Saurat CHAMPION, 2008

Methods	RCT, active/placebo‐controlled, double blind Date of study: unreported Location: multicentre (n = 28) in Europe & Canada
Participants	Randomised: 271 participants (mean age 42, 178 male) Inclusion criteria Participants with moderate‐severe psoriasis (PASI ≥ 10 or BSA ≥ 10), age > 18 years Exclusion criteria Pregnancy, immunosuppression, kidney insufficiency, liver insufficiency, past history of malignant tumours Had received conventional systemic treatments for "Methotrexate" arm Had received biologics Dropouts and withdrawals 15/271 (5.5%): adalimumab group (4), methotrexate group (6), placebo group (5) AEs: adalimumab group (1), methotrexate group (6), placebo group (1) Lack of efficacy: adalimumab group (0), methotrexate group (0), placebo group (4) Withdrawal consent: adalimumab group (2), methotrexate group (0), placebo group (0) Other reason:adalimumab group (1), methotrexate group (0), placebo group (0)
Interventions	Intervention A. Adalimumab (n = 108), SC, 80 mg at week 0, 40 mg at week 1 and 40 mg eow Control intervention B. Methotrexate (n = 110), orally, 7.5‐25 mg weekly C. Placebo (n = 53), SC and orally (same drug administration)
Outcomes	Assessments at 16 weeks Primary outcomes of the trial PASI 75 Secondary outcomes of the trial PASI 50 PASI 90 PASI 100 PGA DLQI AEs
Notes	Funding source: Quote (p 561): "Abbott Laboratories funded this study and participated in the study design, data collection, data management, data analysis and preparation of the manuscript" Declarations of interest (p 558): "J.‐H.S., G.S., L.D., K.P. and J.‐P.O. have served as consultants for Abbott Laboratories. In addition, they have participated in continuing medical education events supported by unrestricted educational grants from Abbott. R.G.L. reports receiving fees as a consultant or advisory board member for Abbott, Amgen, Astellas, Boehringer‐ Ingelheim, Barrier Therapeutics and Genentech; he has received lecture fees from Abbott, Amgen/ Wyeth and Biogen‐Idec, and has been the principal investigator and received grants from Abbott, Amgen, Astellas, Centocor, Galderma and Genentech. K.U., M.K. and A.C. are employees of Abbott. "
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 559):"Randomisation was completed through a central computer‐generated scheme stratified by centre, with block sizes of four" Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 559): "Patient numbers were centrally assigned by an interactive voice‐response system in consecutive order". Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p 559): "Adalimumab (Humira; Abbott Laboratories) or matching placebo for SC injection was provided as sterile preservative‐free solution in prefilled syringes. Oral methotrexate tablets were supplied by Wyeth Pharma (Münster, Germany), and placebo tablets were supplied by Abbott GmbH & Co. KG (Ludwigshafen, Germany). Both the methotrexate and placebo tablets were administered as capsules (encapsulated tablets) as a single weekly dose. The capsules for both methotrexate and placebo were supplied by Fisher Clinical Services (Basel, Switzerland)." Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 559): "Adalimumab (Humira; Abbott Laboratories) or matching placebo for SC injection was provided as sterile preservative‐free solution in prefilled syringes. Oral methotrexate tablets were supplied by Wyeth Pharma (Münster, Germany), and placebo tablets were supplied by Abbott GmbH & Co. KG (Ludwigshafen, Germany). Both the methotrexate and placebo tablets were administered as capsules (encapsulated tablets) as a single weekly dose. The capsules for both methotrexate and placebo were supplied by Fisher Clinical Services (Basel, Switzerland)." Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 271, analysed 271 Management of missing data: quote (p 562): "Data for 16 patients with missing week 16 assessments for PASI, including the 15 patients who discontinued and one additional patient in the methotrexate group, were imputed as nonresponse." Comment: probably done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00235820). The pre‐specified outcomes and those mentioned in the methods section appeared to have been reported except for DLQI that was published in a second study.