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

Authors


  • Funding sources
    This study was funded by UCB Pharma, Brussels, Belgium. UCB was involved in the design and conduct of the study, data collection, data management, data analysis, interpretation of the data and manuscript review and approval.

  • Conflicts of interest
    K.R. has served as consultant and/or paid speaker for and/or has participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Abbott, Biogen Idec, Celgene, Centocor, Janssen-Cilag, Leo, Medac, Merck, MSD (formerly Essex, Schering-Plough), Novartis and Pfizer (formerly Wyeth). J.-P.O. is a consultant for Abbott, Centocor, Galderma, Janssen-Cilag, Leo, Meda Pharma, Merck Serono and UCB Pharma. A.B.G. has current consulting/advisory board agreements with Amgen, Astellas, Centocor (Janssen), Celgene, Bristol-Myers Squibb, Beiersdorf, Abbott, TEVA, Actelion, UCB Pharma, Novo Nordisk, Novartis, Dermipsor, Incyte, Pfizer, Canfite, Merck and Lilly. Research/educational grants paid to Tufts Medical Center: Centocor (Janssen), Amgen, Immune Control, Abbott, Novo Nordisk, UCB Pharma, Novartis, Celgene and Pfizer. I.J.T. and G.C. are full-time employees of UCB Pharma. C.T. is a former employee of UCB Pharma. P.M. has served as consultant and/or paid speaker for and has received grants, consulting and/or speaker fees from Abott Amgen, Biogen Idec, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Merck, Pfizer and UCB Pharma.

Kristian Reich.
E-mail: kreich@dermatologikum.de

Summary

Background  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 (< 0·001 for both treatment arms vs. placebo). A PGA score of clear-almost clear was achieved by 53%, 72% and 2%, respectively (< 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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