Nakagawa 2016

Methods	RCT, active/placebo‐controlled, double blind Date of study: October 2012– March 2013 Setting: multicentre (56) in Japan
Participants	Randomised: 151 participants (mean age 45 years, 120 male) Inclusion criteria Participants with moderate‐severe psoriasis (PASI ≥ 12, BSA ≥ 10), age 20‐70 years Exclusion criteria Past history of malignant tumours, active infection, uncontrolled cardiovascular disorder Had received anti IL17 (RA) treatment Dropouts and withdrawals 6/151 (4%); brodalumab 70 group (2), brodalumab 140 group (0), brodalumab 210 group (0), placebo group (4) AEs: brodalumab 70 group (1) Full consent withdrawal: brodalumab 70 group (1), placebo group (1) Symptoms worsening: placebo group (1)
Interventions	Intervention A. Brodalumab (n = 39), SC, 70 mg, 2 injections week 0, 1 injection eow Control intervention B. Brodalumab (n = 37), SC, 140 mg, 2 injections week 0, 1 injection eow C. Brodalumab (n = 37), SC, 210 mg, 2 injections week 0, 1 injection eow D. Placebo (n = 38), orally (same drug administration)
Outcomes	Assessments at 12 weeks Primary outcomes of the trial % improvement in PASI Secondary outcomes of the trial PASI 75 PGA 0/1 PASI 90/100 AEs
Notes	Funding source: Quote (p 51) “The study was supported by Kyowa Hakko Kirin Co., Ltd.” Declarations of interest (p 51): "H. Nakagawa is a consultant and/or received research grants and/or speaker honoraria from for Kyowa Hakko Kirin Co., Ltd., AbbVie, Mitsubishi‐Tanabe Pharma, Janssen Pharmaceutical K.K., Novartis Pharma K.K., Eli Lilly Japan K.K., LEO Pharma Maruho Corporation Limited and MSD K.K.H. Niiro has no conflict of interest to declare. K. Ootaki is an employee of Kyowa Hakko Kirin Co., Ltd."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (p 45): “were randomised to receive…” Comment: not stated
Allocation concealment (selection bias)	Unclear risk	Quote (p 45): “were randomised to receive…” Comment: not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote (p 51): “double‐blind…” Comment: not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No description of the method used to guarantee blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Randomly assigned 151, analysed 151 Comment: no supplementary explanation regarding the management of missing data
Selective reporting (reporting bias)	High risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT01748539). The pre‐specified outcomes and those mentioned in the methods section appeared to have been reported except for participant‐reported outcome