Будь ласка, використовуйте цей ідентифікатор, щоб цитувати або посилатися на цей матеріал: http://elib.umsa.edu.ua/jspui/handle/umsa/8683
Назва: A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
Автори: Emery, P.
Vencovský, J.
Sylwestrzak, A.
Leszczyński, P.
Porawska, W.
Baranauskaite, A.
Tseluyko, V.
Zhdan, V. M.
Stasiuk, B.
Milasiene, R
Barrera Rodriguez, A. A.
Cheong, S. Y.
Ghil, J.
Ключові слова: Anti-TNF
DMARDs (biologic)
Rheumatoid Arthritis
Дата публікації: 6-лип-2015
Видавець: National Center for Biotechnology Information
Бібліографічний опис: A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy [Electronic resource] / P. Emery, J. Vencovský, A. Sylwestrzak, P. Leszczyński, W. Porawska, A. Baranauskaite,V.Tseluyko, V. M. Zhdan, B. Stasiuk, R. Milasiene, A. Al. Barrera Rodriguez, S. Y. Cheong, J. Ghil // Clinical and epidemiological research. – 2015. – July 6. – P. 1–8. doi: 10.1136/annrheumdis-2015-207588. – Available from: https://www.ncbi.nlm.nih.gov/pubmed/26150601
Серія/номер: NCT01895309, EudraCT 2012-005026-30;
Короткий огляд (реферат): 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.
URI (Уніфікований ідентифікатор ресурсу): http://elib.umsa.edu.ua/jspui/handle/umsa/8683
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