Torii 2010

Methods	RCT, placebo‐controlled, double blind Date of study: not stated Location: 28 centres in Japan
Participants	Randomised: 54 participants (mean age 46 years, 36 male) Inclusion criteria Participants with moderate‐severe psoriasis (PASI ≥ 12, BSA ≥ 10) Exclusion criteria Active infection Past history of malignant tumours Dropouts and withdrawals 7/54 (13%) at W14; Infliximab (3): therapeutic effect (2), adverse event (1) Placebo (4): AE (1), withdrawal of consent (3)
Interventions	Intervention A. Infliximab (n = 35), IV, 5 mg/kg, weeks 0, 2, 6; 10 weeks Control intervention B. Placebo (n = 19), IV, weeks 0, 2, 6; 10 weeks
Outcomes	Assessments at 10 weeks Primary outcomes of the trial PASI75 Secondary outcomes of the trial PASI50 DLQI PGA AE
Notes	Funding: not stated Declarations of interest: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (p 41): "Eligible patients were randomised in a 2:1 ratio to either... using the dynamic allocation method" Comment: no description of the methods used to guarantee the random sequence generation
Allocation concealment (selection bias)	Unclear risk	Quote (p41): "Eligible patients were randomised in a 2:1 ratio to either... using the dynamic allocation method" Comment: no description of the methods used to guarantee allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p41): "The induction phase of th treatment was .. double‐blind placebo controlled trial... Infliximab or placebo was administered by IV drip infusion over a period of at least 2h ... Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p41): "The induction phase of th treatment was .. double‐blind placebo controlled trial... Infliximab or placebo was administered by intravenous drip infusion over a period of at least 2h ... Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 54, analysed 54 Quote (p42): "This primary endpoint analysis was performed on an "intent‐to‐treat" basis...Patients who discontinued the study treatment ... were handled as "not improved" in the assessment" Comment: probably done
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol was available. The pre‐specified outcomes mentioned in the methods section appeared to have been reported.