TRANSFIGURE 2016.

Study characteristics
Methods	RCT, active‐controlled, double‐blind trial, phase 3 Date of study: November 2013 ‐ January 2017 Location: world‐wide
Participants	Randomised: 198 participants Inclusion criteria Chronic moderate‐severe plaque type psoriasis for ≥ 6 months prior to randomisation, including significant nail involvement, defined as NAPSI score ≥ 16 and number of fingernails involved ≥ 4 and PASI score ≥ 12 and BSA score ≥ 10% Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy Exclusion criteria Forms of psoriasis other than chronic plaque type psoriasis (e.g. pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis) Drug‐induced psoriasis (e.g. new onset or current exacerbation from β‐blockers, calcium channel inhibitors or lithium) Ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails that may potentially confound the evaluation of study treatment effects Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL‐17 or the IL‐17 receptor Exposure to any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half‐lives of the investigational treatment, whichever is longer History of hypersensitivity to constituents of the study treatment Other protocol‐defined inclusion/exclusion criteria do apply Dropouts and withdrawals 12/198 (6.1%): Secu 150 (4), Secu 300 (1), PBO (7) Lost to follow‐up: Secu 150 (1), Secu 300 (0), PBO (0) AEs: Secu 150 (2), Secu 300 (0), PBO (0) Lack of efficacy: Secu 150 (0), Secu 300 (0), PBO (2) Participant: Secu 150 (0), Secu 300 (1), PBO (3) Protocol deviation: Secu 150 (1), Secu 300 (0), PBO (1) Physician decision: Secu 150 (0), Secu 300 (0), PBO (1)
Interventions	Intervention A. Biological: secukinumab 150 mg weekly for 5 weeks, then once every 4 weeks up to and including Week 128, n = 67 ControlIntervention B. Biological: secukinumab 300 mg weekly for 5 weeks, then once every 4 weeks up to and including Week 128, n = 66 C. Biological: Placebo, n = 65
Outcomes	At week 16 Primary outcome NAPSI Secondary outcomes NAPSI at 132 weeks PASI 75 at weeks 16 and 132 IGA 0/1 at weeks 16 and 132 AEs
Notes	Funding Quote (p 1): "Funding sources: This study was funded by Novartis Pharma AG, Basel, Switzerland." Conflicts of interest Quote (Appendix): "Conflicts of interest. K.R. has participated in clinical trials sponsored by AbbVie, Amgen, Biogen Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen‐ Cilag, LEO, Lilly, Medac, MSD, Novartis, Pfizer, Takeda and Vertex; and has served as a consultant for AbbVie, Amgen, Biogen Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen‐Cilag, LEO, Lilly, Medac, MSD, Novartis, Pfizer, Takeda and Vertex. J.S. has received educational grants from Novartis, AbbVie and Pfizer; and has received consultancy fees from Novartis, AbbVie, Pfizer and Eli Lilly. P.A. has received grants from Novartis. U.M. has received grants and/or participated in clinical trials for Abbott/AbbVie, Almirall, Amgen, BASF, Biogen Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, Janssen, LEO Pharma, Medac, MSD, Miltenyi Biotech, Novartis, Pfizer, Teva, VBL and Xenoport; has served as an advisor for and/or received speaker honoraria and/or grants from Abbott/Abb‐ Vie, Almirall, Amgen, BASF, Biogen Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, Janssen, LEO Pharma, Medac, MSD, Miltenyi Biotech, Novartis, Pfizer, Teva, VBL and Xenoport; has participated in clinical trials by Novartis, AbbVie, UCB, Valeant, Athenex, MC2 Therapeutics, Dermira, Kadmon, Boehringer Ingelheim, Galderma, Regeneron, Coherus, Tolmar, Amgen, Total, Watson, Sandoz, Xenoport, AbGenomics and Lilly; and has received consulting fees or speaker honoraria from Novartis, Celgene and AbbVie. M.A. has received grants from and/or participated in clinical trials for AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Janssen‐Cilag, LEO, Medac, MSD (formerly Essex, Schering‐Plough), Mundipharma, Novartis, Pfizer (formerly Wyeth), Pohl Boskamp, Sandoz and Xenoport; and has served as an advisor for and/or received speaker honoraria from AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Janssen‐Cilag, LEO, Medac, MSD (formerly Essex, Schering‐Plough), Mundipharma, Novartis, Pfizer (formerly Wyeth), Pohl Boskamp, Sandoz and Xenoport. A.P., P.R., R.Y. and M.M. are full‐time employees of Novartis.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 2):"Randomization was managed via a central interactive randomization system and ensured that an equal number of patients were allocated to secukinumab 300 mg, secukinumab 150 mg or placebo, stratified by body weight (< 90 kg or ≥ 90 kg). At week 16, all patients receiving placebo were rerandomized 1: 1 to receive either 300 mg or 150 mg secukinumab." Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 2):"Randomization was managed via a central interactive randomization system and ensured that an equal number of patients were allocated to secukinumab 300 mg, secukinumab 150 mg or placebo, stratified by body weight (< 90 kg or ≥ 90 kg). At week 16, all patients receiving placebo were rerandomized 1: 1 to receive either 300 mg or 150 mg secukinumab." Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p 2): " TRANSFIGURE was a randomized, double‐blind, placebo‐controlled trial...Patients received subcutaneous treatments of identical appearance once a week for 5 weeks (at baseline and weeks 1, 2, 3 and 4), followed by dosing every 4 weeks, starting at week 4 (Appendixes S3 and S4; see Supporting Information)." Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 2): " TRANSFIGURE was a randomized, double‐blind, placebo‐controlled trial...Patients received subcutaneous treatments of identical appearance once a week for 5 weeks (at baseline and weeks 1, 2, 3 and 4), followed by dosing every 4 weeks, starting at week 4 (Appendixes S3 and S4; see Supporting Information)." Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dealing with missing data Quote (p 2): "Missing values for PASI and Investigator’s Global Assessment (IGA) mod 2011 were imputed using multiple imputation. Missing patient reported outcome values were imputed with last observation carried forward" On ClinicalTrials.gov, randomized 198, analyzed 198
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT01807520) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported REsults are posted on ClinicalTrials.gov