title: Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension.
abstract: BACKGROUND
  Certolizumab pegol (CZP) is a PEGylated antitumour necrosis factor agent.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of CZP in patients with plaque psoriasis.
  
  
  METHODS
  In a randomized, placebo-controlled, double-blind study, 176 patients with moderate to severe psoriasis received placebo or CZP 400 mg at week 0 followed by placebo or CZP (200 or 400 mg) every other week until week 10. Co-primary endpoints were ≥ 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75) and a Physician's Global Assessment (PGA) of clear-almost clear at week 12. A re-treatment extension study was conducted in 71 CZP PASI 75 responders who relapsed during a 12- to 24-week observation period without treatment.
  
  
  RESULTS
  PASI 75 was achieved by 44/59 (75%), 48/58 (83%) and 4/59 (7%) patients in the CZP 200 mg, CZP 400 mg and placebo groups, respectively (P < 0·001 for both treatment arms vs. placebo). A PGA score of clear-almost clear was achieved by 53%, 72% and 2%, respectively (P < 0·001 for both treatment arms vs. placebo). In the re-treatment study median PASI scores were similar at week 12 in the first treatment and re-treatment periods for both CZP groups. Serious adverse events occurred in 3%, 5% and 2% of CZP 200 mg, CZP 400 mg and placebo patients, respectively.
  
  
  CONCLUSIONS
  Treatment with CZP significantly improved psoriasis at week 12. Similar efficacy was observed at week 12 in patients receiving re-treatment for loss of response after drug withdrawal.
authors.affiliation: Dermatologikum Hamburg, Stephansplatz 5, 20354 Hamburg, Germany. kreich@dermatologikum.de
authors.forename: K
authors.initials: K
authors.lastname: Reich
authors.forename: J-P
authors.initials: JP
authors.lastname: Ortonne
authors.forename: A B
authors.initials: AB
authors.lastname: Gottlieb
authors.forename: I J
authors.initials: IJ
authors.lastname: Terpstra
authors.forename: G
authors.initials: G
authors.lastname: Coteur
authors.forename: C
authors.initials: C
authors.lastname: Tasset
authors.forename: P
authors.initials: P
authors.lastname: Mease
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000068582:Certolizumab Pegol; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011565:Psoriasis / Q000188:drug therapy*; D012008:Recurrence; D019233:Retreatment; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D007140:Immunoglobulin Fab Fragments; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol