Blauvelt FEATURE, 2015

Methods	RCT, active/placebo‐controlled, double blind Date of study: May 2012‐January 2013 Location: 32 centres in the USA/Germany/France/Estonia/India/Switzerland
Participants	Randomised: 177 participants (mean age 45 years (secukinumab 300 mg), 46 years (secukinumab 150 mg), 47 years (placebo), 117 male) Inclusion criteria Participants with moderate‐severe psoriasis (PASI ≥ 12, Investigator’s Global Assessment, IGA ≥3, BSA ≥ 10) Age ≥ 18 years Non‐response to topical treatment Non‐response to phototherapy Non‐response to systemic treatment Exclusion criteria Pregnancy, Immunosuppresion, Kidney insufficiency, Liver insufficiency, Had received biologics (IL17) Had uncontrolled cardiovascular disorder Had uncontrolled hypertension Past history of malignant tumours Dropouts and withdrawals 7/177(4%), secukinumab 300 group (3), secukinumab 150 group (1), placebo (3) AEs: secukinumab 300 group (1), secukinumab 150 group (0), placebo (1) Lost to follow‐up: secukinumab 300 group (2), secukinumab 150 group (1), placebo (0) Withdrew consent: secukinumab 300 group (0), secukinumab 150 group (0), placebo (2)
Interventions	Intervention A. Secukinumab (n = 59), SC, 300 mg, weeks 1, 2, 3, 4, 8, 12 B. Secukinumab (n = 59), SC, 150 mg, weeks 1, 2, 3, 4, 8, 12 Control intervention C. Placebo (n = 59), SC, weeks 1, 2, 3, 4, 8, 12
Outcomes	Assessment at 12 weeks Primary outcomes of the trial PASI 75 and IGA 0‐1 Secondary outcomes of the trial Usability of the pre‐filled syringe as assessed by observer rating of successful, hazard‐free self‐injection and subject rating of acceptability by the SIAQ PASI 90/100 over time IGA 0/1 over time AEs
Notes	Funding: Novartis Pharmaceuticals, Basel, Switzerland. Declarations of interest (quote p 484): "A.B. has served as a scientific consultant and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer and Sandoz. J.C.P. has served as a consultant, investigator, speaker or advisory board member for Abbott, Biogen‐Idec (formerly Biogen), Centocor, Essex Pharma, Galderma, Janssen‐Cilag/Janssen‐Ortho, Merck‐Serono (formerly Serono), MSD, Novartis, Pfizer and Wyeth, and has received unrestricted research grants from Biogen‐Idec and Wyeth. A.B.G. has served as scientific consultant and/or clinical study investigator for Abbott, Abbvie, Actelion, Akros Pharma, Amgen, Astellas Pharma, Beiersdorf, BMS, Canfite, Celgene, Coronado BioSciences, CSL Behring, GSK, Immune Control, Incyte, Janssen‐Ortho, Lerner Medical Devices, Lilly ICOS, Merck, Novartis, Novo Nordisk, Pfizer, Teva, UCB, Vertex Pharmaceuticals and Xenoport. K.K. has served as a study investigator for Celgene, Hexal, Mitsubishi and Novartis. H.S. has served as a study investigator, consultant and speaker for Novartis. M.R.‐M. has served as a study investigator for Novartis. V.S., R.P., C.P. and S.C. are full‐time employees of Novartis. C.P. and S.C. own stock in Novartis"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 486): “were randomised via interactive response technology to one of the treatment arms...using a validate system that automated the random assignment of subject numbers to randomisation numbers” Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 486): “were randomised via interactive response technology to one of the treatment arms...using a validate system that automated the random assignment of subject numbers to randomisation numbers” Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p486): “Subjects, study management team, investigator staff, persons performing the assessments and data analysts were blinded...” Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p486): “Subjects, study management team, investigator staff, persons performing the assessments and data analysts were blinded...” Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 177, analysed 177 Dropouts and withdrawals 7/177(4%), secukinumab 300 group (3), secukinumab 150 group (1), placebo (3) AEs: secukinumab 300 group (1), secukinumab 150 group (0), placebo (1) Lost to follow‐up: secukinumab 300 group (2), secukinumab 150 group (1), placebo (0) Withdrew consent: secukinumab 300 group (0), secukinumab 150 group (0), placebo (2) Management of missing data: quote (supplemental appendix) "Missing values were imputed as non‐response for all efficacy analyses regardless of the reason of missing data" Comment: probably done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT01555125). The pre‐specified outcomes and those mentioned in the methods section appeared to have been reported.