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 W (Keck School of Medicine of the University of Southern California. Department of Clinical Research)
Paul, Carle (Paul Sabatier University. Dermatology Department, Toulouse University Hospital (CHU))
Puig Sanz, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Boehncke, Wolf-Henning (University of Geneva. Department of Pathology and Immunology)
Freeman, Michael (The Skin Centre, Benowa, QLD Australia)
Torii, Hideshi (Tokyo Yamate Medical Center. Division of Dermatology)
Papp, Kim (K Papp Clinical Research and Probity Medical Research)
Griffiths, Christopher E. M. (NIHR Manchester Biomedical Research Centre. Dermatology Centre, Salford Royal Hospital, University of Manchester)
Blauvelt, Andrew (Oregon Medical Research Center)
Reich, Kristian (Skinflammation® Center, Hamburg, Germany)
Gooderham, Melinda (Centre for Dermatology and Probity Medical Research, Peterborough, ON Canada)
Terui, Tadashi (Nihon University School of Medicine. Department of Dermatology)
Renda, Lisa (Eli Lilly and Company)
Agada, Noah (Eli Lilly and Company)
Xu, Wen (Eli Lilly and Company)
Gallo, Gaia (Eli Lilly and Company)
Lebwohl, Mark G. (Icahn School of Medicine at Mount Sinai. Department of Dermatology)
Universitat Autònoma de Barcelona

Data:	2019
Resum:	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.
Nota:	Altres ajuts: The studies described herein and the Rapid Service Fee were funded by Eli Lilly and Company.
Drets:	Aquest 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.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Adverse events ; Etanercept ; IL-17 ; Integrated analysis ; Ixekizumab ; Safety ; Psoriasis
Publicat a:	Dermatology and Therapy, Vol. 10 (november 2019) , p. 133-150, ISSN 2190-9172

DOI: 10.1007/s13555-019-00340-3
PMID: 31749092

18 p, 504.6 KB

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