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

Gordon 2006.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind trial
Date of study: March 2003 ‐ June 2004
Location: Multicentre (n = 18) in USA, Canada
Participants Randomised: 148 participants (mean age 44 years, 99 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (BSA ≥ 5)

  • Age ≥ 18

  • Non‐response to topical treatment


Exclusion criteria
  • Pregnancy

  • Had received biologics (anti‐TNF)

  • Had an active infection

  • Had past history of malignant tumours


Dropouts and withdrawals
  • 8/148 (5%)

  • Time and reasons:

    • did not receive the treatment: adalimumab weekly (0), adalimumab eow (1), placebo (0)

    • AE: adalimumab weekly (2), adalimumab eow (2), placebo (1)

    • lack of efficacy: adalimumab weekly (0), adalimumab eow (0), placebo (1)

    • abnormal lab value: adalimumab weekly (1), adalimumab eow (0), placebo (0)

Interventions Intervention
A. Adalimumab (n = 46), SC, 40 mg, 12 weeks, week 0: 2 injections, 1 injection eow
B. Adalimumab, (n = 50), SC, 40 mg, 12 weeks, week 0, week 1: 2 injections, 1 injection weekly
Control intervention
C. Placebo (n = 52), SC, 12 weeks
Outcomes Assessments at 12 weeks
Primary outcomes of the trial
  • PASI 75


Secondary outcomes of the trial
  • PASI 50

  • PASI 100

  • PGA

  • DLQI

Notes Funding, Quote (p 598): "Supported by Abbott Laboratories"
Declarations of interest (p 598): "Dr Gordon has received research support and honoraria and is a consultant for Abbott. Dr Langley is an investigator and has received research funding to conduct research studies with Abbott. Dr Leonardi is a consultant and speaker for Abbott. Dr Menter has received honoraria and is a consultant for Abbott. Dr Kang is an ad‐hoc consultant for Abbott. Dr Heffernan is a consultant for and has received research funding from Abbott. Drs Zhong, Hoffman, and Okun and Ms Lim are full‐time employees of Abbott."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p 599): "Patients were centrally randomised..."
Comment: probably done
Allocation concealment (selection bias) Unclear risk Quote (p 599): "Patients were centrally randomised..."
Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 599): "To maintain blinding, prefilled syringes were identically labelled and all patients received the same number of injections at the same time points"
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 599): "To maintain blinding, prefilled syringes were identically labelled and all patients received the same number of injections at the same time points"
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes Low risk Randomly assigned 148, analysed 147
Dropouts and withdrawals
  • 8/148 (5%)

  • Time and reasons:

    • did not receive the treatment: adalimumab weekly (0), adalimumab eow (1), placebo (0)

    • AE: adalimumab weekly (2), adalimumab eow (2), placebo (1)

    • lack of efficacy: adalimumab weekly (0), adalimumab eow (0), placebo (1)

    • abnormal lab value: adalimumab weekly (1), adalimumab eow (0), placebo (0)


Management of missing data, quote (p 601): "modified intent‐to‐treat analysis... a patient with missing data was counted as a nonresponder at that visit"
Comment: few lost to follow‐up, well‐balanced number and reasons between groups
Selective reporting (reporting bias) Unclear risk Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported