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SAT0562 Long-Term (104-Week) Efficacy and Safety of Apremilast Monotherapy in Dmard-Naïve Patients with Psoriatic Arthritis: A Phase 3, Randomized, Controlled Trial and Open-Label Extension (Palace 4)
  1. A. Wells1,
  2. C. Edwards2,
  3. A. Adebajo3,
  4. A. Kivitz4,
  5. P. Bird5,
  6. K. Shah6,
  7. C. Hu6,
  8. J. Aelion7
  1. 1Rheumatology and Immunotherapy Center, Franklin, United States
  2. 2University Hospital Southampton, Southampton
  3. 3University of Sheffield, Sheffield, United Kingdom
  4. 4Altoona Center for Clinical Research, Duncansville, United States
  5. 5Combined Rheumatology Practice, Kogarah, Australia
  6. 6Celgene Corporation, Warren
  7. 7West Tennessee Research Institute, Jackson, United States

Abstract

Background Apremilast (APR) is an oral phosphodiesterase 4 inhibitor that helps regulate the immune response that causes joint inflammation and other manifestations of psoriatic arthritis (PsA), including skin disease.

Objectives Compare the efficacy and safety of APR monotherapy with placebo (PBO) in patients with active PsA who were DMARD-naïve for up to 104 weeks.

Methods Patients were randomized (1:1:1) to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). Patients whose swollen/tender joint counts (SJC/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 they were initially randomized to PBO, or continued on their initial APR dose. At Week 24, all remaining PBO patients were re-randomized to APR20 or APR30. Double-blind treatment continued to Week 52; patients could continue to receive APR for up to 4 additional years.

Results 527 patients were included in the modified intent-to-treat population in which patients who were randomized in error and did not receive study medication were excluded (PBO: n=176; APR20: n=175; APR30: n=176). At Week 52, a modified ACR20 response was achieved by 58.0% (119/205 [APR30]) and 55.4% (107/193; [APR20]) of patients (Table); $≈ $84% of patients completing 1 year of APR treatment were maintained on therapy at the data cutoff during their second year of APR exposure. At Week 104, patients taking APR demonstrated sustained improvements, as shown by modified ACR20/ACR50/ACR70 response rates, SJC/TJC mean percent change, HAQ-DI mean change, proportion of patients with HAQ-DI exceeding the MCID ≥0.30 threshold, changes in MASES and dactylitis severity scores, and PASI-50/PASI-75 responses (Table). During Weeks >52 to ≤104, the most common adverse events (AEs) among APR-exposed patients were upper respiratory tract infection (4.8%) and nasopharyngitis (3.2%); serious AEs occurred in 5.3%. In general, no change in the types of AEs and no increase in the incidence/severity of AEs were seen with longer-term exposure. Diarrhea and nausea occurred at lower rates in Weeks >52 to ≤104 vs. Weeks 0 to ≤52.

Conclusions Over 104 weeks, APR monotherapy demonstrated sustained response and improvements in PsA signs/symptoms, including enthesitis, dactylitis, physical function, and psoriasis. The ACR20 response was 61% for patients receiving APR30 therapy for 2 years. APR continued to demonstrate an acceptable safety profile and was generally well tolerated.

Disclosure of Interest A. Wells Grant/research support from: Celgene Corporation, C. Edwards Grant/research support from: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Consultant for: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Speakers bureau: Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche, A. Adebajo: None declared, A. Kivitz Grant/research support from: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc, and UCB, Consultant for: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc, and UCB, Speakers bureau: Pfizer Inc, P. Bird Grant/research support from: Celgene Corporation, K. Shah Employee of: Celgene Corporation, C. Hu Employee of: Celgene Corporation, J. Aelion Grant/research support from: Ardea, Astra Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer Inc, Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Consultant for: Ardea, Astra Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer Inc, Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Speakers bureau: AbbVie, Amgen, and UCB

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