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SAT0436 Durability of apremilast response in patients with psoriatic arthritis: long-term (208-week) results from the palace 1 trial
  1. A Kavanaugh1,
  2. DD Gladman2,
  3. JJ Gomez-Reino3,
  4. S Hall4,
  5. E Lespessailles5,
  6. PJ Mease6,
  7. G Schett7,
  8. M McIlraith8,
  9. N Delev8,
  10. M Paris8,
  11. L Teng8,
  12. J Wollenhaupt9
  1. 1UCSD School of Medicine, la Jolla, United States
  2. 2Toronto Western Research Institute, Toronto, Canada
  3. 3Hospital Clínico Universitario, Santiago, Spain
  4. 4Monash University, CabriniHealth, Melbourne, Australia
  5. 5University of Orléans, Orléans, France
  6. 6Swedish Medical Center and University of Washington School of Medicine, Seattle, United States
  7. 7University of Erlangen-Nuremberg, Erlangen, Germany
  8. 8Celgene Corporation, Summit, United States
  9. 9Schön Klinik Hamburg Eilbek, Hamburg, Germany

Abstract

Background Optimizing treatment choice in psoriatic arthritis (PsA) necessitates an understanding of the long-term effects of therapies across varied manifestations of this complex disease. Data from 4 years of apremilast (APR) treatment in PALACE 1 were used to examine disease control across markers of active inflammation, such as SJC, as well as improvements in patient (pt) functionality, as assessed using the HAQ-DI.

Objectives Evaluate long-term outcomes with APR treatment after ≥1 DMARD or biologic in pts with active PsA.

Methods Pts were randomized (1:1:1) to placebo (PBO), APR 30 mg BID (APR30), or APR 20 mg BID (APR20). The PBO-controlled phase continued to Wk 24, at which time all remaining PBO pts were re-randomized to APR30 or APR20. Double-blind APR treatment continued to Wk 52; pts could continue APR for up to 4 additional years in an open-label extension.

Results 504 pts were randomized and received ≥1 dose of study medication (PBO: n=168; APR30: n=168; APR20: n=168); 86.9% (225/259) of pts entering the third year completed 208 wks of APR treatment; overall, this is 44.6% (225/504) of pts randomized at baseline (BL). At Wk 52, 53.2% of APR30 pts achieved a modified ACR20 response (Table), regardless of when APR was started (BL, Wk 16, or Wk 24). At Wk 208, a sustained response rate was observed in APR30 pts, as shown by an ACR20 response rate of 67.5%. Marked improvements in SJC were seen throughout the study, with a mean percent decrease of −84.2% at Wk 208; TJC reductions were consistent (Table). Functionality is of paramount importance to pts; large improvements were seen in HAQ-DI score, with a mean change of −0.47. Pts also note fatigue as a disease- or treatment-related impairment; a mean improvement of 5.7 was seen in FACIT-F score at Wk 208 (Table), and the pt population reached a mean score of 35.7. In addition, long-term treatment led to the maintenance of the proportions meeting the minimal clinically important difference in HAQ-DI score change, achieving ACR50/ACR70 responses and reaching PASI-75 and PASI-50 responses (Table). No new safety concerns were identified with APR treatment up to 208 wks. During Wks >156 to ≤208, the only adverse event (AE) occurring in ≥5% of APR30-exposed pts was URTI (5.2%); most AEs were mild/moderate in severity. Among APR30-exposed pts, serious AEs occurred in 6.7% of pts in Wks >156 to ≤208, consistent with earlier data. Importantly, few discontinuations due to AEs occurred throughout the long-term treatment period.

Conclusions APR30 demonstrated sustained, clinically meaningful improvements in signs and symptoms of PsA, physical function, and associated psoriasis over 208 wks. APR30 continued to demonstrate a favorable safety profile and was generally well tolerated.

Disclosure of Interest A. Kavanaugh Grant/research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, UCB, D. Gladman Grant/research support from: AbbVie, Amgen, BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB, Consultant for: AbbVie, Amgen, BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB, J. Gomez-Reino Grant/research support from: Roche and Schering-Plough, Consultant for: BMS, Pfizer, Roche, Schering-Plough, UCB, S. Hall Consultant for: Boehringer Ingelheim, MSD, Roche, Schering-Plough, Servier, Wyeth, Paid instructor for: Amgen, AstraZeneca, Boehringer Ingelheim, Centocor, GSK, MSD, Pfizer, Sanofi Aventis, Sanofi Pasteur, Schering-Plough, Serono, Wyeth, Speakers bureau: Boehringer Ingelheim, GSK, MSD, Pfizer, Roche, Sanofi Aventis, Schering-Plough, Wyeth, E. Lespessailles Grant/research support from: Amgen, Eli Lilly, Novartis, Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, Servier, P. Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Genentech, Janssen, Eli Lilly, Novartis, Pfizer, Roche, UCB, Consultant for: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Genentech, Janssen, Eli Lilly, Novartis, Pfizer, Roche, UCB, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Genentech, Janssen, Eli Lilly, Pfizer, UCB, G. Schett Grant/research support from: Abbott, Celgene Corporation, Roche, UCB, Consultant for: Abbott, Celgene Corporation, Roche, UCB, M. McIlraith Employee of: Celgene Corporation, N. Delev Employee of: Celgene Corporation, M. Paris Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, J. Wollenhaupt Grant/research support from: Abbott, BMS, MSD, Pfizer, UCB, Consultant for: Abbott, BMS, MSD, Pfizer, UCB

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