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
Abstract Introduction 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 pati...
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Adis, Springer Healthcare
2019-11-01
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doaj-2a47525da5c44479873e7fdf8954686a2020-11-25T04:02:49ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722019-11-0110113315010.1007/s13555-019-00340-3Safety 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 ExposureApril Armstrong0Carle Paul1Luis Puig2Wolf Henning Boehncke3Michael Freeman4Hideshi Torii5Kim Papp6Christopher E. M. Griffiths7Andrew Blauvelt8Kristian Reich9Melinda Gooderham10Tadashi Terui11Lisa Renda12Noah Agada13Wen Xu14Gaia Gallo15Mark G. Lebwohl16Department of Clinical Research, Keck School of Medicine of the University of Southern CaliforniaDermatology Department, Toulouse University Hospital (CHU), Paul Sabatier UniversityHospital de la Santa Creu i Sant Pau, Universitat Autònoma de BarcelonaDivision of Dermatology and Venereology, Geneva University HospitalsThe Skin CentreDivision of Dermatology, Tokyo Yamate Medical CenterK Papp Clinical Research and Probity Medical ResearchDermatology Centre, Salford Royal Hospital, University of Manchester, NIHR Manchester Biomedical Research CentreOregon Medical Research CenterCenter for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg–EppendorfCentre for Dermatology and Probity Medical ResearchDepartment of Dermatology, Nihon University School of MedicineEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanyDepartment of Dermatology, Icahn School of Medicine at Mount SinaiAbstract Introduction 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. Methods 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. Results 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. Conclusions 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. Funding Eli Lilly and Company.http://link.springer.com/article/10.1007/s13555-019-00340-3Adverse eventsEtanerceptIL-17Integrated analysisIxekizumabSafety |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
April Armstrong Carle Paul Luis Puig Wolf Henning Boehncke Michael Freeman Hideshi Torii Kim Papp Christopher E. M. Griffiths Andrew Blauvelt Kristian Reich Melinda Gooderham Tadashi Terui Lisa Renda Noah Agada Wen Xu Gaia Gallo Mark G. Lebwohl |
spellingShingle |
April Armstrong Carle Paul Luis Puig Wolf Henning Boehncke Michael Freeman Hideshi Torii Kim Papp Christopher E. M. Griffiths Andrew Blauvelt Kristian Reich Melinda Gooderham Tadashi Terui Lisa Renda Noah Agada Wen Xu Gaia Gallo Mark G. Lebwohl 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 Dermatology and Therapy Adverse events Etanercept IL-17 Integrated analysis Ixekizumab Safety |
author_facet |
April Armstrong Carle Paul Luis Puig Wolf Henning Boehncke Michael Freeman Hideshi Torii Kim Papp Christopher E. M. Griffiths Andrew Blauvelt Kristian Reich Melinda Gooderham Tadashi Terui Lisa Renda Noah Agada Wen Xu Gaia Gallo Mark G. Lebwohl |
author_sort |
April Armstrong |
title |
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_short |
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_full |
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_fullStr |
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_full_unstemmed |
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_sort |
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 |
publisher |
Adis, Springer Healthcare |
series |
Dermatology and Therapy |
issn |
2193-8210 2190-9172 |
publishDate |
2019-11-01 |
description |
Abstract Introduction 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. Methods 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. Results 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. Conclusions 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. Funding Eli Lilly and Company. |
topic |
Adverse events Etanercept IL-17 Integrated analysis Ixekizumab Safety |
url |
http://link.springer.com/article/10.1007/s13555-019-00340-3 |
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