Etanercept is a recombinant tumour necrosis factor α (TNF-α) soluble receptor fused to the Fc fragment of human immunoglobulin G1 and the first TNF-α inhibitor approved for the treatment of chronic plaque psoriasis in both adults and children.1-4 Etanercept biosimilar SB4 (Benepali® , Biogen, Cambridge, MA, U.S.A.) has been recently approved based on the results of stringent comparability exercises designed to demonstrate similarity to the originator in terms of quality, biological activity, efficacy and safety.5 In two clinical trials, etanercept SB4 was equivalent to the originator with regard to pharmacokinetic properties in healthy volunteers and in terms of efficacy in patients with rheumatoid arthritis, but SB4 has been associated with fewer injection site reactions and less immunogenicity.6 Real life data of etanercept biosimilar SB4 in patients with chronic plaque psoriasis (n=44) are only available only from the study of Egeberg A et al. who found that there were no significant differences in discontinuation risk between etanercept originator and biosimilar SB4.7 This article is protected by copyright. All rights reserved.
Etanercept biosimilar SB4 in the treatment of chronic plaque psoriasis: data from the Psobiosimilars registry
Calzavara-Pinton, P;Venturini, M;
2019-01-01
Abstract
Etanercept is a recombinant tumour necrosis factor α (TNF-α) soluble receptor fused to the Fc fragment of human immunoglobulin G1 and the first TNF-α inhibitor approved for the treatment of chronic plaque psoriasis in both adults and children.1-4 Etanercept biosimilar SB4 (Benepali® , Biogen, Cambridge, MA, U.S.A.) has been recently approved based on the results of stringent comparability exercises designed to demonstrate similarity to the originator in terms of quality, biological activity, efficacy and safety.5 In two clinical trials, etanercept SB4 was equivalent to the originator with regard to pharmacokinetic properties in healthy volunteers and in terms of efficacy in patients with rheumatoid arthritis, but SB4 has been associated with fewer injection site reactions and less immunogenicity.6 Real life data of etanercept biosimilar SB4 in patients with chronic plaque psoriasis (n=44) are only available only from the study of Egeberg A et al. who found that there were no significant differences in discontinuation risk between etanercept originator and biosimilar SB4.7 This article is protected by copyright. All rights reserved.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
