The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis

• DOI: 10.1111/bjd.15152
• Publication Date: 2017-01-20T12:01:27Z
• Authors: C.E.M. Griffiths; D. Thaçi; S. Gerdes; P. Arenberger; G. Pulka; K. Kingo; J. Weglowska; ; N. Hattebuhr; J. Poetzl; H. Woehling; G. Wuerth; M. Afonso
• Keywords: Biosimilar

Summary Background GP2015 is a proposed etanercept biosimilar. Objectives To demonstrate equivalent efficacy, and comparable safety immunogenicity of the originator (ETN, Enbrel®) in patients with moderate-to-severe chronic plaque-type psoriasis. Methods In total, 531 eligible were randomized 1 : to self-administer or ETN twice weekly subcutaneously. Patients ≥ 50% improvement Psoriasis Area Severity Index (PASI 50) at week 12 rerandomized continue same treatment on once-weekly dosing schedule undergo sequence three switches between until 30. Thereafter, continued product they had been assigned last, up 52. Results The difference PASI 75 (75% from baseline score) response rates (primary end point) was −2·3%. 95% confidence interval (−9·85 5·30) well contained within prespecified margin range −18 18. incidence treatment-emergent adverse events 52 (59·8%) (57·3%); switching treatments revealed profiles. Antidrug antibodies, all non-neutralizing, limited five during period 1, one patient switched group, who treated for weeks time finding. Conclusions EGALITY study demonstrated efficacy ETN. results provide final clinical confirmation biosimilarity contribute totality evidence proposing that an