Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomised, placebo-controlled trial with a re-treatment extension
Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P; British Journal of Dermatology (Mar 2012)
Source: Br J Dermatol
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Background: Certolizumab pegol (CZP) is a PEGylated anti-tumour necrosis factor agent.
Objective: To evaluate the efficacy and safety of CZP in patients with plaque psoriasis.
Methods: In a randomised, 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 score (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 12-24 week observation period without treatment.
Results: PASI 75 was achieved by 44/59 (74.6%), 48/58 (82.8%) and 4/59 (6.8%) patients in the CZP 200, 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 52·5%, 72·4% and 1·7%, 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 3·3%, 5·3% and 1·7% of CZP 200, 400 mg and placebo patients, respectively.
Conclusion: 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.