PHOENIX‐2 2008.

Study characteristics
Methods	RCT, placebo‐controlled, double‐blind trial Date of study: March 2006 – September 2007 Location: 70 centres in Europe and North America
Participants	Randomised: 1230 participants (mean age 45 years, 840 male) Inclusion criteria Participants with moderate‐severe psoriasis Authors' assessment ≥ 6 months, PASI ≥ 12, BSA > 10% Age ≥ 18 years Exclusion criteria Had received IL12/23 drug Had an active infection Had past history of malignant tumours Dropouts and withdrawals 33/1230 (2.7%) Ustekinumab 45 (6): AE (2), other (4) Ustekinumab 90 (9): AE (5), death (1), other (3) Placebo (18): lack of efficacy (2), AE (8), other (8)
Interventions	Intervention A. Ustekinumab (n = 409), SC, 45 mg, weeks 0 ‐ 4 and every 12 weeks, 52 weeks Control intervention B. Ustekinumab (n = 411), SC, 90 mg, weeks 0 ‐ 4 and every 12 weeks, 52 weeks C. Placebo (n = 410), SC, weeks 0 ‐ 4, 4 weeks
Outcomes	Assessments at 12 weeks Primary outcomes of the trial PASI 75 Secondary outcomes of the trial PGA cleared or minimal at 12 weeks Change of QoL from baseline at week 12 PASI 90 at 12 weeks
Notes	Funding Centocor Inc (p 1675) Declaration of interest (p 1684): "KP has served as a consultant and advisory board member for Abbott, Alza, Amgen, Celgene, Centocor, Isotechnika, Janssen Ortho Biotech, Johnson & Johnson, Medimmune, MerckSerono, and Wyeth. RGL has received research grants, served on scientific advisory boards, and has been a speaker for Amgen, Biogen‐Idec, Centocor, Genentech, Novartis, Schering‐Plough, and Serono. ML has received honoraria, served as a speaker and advisory board member for Abbott, Amgen, Centocor, Genentech, and Stiefel, and has served as an advisory board member for Astellas and a consultant for UCB. GK has received fees as a consultant or advisory board member for Abbott, Almirall, Alza, Amgen, Anacor, Astellas, Barrier Therapeutics, Boehringer Ingleheim, Bristol Myers Squibb, Centocor, CombinatoRx, Exelixis, Genentech, Genzyme, Isis, L’Oreal, Lupin Limited, Magen Biosciencs, MedaCorp, Medicis, Novartis, Nova Nordisc, Schering‐Plough, Somagenics, theDerm.org, Synvista, Warner Chilcot, UCB, USANA Health Sciences, and ZARS, owns equities and stock in ZARS, and has received lecture fees from Abbott, Amgen, Astellas, Boehringer Ingleheim, Centocor, Connetics, National Psoriasis Foundation, The Foundation for Better Health Care, and Warner Chilcot, and has received partial stipend support for a clinical research fellowship from Abbott, Amgen, and Centocor. KR has received honoraria as a consultant and advisory board member and acted as a paid speaker for Abbot, Biogen‐Idec, Centocor, Janssen‐Cilag, Schering‐Plough, MerckSerono, UCB, and Wyeth. PS, NY, CG, M‐CH, YW, SL, and LTD are employees of Centocor. PS, NY, CG, YW, SL, and LTD own stock in Johnson and Johnson."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 1676): “Patients were randomly assigned... with bias coin assignment via a centralised interactive voice response system (ClinPhone, East Windsor, NJ, USA)” Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 1676): “Patients were randomly assigned... with bias coin assignment via a centralised interactive voice response system (ClinPhone, East Windsor, NJ, USA)” Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (pp 1676‐7): “Double‐blind,..., placebo‐controlled...Site monitors investigators personnel involved in the study conduct,and patients remained blinded... until W52” Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (pp 1676‐7): “Double‐blind,..., placebo‐controlled...Site monitors investigators personnel involved in the study conduct,and patients remained blinded... until W52” Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	1230 included/ 1230 analysed Quote (p 1679): "Efficacy data were analysed by the assigned treatment group... Non‐responder status was assigned for binary variables ... for those patients who discontinued study treatment ..." Comment: ITT analyses
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00307437) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported