Barker 2011.

Study characteristics
Methods	RCT, active‐controlled, open‐label trial Date of study: September 2005 ‐ June 2008 Location: 106 centres in Europe
Participants	Randomised: 868 participants (mean age 43 years, 586 male) Inclusion criteria Participants with moderate‐severe psoriasis (PASI ≥ 12, BSA > 10) Age ≥ 18 years and ≤ 75 Non‐response to topical treatment Exclusion criteria Immunosuppression, kidney insufficiency, liver insufficiency Had received conventional systemic treatments (methotrexate) Had received biologics Had an active infection Had uncontrolled cardiovascular disorder Had past history of malignant tumours Dropouts and withdrawals 71/868 (8%) Infliximab (58), methotrexate (13) Reasons not stated at week 16
Interventions	Intervention A. Infliximab (n = 653), IV, 5 mg/kg, weeks 0, 2, 6, 14, 22 Control intervention B. Methotrexate (n = 215), orally, 15 mg/week for 22 weeks
Outcomes	Assessment at 16 weeks Primary outcomes of the trial PASI 75 Secondary outcomes of the trial PASI 90 PGA 0/1 PASI 50 DLQI SF36
Notes	Funding: financial support for this study was provided by Schering‐Plough Research Institute, now Merck, Sharp & Dohme Corporation, Whitehouse Station, NJ, USA Declarations of interest: (Quote Appendix 1): "J.B. has served as a consultant and/or paid speaker for, and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis including Abbott, Celgene, Centocor, Janssen‐Cilag, Johnson and Johnson, Merck, Novartis, Pfizer, Schering‐Plough and Wyeth. M.H. has served as a consultant and/or paid speaker for, and/or has participated in clinical trials sponsored by Abbott, Amgen, Essex, Janssen, Leo, Medac, Novartis, Pfizer, Schering‐Plough and Wyeth. G.W. has no conflicts of interest to disclose. J.‐P.O. has been a consultant for Schering‐Plough, Abbott, Merck‐Serono, Centocor, Wyeth, Janssen‐Cilag, Meda‐Pharma, Pierre‐Fabre and Galderma. H.Z. is an employee of Merck, Sharp & Dohme. H.v.H. was an employee of Merck, Sharp & Dohme at the time of the RESTORE1 study and during the preparation of this manuscript. K.R. has served as a consultant and/or paid speaker for, and/or participated in clinical trials sponsored by Abbott, Celgene, Centocor, Janssen‐Cilag, Leo, Medac and Merck."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 1110): “At each eligible subject's baseline visit, study centres telephoned the Interactive Voice REsponse Syste .... for randomisation" Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 1110): “At each eligible subject's baseline visit, study centres telephoned the Interactive Voice REsponse Syste .... for randomisation" Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote (p 1110): “open‐label trial” Comment: no blinding
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote (p 1110): “open‐label trial” Comment: no blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 868, analysed 868 Quote (p 1110‐11): "Primary and secondary efficacy analyses were based on the ITT population, the ITT population included all randomised patients. At week 16, patients who dropped out early or had missing data for PASI 75 ... were considered nonresponders" Comment: probably done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00251641). The prespecified outcomes and those mentioned in the Methods section appeared to have been reported