Thaci CLEAR, 2015

Methods	RCT, active‐controlled, double blind Date of study: 27 February 2014–11 May 2015 Location: 137 centres in Europe, Australia and Asia
Participants	Randomised: 676 participants (mean age 46 years, 481 male) Inclusion criteria ‐Participants with moderate‐severe psoriasis (PASI ≥ 12, BSA ≥ 10), age ≥ 18 years Exclusion criteria Immunosuppression, active infection Had received anti IL17 drug or ustekinumab Dropouts and withdrawals 32/676 (4.7%) Did not receive the treatment (4) Information consent obtained the day after study‐related procedure (1, excluded from the efficacy analysis) AE (7) Lost to follow‐up (3) Protocol deviation (5) Participant/guardian decision (7) Physician decision (1) Non compliance with study treatment (1) Technical problem (1)
Interventions	Intervention A. Secukinumab (n = 334), SC, 300 mg weeks 0, 1, 2, 3 then monthly Control intervention B. Ustekinumab (n = 335), SC, 45/90 mg weeks 0, 4 then every 12 weeks
Outcomes	Assessments at 16 weeks Primary outcomes of the trial PASI 90 Secondary outcomes of the trial PASI 75 PASI 90 at week 54 DLQI AEs
Notes	Funding source: Quote (p 400): "Novartis Pharma supported this study" Declarations of interest (p 400): "Dr Thaçi has served as a consultant, served as an advisory board member, and/or received honoraria for lecturing for AbbVie, Amgen, Biogen‐Idec, Celgene, Eli Lilly, Janssen‐Cilag, Leo Pharma, MSD, Novartis, Pfizer, Regeneron, and Sanofi. Dr Blauvelt has served as a scientific consultant and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Ortho Biotech, Merck, Novartis, Pfizer, and Sandoz. Dr Reich has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Amgen, Biogen‐Idec, Celgene, Centocor, Covagen, Eli Lilly, Forward Pharma, GSK, Janssen‐Cilag, Leo Pharma, Medac, MSD, Novartis, Pfizer, Vertex, Takeda, and Xenoport..."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 402): “were randomised via an interactive response technology system" Randomization was conducted via Interactive Response Technology, which assigned a randomisation number that linked the subject to a treatment arm and specified unique medication pack number Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p402): “were randomised via an interactive response technology system “ Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p402) : “To maintain blinding, placebo injections matching the secukinumab regimen were given in the ustekinumab group” Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p402) : “To maintain blinding, placebo injections matching the secukinumab regimen were given in the ustekinumab group” Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 676, analysed 669 Management of missing data: Quote (p 403): “Missing values with respect to response variables based on PASI and IGA mod 2011 scores were imputed as nonresponse (nonresponder imputation)." Comment: however it was not an ITT analysis as 7 participants were not taken into account but low rate of dropout
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT02074982). The pre‐specified outcomes and those mentioned in the methods section appeared to have been reported.