Piskin 2003

Methods	RCT, active‐controlled, open‐label trial Date of study: not stated Location: Amsterdam and throughout the Netherlands, number not stated
Participants	Randomised: 10 participants (ciclosporin (5), mean age 41 years, 4 male; Methotrexate (5), mean age 45 years, 3 male) Inclusion criteria Participants with moderate‐severe psoriasis, PASI ≥ 8 Age ≥ 18 Non‐response to topical treatment Exclusion criteria Not stated Dropouts and withdrawals Not stated All participants seemed to be evaluated at week 12
Interventions	Intervention A. Ciclosporin (n = 5), orally, 3 mg/kg/d, 16 weeks Control intervention B. Methotrexate (n = 5), orally, 15 mg/kg/week, 16 weeks
Outcomes	Assessments at 12 weeks Primary and secondary outcomes of the trial Not clearly defined Outcomes of the trial PASI 75 Number of cutaneous T‐cell 1‐2 Creatine kinase balance Psoriatic skin
Notes	Funding not declared Declarations of interest: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (p 559): "Patients were randomised..." Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias)	Unclear risk	Quote (p 559): "Patients were randomised..." Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote (p 559): “Laboratory results were obtained in a blinded fashion before randomisation and at week 12 of therapy. The code was broken only after all definitive results were obtained from all participating patients." Comment: open‐label trial, no double dummy used to guarantee blinding of participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: no description of the method used to guarantee blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	10 included/10 analysed Comment: no statistical analyses section; however, the results were available for the 10 participants initially randomised. Methods for dealing with missing data: not applicable
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.