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Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4

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Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4

Annals of Rheumatic Diseases

Published online: December 2017

DOI: http://dx.doi.org/10.1136/annrheumdis-2017-211591

Paul Emery1, Jiří Vencovský, Anna Sylwestrzak, Piotr Leszczyński, Wieslawa Porawska, Barbara Stasiuk, Joanna Hilt, Zdenka Mosterova, Soo Yeon Cheong, Jeehoon Ghil

Objectives: SB4 (Benepali, Brenzys) is a biosimilar of reference etanercept (ETN). In a randomised, double-blind, 52-week study, SB4 demonstrated comparable efficacy and safety to ETN in patients with rheumatoid arthritis (RA). The open-label extension period evaluated long-term efficacy, safety and immunogenicity when continuing SB4 versus switching from ETN to SB4.

Methods: In the randomised, double-blind phase, patients received weekly subcutaneous administration of 50 mg SB4 or ETN with background methotrexate for up to 52 weeks. Patients in the Czech Republic and Poland who completed the 52-week visit were enrolled in the open-label extension period and received SB4 for 48 additional weeks. Efficacy, safety and immunogenicity were assessed up to week 100.

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