Bagel 2012

Methods	RCT, placebo‐controlled, double blind Date of study: not stated Location: North America
Participants	Randomised: 124 participants (median age 39 years (etanercept) and 42 years (placebo), 69 male) Inclusion criteria Participants with moderate‐severe psoriasis: ≥ 30% of scalp surface area affected (PASI > 10, BSA > 10) Age > 18 years Exclusion criteria Had past history of malignant tumours in the past 5 years, had an active infection, had a significant medical problem Dropouts and withdrawals 26/124 (21%) Not received study treatment: etanercept (3), placebo (0) AEs: etanercept (5), placebo (0) Withdrawal of consent: etanercept (1), placebo (5)
Interventions	Intervention A. Etanercept (n = 62), SC, 50 mg, twice a week Control intervention B. Placebo (n = 62), SC, twice a week
Outcomes	Assessment at 12 weeks Primary outcomes of the trial % change in PSSI score Secondary outcomes of the trial % change in PSSI score at 24 weeks for group B Proportion PSSI at 12 weeks Participant satisfaction AEs PASI 50/75/90 improvement through 24 weeks Proportion PGA 0 or 1 Mean PASI improvement from baseline
Notes	Funding: Amgen Inc Declarations of interest (quote p86): "Dr Bagel receives a salary as founder of the Psoriasis Treatment Center of Central New Jersey. He has received speaker honoraria from Leo Pharma, Galderma, Centocor, Abbott, and Amgen. He has also been compensated as a consultant for Galderma and has served as an investigator for Centocor, Abbott, and Amgen. Dr Lynde has received research grants and honoraria from Amgen, Abbott, Merck, Ortho Biotech, Leo Pharma, and Galderma, for whom he has served as an advisory board member, consultant, and speaker. He has also served as an investigator for Amgen, Abbott, Merck, Ortho Biotech, and Leo Pharma. Dr Tyring has received a research grant and honoraria from Amgen, for whom he has served as a consultant, investigator, and speaker. He has also served as an investigator and/or speaker for Abbott, Leo Pharma, Galderma, GSK, Novartis, Merck, Epiphany, Inhibitex, AiCuris, and Pfizer. Dr Kricorian, Yifei Shi, and Dr Klekotka are employees of Amgen Inc. and have received Amgen stock/stock options."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p87): "Each patient provided written informed consent and received a unique identification number and randomised assignment from an Interactive Web Response System" Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p87): "Each patient provided written informed consent and received a unique identification number and randomised assignment from an Interactive Web Response System" Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p87): "patients and clinicians were blinded throughout the study as to treatment assignments." Comment: probably done, placebo‐controlled
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote:"patients and clinicians were blinded throughout the study as to treatment assignments." Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 124, analysed 124 Dropouts and withdrawals 26/124 (21%) Not received study treatment; etanercept (3), placebo (0) AEs; etanercept (5), placebo (0) Withdrawal of consent; etanercept (1), placebo (5) Quote (p89): "included in ITT efficacy analysis" Management of missing data: Quote (p88): "Last observation carried forward imputation was used for missing values" Comment: probably done
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available. The outcomes mentioned in the methods section appeared to have been reported except for QoL.