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
Por:
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
Publicada:
1 feb 2020
Resumen:
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.
Filiaciones:
Armstrong, A:
Univ Southern Calif, Keck Sch Med, Dept Clin Res, Los Angeles, CA 90033 USA
Paul, C:
Paul Sabatier Univ, Dermatol Dept, Toulouse Univ Hosp CHU, Toulouse, France
Puig, L:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Barcelona, Spain
Boehncke, WH:
Geneva Univ Hosp, Div Dermatol & Venereol, Geneva, Switzerland
Univ Geneva, Dept Pathol & Immunol, Geneva, Switzerland
Freeman, M:
Skin Ctr, Benowa, Qld, Australia
Torii, H:
Tokyo Yamate Med Ctr, Div Dermatol, Tokyo, Japan
Papp, K:
K Papp Clin Res, Waterloo, ON, Canada
Prob Med Res, Waterloo, ON, Canada
Griffiths, CEM:
Univ Manchester, NIHR Manchester Biomed Res Ctr, Salford Royal Hosp, Dermatol Ctr, Manchester, Lancs, England
Blauvelt, A:
Oregon Med Res Ctr, Portland, OR USA
Reich, K:
Univ Med Ctr Hamburg Eppendorf, Ctr Translat Res Inflammatory Skin Dis, Inst Hlth Serv Res Dermatol & Nursing, Hamburg, Germany
Skinflammat Ctr, Hamburg, Germany
Gooderham, M:
Prob Med Res, Waterloo, ON, Canada
Ctr Dermatol, Peterborough, ON, Canada
Terui, T:
Nihon Univ, Dept Dermatol, Sch Med, Tokyo, Japan
Renda, L:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Agada, N:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Xu, W:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Gallo, G:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Lebwohl, MG:
Icahn Sch Med Mt Sinai, Dept Dermatol, New York, NY 10029 USA
Gold, Green Published
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