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. 2020 Jan 9;2020(1):CD011535. doi: 10.1002/14651858.CD011535.pub3

Papp AMAGINE‐1 2016.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind
Date of study: 29 August 2012 ‐ 12 March 2014
Location: 73 centres worldwide (Europe, USA and Canada)
Participants Randomised: 661 participants (mean age 46 years, 484 male)
Inclusion criteria
  • Aged 18 ‐ 75

  • Participants with moderate‐severe psoriasis (PASI ≥ 12, PPGA ≥ 3 and BSA ≥ 10), failed to respond to, had a contraindication to, or were intolerant to at least 1 conventional systemic treatment


Exclusion criteria
  • Not plaque‐type psoriasis

  • Active infection (TB, hepatitis B, C or HIV), had Crohn's disease and any uncontrolled significant medical condition

  • Had a myocardial infarction or unstable angina pectoris within 12 months before the first dose

  • Had active malignancy or a history of malignancy within 5 years


Dropouts and withdrawals
  • 33/661(5%); brodalumab 210 (10), brodalumab 140 (11), placebo (12)

  • Ineligibility determined: brodalumab 210 (0), brodalumab 140 (0), placebo (2)

  • Not received study medication

  • AEs: brodalumab 210 (2), brodalumab 140 (3), placebo (3)

  • Death: brodalumab 210 (0), brodalumab 140 (0), placebo (0)

  • Lost to follow‐up: brodalumab 210 (1), brodalumab 140 (1), placebo (1)

  • Withdrawal consent: brodalumab 210 (4), brodalumab 140 (3), placebo (3)

  • Other reason: brodalumab 210 (3), brodalumab 140 (4), placebo (3)

Interventions Intervention
A. Brodalumab (n = 222), SC, 210 mg every 2 weeks
Control intervention
B. Brodalumab (n = 219), SC, 140 mg every 2 weeks
C. Placebo (n = 220)
Outcomes Assessments at 12 weeks
Primary outcomes of the trial
  • PASI 75

  • PGA success


Secondary outcomes of the trial
  • PASI 100 and PGA 0

  • Participant‐reported outcomes

  • AEs

Notes Funding source:
Quote (p 1): "This study was funded by Amgen Inc. & AstraZeneca/MedImmune."
Declarations of interest (pp 13‐14): "K.A.P. has served as a consultant, investigator and/or speaker for AbbVie, Amgen Inc., Astellas Pharma, Bayer AG, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Forward Pharma, Galderma, Janssen Biotech Inc., LEO Pharma, Merck, Novartis, Pfizer, Roche and UCB Pharma. K.R. 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 Inc., Biogen‐Idec, Celgene, Centocor, Covagen, Forward Pharma, GSK, Janssen‐Cilag, LEO Pharma, Lilly, Medac, MSD, Novartis, Pfizer, Takeda and Vertex. C.P. has served as a consultant and investigator for Amgen Inc., AbbVie, Boehringer, Janssen‐Cilag, LEO Pharma, Lilly, Novartis and Pfizer. A.B. has served as a consultant and investigator for AbbVie, Amgen Inc., Anacor, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Genentech, Janssen, Merck, Novartis, Pfizer, Regeneron and Sandoz."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (pp 2 and 3): "Patients were randomized... IP supply was controlled by interactive voice response system and box numbers were assigned at each visit"
Comment: no description of the method used to guarantee the random sequence generation
Allocation concealment (selection bias) Low risk Quote (pp 2 and 3): "Patients were randomized...IP supply was controlled by interactive voice response system and box numbers were assigned at each visit".
Comment: probably done
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 3): "Randomizations remained blinded to all patients and investigators... Throughout the study, patients received placebo as needed to maintain the blind until it was broken."
Comment: probably done, placebo‐controlled
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 3): "Randomizations remained blinded to all patients and investigators... Throughout the study, patients received placebo as needed to maintain the blind until it was broken."
Comment: probably done, placebo‐controlled
Incomplete outcome data (attrition bias)
All outcomes Low risk Randomly assigned 661, 661 analysed
Management of missing data: quote (pp 4‐5): "The full analysis set included all randomised patients... Mutiple imputations for missing data"
Comment: probably done
Selective reporting (reporting bias) Low risk Comment: the protocol for the study was available on ClinicalTrials.gov (NCT01708590; AMAGINE‐1). The prespecified outcomes and those mentioned in the Methods section appeared to have been reported.