Cargando…

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

OBJECTIVES: Efficacy, 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 arthritis (RA) who switched from INF to SB2 with those i...

Descripción completa

Detalles Bibliográficos
Autores principales:	Smolen, Josef S, Choe, Jung-Yoon, Prodanovic, Nenad, Niebrzydowski, Jaroslaw, Staykov, Ivan, Dokoupilova, Eva, Baranauskaite, Asta, Yatsyshyn, Roman, Mekic, Mevludin, Porawska, Wieslawa, Ciferska, Hana, Jedrychowicz-Rosiak, Krystyna, Zielinska, Agnieszka, Lee, Younju, Rho, Young Hee
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2018
Materias:	Clinical and Epidemiological Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5867419/ https://www.ncbi.nlm.nih.gov/pubmed/29042358 http://dx.doi.org/10.1136/annrheumdis-2017-211741

Ejemplares similares

Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results
por: Smolen, Josef S., et al.
Publicado: (2017)

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
por: Choe, Jung-Yoon, et al.
Publicado: (2017)

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: Fifty‐Two–Week Phase III Randomized Study Results
por: Weinblatt, Michael E., et al.
Publicado: (2018)

Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate‐to‐Severe Rheumatoid Arthritis
por: Weinblatt, Michael E., et al.
Publicado: (2017)

Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars
por: Ebbers, Hans C., et al.
Publicado: (2020)

Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab)
por: Hong, Juyong, et al.
Publicado: (2016)

Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study
por: Fautrel, Bruno, et al.
Publicado: (2023)

Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4
por: Emery, Paul, et al.
Publicado: (2017)

A Cost-Utility Analysis of Switching from Reference to Biosimilar Infliximab Compared to Maintaining Reference Infliximab in Adult Patients with Crohn’s Disease
por: Hughes, Avery, et al.
Publicado: (2020)

PERFUSE: Non-Interventional Cohort Study of Patients Receiving Infliximab Biosimilar SB2: Results in Pediatric Patients
por: Martinez-Vinson, Christine, et al.
Publicado: (2022)

Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study
por: Yoo, Dae Hyun, et al.
Publicado: (2017)

A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade(®)) in Healthy Subjects
por: Shin, Donghoon, et al.
Publicado: (2015)

52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis
por: Emery, Paul, et al.
Publicado: (2017)

Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab
por: Feagan, Brian G., et al.
Publicado: (2018)

Evaluation of the physicochemical and biological stability of reconstituted and diluted SB2 (infliximab)
por: Kim, Jihyun, et al.
Publicado: (2018)

Switching from Infliximab Originator to SB2 Biosimilar in Inflammatory Bowel Diseases: A Multicentric Prospective Real-Life Study
por: Massimi, Davide, et al.
Publicado: (2021)

Infusion reaction to infliximab biosimilar after transitioning from infliximab
por: Kashlan, Reem, et al.
Publicado: (2020)

Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product
por: Saleem, Ramsey, et al.
Publicado: (2020)

Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximab
por: Fischer, Sarah, et al.
Publicado: (2021)

Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult Patients with Immune-Mediated Inflammatory Diseases: A Post-Marketing Surveillance in Korea
por: Kim, Dong W., et al.
Publicado: (2023)

Infliximab and biosimilar infliximab in psoriasis: efficacy, loss of efficacy, and adverse events
por: Subedi, Smriti, et al.
Publicado: (2019)

A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
por: Emery, Paul, et al.
Publicado: (2017)

Biosimilar infliximab use in paediatric IBD
por: Richmond, Lisa, et al.
Publicado: (2018)

Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects
por: Shin, Donghoon, et al.
Publicado: (2018)

A comparative study of PF‐06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderate to severe active rheumatoid arthritis: A subgroup analysis
por: Kameda, Hideto, et al.
Publicado: (2020)

PERFUSE: a French non-interventional study of patients with inflammatory bowel disease receiving infliximab biosimilar SB2: a 12-month analysis
por: Bouhnik, Yoram, et al.
Publicado: (2023)

Switching and Discontinuation Patterns Among Patients Stable on Originator Infliximab Who Switched to an Infliximab Biosimilar or Remained on Originator Infliximab
por: Fitzgerald, Timothy, et al.
Publicado: (2021)

SB8: A Bevacizumab Biosimilar
por: Syed, Yahiya Y.
Publicado: (2020)

Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis
por: Peng, Kuan, et al.
Publicado: (2023)

PF-06438179/GP1111: An Infliximab Biosimilar
por: Al-Salama, Zaina T.
Publicado: (2018)

Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product
por: Abdalla, Abuelmagd, et al.
Publicado: (2017)

Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis
por: Genovese, Mark C., et al.
Publicado: (2020)

Efficacy of Infliximab Biosimilar for Maintenance Therapy in Pediatric Inflammatory Bowel Disease Following Infliximab Originator
por: Hinshaw, Amie, et al.
Publicado: (2022)

Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment
por: Lee, Jae Hee, et al.
Publicado: (2019)

PB2051: POPULATION PHARMACOKINETIC/PHARMACODYNAMIC/EFFICACY MODELING OF SB12 (PROPOSED ECULIZUMAB BIOSIMILAR) AND REFERENCE ECULIZUMAB
por: Lee, Hyuna, et al.
Publicado: (2023)

Correction to: SB8: A Bevacizumab Biosimilar
por: Syed, Yahiya Y.
Publicado: (2020)

FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension
por: Genovese, Mark C., et al.
Publicado: (2019)

A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy
por: Cohen, Stanley B., et al.
Publicado: (2018)

Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54
por: Alten, Rieke, et al.
Publicado: (2019)

Correction to: PF-06438179/GP1111: An Infliximab Biosimilar
por: Al-Salama, Zaina T.
Publicado: (2018)

Cannot write session to /tmp/vufind_sessions/sess_2ahbhmn938kmetc9ksghe8f2v7