Ortonne 2013.

Study characteristics
Methods	RCT, active‐controlled, open‐label study Date of study: 21 September 2007 ‐ August 2009 Setting: 17 centres in Austria, France, Greece and Italy
Participants	Randomised: 72 participants randomised, 69 analysed (mean age 46 years, 50 male) Inclusion criteria Participants with moderate‐severe psoriasis PASI ≥ 10, PGA moderate or severe, BSA > 10, DLQI > 10 Age 18 ‐ 70 years Overall NAPSI > 14 Exclusion criteria TB infection; recent serious infection within 1 month of etanercept administration or active infection at screening; or known history of HIV infection Prior exposure to any biologic treatment was prohibited Dropouts and withdrawals 12/72 (17%), BIW/QW group (7), QW/QW group (5) AEs: BIW/QW group (2), QW/QW group (1) Participants' request or withdrawal request: BIW/QW group (1), QW/QW group (4) Death: BIW/QW group (1) Other: BIW/QW group (3)
Interventions	Intervention A. Etanercept twice‐a‐week/once‐a‐week group (n = 38), 50 mg SC twice a week for 12 weeks then 50 mg once a week to week 24 Control intervention B. Etanercept once‐a‐week/once‐a‐week group (n = 34), 50 mg SC injections once a week for the full 24‐week treatment period
Outcomes	Assessments at 24 weeks Primary outcomes of the trial NAPSI Secondary outcomes of the trial NAPSI 50/75 PASI 50/75 PGA0/1 DLQI AEs
Notes	Funding source, quote (p 1080): "TWyeth Research, which was acquired by Pfizer in October 2009, sponsored this clinical trial and was responsible for the collection and analysis of data. Editorial ⁄medical writing assistance was funded by Pfizer Inc." Declarations of interest (p 1080):" J.P.O. has been an investigator or consultant for Schering‐Plough, Abbott, Merck‐Serono, Centocor, Pfizer, Janssen‐Cilag, Meda‐Pharma, Pierre‐Fabre, Galderma and Leo‐Pharma. C.P. has been an investigator or consultant for Abbott, Amgen, Celgene, Janssen Cilag, Leo Pharma, Novartis and Pfizer Inc. E.B. has no conflicts of interest. V.M., G.G., Y.B. and J.M.G. are employees of Pfizer Inc."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 1081): “Patients were randomised by the investigator or other authorized person using an automatic online enrolment system in a 1:1 ratio” Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 1081): “Patients were randomised by the investigator or other authorized person using an automatic online enrolment system in a 1:1 ratio” Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote (p 1081): “This was a multicenter, multinational, randomised, open‐label study” Comment: not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote (p 1081): “This was a multicenter, multinational, randomised, open‐label study” Comment: not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	72 included/69 analysed Quote (p 1082): "All efficacy analyses were based on the modified intent‐to treat (mITT) population, which was defined as all patients who had received one or more doses of ETN and had baseline and post baseline data...The MMRM and GEE models have been developed for the analysis of longitudinal categorical data and to handle missing data without any imputation; this kind of model is preferred to the last‐observation carried forward approach for analysis of longitudinal data" Comment: probably done
Selective reporting (reporting bias)	Low risk	Comment: The protocol for the study was available on ClinicalTrials.gov (NCT00581100) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported