gms | German Medical Science

43. Kongress der Deutschen Gesellschaft für Rheumatologie, 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 25. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

02.-05. September 2015, Bremen

Long-term (104-Week) Efficacy and Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Psoriatic Arthritis: Results From a Phase III, Randomized, Controlled Trial and Open-Label Extension (PALACE 1)

Meeting Abstract

  • Arthur Kavanaugh - UCSD, Division of Rheumatology, Allergy and Immunology, La Jolla, United States of America
  • Georg Schett - Universitätsklinikum Erlangen, Medizinische Klinik 3, Rheumatologie und Immunologie, Erlangen
  • Adewale Adebajo - University of Sheffield, Sheffield, United Kingdom
  • D. Gladman - Toronto Western Hospital, Toronto Western Research Institute, Division of Health Care and Outcomes Research, Toronto, Canada
  • Juan Jesús Gomez-Reino - Hospital Clinico Universitario, Medical School, Universidad de Santiago de Compostela, Rheumatologie, Santiago de Compostela, Spanien
  • Stephen Hall - Monash University, Melbourne, Australia, Melbourne, Australia
  • Eric Lespessailles - Centre Hospitalier Régional d'Orléans, Rhumatologie, Orléans, France
  • Philip Mease - Swedish Medical Center and University of Washington, Seattle, United States of America
  • Kamal Shah - Celgene, Drug safety, Warren, United States of America
  • ChiaChi Hu - Celgene Corporation,, Warren, USA
  • Jürgen Wollenhaupt - Schön Klinik Hamburg Eilbek, Klinik für Rheumatologie und klinische Immunologie, Hamburg

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Bremen, 02.-05.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. DocSpA.28

doi: 10.3205/15dgrh234, urn:nbn:de:0183-15dgrh2344

Published: September 1, 2015

© 2015 Kavanaugh et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at



Introduction: PALACE 1 compared apremilast (APR) efficacy/safety with placebo in patients with active psoriatic arthritis despite prior conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics. We report APR efficacy/safety over 104 weeks.

Methods: Patients were randomized (1:1:1) to placebo, APR 30 mg BID (APR30), or APR 20 mg BID (APR20) stratified by baseline DMARD use (yes/no). Patients whose swollen and tender joint counts had not improved ≥20% at Week 16 were considered non-responders and were required to be re-randomized (1:1) to APR30 or APR20 if initially randomized to placebo, or continued on their initial APR dose. At Week 24, all remaining placebo patients were re-randomized to APR30 or APR20. Double-blind APR treatment continued to Week 52; patients could continue APR up to an additional 4 years.

Results: 504 patients received ≥1 dose of placebo (n=168), APR30 (n=168), or APR20 (n=168). At Week 52, 53.2% (APR30) and 59.6% (APR20) of patients achieved modified ACR20 responses; ≈80% (285/344) of patients completing Week 52 were still receiving APR at the data cutoff during year 2. At Week 104, APR patients demonstrated sustained improvements in modified ACR (20%/50%/70%) response (APR30: 65.3%/34.0%/19.6%; APR20: 60.9%/32.4%/16.5%); swollen/tender joint count mean percent change (APR30: -77.3%/-71.0%; APR20: -67.6%/-67.1%); Health Assessment Questionnaire-Disability Index mean change (APR30: -0.41; APR20: -0.31); 28-joint count Disease Activity Score (C-reactive protein) mean change (APR30: -1.84; APR20: -1.64); 28-joint count Disease Activity Score (C-reactive protein) <2.6 achievement (APR30: 38.9%; APR20: 32.9%); and 75%/50% reduction from baseline Psoriasis Area and Severity Index response (APR30: 29.6%/54.9%; APR20: 31.6%/52.6%). No new safety concerns occurred through Week 104. Nasopharyngitis and upper respiratory tract infection occurred in ≥5% of APR-exposed patients (Weeks >52-≤104); most adverse events (AEs) were mild/moderate with no long-term increase in incidence/severity. Diarrhea/nausea rates were lower in Weeks >52-≤104 (1.7%/1.2%) vs. Weeks 0 to ≤52 (15.3%/12.4%). Serious AEs occurred in 4.7% (APR30) and 6.4% (APR20) (Weeks >52-≤104). Fewer discontinuations due to AEs occurred during Weeks >52-≤104 (1.5%) vs. Weeks 0-≤52 (8.2%).

Conclusion: Over 104 weeks, APR demonstrated sustained, clinically meaningful improvements in psoriatic arthritis signs/symptoms, physical function, and psoriasis; had an acceptable safety profile; and was generally well tolerated.