Bissonnette 2013

Methods	RCT, placebo‐controlled, single blind Date of study: May 2009‐June 2011 Location: Montréal, Quebec, Canada (5 centres)
Participants	Randomised: 30 participants (median age 56 years (adalimumab) and 57 years (placebo), 23 male) Inclusion criteria Participants with moderate‐severe psoriasis (BSA>5) Age ≥ 18 years and ≤ 80 Non‐response to topical treatment Exclusion criteria Immunosuppression, kidney insufficiency Had an active infection, had uncontrolled cardiovascular disorder, had uncontrolled diabetes, had uncontrolled hypertension, had past history of malignant tumours Dropouts and withdrawals 2/30 (7%) Discontinued intervention (1, placebo group) Death myocardial infarction (1, adalimumab group)
Interventions	Intervention A. Adalimumab (n = 20), SC, 80/40 mg, eow Control intervention B. Topical treatment, phototherapy or no treatment (n = 10)
Outcomes	Assessment at 16 weeks Primary outcomes of the trial The change in the average of max TBR values of carotid arteries Secondary outcomes of the trial PASI 75 at week 16 Change in average of max TBR of vessels Change in the most diseased segment T
Notes	Funding: Abbott laboratories Declarations of interest: (quote p 89) "Dr Bissonnette and Dr Bolduc have been investigators, advisors and/ or consultants and received grants and/or honoraria from Abbott, Amgen, Astellas, Novartis, Janssen Ortho, Pfizer, Celgene, and Tribute. Drs Tardif, Harel, Pressacco, and Guertin have no conflicts of interest to declare."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p84): "were randomised a concealed computer generated code created by the sponsor" Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p84): "were randomised a concealed computer generated code created by the sponsor" Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote (83‐4): "single‐blind (cardiologist and all staff involved in vascular imaging and analysis were blinded to treatment assignment)" Comment: no blinding
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote (83‐4): "single‐blind (cardiologist and all staff involved in vascular imaging and analysis were blinded to treatment assignment)" Comment: probably done; however, no statement regarding secondary outcomes
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 30, analysed 30 Quote (p84): "For all end points, the analysis was conducted on the ITT population, ... for the PASI 75 end point,... a nonresponder imputation method was used" Comment: probably done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00940862). The pre‐specified outcomes and those mentioned in the methods section appeared to have been reported.