Multiple switches between GP2015, an etanercept
biosimilar, with originator product do not impact efﬁcacy,
safety and immunogenicity in patients with chronic
plaque-type psoriasis: 30-week results from the phase 3,
conﬁrmatory EGALITY study
* D. Thac
Psoriasis-Center at the Department of Dermatology, Universitaetsklinikum Schleswig-Holstein, Kiel, Germany
Comprehensive Center for Inﬂammation Medicine, University Hospital Schleswig-Holstein, L
Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Centre, Manchester,
Department of Dermatology, Charles University, Third Medical Faculty and Faculty Hospital Kralovske Vinohrady, Prague 10, Czech
Global Clinical Development, Biopharmaceuticals, Hexal AG, Holzkirchen, Germany
*Correspondence: S. Gerdes. E-mail: email@example.com
Background EGALITY was a phase III conﬁrmatory efﬁcacy and safety study conducted in patients with plaque-type
psoriasis as a part of totality of evidence gathered during the development of GP2015, an etanercept biosimilar.
Objective To demonstrate equivalent efﬁcacy and comparable safety and immunogenicity of GP2015 and the etaner-
cept originator product (ETN, Enbrel
) and evaluate effects of repeated switching between GP2015 and ETN. Results for
efﬁcacy, safety and immunogenicity during treatment period (TP) 2 (TP2) are presented pooling the two continued treat-
ment arms (pooled continued) versus the two treatment arms with repeated switches (pooled switched).
Methods Patients (n = 531) were randomized 1:1 to self-administer GP2015 or ETN twice-weekly subcutaneously dur-
ing TP1. Patients with a ≥50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 12 were re-rando-
mized for TP2 to continue the same treatment at once-weekly dosing or to undergo three consecutive treatment
switches between GP2015 and ETN until week 30. Patients continued the last-assigned treatment during TP2, until week
Results Mean (standard deviation [SD]) PASI scores at baseline were similar in patients who underwent multiple
switches compared to those with continued treatments during TP2. During TP2, PASI 50, PASI 75 and PASI 90 response
rates, percent change from baseline in PASI scores and all other efﬁcacy parameters were similar between the pooled
switched and pooled continued treatment groups at all time points. The incidence of treatment-emergent adverse events
including injection site reactions was comparable between the pooled switched (36.7%) and pooled continued (34.9%)
groups. None of the patients in either treatment group were positive for binding anti-drug antibodies in TP2.
Conclusion Treatment efﬁcacy, safety and immunogenicity were similar between the pooled continued and pooled
switched treatments during TP2, indicating that there are no effects in the short term on clinical data of multiple switches
between GP2015 and ETN.
Received: 20 June 2017; Accepted: 20 September 2017
Conﬂicts of interest disclosures
Dr Gerdes has been an advisor and/or received speakers’ honoraria and/or received grants and/or participated in
clinical trials of the following companies: Abbott/AbbVie, Almirall-Hermal, Amgen, Bayer HealthCare, Biogen
Idec, Bioskin, Boehringer-Ingelheim, Celgene, Centocor, Dermira, Eli Lilly, Foamix, Forward Pharma, Galderma,
Hexal AG, Isotechnika, Janssen-Cilag, Leo Pharma, Medac, Merck Serono, Mitsubishi Tanabe, MSD, Novartis,
Pﬁzer, Sandoz Biopharmaceuticals, Schering-Plough, Takeda, Teva, UCB Pharma, VBL therapeutics and Wyeth
i has received research support from Abbvie, Almiral, Amgen, Astellas, Biogen-Idec, Boehringer-
Ingelheim, Celgene, Dignity, Elli-Lilly, Forward-Pharma, GlaxoSmithKline, Leo, Janssen-Cilag, Maruho, MSD,
© 2017 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd
on behalf of European Academy of Dermatology and Venereology.
2017, 32, 420–427
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and
distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modiﬁcations or adaptations are made.