Flytström 2008

Methods	RCT, active‐controlled, open‐label trial Date of study: Feb 2002‐Feb 2005 Location: multicentre (n = 5), Sweden
Participants	Randomised: 84 participants (mean age: 48 years (methotrexate), 46 years (ciclosporin); 55 male) Inclusion criteria Participants with moderate‐severe psoriasis Age ≥18 Non response to topical treatment Non‐response to phototherapy One previous treatment line allowed Exclusion criteria Pregnancy, immunodepression, kidney insufficiency, liver insufficiency Had uncontrolled hypertension Had past history of malignant tumours Dropouts and withdrawals 16/84 (19%): methotrexate group (4), ciclosporin group (12) 7 with exclusion criteria: methotrexate group (2), ciclosporin group (5) 7 consent withdrawal: methotrexate group (2), ciclosporin group (5) 2 ineligible: ciclosporin group
Interventions	Intervention A. Methotrexate + folic acid (n = 41), orally, 7.5 mg/kg /week (5 mg folic acid except days of methotrexate), 12 weeks Control intervention B. Ciclosporin (n = 43), orally, 3 mg/kg, divided into 2 doses, 12 weeks
Outcomes	Assessments at 12 weeks Primary outcomes of the trial PASI Secondary outcomes of the trial DLQI SF‐36 VAS for patient assessment
Notes	Funding (p121): "Financial support from the Swedish Psoriasis Association and the Welander foundation" Declarations of interest (p116): "none declared"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 117): "Randomization was performed with the use of computer‐generated random numbers, numbers by calling a central telephone number" Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 117): "Randomization was performed with the use of computer‐generated random numbers, numbers by calling a central telephone number" Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: not blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote (p 117): "Blinded assessors performed the PASI at baseline and monthly thereafter" Comment: no description of method used to guarantee no communication between care givers or participants and assessors
Incomplete outcome data (attrition bias) All outcomes	High risk	Randomly assigned 84, analysed 68 Management of missing data: not ITT analysis
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