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The EGALITY study: a confirmatory, randomized, double‐blind study comparing the efficacy, safety and immunogenicity of GP 2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate‐to‐severe chronic plaque‐type psoriasis
Author(s) -
Griffiths C.E.M.,
Thaçi D.,
Gerdes S.,
Arenberger P.,
Pulka G.,
Kingo K.,
Weglowska J.,
Hattebuhr N.,
Poetzl J.,
Woehling H.,
Wuerth G.,
Afonso M.
Publication year - 2017
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.15152
Subject(s) - medicine , etanercept , biosimilar , psoriasis area and severity index , adverse effect , dosing , immunogenicity , randomized controlled trial , clinical endpoint , confidence interval , psoriasis , rheumatoid arthritis , antibody , immunology
Summary Background GP 2015 is a proposed etanercept biosimilar. Objectives To demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP 2015 and the etanercept originator ( ETN , Enbrel ® ) in patients with moderate‐to‐severe chronic plaque‐type psoriasis. Methods In total, 531 eligible patients were randomized 1 : 1 to self‐administer GP 2015 or ETN twice weekly subcutaneously. Patients with ≥ 50% improvement in Psoriasis Area and Severity Index ( PASI 50) at week 12 were rerandomized to continue the same treatment on a once‐weekly dosing schedule or to undergo a sequence of three treatment switches between GP 2015 and ETN until week 30. Thereafter, patients continued treatment with the product they had been assigned to last, up to week 52. Results The difference in PASI 75 (75% improvement from baseline PASI score) response rates at week 12 between GP 2015 and ETN (primary end point) was −2·3%. The 95% confidence interval (−9·85 to 5·30) was well contained within the prespecified margin range of −18 to 18. The incidence of treatment‐emergent adverse events up to week 52 was comparable between continued GP 2015 (59·8%) and ETN (57·3%); switching treatments revealed comparable safety profiles. Antidrug antibodies, all non‐neutralizing, were limited to five patients on ETN during treatment period 1, and one patient in the switched ETN group, who had been treated with GP 2015 for 12 weeks at the time of the finding. Conclusions The EGALITY study demonstrated equivalent efficacy and comparable safety and immunogenicity of GP 2015 and ETN . The study results provide the final clinical confirmation of biosimilarity and contribute to the totality of the evidence proposing that GP 2015 is an etanercept biosimilar.