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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

Yang 2012.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind
Date of study: February 2009 ‐ February 2010
Location: 9 centres in China
Participants Randomised: 129 participants (mean age 39 years (infliximab) and 40 years (placebo), 95 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (PASI ≥ 12, BSA ≥ 10), age 18 ‐ 65 years

  • Had a diagnosis of plaque psoriasis for at least 6 months

  • Had failed to respond to conventional systemic treatment of psoriasis including: ciclosporin, methotrexate, or acitretin as previous treatment


Exclusion criteria
  • Non‐plaque forms of psoriasis

  • A history of a chronic infectious disease or opportunistic infection

  • A serious infection within 2 months of enrolment

  • Active or latent TB

  • Pregnancy or planned pregnancy within 12 months of enrolment

  • A history of lymphoproliferative disease

  • An active malignancy or history of malignancy within 5 years


Dropouts and withdrawals
  • 2/129 (1.55%): infliximab group (1), placebo group (1)

  • Withdrawal of informed consent: infliximab group (0), placebo group (1)

  • Adverse event: infliximab group (1), placebo group (0)

Interventions Intervention
A. Infliximab (n = 84), IV, 5 mg/kg, weeks 0, 2, 6, 14, 22; 22 weeks
Control intervention
B. Placebo (n = 45), IV, weeks 0, 2, 6 then infliximab 5 mg/kg weeks 10, 12, 16
Outcomes Assessments at 10 weeks
Primary outcomes of the trial
  • PASI 75


Secondary outcomes of the trial
  • PGA

  • DLQI

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 1846): "This randomised, double‐blind, placebo controlled trial... Eligible patients were randomly assigned in a 1:2 ratio to the placebo and infliximab"
Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias) Unclear risk Quote (p 1846): "This randomised, double‐blind, placebo controlled trial... Eligible patients were randomly assigned in a 1:2 ratio to the placebo and infliximab"
Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 1846): "This randomised, double‐blind, placebo controlled trial... Eligible patients were randomly assigned in a 1:2 ratio to the placebo and infliximab... Infliximab 5 mg/kg or placebo was administered by intravenous drip infusion over a period of at least 2 hours on the starting day of treatment (week 0) and at weeks 2 and 6 (induction)".
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 1846): "This randomised, double‐blind, placebo controlled trial... Eligible patients were randomly assigned in a 1:2 ratio to the placebo and infliximab... Infliximab 5 mg/kg or placebo was administered by intravenous drip infusion over a period of at least 2 hours on the starting day of treatment (week 0) and at weeks 2 and 6 (induction)".
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Randomly assigned 129, 129 Analysed
Quote: "In the primary efficacy analysis, data from all randomised subjects were analysed according to their assigned treatment group..."
Comment: no description of the method used to manage the missing data
Selective reporting (reporting bias) Unclear risk Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported