Výsledky vyhledávání - "Wieskawa Porawska"

A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy

Autor: Jung-Yoon Choe, Asta Baranauskaite, Josef S Smolen, Eva Dokoupilova, Nenad Prodanovic, Hana Ciferska, Young Hee Rho, Wieskawa Porawska, Roman Yatsyshyn, Mevludin Mekic, Krystyna Jedrychowicz-Rosiak, J. Choi, Agnieszka Zielińska, Ivan Staykov, Jaroslaw Niebrzydowski

Publikováno v: Annals of the Rheumatic Diseases

ObjectivesTo compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of SB2 to the infliximab reference product (INF) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy.MethodsThis is a phase III

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::de1b2b7ea34ef6f1c827b5d430704cb8
http://europepmc.org/articles/PMC5264229

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Autor: Roman Yatsyshyn, Eva Dokoupilova, Young Hee Rho, Jung-Yoon Choe, J. Choi, Asta Baranauskaite, Nenad Prodanovic, Krystyna Jedrychowicz-Rosiak, Jaroslaw Niebrzydowski, Ivan Staykov, Wieskawa Porawska, Mevludin Mekic, Hana Ciferska, Agnieszka Zielińska, Josef S Smolen

Publikováno v: Rheumatology (Oxford, England)

Objectives SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including str

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::08aa3f25a3ed2d83d5d80de98f49d25a
https://pubmed.ncbi.nlm.nih.gov/28957563

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FRI0162 Comparable Safety and Immunogenicity and Sustained Efficacy after Transition To SB2 (An Infliximab Biosimilar) vs Ongoing Infliximab Reference Product in Patients with Rheumatoid Arthritis: Results of Phase III Transition Study

Autor: J.-Y. Choe, Eva Dokoupilova, Agnieszka Zielińska, Josef S Smolen, J. Choi, Young Hee Rho, Wieskawa Porawska, Ivan Staykov, Roman Yatsyshyn, Nenad Prodanovic, A. Baranauskaite, Mevludin Mekic, Krystyna Jedrychowicz-Rosiak, Hana Ciferska, Jaroslaw Niebrzydowski

Publikováno v: Annals of the Rheumatic Diseases. 75:488.1-488

Background SB2 is developed as a biosimilar of the infliximab reference product (INF). The 30-week and 54-week results of Phase III study have been reported1,2. Objectives To evaluate the safety, immunogenicity, and efficacy in patients with RA who t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::1fa01ea6d5be3bdfce6f32f0680cd0cf
https://doi.org/10.1136/annrheumdis-2016-eular.3122

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