Laburte 1994

Methods	RCT, active‐controlled, open‐label trial Date of study: not stated Location: 27 centres worldwide
Participants	Randomised: 251 participants (mean age 41 years, 176 male) Inclusion criteria Participants with moderate‐severe psoriasis (PASI ≥ 18) Exclusion criteria Kidney insufficiency Had past history of malignant tumours Dropouts and withdrawals Not stated
Interventions	Intervention A. Ciclosporin A (n = 119), orally, 2.5 mg/kg/d, 12 weeks Control intervention B. Ciclosporin A (n = 132), orally, 5 mg/kg/d, 12 weeks
Outcomes	Period assessments: 12 weeks Primary or secondary outcomes of the trial: PASI 75 PASI < 8 Outcmes of the trial Overall assessment score Nails, pruritus, severity, arthropathy Safety
Notes	Funding and declarations of interest: not stated but the first author was employed by Sandoz Pharma Ltd
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (p 367): "... was an open randomised study in parallel group" Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias)	Unclear risk	Quote (p 367): "... was an open randomised study in parallel group" Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote (p 367): "... was an open randomised study in parallel group" Comment: no blinding
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote (p 367): "... was an open randomised study in parallel group" Comment: no blinding
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Management of missing data: no description of the method used to guarantee management of missing data
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.