title: The treatment of moderate to severe psoriasis with a new anti-CD11a monoclonal antibody.
abstract: BACKGROUND
  Anti-CD11a (hu1124) is a humanized monoclonal antibody directed against the CD11a subunit of LFA-1. This study investigated whether treatment with anti-CD11a antibody provides clinical benefit to patients with moderate to severe plaque psoriasis.
  
  
  METHODS
  This was a double-blind, placebo-controlled, phase II, multicenter study. In total, 145 patients with minimum Psoriasis Area and Severity Index scores of 12 and affected body surface area of 10% or more were sequentially enrolled into low-dose (0.1 mg/kg, n = 22) or high-dose (0.3 mg/kg, n = 75) groups. Within groups, patients were randomized to treatment or placebo (n = 48) in a 2:1 ratio. Drug was administered intravenously at weekly intervals for 8 weeks.
  
  
  RESULTS
  The percentage of subjects achieving more than 50% improvement in physician's global assessment at day 56 (1 week after final dose) was 15% and 48% for placebo and 0.3 mg/kg of drug, respectively (P =.002). A physician's global assessment of excellent (>75% improvement) was greater in the 0.3 mg/kg group versus placebo (25% vs 2%, P =.0003). Average Psoriasis Area and Severity Index scores at day 56 were 13.9 +/- 7.5 (placebo) and 10.9 +/- 8.4 (0.3 mg/kg) (P <.0001). Epidermal thickness was reduced in the 0.3 mg/kg group compared with the placebo group (37% vs 19%, P =.004). Treatment was well tolerated; mild to moderate flu-like complaints were the most common adverse events. White blood cell counts and lymphocyte counts transiently increased. Depletion of circulating lymphocytes did not occur.
  
  
  CONCLUSIONS
  Anti-CD11a antibody administered intravenously in 8 weekly doses of 0.3 mg/kg was well tolerated and induced clinical and histologic improvements in psoriasis.
authors.affiliation: Probity Medical Research, 30 Union St. East, Waterloo, Ontario N2J 1B7, Canada. kapapp@probitymedical.com
authors.forename: K
authors.initials: K
authors.lastname: Papp
authors.forename: R
authors.initials: R
authors.lastname: Bissonnette
authors.forename: J G
authors.initials: JG
authors.lastname: Krueger
authors.forename: W
authors.initials: W
authors.lastname: Carey
authors.forename: D
authors.initials: D
authors.lastname: Gratton
authors.forename: W P
authors.initials: WP
authors.lastname: Gulliver
authors.forename: H
authors.initials: H
authors.lastname: Lui
authors.forename: C W
authors.initials: CW
authors.lastname: Lynde
authors.forename: A
authors.initials: A
authors.lastname: Magee
authors.forename: D
authors.initials: D
authors.lastname: Minier
authors.forename: J P
authors.initials: JP
authors.lastname: Ouellet
authors.forename: P
authors.initials: P
authors.lastname: Patel
authors.forename: J
authors.initials: J
authors.lastname: Shapiro
authors.forename: N H
authors.initials: NH
authors.lastname: Shear
authors.forename: S
authors.initials: S
authors.lastname: Kramer
authors.forename: P
authors.initials: P
authors.lastname: Walicke
authors.forename: R
authors.initials: R
authors.lastname: Bauer
authors.forename: R L
authors.initials: RL
authors.lastname: Dedrick
authors.forename: S S
authors.initials: SS
authors.lastname: Kim
authors.forename: M
authors.initials: M
authors.lastname: White
authors.forename: M R
authors.initials: MR
authors.lastname: Garovoy
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000276:immunology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007958:Leukocyte Count; D018655:Lymphocyte Count; D016169:Lymphocyte Function-Associated Antigen-1 / Q000276:immunology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D016169:Lymphocyte Function-Associated Antigen-1