FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2898893516> ?p ?o ?g. }

• W2898893516 abstract "Background Non-inferiority of BCD-055 in direct comparison to infliximab originator after 30 weeks of treatment in patients with ankylosing spondylitis (AS) was shown previously1. Here we present 54 week safety and efficacy data in ITT population from international double-blind randomised ASART-2 clinical trial. Objectives To compare BCD-055, proposed infliximab biosimilar and infliximab originator in terms of efficacy and safety in patients with AS. Methods Adult patients (n=199) aged 18–65 years, with active AS (BASDAI>4) received 5 mg/kg of BCD-055 (n=132) or infliximab (n=67) IV on w0, w2 and w6 and then every 8 w until w54. The results of the primary endpoint assessment (ASAS20 at w30) were presented earlier1. Secondary endpoints were proportion of patients, achieved ASAS20/40, and mean change from baseline in BASDAI, BASMI, BASFI, MASES, SF36 scores, chest excursion and TJC44 at w54. Rate of AEs and proportion of patient with ADA to infliximab in both groups were also evaluated. Results The proportions of patients achieved ASAS20/ASAS40 were similar in both study groups at w54 (Abstract SAT0267 – figure 1). Improvement in AS symptoms showed similar dynamics in both groups: significant decrease in AS activity (BASDAI) and improvement in other secondary endpoints has developed within the first 14 weeks of treatment in both study groups and remained at achieved level until w54. The magnitude of changes of all evaluated parameters did not differ between groups. No statistically significant differences in rates of AEs were found between study groups (table 1). Most common reported AEs were infections, hematologic and vascular disorders, hypersensitivity reactions. Formation of ADA to infliximab was detected with similar frequency in both groups. Conclusions The 54 week results supports previously confirmed similar efficacy and safety of BCD-055, proposed infliximab biosimilar, and infliximab originator in patients with active AS. At all evaluated time points the efficacy as well as rate of AEs/SAEs did not differ between BCD-055 and infliximab originator groups. Reference [1] Denisov L, Gordeev I, Mazurov V, et al. FRI0208 Comparison of efficacy, safety and pharmacokinetics of infliximab biosimilar (BCD-055) and innovator infliximabAnn Rheum Dis2017;76:560–561. Disclosure of Interest L. Denisov: None declared, P. Shesternya: None declared, T. Plaksina: None declared, T. Kropotina: None declared, N. Soroka: None declared, E. Kunder: None declared, A. Lutskii Employee of: JSC BIOCAD, A. Eremeeva Employee of: JSC BIOCAD, E. Dokukina Employee of: JSC BIOCAD, E. Chernyaeva Employee of: JSC BIOCAD, R. Ivanov Employee of: JSC BIOCAD, V. Mazurov: None declared" @default.
• W2898893516 created "2018-11-09" @default.
• W2898893516 creator A5002259667 @default.
• W2898893516 creator A5008384446 @default.
• W2898893516 creator A5016536735 @default.
• W2898893516 creator A5036914604 @default.
• W2898893516 creator A5038473161 @default.
• W2898893516 creator A5045484635 @default.
• W2898893516 creator A5053267888 @default.
• W2898893516 creator A5056377971 @default.
• W2898893516 creator A5072419462 @default.
• W2898893516 creator A5075361314 @default.
• W2898893516 creator A5084314819 @default.
• W2898893516 creator A5059123564 @default.
• W2898893516 date "2018-06-01" @default.
• W2898893516 modified "2023-09-23" @default.
• W2898893516 title "SAT0267 Efficacy and safety of bcd-055, proposed infliximab biosimilar, compared to infliximab: 54-week results from asart-2 phase 3 clinical study" @default.
• W2898893516 doi "https://doi.org/10.1136/annrheumdis-2018-eular.2390" @default.
• W2898893516 hasPublicationYear "2018" @default.
• W2898893516 type Work @default.
• W2898893516 sameAs 2898893516 @default.
• W2898893516 citedByCount "1" @default.
• W2898893516 countsByYear W28988935162019 @default.
• W2898893516 crossrefType "proceedings-article" @default.
• W2898893516 hasAuthorship W2898893516A5002259667 @default.
• W2898893516 hasAuthorship W2898893516A5008384446 @default.
• W2898893516 hasAuthorship W2898893516A5016536735 @default.
• W2898893516 hasAuthorship W2898893516A5036914604 @default.
• W2898893516 hasAuthorship W2898893516A5038473161 @default.
• W2898893516 hasAuthorship W2898893516A5045484635 @default.
• W2898893516 hasAuthorship W2898893516A5053267888 @default.
• W2898893516 hasAuthorship W2898893516A5056377971 @default.
• W2898893516 hasAuthorship W2898893516A5059123564 @default.
• W2898893516 hasAuthorship W2898893516A5072419462 @default.
• W2898893516 hasAuthorship W2898893516A5075361314 @default.
• W2898893516 hasAuthorship W2898893516A5084314819 @default.
• W2898893516 hasBestOaLocation W28988935161 @default.
• W2898893516 hasConcept C126322002 @default.
• W2898893516 hasConcept C141071460 @default.
• W2898893516 hasConcept C17991360 @default.
• W2898893516 hasConcept C203092338 @default.
• W2898893516 hasConcept C2776260265 @default.
• W2898893516 hasConcept C2777138892 @default.
• W2898893516 hasConcept C2777402515 @default.
• W2898893516 hasConcept C2777453003 @default.
• W2898893516 hasConcept C2777575956 @default.
• W2898893516 hasConcept C535046627 @default.
• W2898893516 hasConcept C59491497 @default.
• W2898893516 hasConcept C71924100 @default.
• W2898893516 hasConceptScore W2898893516C126322002 @default.
• W2898893516 hasConceptScore W2898893516C141071460 @default.
• W2898893516 hasConceptScore W2898893516C17991360 @default.
• W2898893516 hasConceptScore W2898893516C203092338 @default.
• W2898893516 hasConceptScore W2898893516C2776260265 @default.
• W2898893516 hasConceptScore W2898893516C2777138892 @default.
• W2898893516 hasConceptScore W2898893516C2777402515 @default.
• W2898893516 hasConceptScore W2898893516C2777453003 @default.
• W2898893516 hasConceptScore W2898893516C2777575956 @default.
• W2898893516 hasConceptScore W2898893516C535046627 @default.
• W2898893516 hasConceptScore W2898893516C59491497 @default.
• W2898893516 hasConceptScore W2898893516C71924100 @default.
• W2898893516 hasLocation W28988935161 @default.
• W2898893516 hasOpenAccess W2898893516 @default.
• W2898893516 hasPrimaryLocation W28988935161 @default.
• W2898893516 isParatext "false" @default.
• W2898893516 isRetracted "false" @default.
• W2898893516 magId "2898893516" @default.
• W2898893516 workType "article" @default.