Leonardi PHOENIX‐1, 2008

Methods	RCT, placebo‐controlled, double‐blind trial Date of study: December 2005–September 2007 Location: 48 centres in USA, Canada, Belgium
Participants	Randomised: 766 participants (mean age 45 years, 531 male) Inclusion criteria Participants with moderate‐severe psoriasis, authors' assessment > 6 months, PASI ≥ 12, BSA > 10% Age ≥ 18 Exclusion criteria Had received conventional systemic treatments Had received biologics (IL12/23) Had an active infection Had past history of malignant tumours Dropouts and withdrawals 23/766 (3%) : Ustekinumab 45 (1) (other 1) Ustekinumab 90 (10) (lack of efficacy (1), adverse event (2) other (7)) Placebo (12) (lack of efficacy (3), adverse event (6) other (3))
Interventions	Intervention A. Ustekinumab (n = 255), SC, 45 mg, weeks 0‐4 and every 12 weeks, 40 weeks Control intervention B. Ustekinumab (n = 256), SC, 90 mg, weeks 0‐4 and every 12 weeks, 40 weeks C. Placebo (n = 255), SC, weeks 0‐4, 40 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 DLQI from baseline at 12 weeks PASI 90 at week 12 Side effects
Notes	Funding source, quote (p 1665): Centocor Inc. Declarations of interest (p 1673): "CLL has served as a consultant for Abbott, Amgen, Centocor, and Genentech, as an investigator for Abbott, Allergan, Altana, Alza, Amgen, Astellas, Celgene, Centocor, Genentech, Bristol Myers, Eli Lilly, Fujisawa, Galderma, CombinatoRx, 3M Pharmaceuticals, Perrigo Isreal Pharamceutical, ScheringPlough, Serono, RTL, Novartis, Vitae, and Wyeth, and as a speaker for Abbott, Amgen, Centocor, Genentech, and Warner Chilcott. ABK has served as an investigator and consultant for Abbott, Amgen, and Centocor and has been a study steering committee member, speaker, and fellowship funding recipient from Centocor. KAP has served as a consultant and advisory board member for Abbott, Alza, Amgen, Celgene, Centocor, Johnson and Johnson, Isotechnika, Janssen Ortho Biotech, Medimmune, MerckSerono, and Wyeth. KBG has served as a consultant for Abbott, Amgen, Astellas, Centocor, and Genentech and has received grant support from Abbott, Astellas, and Centocor. NY, CG, YW, SL, and LTD are employees of Centocor and own stock in Johnson and Johnson."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 1667‐68): “...via a centralised interactive voice response system” Comment: probably done
Allocation concealment (selection bias)	Unclear risk	Quote (p 1667‐68): “...via a centralised interactive voice response system” Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p 1666‐67): “This phase 3, double‐blind, placebo‐controlled... Patients received placebo injections as needed to preserve the blind. The study sponsor was unblinded to treatment... Site monitors, investigators, site personnel involved in the study conduct, and patients remained blinded until week 76” Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 1666‐67): “This phase 3, double‐blind, placebo‐controlled... Patients received placebo injections as needed to preserve the blind. The study sponsor was unblinded to treatment... Site monitors, investigators, site personnel involved in the study conduct, and patients remained blinded until week 76” Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Included 255/256/255 Analysed 255/256/255 Quote (p 1668): "Efficacy data from all randomised patients were analysed according to the assigned treatment group.... Patients who discontinued study treatment... were deemed to be treatment failures" Comment: probably done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00267969). The pre‐specified outcomes and those mentioned in the methods section appeared to have been reported.