Efficacy and safety of etanercept in psoriasis and psoriatic arthritis in the PRESTA study: analysis in patients from Central and Eastern Europe

Abstract

Background: Data are limited on the effectiveness of anti-TNF and other biologics on psoriatric arthritis (PsA) in Central and Eastern Europe (CEE). The objective of this analysis was to evaluate the efficacy of etanercept (ETN) in PsA patients from CEE.

Methods: In PRESTA, patients were randomized to receive ETN 50 mg BIW or 50 mg QW for 12 weeks (double-blind phase) and ETN 50 mg QW for 12 additional weeks (open label). In this analysis, only patients from Czech Republic, Hungary, Poland and Serbia were included. The primary efficacy variable was the proportion of subjects achieving a physician global assessment (PGA) of psoriasis status: “clear” or “almost clear” at week 12.

Results: In the 307 patients, 54% BIW/QW compared with 40% (QW/QW) (p = .02), achieved “clear”/”almost clear” for PGA of psoriasis at week 12 increasing, to 68% and 60%, respectively (p = .134) by week 24. Mean improvement from baseline in PASI were 59% versus 49% (p = .005) at week 6 and 87% versus 81% (p < .05) at week 24, for the BIW/QW and QW/QW groups, respectively. ETN was well tolerated in both groups over 24 weeks.

Conclusions: Both dose regimens of ETN provided significant improvements in efficacy in PsA treatment and were well tolerated.

Keywords:

• Efficacy
• etanercept
• psoriatic arthritis
• safety

Acknowledgements

We wish to thank all patients who participated in the trial and investigators of the participating centers.

Disclosure statement

ND has received grant support from Pfizer, MSD, Abbvie, Roche; consultant fees from Pfizer, Abbvie, Roche; speaker fees from Pfizer, MSD, Abbvie, Roche, Gedeon Richter, Boehringer Ingelheim. SK has received institutional funding for research and/or honoria for consulting/and or conference support from Novartis, Bristol- Mayer Squibb, Pfizer, Janssen. LK has received honoraria from Pfizer, Novartis, Abbvie, Janssen, Lilly, Galderma, Richter, Ewopharma Ltd. NB has no disclosures. BB has received research support from Pfizer, J&J, Abbvie, Ablinx; speaker fees from Gedeon Richter, Boehringer Ingelheim. MM has received consultancy fees from Roche, MSD, Celgene, Pfizer; speaker fees from MSD, Roche, Medac, Pfizer, Abbvie, UCB, Berliner Chemie; investigator fees from Sanofi, BMS, UCB, HGS. WT has received honorarium from Pfizer and Biogen; congress participation sponsorship from Roche and Abbvie; speaker fees from Roche, Medac, Gedeon Richter.

ED has received investigator fees from Pfizer. PV has no disclosures. AS is an employee of inVentiv Health and was a paid contractor of Pfizer to provide statistical support for the development of this paper. EA is a full-time employee of Pfizer.

Additional information

Funding

The PRESTA study was sponsored by Pfizer. Medical writing support was provided by John Bilbruck and Paul Oakley of Engage Scientific Solutions, and was funded by Pfizer.