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  • Secukinumab demonstrates a consistent safety profile with up to 5 years’ treatment in patients with psoriatic arthritis and moderate-to-severe plaque psoriasis: updated pooled safety analyses

    Author(s)
    McInnes, Iain B
    Mease, Philip J
    Reich, Kristian
    Nash, Peter
    Widmer, Albert
    Abrams, Ken
    Pricop, Luminita
    Fox, Todd
    Griffith University Author(s)
    Nash, Peter
    Year published
    2019
    Metadata
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    Abstract
    Background: Pooled safety data from secukinumab (SEC) studies in psoriasis and psoriatic arthritis (PsA) have been reported previously. Objectives: To report updated longer-term safety data with up to 5 years of SEC treatment from psoriasis and PsA studies. Methods: The moderate-to-severe plaque psoriasis and active PsA data pool consisted of 15 Phase 2 and 3 Phase 3 studies. Different SEC doses in the studies included intravenous (up to 10 mg/kg) or subcutaneous (s.c.; 75-300 mg) loading, followed by s.c. maintenance dosing (300, 150 or 75 mg). Placebo patients were rerandomised to SEC at 12-24 weeks depending on study ...
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    Background: Pooled safety data from secukinumab (SEC) studies in psoriasis and psoriatic arthritis (PsA) have been reported previously. Objectives: To report updated longer-term safety data with up to 5 years of SEC treatment from psoriasis and PsA studies. Methods: The moderate-to-severe plaque psoriasis and active PsA data pool consisted of 15 Phase 2 and 3 Phase 3 studies. Different SEC doses in the studies included intravenous (up to 10 mg/kg) or subcutaneous (s.c.; 75-300 mg) loading, followed by s.c. maintenance dosing (300, 150 or 75 mg). Placebo patients were rerandomised to SEC at 12-24 weeks depending on study design. Adverse events (AEs) were reported as exposure-adjusted incident rates (EAIR) per 100 patientyears and analyses included all patients who received ≥1 dose of SEC. Results: A total of 5,181 and 1,380 patients from psoriasis and PsA studies representing an exposure of 10,416.9 and 3,866.9 patient-years, respectively, were included in this study. The most frequently reported AE was viral upper respiratory tract infection (Table 1). EAIRs for serious infections, Candida infections, inflammatory bowel disease and major adverse cardiac events were low and similar in both psoriasis and PsA indications (Table 1). No cases of tuberculosis were reported. Conclusion: SEC demonstrated a favourable safety profile during long-term treatment (up to 5 years) in patients with moderate-to-severe plaque psoriasis or PsA, hence, supporting long-term use. The safety profile of SEC was consistent with previous reports and comparable across psoriasis and PsA patients.
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    Conference Title
    Rheumatology
    Volume
    58
    Issue
    Supplement_3
    DOI
    https://doi.org/10.1093/rheumatology/kez107.073
    Subject
    Clinical Sciences
    Immunology
    Public Health and Health Services
    Science & Technology
    Life Sciences & Biomedicine
    Rheumatology
    Publication URI
    http://hdl.handle.net/10072/401732
    Collection
    • Conference outputs

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