasis. Ixekizumab has demonstrated efficacy and is well tolerated for the treatment of moderate-to-severe plaque psoriasis. We examined the safety and tolerability of up to 5 years of ixekizumab therapy in patients with psoriasis. I...

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Autores: Armstrong, April W, Paul, Carle|||0000-0003-0165-5263, Puig Sanz, Lluís|||0000-0001-6083-0952, Boehncke, Wolf-Henning|||0000-0002-1225-7124, Freeman, Michael, Torii, Hideshi, Papp, Kim, Griffiths, Christopher E. M., Blauvelt, Andrew|||0000-0002-2633-985X, Reich, Kristian|||0000-0001-5248-4332, Gooderham, Melinda|||0000-0001-8926-0113, Terui, Tadashi, Renda, Lisa, Agada, Noah, Xu, Wen, Gallo, Gaia, Lebwohl, Mark G.
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:227862
Acceso en línea:https://ddd.uab.cat/record/227862
https://dx.doi.org/urn:doi:10.1007/s13555-019-00340-3
Access Level:acceso abierto
Palabra clave:Adverse events
Etanercept
IL-17
Integrated analysis
Ixekizumab
Safety
Psoriasis
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spelling Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe PsoriasisResults from Greater Than 17,000 Patient-Years of ExposureArmstrong, April WPaul, Carle|||0000-0003-0165-5263Puig Sanz, Lluís|||0000-0001-6083-0952Boehncke, Wolf-Henning|||0000-0002-1225-7124Freeman, MichaelTorii, HideshiPapp, KimGriffiths, Christopher E. M.Blauvelt, Andrew|||0000-0002-2633-985XReich, Kristian|||0000-0001-5248-4332Gooderham, Melinda|||0000-0001-8926-0113Terui, TadashiRenda, LisaAgada, NoahXu, WenGallo, GaiaLebwohl, Mark G.Adverse eventsEtanerceptIL-17Integrated analysisIxekizumabSafetyPsoriasisLong-term safety data are critical for evaluating therapies for psoriasis. Ixekizumab has demonstrated efficacy and is well tolerated for the treatment of moderate-to-severe plaque psoriasis. We examined the safety and tolerability of up to 5 years of ixekizumab therapy in patients with psoriasis. Integrated safety data were analyzed from 13 ixekizumab clinical studies. Rates of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest were analyzed for the 12-week induction period in the combined pivotal studies, and for all pooled studies by year(s) of therapy and overall, reported as exposure-adjusted incidence rates (IRs) per 100 patient-years (p-y) and/or frequencies. Total ixekizumab exposure was 17,003.4 p-y (N = 5898); 2749 patients had ≥ 4 years of exposure. When compared across years of exposure, rates for AEs remained largely stable or declined, including TEAEs leading to discontinuation (3.8/100 p-y in year 1, declining to 2.0/100 p-y in year 5); SAEs (range 6.2-7.0/100 p-y); serious infections (range 1.3-1.7/100 p-y); nonmelanoma skin cancer (ranging from 0.5/100 p-y in year 1 to 0.2/100 p-y in years 4-5); other malignancies (range 0.4-0.6/100 p-y); inflammatory bowel disease including ulcerative colitis and Crohn's disease (IR 0.2/100 p-y); and major adverse cardiovascular events (MACE) (range 0.3-0.7/100 p-y). Candidiasis was reported in 327 patients (IR 1.9/100 p-y), with the majority identified as mucocutaneous. The rate of injection site reactions was 15.5/100 p-y during year 1 and 2.0-2.3/100 p-y by years 3-5. The decrease in rates of TEAEs and the stable rates of SAEs, other malignancies and MACE during up to 5 years of ixekizumab dosing are consistent with previous reports describing a favorable safety profile of ixekizumab following shorter durations of exposure. Eli Lilly and Company.Universitat Autònoma de Barcelona 22019-01-0120192019-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/227862https://dx.doi.org/urn:doi:10.1007/s13555-019-00340-3reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2278622026-06-06T12:50:31Z
dc.title.none.fl_str_mv Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis
Results from Greater Than 17,000 Patient-Years of Exposure
title Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis
spellingShingle Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis
Armstrong, April W
Adverse events
Etanercept
IL-17
Integrated analysis
Ixekizumab
Safety
Psoriasis
title_short Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis
title_full Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis
title_fullStr Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis
title_full_unstemmed Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis
title_sort Safety of Ixekizumab Treatment for up to 5 Years in Adult Patients with Moderate-to-Severe Psoriasis
dc.creator.none.fl_str_mv Armstrong, April W
Paul, Carle|||0000-0003-0165-5263
Puig Sanz, Lluís|||0000-0001-6083-0952
Boehncke, Wolf-Henning|||0000-0002-1225-7124
Freeman, Michael
Torii, Hideshi
Papp, Kim
Griffiths, Christopher E. M.
