Výsledky vyhledávání - "Krystyna Jedrychowicz‐Rosiak"

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis

Autor: Margarita Pileckyte, Asta Baranauskaite, Eva Dokoupilova, Michael E. Weinblatt, Agnieszka Zielińska, Artur Racewicz, Krystyna Jedrychowicz-Rosiak, Jeehoon Ghil, Inyoung Baek, Janusz Jaworski

Publikováno v: Arthritis & Rheumatology. 70:832-840

Objective The 24-week equivalent efficacy and comparable safety results of the biosimilar SB5 and reference adalimumab (ADA) from the phase III randomized study in patients with moderate-to-severe rheumatoid arthritis (RA) have been reported previous

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b42d84a65e8749094a4cee9ee604336e
https://doi.org/10.1002/art.40444

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Phase III Randomized Study of SB 5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate‐to‐Severe Rheumatoid Arthritis

Autor: Michael E. Weinblatt, Asta Baranauskaite, Jaroslaw Niebrzydowski, Eva Dokoupilova, Agnieszka Zielinska, Janusz Jaworski, Artur Racewicz, Margarita Pileckyte, Krystyna Jedrychowicz‐Rosiak, Soo Yeon Cheong, Jeehoon Ghil, S. Sokolovic, M. Mekic, N. Prodanovic, B. Gajic, E. Karaselimovic‐Dzambasovic, B. Pojskic, A. Toncheva, P. Dimitar, L. Rodina, M. Geneva‐Popova, I. Staykov, R. Stoilov, L. Podrazilova, Z. Mosterova, G. Simkova, J. Kopackova, Z. Stejfova, J. Vencovsky, Z. Urbanova, L. Janska, D. Galatíkova, S. Stropuviene, I. Sniuoliene, K. Sitek‐Ziolkowska, M. Rell‐Bakalarska, R. Kolasa, S. Daniluk, B. Sliwowska, M. Bartosik‐Twardowska, J. Brzezicki, M. Konieczny, S. Jeka, J. Choe, S. Bae, Y. Kang, L. Prystupa, Z. Vyacheslav, I. Gasanov, R. Yatsyshyn, D. Rekalov, O. Iaremenko, M. Stanislavchuk, V. Tseluyko

Publikováno v: Arthritis & Rheumatology (Hoboken, N.j.)

Objective SB5 is a biosimilar agent for adalimumab (ADA). The aim of this study was to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of SB5 in comparison with reference ADA in patients with rheumatoid arthritis (RA). Method

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bd57157bedc7b756d3a592490108b340
https://doi.org/10.1002/art.40336

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Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study

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

Publikováno v: Annals of the Rheumatic Diseases

ObjectivesEfficacy, safety and immunogenicity results from the phase III study of SB2, a biosimilar of reference infliximab (INF), were previously reported through 54 weeks. This transition period compared results in patients with rheumatoid arthriti

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d9f1469df3aaa12666094e170df00843
https://doi.org/10.1136/annrheumdis-2017-211741

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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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The effects of the spleen tyrosine kinase inhibitor fostamatinib on ambulatory blood pressure in patients with active rheumatoid arthritis: results of the OSKIRA-ABPM (ambulatory blood pressure monitoring) randomized trial

Autor: Jeffrey L. Miller, George D. Kitas, Millie Wang, Roumen Nakov, Michael E. Weinblatt, Jiri Vencovsky, Seva Panfilov, Krystyna Jedrychowicz-Rosiak, Gabriel Abreu, William B. White

Publikováno v: Journal of the American Society of Hypertension : JASH. 8(11)

Clinical trials of fostamatinib in patients with rheumatoid arthritis showed blood pressure (BP) elevation using clinic measurements. The OSKIRA-ambulatory BP monitoring trial assessed the effect of fostamatinib on 24-hour ambulatory systolic BP (SBP

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::82bde04806e650d122bb18b1071cde48
https://pubmed.ncbi.nlm.nih.gov/25455003

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FRI0161 Sustained Efficacy and Comparable Safety and Immunogenicity after Transition To SB5 (An Adalimumab Biosimilar) vs Continuation of The Adalimumab Reference Product in Patients with Rheumatoid Arthritis: Result of Phase III Study

Autor: K. Sitek-Ziolkowska, A. Racewicz, Krystyna Jedrychowicz-Rosiak, Eva Dokoupilova, Asta Baranauskaite, Vyacheslav Zhdan, Jaroslaw Niebrzydowski, Jeehoon Ghil, Michael E. Weinblatt, Agnieszka Zielińska, Margarita Pileckyte, Janusz Jaworski, S.Y. Cheong

Publikováno v: Annals of the Rheumatic Diseases. 75:487.2-487

Background SB5 is a biologic agent developed as a biosimilar of the adalimumab reference product (ADL). The 24-week results of Phase III study results have been reported1. Objectives To evaluate the efficacy, safety, and immunogenicity in patients wi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::9caa50f6220d8f5322d42b8dcc8f4bda
https://doi.org/10.1136/annrheumdis-2016-eular.1762

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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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