Seo 2020.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind, parallel arms study Date of study: January 2017 to August 2018 Location: Korea (10 sites) |
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Participants |
Randomised: 62 participants Inclusion criteria
Exclusion criteria
Baseline characteristics N = 62, mean age of 44 years and 61% men Dropouts and withdrawals 17/62 (27.5%); placebo (8), brodalumab (9)
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Interventions |
Intervention A. Brodalumab 210 mg SC injection at weeks 1, 2, 4, 6, 8, 10, and Q2W thereafter, until week 62, n = 40 Control intervention B. Placebo SC injection at weeks 1, 2, 4, 6, 8, 10, and Q2W thereafter, until week 62, n = 22 |
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Outcomes |
At week 12 Primary outcomes
Secondary outcomes
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Notes |
Funding source: Quote (p 816): "funded by Kyowa Kirin Korea Co., Ltd." Declarations of interest: Quote (p 816): "Haeyoun Jeong is a full‐time employee of Kyowa Kirin Korea Co., Ltd. The other authors have no conflicts of interest to declare." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (p 808): "This phase III, randomized, multicenter study consisted of a 12‐ week double‐blind phase followed by a 52‐week open‐label extension phase... patients were randomized to receive brodalumab 210 mg Q2W or placebo for 12 weeks at a 2:1 ratio and were stratified by bodyweight at screening (≤ 70 kg, > 70 kg), prior use of biologic agents, and investigative site. Randomization was performed through a dynamic allocation procedure using an IWRS. The IP was administrated after coordination with the IWRS vendor, Cenduit, an IQVIA business (Durham, NC, USA)." Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote (p 808): "This phase III, randomized, multicenter study consisted of a 12‐week double‐blind phase followed by a 52‐week open‐label extension phase... patients were randomized to receive brodalumab 210 mg Q2W or placebo for 12 weeks at a 2:1 ratio and were stratified by bodyweight at screening (≤ 70 kg, > 70 kg), prior use of biologic agents, and investigative site. Randomization was performed through a dynamic allocation procedure using an IWRS. The IP was administrated after coordination with the IWRS vendor, Cenduit, an IQVIA business (Durham, NC, USA)." Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote (p 808): "This phase III, randomized, multicenter study consisted of a 12‐week double‐blind phase followed by a 52‐week open‐label extension phase..." Comment: no description of the method used to guarantee blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote (p 808): "This phase III, randomized, multicenter study consisted of a 12‐week double‐blind phase followed by a 52‐week open‐label extension phase..." Comment: no description of the method used to guarantee blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dealing with missing data: Quote (p 810): "The populations analyzed were the FAS, which included all randomized patients; the PPS, which included all patients in the FAS but excluded those who had received no treatment, had no post‐dosing primary efficacy data available, failed to meet major eligibility criteria, or had major protocol deviations ... investigative site to examine the treatment difference in the PASI 75 response and sPGA success at week 12 using the last observation carried forward method or non‐responder imputation method for missing data." Randomised 62, analysed 62 Note high rate of dropout: 27% |
Selective reporting (reporting bias) | Low risk | Comment: the protocol for the study was available on ClinicalTrials.gov (NCT02982005). The prespecified outcomes and those mentioned in the Methods section appeared to have been reported. No results are posted on ClinicalTrials.gov. |