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

Chaudhari 2001.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind
Date of study: not stated
Location: single centre, New Jersey, USA
Participants Randomised: 33 participants (age mean 35 years (infliximab 10), 51 years (infliximab 5), 45 years (placebo), 23 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (BSA ≥ 5)

  • Non‐response to topical treatment


Exclusion criteria
  • Immunosuppression

  • Had received biologics

  • Had an active infection

  • Had past history of malignant tumours


Dropouts and withdrawals
  • 3/33 (9%)

  • Time and reasons: worsening psoriasis (n = 1 from infliximab 10 mg/kg group), mild rash (n = 1 from infliximab 5 mg/kg group), lack improvement disease (n = 1 from placebo group)

Interventions Intervention
A. Infliximab (n = 11), IV, 5 mg/kg, weeks 0, 2, 6, 10
Control intervention
B. Infliximab (n = 11), IV, 10 mg/kg, weeks 0, 2, 6, 10
C. Placebo (n = 11), IV, 20 mL, weeks 0, 2, 6, 10
Outcomes Assessment at 10 weeks
Primary outcomes of the trial
  • PGA good, excellent or clear


Secondary outcomes of the trial
  • PASI 75

Notes Funding: Y Johnson and Johnson, Centocor Inc
Declarations of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p 1843): "...were randomly assigned... by means of a lock‐of‐six randomisation scheme"
Comment: probably done
Allocation concealment (selection bias) Unclear risk Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 1843): "Placebo was supplied in a identical manner except that it did not contain IFX...The infliximab infusion solution was given by investigators unaware of treatment assignment..."
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 1843): "All assessments were done in a masked manner"
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes Low risk Randomly assigned 33, analysed 33
Dropouts and withdrawals
  • 3/33 (9%)

  • Time and reasons: worsening psoriasis (n = 1 from infliximab 10 mg/kg group), mild rash (n = 1 from infliximab 5 mg/kg group), lack improvement disease (n = 1 from placebo group)


Management of missing data: Quote (p 1844): "The primary analysis was done according to ITT, all randomised patients were included"
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