gms | German Medical Science

42. Kongress der Deutschen Gesellschaft für Rheumatologie, 28. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 24. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

17.-20. September 2014, Düsseldorf

Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with Psoriatic Arthritis: Results of phase 3, randomized, placebo-controlled trials (PALACE 1, 2, and 3)

Meeting Abstract

  • Georg Schett - Universitätsklinikum Erlangen, Medizinische Klinik 3, Rheumatologie und Immunologie, Erlangen
  • Sergio Chimenti - University of Rome Tor Vergata, Department of Dermatology, Rom, Italien
  • Francisco J. Blanco - INIBIC-Hospital Universitario A Coruña, Coruña, Spanien
  • Frank Behrens - CIRI am Klinikum der Johann Wolfgang Goethe-Universität, Rheumatologie, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main
  • Arthur Kavanaugh - UCSD, Division of Rheumatology, Allergy and Immunology, La Jolla, United States of America
  • Kim Papp - Probity Medical Research, Waterloo, Kanada
  • Randal Stevens - Celgene Corporation, Summit, NJ, United States of America
  • ChiaChi Hu - Celgene Corporation, Warren, USA
  • Christopher Edwards - Southampton University Hospitals NHS Trust, Southampton General Hospital, Department of Rheumatology, Southampton, United Kingdom
  • Markus Altmann - Celgene GmbH, München

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 42. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 28. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 24. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Düsseldorf, 17.-20.09.2014. Düsseldorf: German Medical Science GMS Publishing House; 2014. DocSP.09

doi: 10.3205/14dgrh242, urn:nbn:de:0183-14dgrh2424

Published: September 12, 2014

© 2014 Schett et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Background: PALACE 1, 2, and 3 compared the efficacy/safety of apremilast (APR) with placebo in patients with active PsA despite prior conventional DMARDs and/or biologics.

Methods: Patients were randomized (1:1:1) to placebo, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no). Patients whose SJC and TJC had not improved by ≥20% at Week 16 were considered non-responders and were required to be re-randomized (1:1) to APR20 or APR30 if initially randomized to placebo, or continued on their initial apremilast dose. At Week 24, all remaining placebo patients were re-randomized to APR20 or APR30.

Results: At Week 16, significantly more APR20 and APR30 patients achieved an ACR20 (primary endpoint) vs. placebo (P≤0.0295, APR vs. PBO). Significantly more APR20 (18.8%-20.9%) and APR30 (22.0%-22.2%) patients with baseline psoriasis BSA ≥3% achieved PASI-75 vs. placebo (2.7%-7.9%) (P≤0.0134, APR vs. placebo). Improvements in PsA and psoriasis signs/symptoms were maintained over 52 weeks in patients receiving APR from baseline. In patients with baseline enthesitis or dactylitis, median percent change in MASES and dactylitis count was not significant with APR20 or APR30 vs. placebo at Week 16, except for MASES in PALACE 1 (P=0.0466, APR20 vs. placebo). Clinically meaningful improvements from baseline in MASES and dactylitis count were observed at Week 52. Median percent change from baseline in MASES at Week 52 was -60.0% to -100.0% (APR20) and -60.0% to -66.7% (APR30). Median percent change from baseline in dactylitis count was -100.0% with APR20 and APR30 in PALACE 1-3. The most common AEs reported in patients treated with APR up to 24 weeks (PALACE 1-3, pooled) were diarrhea (12.2%), nausea (10.1%), and headache (8.0%). The APR safety profile through 52 weeks was similar to that observed with APR for up to 24 weeks of treatment.

Conclusion: APR demonstrated clinically meaningful improvements in PsA at Week 52, including signs/symptoms, enthesitis, dactylitis, and psoriasis. APR demonstrated an acceptable safety profile and was generally well-tolerated through 52 weeks.