Yan 2011

Methods	RCT, active‐controlled, Date of study: April 2007‐January 2009 Setting: 7 centres in China
Participants	Randomised: 212 participants Inclusion criteria Definition moderate‐severe psoriasis (PASI ≥ 12, BSA ≥ 10) Age 18‐65 years Exclusion criteria Pregnancy, kidney insufficiency, liver insufficiency Had an active infection Had past history of malignant tumours Dropouts and withdrawals 20/212 (9%) Alefacept (7): AE (1), lost to follow‐up (6) Methotrexate (13): AE (3), lost to follow‐up (8), deviation (2)
Interventions	Intervention A. Alefacept + placebo oral methotrexate (n = 107), IM, 15 mg/week, 12 weeks Control intervention B. Methotrexate + placebo (n = 105), IM, alefacept, orally, 7.5 mg/week, 12 weeks
Outcomes	Time to evaluate assessment: not stated Primary outcomes of the trial Not clearly defined Secondary outcomes of the trial PASI PGA DLQI VAS
Notes	Funding source (p 742): none reported Declarations of interest (p 742): none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (p 738): "Each patient was assigned a random number in a chronological order" Comment: no description of the method used to guarantee random sequence generation
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 738): " The present study,..., double‐blind, double dummy... Patients in the experimental group were intramuscularly injected with... and orally administered with the bank dummy methotrexate... and the patients in the control group..." Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 738): "The present study,..., double‐blind, double dummy... Patients in the experimental group were intramuscularly injected with... and orally administered with the bank dummy methotrexate... and the patients in the control group..." Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote (p 739): "Full set analysis was assessed" Comment: no description of the methods used for dealing with missing data
Selective reporting (reporting bias)	High risk	Comment: no protocol available. No primary outcome clearly identified