EGALITY 2017.

Study characteristics
Methods	Randomised, active‐controlled, double‐blind phase 3 trial date: 24 June 2013 to 30 March 2015 Location: 74 centres in 11 European countries and South Africa
Participants	Total sample size: 531 Inclusion criteria Men or women at least 18 years of age at time of screening Chronic plaque‐type psoriasis diagnosed for at least 6 months before baseline Moderate‐to‐severe psoriasis as defined at baseline by: PASI score of 10 or greater and, Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 ‐ 4) and, BSA affected by plaque‐type psoriasis of 10% or greater Chronic plaque‐type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator Exclusion Criteria Forms of psoriasis other than chronic plaque‐type Drug‐induced psoriasis Ongoing use of prohibited treatments Previous exposure to etanercept Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept Dropouts and withdrawals 20/531 (3.8%); GP2015 group (8), etanercept group (12) Protocol deviation: GP2015 group (1), etanercept group (1) Participant's decision: GP2015 group (2), etanercept group (5) AEs: GP2015 group (4), etanercept group (3) Lost to follow‐up: GP2015 group (1), etanercept group (0) Death: GP2015 group (0), etanercept group (1) Others: GP2015 group (0), etanercept group (2)
Interventions	Intervention A. GP2015, n = 264 Control intervention B. Etanercept ((Enbrel; Amgen Inc., Thousand Oaks, CA, USA; European Union authorised), n = 267 50 mg subcutaneous injection until week 12
Outcomes	Assessment at week 12 Primary outcome proportion of participants who achieved PASI 75 Secondary outcomes PASI 50, 75, 90 and 100 response rates IGA of disease activity Safety Tolerability and immunogenicity
Notes	Funding source: Quote (p 928): "The study was funded by Hexal AG, a Sandoz company. The funder had a role in the study design, data collection, data analysis and manuscript preparation." Conflict of interest Quote (appendix): "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 Pharma. Professor Thaci 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, Mitsubishi Pharma, Novartis, Pfizer, Roche and Sandoz and honoraria from AbbVie, Biogen‐Idec, Celgene, Janssen, Leo, Mundipharma, Novartis, Pfizer and Roche‐Possay. Professor Thaci has acted as a consultant for Abbvie, Biogen‐Idec, Celgene, Dignity, Galapagos, Maruho, Mitsubishi, Novartis, Pfizer and Xenoport and been part of scientific advisory boards for AbbVie, Amgen, Biogen‐Idec, Celgene, Eli‐Lilly, GlaxoSmithKline, Janssen, Leo‐Pharma, Mundipharma, Novartis, Pfizer and Sandoz. Professor Griffiths has received consultancy/honoraria and/or research funding from Abbvie, Galderma, Janssen, LEO‐Pharma, Lilly, MSD, Novartis, Pfizer, Regeneron, Roche, Sandoz, Sun Pharmaceuticals and UCB Pharma. Professor Arenberger has received grants from Novartis. J Poetzl and H Woehling are employees of Hexal AG. G Wuerth and M Afonso were employees of Hexal AG at the time of the study.3
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 929‐Supplemental Appendix): "EGALITY was a multicentre, randomized, double‐blind, confirmatory efficacy and safety study conducted..In treatment period 1, patients were randomized 1 : 1 to self‐administer50 mg GP2015 or 50 mg ETN."; " During treatment period 1, patients were randomised via the Interactive Response Technology (IRT) that assigned a unique patient identification number in the IRT system with the treatment arm to which the patient had been assigned. Randomisation was stratified by body weight (<90 kg; ≥90 kg) and prior therapy (no prior systemic therapy, any prior systemic therapy including biologic immunomodulating agents, or prior treatment with a tumour necrosis factor [TNF antagonist])." Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 929‐Supplemental Appendix): "EGALITY was a multicentre, randomized, double‐blind, confirmatory efficacy and safety study conducted..In treatment period 1, patients were randomized 1 : 1 to self‐administer50 mg GP2015 or 50 mg ETN."; " During treatment period 1, patients were randomised via the Interactive Response Technology (IRT) that assigned a unique patient identification number in the IRT system with the treatment arm to which the patient had been assigned. Randomisation was stratified by body weight (<90 kg; ≥90 kg) and prior therapy (no prior systemic therapy, any prior systemic therapy including biologic immunomodulating agents, or prior treatment with a tumour necrosis factor [TNF antagonist])" Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p 929): "EGALITY was a multicentre, randomized, double‐blind, confirmatory efficacy and safety study conducted..In treatment period 1, patients were randomized 1 : 1 to self‐administer50 mg GP2015 or 50 mg ETN." Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 929): "EGALITY was a multicentre, randomized, double‐blind, confirmatory efficacy and safety study conducted..In treatment period 1, patients were randomized 1 : 1 to self‐administer50 mg GP2015 or 50 mg ETN." Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 531 Management of missing data: Quote (Supplemental appendix): "The FAS during treatment period 1 included all randomised patients to whom the study treatment was assigned. For the primary endpoint analysis based on the FAS missing values with respect to the PASI response at week 12 were included as non‐responders regardless of the reason for missing data." Equivalence trial: Quote (p 931): "The primary efficacy analysis was based on the per protocol set (PPS), which consisted of all patients who completed the study until week 12 without major protocol deviations...The analysis was repeated on the full analysis set (FAS) following the intent‐to‐treat principle as a sensitivity analysis." Table 1: Both per protocol and full‐set analyses Comment: done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT01891864) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported. Results posted on ClinicalTrials.gov