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  • Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2

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    Author(s)
    Genovese, Mark C
    Combe, Benard
    Kremer, Joel M
    Tsai, Tsen-Fang
    Behrens, Frank
    Adams, David H
    Lee, Chin
    Kerr, Lisa
    Nash, Peter
    Griffith University Author(s)
    Nash, Peter
    Year published
    2018
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    Abstract
    Objectives. To assess the long-term safety and efficacy of ixekizumab, an IL-17A antagonist, in patients with active PsA. Methods. In SPIRIT-P2 (NCT02349295), patients (n = 363) with previous inadequate response to TNF inhibitors entered the double-blind period (weeks 0-24) and received placebo or ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) following a 160-mg starting dose at week 0. During the extension period (weeks 24-156), patients maintained their original ixekizumab dose, and placebo patients received IXEQ4W or IXEQ2W (1:1). We present the accumulated safety findings (week 24 up to 156) at the ...
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    Objectives. To assess the long-term safety and efficacy of ixekizumab, an IL-17A antagonist, in patients with active PsA. Methods. In SPIRIT-P2 (NCT02349295), patients (n = 363) with previous inadequate response to TNF inhibitors entered the double-blind period (weeks 0-24) and received placebo or ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) following a 160-mg starting dose at week 0. During the extension period (weeks 24-156), patients maintained their original ixekizumab dose, and placebo patients received IXEQ4W or IXEQ2W (1:1). We present the accumulated safety findings (week 24 up to 156) at the time of this analysis for patients who entered the extension period (n = 310). Exposure-adjusted incidence rates (IRs) per 100 patient years are presented. ACR responses are presented on an intent-to-treat basis using non-responder imputation up to week 52. Results. From week 24 up to 156 (with 228 patient years of ixekizumab exposure), 140 [61.3 IR] and 15 (6.6 IR) patients reported infections and serious adverse events, respectively. Serious adverse events included one death and four serious infections. In all patients initially treated with IXEQ4W and IXEQ2W at week 0 (non-responder imputation), ACR20 (61 and 51%), ACR50 (42 and 33%) and ACR70 (26 and 18%) responses persisted out to week 52. Placebo patients re-randomized to ixekizumab demonstrated efficacy as measured by ACR responses at week 52. Conclusion. During the extension period, the overall safety profile of ixekizumab remained consistent with that observed with the double-blind period, and clinical improvements persisted up to 1 year.
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    Journal Title
    Rheumatology
    Volume
    57
    Issue
    11
    DOI
    https://doi.org/10.1093/rheumatology/key182
    Copyright Statement
    © The Author(s) 2018. Published by Oxford University Press on behalf of the British Society for Rheumatology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
    Subject
    Clinical sciences
    Immunology
    Health services and systems
    Public health
    Science & Technology
    Life Sciences & Biomedicine
    Rheumatology
    ixekizumab
    interleukin-17A
    Publication URI
    http://hdl.handle.net/10072/399824
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    • Journal articles

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