A randomized study comparing the combination of nbUVB and etanercept to etanercept monotherapy in patients with psoriasis who do not exhibit an excellent response after 12 weeks of etanercept

Abstract

Background: There is a lack of data on the combination of phototherapy with etanercept in patients who have not shown an excellent response to etanercept monotherapy. Objectives: To study the combination of narrow-band ultraviolet B (nbUVB) phototherapy with etanercept in patients not demonstrating an improvement of 90% in their Psoriasis Area Severity Index (PASI-90) after 12 weeks of etanercept. Patients and methods: Psoriatic patients not reaching PASI-90 after 12 weeks of etanercept therapy were randomized (1:1) to receive either etanercept (50 mg once a week) monotherapy or in combination with nbUVB three times weekly for periods of 4 weeks. Results: Seventy-five patients were randomized. Only 21.6% of patients achieved adherence of 80% or more for nbUVB treatments. At week 24, PASI-90 was reached by 16.2% of patients in the etanercept plus nbUVB group when compared with 15.8% of patients in the etanercept monotherapy group (p = 1.000). In patients with high adherence to nbUVB, the PASI-90 at week 16 was 42.9% for etanercept with nbUVB when compared with 3.4% for etanercept monotherapy (p = 0.018). Both treatments were well tolerated. Conclusion: Addition of nbUVB after 12 weeks of etanercept did not significantly improve the clinical response except for a subset of patients with high adherence to nbUVB.Clinical Trials Registration number: NCT00640393.

Key words::

• etanercept
• ultraviolet B
• psoriasis
• tumor necrosis factor antagonist
• phototherapy

Declaration of interest: Research funded and study medication provided by Amgen Canada, Inc., and Wyeth, A Pfizer Company. Dr. Lynde has been an investigator, speaker, clinical researcher, and/or consultant for Abbott, Amgen/Wyeth, Astellas, EMD Serono, Galderma, Graceway, Leo Pharma, Merck Frosst, Sanofi Aventis, Schering Plough, Stiefel, and Ortho Bio Centocor. He has received compensation in the form of grants and/or honoraria. Dr. Guenther has been an investigator, speaker, advisory board member, and consultant for the following companies: Abbott, Amgen, Astellas, Biogen Idec, Centocor, EMD Serono, Galderma, Leo Pharma, Novartis, and Schering. Dr. Guenther has been a speaker, advisory board member, and consultant for Wyeth. Dr. Guenther has been an investigator for Celgene. Dr. Guenther has received compensation in the form of grants and/or honoraria. Dr. Gupta has received grants and/or honoraria from Abbott Laboratories, LeoPharma, Merck, and Pfizer. Dr. Poulin has been an investigator and/or speaker and/or member of advisory boards for Abbott, Advitech, Amgen, Astellas-Biogen, Boehringer-Ingelheim, Bristol-Myers-Squibb, Celgene, Centocor, Galderma, GSK, Isotechnika, Janssen-Ortho, Janssen-CILAG, Johnson & Johnson, LeoPharma, Lilly, Merck-Serono, Novartis, Pfizer, Pharmascience, Schering-Plough, and Wyeth. He has received compensation in the form of grants and/or honoraria. Ms. Levesque is a full-time employee of Innovaderm Research. Robert Bissonnette has been a speaker, consultant, advisory board member, and/or investigator and has received honoraria and/or grants from Abbott, Amgen, Astellas, Boehringer-Ingelheim, Celgene, Centocor, Isotechnika, Janssen-Ortho, LeoPharma, Merck, Merck-Serono, Novartis, Pfizer, and is a full-time employee of Innovaderm Research. Research funded and medication provided by Amgen Canada, Inc., and Wyeth, A Pfizer Company. Neither company was involved in study design, data collection, data analysis, manuscript preparation, or publication decisions.