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A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy

OBJECTIVES: To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS: This is a phase III, randomised, double-blind, parallel-group, multicent...

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Autores principales: Emery, Paul, Vencovský, Jiří, Sylwestrzak, Anna, Leszczyński, Piotr, Porawska, Wieslawa, Baranauskaite, Asta, Tseluyko, Vira, Zhdan, Vyacheslav M, Stasiuk, Barbara, Milasiene, Roma, Barrera Rodriguez, Aaron Alejandro, Cheong, Soo Yeon, Ghil, Jeehoon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5264222/
https://www.ncbi.nlm.nih.gov/pubmed/26150601
http://dx.doi.org/10.1136/annrheumdis-2015-207588
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author Emery, Paul
Vencovský, Jiří
Sylwestrzak, Anna
Leszczyński, Piotr
Porawska, Wieslawa
Baranauskaite, Asta
Tseluyko, Vira
Zhdan, Vyacheslav M
Stasiuk, Barbara
Milasiene, Roma
Barrera Rodriguez, Aaron Alejandro
Cheong, Soo Yeon
Ghil, Jeehoon
author_facet Emery, Paul
Vencovský, Jiří
Sylwestrzak, Anna
Leszczyński, Piotr
Porawska, Wieslawa
Baranauskaite, Asta
Tseluyko, Vira
Zhdan, Vyacheslav M
Stasiuk, Barbara
Milasiene, Roma
Barrera Rodriguez, Aaron Alejandro
Cheong, Soo Yeon
Ghil, Jeehoon
author_sort Emery, Paul
collection PubMed
description OBJECTIVES: To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS: This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured. RESULTS: 596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was −9.41% to 4.98%, which is completely contained within the predefined equivalence margin of −15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%). CONCLUSIONS: SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN. TRIAL REGISTRATION NUMBERS: NCT01895309, EudraCT 2012-005026-30.
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spelling pubmed-52642222017-02-06 A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy Emery, Paul Vencovský, Jiří Sylwestrzak, Anna Leszczyński, Piotr Porawska, Wieslawa Baranauskaite, Asta Tseluyko, Vira Zhdan, Vyacheslav M Stasiuk, Barbara Milasiene, Roma Barrera Rodriguez, Aaron Alejandro Cheong, Soo Yeon Ghil, Jeehoon Ann Rheum Dis Clinical and Epidemiological Research OBJECTIVES: To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS: This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured. RESULTS: 596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was −9.41% to 4.98%, which is completely contained within the predefined equivalence margin of −15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%). CONCLUSIONS: SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN. TRIAL REGISTRATION NUMBERS: NCT01895309, EudraCT 2012-005026-30. BMJ Publishing Group 2017-01 2015-07-06 /pmc/articles/PMC5264222/ /pubmed/26150601 http://dx.doi.org/10.1136/annrheumdis-2015-207588 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Clinical and Epidemiological Research
Emery, Paul
Vencovský, Jiří
Sylwestrzak, Anna
Leszczyński, Piotr
Porawska, Wieslawa
Baranauskaite, Asta
Tseluyko, Vira
Zhdan, Vyacheslav M
Stasiuk, Barbara
Milasiene, Roma
Barrera Rodriguez, Aaron Alejandro
Cheong, Soo Yeon
Ghil, Jeehoon
A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
title A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
title_full A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
title_fullStr A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
title_full_unstemmed A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
title_short A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
title_sort phase iii randomised, double-blind, parallel-group study comparing sb4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
topic Clinical and Epidemiological Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5264222/
https://www.ncbi.nlm.nih.gov/pubmed/26150601
http://dx.doi.org/10.1136/annrheumdis-2015-207588
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