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. 2023 Jul 12;2023(7):CD011535. doi: 10.1002/14651858.CD011535.pub6

Torii 2010.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind study
Date of study: not stated
Location: 28 centres in Japan
Participants Randomised: 54 participants
Inclusion criteria
  • Participants with moderate‐severe psoriasis (PASI ≥ 12, BSA ≥ 10)


Exclusion criteria
  • Active infection

  • Past history of malignant tumours


Baseline characteristics
N = 54 participants, mean age 46 years, 36 male
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 outcome
  • PASI 75


Secondary outcomes
  • PASI 50

  • DLQI

  • PGA

  • AE

Notes Funding source: 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 (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 allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 41): "The induction phase of the 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 (p 41): "The induction phase of the 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 (p 42): "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 prespecified outcomes mentioned in the Methods section appeared to have been reported.