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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.

AbstractBACKGROUND:
Certolizumab pegol (CZP) is a PEGylated antitumour necrosis factor agent.
OBJECTIVES:
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.
AuthorsK Reich, J-P Ortonne, A B Gottlieb, I J Terpstra, G Coteur, C Tasset, P Mease
JournalThe British journal of dermatology (Br J Dermatol) Vol. 167 Issue 1 Pg. 180-90 (Jul 2012) ISSN: 1365-2133 [Electronic] England
PMID22413944 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright© 2012 The Authors. BJD © 2012 British Association of Dermatologists.
Chemical References
  • Antibodies, Monoclonal, Humanized
  • Dermatologic Agents
  • Immunoglobulin Fab Fragments
  • Polyethylene Glycols
  • Certolizumab Pegol
Topics
  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects)
  • Certolizumab Pegol
  • Dermatologic Agents (administration & dosage, adverse effects)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulin Fab Fragments (administration & dosage, adverse effects)
  • Male
  • Middle Aged
  • Polyethylene Glycols (administration & dosage, adverse effects)
  • Psoriasis (drug therapy)
  • Recurrence
  • Retreatment
  • Treatment Outcome
  • Young Adult

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