Abstract | BACKGROUND: 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.
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Authors | K Reich, J-P Ortonne, A B Gottlieb, I J Terpstra, G Coteur, C Tasset, P Mease |
Journal | The British journal of dermatology
(Br J Dermatol)
Vol. 167
Issue 1
Pg. 180-90
(Jul 2012)
ISSN: 1365-2133 [Electronic] England |
PMID | 22413944
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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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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