title: Evaluation of safety and clinical activity of multiple doses of the anti-CD80 monoclonal antibody, galiximab, in patients with moderate to severe plaque psoriasis.
abstract: BACKGROUND
  Reduction in lesional, activated T cells induces improvement in psoriatic plaques. Galiximab (IDEC-114), an IgG(1) anti-CD80 antibody, binds to CD80, a costimulatory molecule involved in T-cell activation.
  
  
  OBJECTIVE
  A Phase I/II, multidose, multischedule, dose-finding study of galiximab to evaluate safety, pharmacokinetics, and clinical activity was conducted in 35 patients with moderate to severe plaque psoriasis.
  
  
  METHODS
  Seven cohorts of five patients received galiximab intravenously on three different schedules at different dose levels.
  
  
  RESULTS
  Adverse events (AEs) commonly occurred as mild and self-limiting. Improvements were observed in most cohorts without evidence of a dose response in Psoriasis Area and Severity Index (50% or greater reduction in PASI score in 40% of patients), Physician's Global Psoriasis Assessment (PGA rating of Good or above in 57% of patients), and Psoriasis Severity Scale (PSS, baseline mean of 7.6 decreased by Study Day 127 to 5.0). An association was observed between reduction in CD3(+) cell count in histologic studies and reduction in PASI score. No antibodies to galiximab were detected.
  
  
  CONCLUSIONS
  Galiximab appears to be safe and well tolerated with preliminary evidence of clinical and histologic response.
authors.affiliation: Clinical Research Center, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ 08901-0019, USA. gottliab@umdnj.edu
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
authors.forename: Sewon
authors.initials: S
authors.lastname: Kang
authors.forename: Kenneth G
authors.initials: KG
authors.lastname: Linden
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
authors.forename: Ahsan A
authors.initials: AA
authors.lastname: Abdulghani
authors.forename: Michael
authors.initials: M
authors.lastname: Goldfarb
authors.forename: Nicole
authors.initials: N
authors.lastname: Chieffo
authors.forename: Mark C
authors.initials: MC
authors.lastname: Totoritis
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D007275:Injections, Intravenous; D015603:Keratinocytes / Q000378:metabolism / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012867:Skin / Q000276:immunology / Q000378:metabolism / Q000473:pathology*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; C437823:galiximab