ACCEPT 2010.

Study characteristics
Methods	RCT, active‐controlled, open‐label trial Date of study: 26 March 2007 ‐ 15 January 2009 Location: 67 centres in Manchester, UK
Participants	Randomised: 903 participants (mean age 45 years, 613 male) Inclusion criteria Participants with moderate‐severe psoriasis Authors' assessment > 6 months, PASI ≥ 12, PGA > 3, BSA > 10% Age ≥ 18 years Non‐response to phototherapy Non‐response to conventional systemic treatment Exclusion criteria Had received biologics Had an active infection Had past history of malignant tumours Dropouts and withdrawals 24/903 (2.7%) Ustekinumab 45 mg (8): AE (2), lost to follow‐up (2), other (4) Ustekinumab 90 mg (5): AE (1), lost to follow‐up (2), other (2) Etanercept (11): AE (5), lost to follow‐up (1), other (5)
Interventions	Intervention A. Ustekinumab (n = 209), SC, 45 mg, weeks 0 ‐ 4, 4 weeks Control intervention B. Ustekinumab (n = 347), SC, 90 mg, weeks 0 ‐ 4, 4 weeks C. Etanercept (n = 347), SC, 50 mg x 2/weeks, 12 weeks
Outcomes	Assessments at 12 weeks Primary outcomes of the trial PASI 75 Secondary outcomes of the trial Number of participants PGA 0/1 at week 12 PASI 90 at weeks 8 ‐ 12 Difference PASI at week 12 and 12 weeks after retreatment on recurrence of psoriasis AEs
Notes	Funding, Quote (p 127): "Supported by Centocor Research and Development." Declarations of interest (p 127) "Dr. Griffiths reports receiving consulting and lecture fees from Abbott, Janssen‐Cilag, Merck Serono, Novartis, Schering‐Plough, and Wyeth and grant support from Merck Serono; Dr. Strober, receiving consulting and lecture fees from Centocor, Johnson & Johnson, Amgen, and Abbott Laboratories and grant support from Amgen and Abbott Laboratories; Dr. van de Kerkhof, receiving consulting fees from Schering‐Plough, Celgene, Centocor, Almirall, UCB, Wyeth, Pfizer, Soffinova, Abbott, Actelion, Galderma, Novartis, Janssen‐Cilag, and Leo Pharma; Dr. Ho, receiving advisory‐board and lecture fees from Schering, Abbott, Janssen‐Ortho, Pfizer, Amgen, and Wyeth and grant support from Centocor, Abbott, Amgen, and Wyeth; Dr. Menter, receiving advisory‐board, consulting, and lecture fees from Abbott, Amgen, Astellas, Biogen Idec, Celgene, Centocor, Genentech, Warner Chilcott, and Wyeth; Drs. Yeilding, Guzzo, Xia, and Dooley and Ms. Li, being employees of Johnson & Johnson and having equity and holding stock options in Johnson & Johnson; Dr. Zhou, being an employee of Johnson & Johnson, having equity and holding stock options in Johnson & Johnson, and having equity in Wyeth; Dr. Fidelus‐Gort, being a former employee of Johnson & Johnson and having equity and holding stock options in Johnson & Johnson; and Dr. Goldstein, receiving consulting fees from Centocor. No other potential conflict of interest relevant to this article was reported."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (p 119): “We randomly assigned...” Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias)	Unclear risk	Quote (p 119): “We randomly assigned...” Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote (p 119): “Patients were aware of their treatment assignment”, ... “All study personnel, except those who dispensed or administered a study agent remained unaware of the treatment assignments" Comment: high risk for participants and unclear risk for personnel (no description of means used to avoid communication between participants and personnel and very difficult to avoid)
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote (p 119): “All study personnel, except those who dispensed or administered a study agent remained unaware of the treatment assignments" Comment: no description of the method used to assess the primary outcome
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	903 participants underwent randomisation, 903 were analysed Comment: methods for dealing with missing data not specified
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00454584). The prespecified outcomes and those mentioned in the Methods section appeared to have been reported