Langley ERASURE, 2014

Methods	RCT, placebo‐controlled, double‐blind trial Date of study: June 2011‐April 2013 Location: 88 centres worldwide (Erasure)
Participants	Randomised: 738 participants mean age 45 years, 509 male Inclusion criteria Participants with moderate‐severe psoriasis PASI ≥ 12, IGA 3‐4, BSA ≥ 10% Age ≥ 18 Non response to topical treatment Non‐response to phototherapy Non‐response to conventional systemic treatment Exclusion criteria Immunosuppression, Had an active infection Had past history of malignant tumours Dropouts and withdrawals 38/738 (5.1%) AEs: secukinumab 300 (3), secukinumab 150 (5), placebo (4) Lack of efficacy: secukinumab 300 (1), secukinumab 150 (1), placebo (0) Withdrew consent: secukinumab 300 (1), secukinumab 150 (9), placebo (8) Lost to follow‐up: secukinumab 300 (0), secukinumab 150 (0), placebo (3) Protocol deviation: secukinumab 300 (1), secukinumab 150 (0), placebo (1) Became pregnant: secukinumab 300 (1), secukinumab 150 (0), placebo (0)
Interventions	Intervention A. Secukinumab 300 (n = 245), SC, 300 mg, weeks 0, 1, 2, 3, 4 and every 4 weeks, 12 weeks Control intervention B. Secukinumab 150 (n = 245), SC, 150 mg, weeks 0, 1, 2, 3, 4 and every 4 weeks, 12 weeks C. Placebo (n = 248), SC, weeks 0, 1, 2, 3, 4 and every 4 weeks
Outcomes	Assessments at 12 weeks Primary outcomes of the trial PASI 75 IGA score at 0 or 1 Secondary outcomes of the trial PASI 50, PASI 75, PASI 90, PASI 100 Response of 0 or 1 on the modified IGA at each study visit until week 52 Score of 0 or 1 on the DLQI at weeks 12 and 52
Notes	Funding source, quote (p 326): "funded by Novartis Pharmaceuticals" Declarations of interest (p 337): "Disclosure forms provided by the authors are available with the full text of this article at NEJM.org." Langley received personal fees from Eli Lilly, Leo, Novartis, Janssen, Amgen, AbbVie, Celgene, Merck, Pfizer.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (protocol and Appendix): "Randomization numbers were generated by the Interactive Response Technology (IRT) provider using a validated system, which automated the random assignment of subject numbers to randomisation numbers..." Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (protocol and Appendix): "Randomization numbers were generated by the Interactive Response Technology (IRT) provider using a validated system, which 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 (protocol and Appendix): “Subjects, investigator staff, persons performing the assessments, and data analysts were blinded to the identity of the treatment from the time of randomisation until primary objective analyses" Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (protocol and Appendix): “Subjects, investigator staff, persons performing the assessments, and data analysts were blinded to the identity of the treatment from the time of randomisation until primary objective analyses" Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	738 included/738 analysed Quote (p 329): "The analyses of the efficacy end points included all the patients who underwent randomisation according to the treatment assigned at randomisation... Missing values ... were conservatively imputed as nonresponses, regardless 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 (NCT01365455). The pre‐specified outcomes and those mentioned in the methods section appeared to have been reported.