Blauvelt, Andrew|||0000-0002-2633-985X
Reich, Kristian|||0000-0001-5248-4332
Gooderham, Melinda|||0000-0001-8926-0113
Terui, Tadashi
Renda, Lisa
Agada, Noah
Xu, Wen
Gallo, Gaia
Lebwohl, Mark G.
author Armstrong, April W
author_facet Armstrong, April W
Paul, Carle|||0000-0003-0165-5263
Puig Sanz, Lluís|||0000-0001-6083-0952
Boehncke, Wolf-Henning|||0000-0002-1225-7124
Freeman, Michael
Torii, Hideshi
Papp, Kim
Griffiths, Christopher E. M.
Blauvelt, Andrew|||0000-0002-2633-985X
Reich, Kristian|||0000-0001-5248-4332
Gooderham, Melinda|||0000-0001-8926-0113
Terui, Tadashi
Renda, Lisa
Agada, Noah
Xu, Wen
Gallo, Gaia
Lebwohl, Mark G.
author_role author
author2 Paul, Carle|||0000-0003-0165-5263
Puig Sanz, Lluís|||0000-0001-6083-0952
Boehncke, Wolf-Henning|||0000-0002-1225-7124
Freeman, Michael
Torii, Hideshi
Papp, Kim
Griffiths, Christopher E. M.
Blauvelt, Andrew|||0000-0002-2633-985X
Reich, Kristian|||0000-0001-5248-4332
Gooderham, Melinda|||0000-0001-8926-0113
Terui, Tadashi
Renda, Lisa
Agada, Noah
Xu, Wen
Gallo, Gaia
Lebwohl, Mark G.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Adverse events
Etanercept
IL-17
Integrated analysis
Ixekizumab
Safety
Psoriasis
topic Adverse events
Etanercept
IL-17
Integrated analysis
Ixekizumab
Safety
Psoriasis
description Long-term safety data are critical for evaluating therapies for psoriasis. Ixekizumab has demonstrated efficacy and is well tolerated for the treatment of moderate-to-severe plaque psoriasis. We examined the safety and tolerability of up to 5 years of ixekizumab therapy in patients with psoriasis. Integrated safety data were analyzed from 13 ixekizumab clinical studies. Rates of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest were analyzed for the 12-week induction period in the combined pivotal studies, and for all pooled studies by year(s) of therapy and overall, reported as exposure-adjusted incidence rates (IRs) per 100 patient-years (p-y) and/or frequencies. Total ixekizumab exposure was 17,003.4 p-y (N = 5898); 2749 patients had ≥ 4 years of exposure. When compared across years of exposure, rates for AEs remained largely stable or declined, including TEAEs leading to discontinuation (3.8/100 p-y in year 1, declining to 2.0/100 p-y in year 5); SAEs (range 6.2-7.0/100 p-y); serious infections (range 1.3-1.7/100 p-y); nonmelanoma skin cancer (ranging from 0.5/100 p-y in year 1 to 0.2/100 p-y in years 4-5); other malignancies (range 0.4-0.6/100 p-y); inflammatory bowel disease including ulcerative colitis and Crohn's disease (IR 0.2/100 p-y); and major adverse cardiovascular events (MACE) (range 0.3-0.7/100 p-y). Candidiasis was reported in 327 patients (IR 1.9/100 p-y), with the majority identified as mucocutaneous. The rate of injection site reactions was 15.5/100 p-y during year 1 and 2.0-2.3/100 p-y by years 3-5. The decrease in rates of TEAEs and the stable rates of SAEs, other malignancies and MACE during up to 5 years of ixekizumab dosing are consistent with previous reports describing a favorable safety profile of ixekizumab following shorter durations of exposure. Eli Lilly and Company.
publishDate 2019
dc.date.none.fl_str_mv 2
2019-01-01
2019
2019-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/227862
https://dx.doi.org/urn:doi:10.1007/s13555-019-00340-3
url https://ddd.uab.cat/record/227862
https://dx.doi.org/urn:doi:10.1007/s13555-019-00340-3
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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