Reich 2012a.

Study characteristics
Methods	RCT, placebo‐controlled, double‐blind Date of study: October 2005 ‐ November 2006 Location: 15 centres in France and Germany
Participants	Randomised: 176 participants, mean age 43 years, 123 male Inclusion criteria Participants with moderate‐severe psoriasis (PASI ≥ 12, BSA ≥ 10), age ≥ 18 years Non‐response to conventional systemic treatment Non‐response to biologics Exclusion criteria Pregnancy, kidney insufficiency, liver insufficiency Had an active infection Had uncontrolled cardiovascular disorder Had uncontrolled diabetes Had uncontrolled hypertension Had past history of malignant tumours Dropouts and withdrawals 28/176 (16%) Placebo (19): lack efficacy (14), AE (3), lost to follow‐up (2) Certolizumab 200 (5): lack efficacy (3), AE (2) Certolizumab 400 (4): lack efficacy (1), AE (2), pregnancy(1)
Interventions	Intervention A. Certolizumab (n = 59), SC, 200 mg, Certolizumab pegol (CZP) 400 mg week 0 – certolizumab 200 mg weeks 1‐10, 10 weeks Control intervention B. Certolizumab (n = 58), SC, 400 mg, certolizumab 400 mg week 0 – certolizumab 400 mg weeks 1 ‐ 10, 10 weeks C. Placebo (n = 59), SC, certolizumab 400 mg week 0 – placebo weeks 1 ‐ 10, 10 weeks
Outcomes	Assessments at 12 weeks Primary outcomes of the trial PASI 75 PGA Secondary outcomes of the trial PASI 50 PASI 90 Time to PASI 75 response Time to relapse Change from baseline BSA DLQI PGA week 12
Notes	Funding source quote (p 180): "This study was funded by UCB Pharma, Brussels, Belgium" Declarations of interest (p 180): "K.R. has served as consultant and ⁄ or paid speaker for and ⁄ or has participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Abbott, Biogen Idec, Celgene, Centocor, Janssen‐Cilag, Leo, Medac, Merck, MSD (formerly Essex, Schering‐Plough), Novartis and Pfizer (formerly Wyeth). J.‐P.O. is a consultant for Abbott, Centocor, Galderma, Janssen‐ Cilag, Leo, Meda Pharma, Merck Serono and UCB Pharma. A.B.G. has current consulting ⁄ advisory board agreements with Amgen, Astellas, Centocor (Janssen), Celgene, Bristol‐Myers Squibb, Beiersdorf, Abbott, TEVA, Actelion, UCB Pharma, Novo Nordisk, Novartis, Dermipsor, Incyte, Pfizer, Canfite, Merck and Lilly. Research ⁄ educational grants paid to Tufts Medical Center: Centocor (Janssen), Amgen, Immune Control, Abbott, Novo Nordisk, UCB Pharma, Novartis, Celgene and Pfizer. I.J.T. and G.C. are full‐time employees of UCB Pharma. C.T. is a former employee of UCB Pharma. P.M. has served as consultant and ⁄ or paid speaker for and has received grants, consulting and ⁄ or speaker fees from Abott Amgen, Biogen Idec, Bristol‐Myers Squibb, Celgene, Janssen, Novartis, Merck, Pfizer and UCB Pharma."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 181): "Eligible patients were randomised to receive... Randomization was centralized using a dynamic allocation procedure... Treatment was assigned using an interactive voice‐response system"“Randomization was conducted via Interactive Response Technology, which assigned a randomisation number that linked the subject treatment arm and specified unique medication pack number Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 181): "Eligible patients were randomised to receive... Randomization was centralized using a dynamic allocation procedure... Treatment was assigned using an interactive voice‐response system" Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p 181): "CZP... or matching placebo in liquid formulation for subcutaneous injection... Study doses of CZP or placebo were prepared containing the same volume and labelled in the same manner by designed unblinded pharmacists" Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 181): "CZP... or matching placebo in liquid formulation for subcutaneous injection... Study doses of CZP or placebo were prepared containing the same volume and labelled in the same manner by designed unblinded pharmacists" Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	176 included/176 analysed Quote (p 182): "Co‐primary efficacy assessments were performed on the intention‐to‐treat population... Nonresponder imputations for missing values were used for the primary analysis" Comment: probably done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00245765). The prespecified outcomes and those mentioned in the Methods section appeared to have been reported, except for pharmacokinetic profile of CDP870