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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

Standard

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. / Armstrong, April; Paul, Carle; Puig, Luis; Boehncke, Wolf Henning; Freeman, Michael; Torii, Hideshi; Papp, Kim; Griffiths, Christopher E M; Blauvelt, Andrew; Reich, Kristian; Gooderham, Melinda; Terui, Tadashi; Renda, Lisa; Agada, Noah; Xu, Wen; Gallo, Gaia; Lebwohl, Mark G.

in: DERMATOLOGY THER, Jahrgang 10, Nr. 1, 02.2020, S. 133-150.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Armstrong, A, Paul, C, Puig, L, Boehncke, WH, Freeman, M, Torii, H, Papp, K, Griffiths, CEM, Blauvelt, A, Reich, K, Gooderham, M, Terui, T, Renda, L, Agada, N, Xu, W, Gallo, G & Lebwohl, MG 2020, '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 THER, Jg. 10, Nr. 1, S. 133-150. https://doi.org/10.1007/s13555-019-00340-3

APA

Armstrong, A., Paul, C., Puig, L., Boehncke, W. H., Freeman, M., Torii, H., Papp, K., Griffiths, C. E. M., Blauvelt, A., Reich, K., Gooderham, M., Terui, T., Renda, L., Agada, N., Xu, W., Gallo, G., & Lebwohl, M. G. (2020). 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 THER, 10(1), 133-150. https://doi.org/10.1007/s13555-019-00340-3

Vancouver

Armstrong A, Paul C, Puig L, Boehncke WH, Freeman M, Torii H et al. 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 THER. 2020 Feb;10(1):133-150. https://doi.org/10.1007/s13555-019-00340-3

Bibtex

@article{d50bd6cbdcac42edac11e87e0385ae54,
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",
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.",
author = "April Armstrong and Carle Paul and Luis Puig and Boehncke, {Wolf Henning} and Michael Freeman and Hideshi Torii and Kim Papp and Griffiths, {Christopher E M} and Andrew Blauvelt and Kristian Reich and Melinda Gooderham and Tadashi Terui and Lisa Renda and Noah Agada and Wen Xu and Gaia Gallo and Lebwohl, {Mark G}",
year = "2020",
month = feb,
doi = "10.1007/s13555-019-00340-3",
language = "English",
volume = "10",
pages = "133--150",
journal = "DERMATOLOGY THER",
issn = "2193-8210",
publisher = "Springer",
number = "1",

}

RIS

TY - JOUR

T1 - 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

AU - Armstrong, April

AU - Paul, Carle

AU - Puig, Luis

AU - Boehncke, Wolf Henning

AU - Freeman, Michael

AU - Torii, Hideshi

AU - Papp, Kim

AU - Griffiths, Christopher E M

AU - Blauvelt, Andrew

AU - Reich, Kristian

AU - Gooderham, Melinda

AU - Terui, Tadashi

AU - Renda, Lisa

AU - Agada, Noah

AU - Xu, Wen

AU - Gallo, Gaia

AU - Lebwohl, Mark G

PY - 2020/2

Y1 - 2020/2

N2 - 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.

AB - 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.

U2 - 10.1007/s13555-019-00340-3

DO - 10.1007/s13555-019-00340-3

M3 - SCORING: Journal article

C2 - 31749092

VL - 10

SP - 133

EP - 150

JO - DERMATOLOGY THER

JF - DERMATOLOGY THER

SN - 2193-8210

IS - 1

ER -