Lebwohl 2003

Methods	RCT, placebo‐controlled, double blind Date of study: 23 March 2000‐05 January 2001 Location: 64 centres in Europe, USA and Canada
Participants	Randomised: 507 participants (mean age 45 years, 333 male) Inclusion criteria Participants with moderate‐severe psoriasis (BSA ≥ 10) Age ≥ 18 years Exclusion criteria Pregnancy, immunosuppression Had an active infection had past history of malignant tumours Dropouts and withdrawals 62/507 (12.2%) AE (10): alefacept 10 (4), alefacept 15 (2), placebo (4) Worsening (13): alefacept 10 (5), alefacept 15 (2), placebo (6) Request (25): alefacept 10 (8), alefacept 15 (6), placebo (11) Laboratory (1): alefacept 10 (1), alefacept 15 (0), placebo (0) Lost to follow‐up (2): alefacept 10 (0), alefacept 15 (2), placebo (0) Other (11): alefacept 10 (3), alefacept 15 (3), placebo (5)
Interventions	Intervention A. Alefacept 10 (n = 173), IM, 10 mg once a week, 12 weeks Control intervention B. Alefacept 15 (n = 166), IM, 15 mg once a week, 12 weeks C. Placebo (n = 168), IM, 0.9 mL once a week, 12 weeks
Outcomes	Assessments at 12 weeks Primary or secondary outcomes of the trial Not clearly identified Outcomes of the trial PASI 50 PASI 75 PGA clear/almost clear Side effects
Notes	Funding source, quote (p 725): "Support for this research and data monitoring and analysis were provided by Biogen Inc." Declarations of interest: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 720): "The present multicenter, randomised...ICT Inc..., a contract research organization, was responsible for patient randomisation and tracking and study inventory" Comment: unlikely to introduce selection bias
Allocation concealment (selection bias)	Low risk	Quote: "a contract research organization, was responsible for patient randomisation and tracking and study inventory" "Unblinded pharmacist prepared, coded… and maintained drug accountability” Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p 720): "Unblinded pharmacist prepared, coded… and maintained drug accountability” Comment: placebo‐controlled, probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 720): "All efficacy measures were assessed ... by a dermatologist blinded to treatment" Comment: placebo‐controlled, probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	507 included/507 analysed Quote (p 721): "Statistical analyses for efficacy measures were based on the intent‐to‐treat population composed of those patients who were randomised, had at least 1 injection and had a baseline assessment" Comment: no description of the method used to manage missing data however number and reasons for withdrawal well‐balanced between groups
Selective reporting (reporting bias)	High risk	Comment: no protocol was available. No pre‐specified primary outcome