title: Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study.
abstract: BACKGROUND
  ABP 501 is a biosimilar of adalimumab.
  
  
  OBJECTIVE
  We sought to compare the efficacy and safety of ABP 501 with adalimumab.
  
  
  METHODS
  This 52-week, double-blind study randomized patients with moderate to severe psoriasis to ABP 501 or adalimumab. At week 16, those with 50% or more improvement in Psoriasis Area and Severity Index score from baseline on ABP 501 continued the same treatment, whereas adalimumab-treated patients were rerandomized to adalimumab or ABP 501. Clinical similarity in Psoriasis Area and Severity Index percent improvement from baseline to week 16 (primary end point) was established if the point estimate of treatment difference and its 2-sided 95% confidence interval between groups was within equivalence margin of ±15. Patients, including those undergoing a single transition at week 16, were evaluated for safety and immunogenicity.
  
  
  RESULTS
  Psoriasis Area and Severity Index percent improvement at week 16 was 80.9 for ABP 501 and 83.1 for adalimumab (least-square mean difference -2.18 [95% confidence interval -7.39 to 3.02]). Adverse events (67.2% [117/174] vs 63.6% [110/173]) and antidrug antibody incidence (55.2% [96/174] vs 63.6% [110/173]) for ABP 501 vs adalimumab were similar. Safety, including immunogenicity, was similar among groups after single transition (week 20).
  
  
  CONCLUSIONS
  The 52-week data are not reported here.
  
  
  CONCLUSIONS
  ABP 501 was shown to be clinically similar to adalimumab. Safety and immunogenicity were not impacted immediately after single transition (adalimumab to ABP 501).
authors.affiliation: K Papp Clinical Research, Waterloo, Ontario, Canada; Probity Medical Research, Waterloo, Ontario, Canada. Electronic address: kapapp@probitymedical.com.
authors.forename: Kim
authors.initials: K
authors.lastname: Papp
authors.affiliation: Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, Assistance Publique-Hopitaux de Paris Saint-Louis Hospital, Paris, France.
authors.forename: Herve
authors.initials: H
authors.lastname: Bachelez
authors.affiliation: Dermatology Unit, Department of Neuroscience, Mental Health and Sensory Systems (NeSMOS) Department, Sapienza University of Rome, Rome, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Costanzo
authors.affiliation: Probity Medical Research, Carlton, Australia; Department of Medicine (Dermatology), University of Melbourne, St Vincent's Hospital Melbourne, Skin and Cancer Foundation Inc, Melbourne, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Foley
authors.affiliation: Probity Medical Research, Waterloo, Ontario, Canada; SKiN Centre for Dermatology, Peterborough, Ontario, Canada.
authors.forename: Melinda
authors.initials: M
authors.lastname: Gooderham
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Primal
authors.initials: P
authors.lastname: Kaur
authors.affiliation: Dermoklinika Medical Centre, Lodz, Poland.
authors.forename: Joanna
authors.initials: J
authors.lastname: Narbutt
authors.affiliation: Psoriasis Research and Treatment Center, University Hospital Charité, Berlin, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Philipp
authors.affiliation: Probity Medical Research, Woolloongabba, Australia; Veracity Clinical Research, Woolloongabba, Australia.
authors.forename: Lynda
authors.initials: L
authors.lastname: Spelman
authors.affiliation: Regional Hospital, Department of Dermatology, Wroclaw, Poland.
authors.forename: Jolanta
authors.initials: J
authors.lastname: Weglowska
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Nan
authors.initials: N
authors.lastname: Zhang
authors.affiliation: Probity Medical Research, Farmington, Connecticut; University of Connecticut Health Center, Connecticut.
authors.forename: Bruce
authors.initials: B
authors.lastname: Strober
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index
chemical_list: D059451:Biosimilar Pharmaceuticals; D000068879:Adalimumab
keywords: ABP 501; adalimumab; biosimilar; efficacy; equivalence; psoriasis; safety