Strohal PRISTINE, 2013

Methods	RCT, active‐controlled, double blind Date of study: April 2008‐March 2012 Location: 32 centres in Europe, Latin America and Asia
Participants	Randomised: 273 participants (mean age 44 years, 190 male) Inclusion criteria Participants with moderate‐severe psoriasis (PASI ≥ 10, BSA ≥ 10), age ≥ 18 years Non‐response to topical treatment Non‐response to phototherapy Non‐response to conventional systemic treatment Exclusion criteria Had received biologics Had an active infection Dropouts and withdrawals 25/273 (9%) Time and reasons: No efficacy evaluations (3) Etanercept once a week (10): AE (3), lack of efficacy (1), decision (5), other (1) Etanercept twice a week (12): AE (6), lack of efficacy (1), decision (2), deviation (1), other (2)
Interventions	Intervention A. Etanercept (n = 137), SC, 50 mg, once a week, 24 weeks Control intervention B. Etanercept (n = 136), SC, 50 mg, twice a week, 24 weeks
Outcomes	Assessments at 24 weeks Primary outcomes of the trial PASI 75 Secondary outcomes of the trial PASI 50, 75, 90 Mean PASI PGA (Physician Global Assessment) 0/1 DLQI AE
Notes	Funding source, quote (p 177): "The PRISTINE trial was sponsored by Pfizer Inc..." Declarations of interest (p 177‐178): "Robert Strohal has been a paid consultant of and has received research grants from Pfizer Inc, which provided funding for the PRISTINE study. He is also a member of the Pfizer European Expert Board and of the Pfizer Speakers Bureau. Luis Puig has been a paid consultant of and has received research grants from Pfizer; he has served on Pfizer advisory boards and the Speakers Bureau. Edgardo Chouela is a paid consultant and speaker for Pfizer Inc and Galderma and has conducted clinical studies for Novartis, Jannssen, Pfizer and Roche. Tsen‐Fang Tsai has been a paid consultant of Pfizer Inc; he has served as an investigator and received honoraria for serving as an advisor and speaker for Pfizer. Jeffrey Melin, Bruce Freundlich and Charles Molta were previous employees of Wyeth and Pfizer Inc. Joanne Fuiman, Ronald Pedersen and Deborah Robertson are current employees of Pfizer Inc."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (p 170): "Subjects were randomly assigned to one of the 2 etanercept treatment groups... in 1:1 treatment allocation" Comment: not specified
Allocation concealment (selection bias)	Unclear risk	Quote (p 170): "Subjects were randomly assigned to one of the 2 etanercept treatment groups... in 1:1 treatment allocation" Comment: not specified
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p 170): "The study consisted of a 12‐week double‐blind treatment period" Comment: probably done, placebo‐controlled
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 170): "The study consisted of a 12‐week double‐blind treatment period" Comment: probably done, placebo‐controlled
Incomplete outcome data (attrition bias) All outcomes	Low risk	273 enrolled and randomised and 270 analysed Quote (p 171): "All efficacy analyses were performed using the modified intent‐to‐treat population which included all randomised subjects who received at least one dose of etanercept and had both baseline and on therapy PASI evaluations. The last observation‐carried‐forward method was used for the imputation of missing data..." Comment: mITT and only 3 of 273 participants not included in the analyses of the primary outcome
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00663052). The pre‐specified outcomes mentioned in the methods section appeared to have been reported.