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Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F18%3A43915625" target="_blank" >RIV/00216208:11120/18:43915625 - isvavai.cz</a>

  • Alternative codes found

    RIV/00064173:_____/18:N0000170

  • Result on the web

    <a href="https://doi.org/10.1111/jdv.14605" target="_blank" >https://doi.org/10.1111/jdv.14605</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1111/jdv.14605" target="_blank" >10.1111/jdv.14605</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study

  • Original language description

    EGALITY was a phase III confirmatory efficacy and safety study conducted in patients with plaque-type psoriasis as a part of totality of evidence gathered during the development of GP2015, an etanercept biosimilar. Objective: To demonstrate equivalent efficacy and comparable safety and immunogenicity of GP2015 and the etanercept originator product (ETN, Enbrel(R)), and evaluate effects of repeated switching between GP2015 and ETN. Results for efficacy, safety and immunogenicity during treatment period (TP) 2 (TP2) are presented pooling the two continued treatment arms (pooled continued) versus the two treatment arms with repeated switches (pooled switched). Conclusion: Treatment efficacy, safety and immunogenicity were similar between the pooled continued and pooled switched treatments during TP2, indicating that there are no effects in the short term on clinical data of multiple switches between GP2015 and ETN.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30216 - Dermatology and venereal diseases

Result continuities

  • Project

  • Continuities

    N - Vyzkumna aktivita podporovana z neverejnych zdroju

Others

  • Publication year

    2018

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Journal of the European Academy of Dermatology and Venereology

  • ISSN

    0926-9959

  • e-ISSN

  • Volume of the periodical

    32

  • Issue of the periodical within the volume

    3

  • Country of publishing house

    GB - UNITED KINGDOM

  • Number of pages

    8

  • Pages from-to

    420-427

  • UT code for WoS article

    000427481900039

  • EID of the result in the Scopus database

    2-s2.0-85032795243