Abstract
Psoriasis, a chronic inflammatory skin disease, is characterized by periods of remission and relapse of lesions. Etanercept is approved for treatment of moderate-to-severe plaque psoriasis (25 mg twice weekly or 50 mg weekly). This review of three clinical trials evaluated the efficacy and safety of long-term, continuous (≥48 weeks) etanercept therapy in 1887 subjects with moderate-to-severe psoriasis (total exposure: 2458.0 subject-years). Efficacy end points across the three studies included: percent subjects achieving improvement of ≥75% from baseline in the Psoriasis Area and Severity Index; mean percentage improvement from baseline of Psoriasis Area and Severity Index; mean Physician’s Global Assessment psoriasis score; and Dermatology Life Quality Index total score (mean percentage improvement from baseline). Safety was also assessed. This article summarizes the sustained efficacy of long-term continuous etanercept therapy, which was generally consistent across the three trials. There were no new or unexpected safety signals with up to 144 weeks of continuous etanercept therapy. Long-term continuous etanercept therapy may be an option for some psoriasis patients.
Acknowledgements
The authors thank David Qu for assistance with statistical content, Wenzhi Li for reviewing the literature on problems with dichotomous variables, and Robyn Boyle, RPh and Precise Publications, LLC, for assistance in drafting and revising the manuscript with direction of the authors, in accordance with standards of the International Committee of Medical Journal Editors.
Financial & competing interests disclosure
These clinical trials were sponsored by Amgen Inc. and Wyeth Research, which was acquired by Pfizer Inc. in October 2009, and they were responsible for the collection and analysis of data. The authors and the sponsor were involved in the study design, interpretation of data, manuscript preparation and decision to publish. All statistical analyses were performed by the Global Biostatistics and Programming Department of Wyeth Research. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit the report for publication.
Kim A Papp has acted as an investigator, speaker or consultant and advisory board member for Abbott, Alza, Amgen, Astellas, Celgene, Centocor, Isotechnika, Janssen-Cilag, Janssen Ortho Biotech, Johnson & Johnson, MedImmune, Merck Serono, Pfizer, Schering-Plough and Wyeth/Pfizer. Gregor BE Jemec has acted as an investigator or Advisory Board member for Abbott, Actelion, Astion, Basilea, Centocor, Coloplast, Jansen-Cilag, Leo, MSD and Wyeth/Pfizer. Charles Molta, Deborah Robertson, Joanne Estojak, Ronald Pedersen, Robert Boggs and Joanne Foehl are all employees or former employees of Pfizer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing assistance funded by Wyeth/Pfizer was utilized in the production of this manuscript. Robyn Boyle, RPh with Precise Publications, LLC was responsible for assistance in drafting and revising the manuscript.