Ellis 2001

Methods	RCT, active placebo‐controlled, double blind Date of study: 14 May 1998‐22 February 1999 Location: 22 centres in USA
Participants	Randomised: 229 participants (mean age 45 years, 163 male) Inclusion criteria Participants with moderate‐severe psoriasis (BSA ≥ 10) Age ≥ 18 years ≤ 70 Non‐response to phototherapy Non‐response to conventional systemic treatment Exclusion criteria Pregnancy, kidney insufficiency, liver insufficiency, Had an active infection Had past history of malignant tumours Dropouts and withdrawals 32/229 (14%): alefacept 0.025 (6), alefacept 0.075 (7), alefacept (9), placebo (10) 5 lost to follow‐up: alefacept 0.025 (2), alefacept 0.075 (0), alefacept (2), placebo (1) 9 withdrawals: alefacept 0.025 (0), alefacept 0.075 (1), alefacept (5), placebo (3) 4 AEs: alefacept 0.025 (1), alefacept 0.075 (3), alefacept (0), placebo (0) 2 lab abnormalities: alefacept 0.025 (1), alefacept 0.075 (3), alefacept (0), placebo (0) 8 worsening: alefacept 0.025 (2), alefacept 0.075 (1), alefacept (0), placebo (5) 4 other: alefacept 0.025 (1), alefacept 0.075 (1), alefacept (1), placebo (1)
Interventions	Intervention A. Alefacept (n = 57), IV, 0.025 mg/kg, once a week, 12 weeks Control intervention B. Alefacept (n = 55), IV, 0.075 mg/kg, once a week, 12 weeks C. Alefacept (n = 58), IV, 0.150 mg/kg, once a week, 12 weeks D. Placebo (n = 59), IV, once a week, 12 weeks
Outcomes	Assessments at 14 weeks Primary or secondary outcomes of the trial Not stated Outcomes of the trial Mean change PASI PGA clear/almost clear PASI 75 PASI 50
Notes	Funding (p 254) : "supported by Biogen and a grant from the National Institutes of Health ... at the university of Utah" Declarations of interest (p 254): "A patent on the use of alefacept (LFA3TIP) for the treatment of psoriasis has been assigned to Biogen and the University of Michigan; neither Dr. Ellis nor Dr. Krueger has a financial interest in the patent. Dr. Ellis and Dr. Krueger are consultants to Biogen, as well as to other companies that manufacture treatments for psoriasis."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 249): “Randomization scheme was generated before the study, with a block size of four at each center” Comment: probably done
Allocation concealment (selection bias)	Unclear risk	Quote (p 249): “Randomization scheme was generated before the study, with a block size of four at each center” Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p 249): "Double blind... all preparations were identical in appearance" Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: no specific description of the method used to guarantee blinding of outcome assessment however considering that this is a placebo‐controlled trial with no known systematic AEs we considered the risk as low
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote (p 250): "were conducted according to the intention‐to‐treat principle" Dropouts and withdrawals 32/229 (14%); alefacept 0.025 (6), alefacept 0.075 (7), alefacept (9), placebo (10) no imbalance in reasons Comment: no description of the method used to guarantee missing data management, number of participants analysed not stated
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol was available. The pre‐specified outcomes mentioned in the methods section appeared to have been reported