The efficacy and safety of etanercept when used with as-needed adjunctive topical therapy in a randomised, double-blind study in subjects with moderate-to-severe psoriasis (the PRISTINE trial)

Abstract

Objective: To assess the efficacy and safety of two etanercept dose regimens for psoriasis treatment. Methods: Subjects were ≥18 years old with stable moderate-to-severe plaque psoriasis. Subjects were randomised to etanercept 50 mg once weekly (QW) or 50 mg twice weekly (BIW) double-blind for 12 weeks, followed by 50 mg QW open label in all subjects through week 24. Only mild topical corticosteroids were permitted on scalp, axillae and groin for first 12 weeks; topical medications (corticosteroids of all potencies, vitamin D analogues and combination products) were allowed as needed for second 12 weeks at physicians' discretion, consistent with “real-world” therapeutic practice. An independent ethics committee reviewed and approved the study protocol. Results: At week 24, 59.9% and 78.2% in the QW/QW and BIW/QW groups achieved PASI 75 improvement. Mean percentage PASI improvement in these groups was 58.5% and 74.1% at week 12 and 70.7% and 81.3% at week 24. Although permitted from weeks 12 to 24, topical agents were used in only 27.7% and 22.6% in the QW/QW and BIW/QW groups by week 24. Conclusion: Both etanercept regimens were efficacious in moderate-to-severe psoriasis, although the BIW/QW regimen consistently provided higher response rates than the QW/QW regimen. More potent topical medications were used electively in <25% of subjects in each group.

Key words::

• etanercept
• psoriasis
• treatment efficacy
• safety
• corticosteroids
• vitamin D analogue

Acknowledgments

The authors would like to thank Heather Jones and Annette Szumski at Pfizer Inc for assistance with data analysis and statistical content and for assistance with the manuscript preparation, as well as Michael E. Kuligowski, MD, at Pfizer Inc for editorial support. We also thank the PRISTINE trial investigators, their staffs and subjects for their participation in the trial. In addition to the authors Robert Strohal, Luis Puig, Edgardo Chouela and Tsen-Fang Tsai, the PRISTINE trial investigators include Peter Altmeyer, Bochum, Germany; Mario Amaya-Guerra, Nuevo León, Mexico; Matthias Augustin, Hamburg, Germany; Hugo Cabrera, Buenos Aires, Argentina; Petra Cetkovska, Plzen-Bory, Czech Republic; Jozef De Weert, Gent, Belgium; Stefan Duban, Jihlava, Czech Republic; Dagmar Galatikova, Bruntal, Czech Republic; Ricardo Galimberti, Buenos Aires, Argentina; Pierre-Dominique Ghislain, Brussels, Belgium; Minerva Gomez, Nuevo León, Mexico; Zsuzsanna Karolyi, Miskolc, Hungary; Sarolta Karpati, Budapest, Hungary; Andreas Katsambas, Athens, Greece; Lajos Kemeny, Szeged, Hungary; Joo-Heung Lee, Seoul, Korea; Woan Lee, Taipei, Taiwan; Ulrich Mrowietz, Kiel, Germany; Nopadon Noppakun, Bangkok, Thailand; Ketty Peris, L'Aquila, Italy; Natta Rajatanavin, Bangkok, Thailand; Eva Remenyik, Debrecen, Hungary; Johannes Ring, Muenchen, Germany; Thomas Rosenbach, Osnabrueck, Germany; Michael Sticherling, Erlangen, Germany; Diamant Thaci, Frankfurt, Germany; Guadalupe Villanueva, Jalisco, Mexico; and Jai II Youn, Seoul, Korea.

Declaration of interest: The PRISTINE trial was sponsored by Pfizer Inc. Editorial/medical writing support was provided by Donna McGuire at UBC Scientific Solutions and was funded by Pfizer Inc. Robert Strohal has been a paid consultant of and has received research grants from Pfizer Inc, which provided funding for the PRISTINE study. He is also a member of the Pfizer European Expert Board and of the Pfizer Speakers Bureau. Luis Puig has been a paid consultant of and has received research grants from Pfizer; he has served on Pfizer advisory boards and the Speakers Bureau. Edgardo Chouela is a paid consultant and speaker for Pfizer Inc and Galderma and has conducted clinical studies for Novartis, Jannssen, Pfizer and Roche. Tsen-Fang Tsai has been a paid consultant of Pfizer Inc; he has served as an investigator and received honoraria for serving as an advisor and speaker for Pfizer. Jeffrey Melin, Bruce Freundlich and Charles Molta were previous employees of Wyeth and Pfizer Inc. Joanne Fuiman, Ronald Pedersen and Deborah Robertson are current employees of Pfizer Inc.