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. 2020 Jan 20;2020(1):CD011628. doi: 10.1002/14651858.CD011628.pub2

Bissonnette 2008.

Methods Placebo‐controlled, parallel‐arm trial
Three centres in Canada (community centre clinics)
Period of inclusion not stated
Participants Inclusion criteria
  • Moderate to severe palmoplantar pustulosis (PPPASI score ≥ 8)

  • Age ≥ 18 years


Exclusion criteria
  • Pregnancy

  • Immunosuppression

  • Kidney insufficiency

  • Liver insufficiency

  • Washout of 4 weeks for systemic medications and biologics

  • Washout of 2 weeks for PUVA therapy

  • Active infection

  • Uncontrolled cardiovascular condition

  • Uncontrolled diabetes


Baseline data: participants were randomised 2:1 to subcutaneous injections of either etanercept 50 mg twice per week (n = 10) or placebo (n = 5)
  • Median age (range), years: 53 (26 to 61)

  • Male/female: 1/9; 0/5

  • Proportion of participants having psoriatic lesions elsewhere: 8/15


Withdrawal: no dropouts
Interventions Intervention
A: etanercept 50 mg subcutaneously twice per week (10 participants)
Control intervention
B: placebo (5 participants)
Co‐interventions: none
Duration of treatment: 3 months
Outcomes Primary outcome
  • Percentage change in PPPASI scale score


Other outcome
  • Adverse events

Notes The study was funded by Amgen Canada Inc and Wyeth Pharmaceuticals
Clinical trial: NCT00353119
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Subjects were randomised 2:1 to receive subcutaneous injections of either etanercept 50 mg or a placebo"
Comment: insufficient information about the sequence generation process to permit judgement
Allocation concealment (selection bias) Unclear risk Quote: "Subjects were randomised 2:1 to receive subcutaneous injections of either etanercept 50 mg or a placebo"
Comment: the method use to guarantee concealment is not described
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "double‐blind study"
Comment: double‐blind placebo‐controlled. We consider blinding at low risk for trial vs placebo with no obvious clinical adverse events or known specific taste of experimental drug
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "double‐blind study"
Comment: double‐blind placebo‐controlled. We consider blinding at low risk for trial vs placebo with no obvious clinical adverse events or known specific taste of experimental drug
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "All randomised subjects completed the study"
Comment: no missing data (no dropouts neither in the intervention group nor in the control group)
Selective reporting (reporting bias) Low risk Comment: the study protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes of interest in the review have been reported in the pre‐specified way