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SAT0448 Apremilast treatment and long-term (up to 156 weeks) improvements in dactylitis and enthesitis in patients with psoriatic arthritis: analysis of a large database of the phase iii clinical development program
  1. DD Gladman1,
  2. A Kavanaugh2,
  3. JJ Gomez-Reino3,
  4. J Wollenhaupt4,
  5. M Cutolo5,
  6. G Schett6,
  7. E Lespessailles7,
  8. M McIlraith8,
  9. C Hu8,
  10. CJ Edwards9,
  11. CA Birbara10,
  12. PJ Mease11
  1. 1Toronto Western Hospital, Toronto, Canada
  2. 2University of California, San Diego, School of Medicine, la Jolla, United States
  3. 3Hospital Clínico Universitario, Santiago, Spain
  4. 4Schön Klinik Hamburg Eilbek, Hamburg, Germany
  5. 5University of Genova, Genova, Italy
  6. 6University of Erlangen-Nuremberg, Erlangen, Germany
  7. 7University of Orléans, Orléans, France
  8. 8Celgene Corporation, Summit, United States
  9. 9University Hospital Southampton, Southampton, United Kingdom
  10. 10University of Massachusetts Medical School, Worcester
  11. 11Swedish Medical Center and University of Washington School of Medicine, Seattle, United States

Abstract

Background Dactylitis and enthesitis, hallmark features of psoriatic arthritis (PsA), may be difficult to manage. PALACE 1, 2, and 3 compared the efficacy and safety of apremilast (APR) with placebo (PBO) in patients (pts) with active PsA despite prior conventional DMARDs and/or biologics.

Objectives Report the impact of long-term APR 30 mg BID (APR30) treatment on dactylitis and enthesitis in pts with active PsA.

Methods Pts were randomized (1:1:1) to PBO, APR30, or APR 20 mg BID (APR20) stratified by baseline (BL) DMARD use (yes/no). After the 24-wk PBO-controlled phase, all pts received APR30 or APR20 and could enroll in long-term follow-up. Data for pts entering the study with pre-existing dactylitis or enthesitis were pooled across PALACE 1–3, as prespecified, to allow for robust analysis. Dactylitis count (number of digits [hands/feet] with dactylitis present [0=absence, 1=presence]; range: 0–20) was used to assess dactylitis improvement. Enthesitis was evaluated based on MASES (range: 0–13), indicating the number of painful entheses out of 13 enthesis sites. Wk 24 analyses used LOCF for missing values and data for early escape pts; Wks 52 and 156 used data as observed.

Results Among pts with dactylitis (n=610) or enthesitis (n=915) at BL and ≥1 post-BL value, BL mean dactylitis counts ranged from 3.2 to 3.4 and MASES ranged from 4.4 to 4.8. At Wk 24, mean change in dactylitis count was −1.8 (APR30) vs −1.3 (PBO) (P=0.0097); more APR30 pts achieved a dactylitis count of 0 vs PBO pts (Table). Mean change in MASES was −1.3 (APR30) vs −0.9 (PBO) (P=0.0194); more APR30 pts achieved a MASES of 0 vs PBO pts. Significant effect on enthesitis was confirmed in the PSA-006 (ACTIVE) study of APR in pts with a maximum of 1 previous DMARD treatment, in which the Gladman Enthesitis Index was used, focusing on more peripheral sites of activity: significant effect for APR vs PBO was seen as early as Wk 2, and at Wk 24, mean changes were −1.5 vs −0.5 (P=0.0032, MMRM). Sustained improvements in dactylitis and enthesitis severity were seen in APR pts at Wk 156 in PALACE 1–3 (Table): for dactylitis, 79.6% achieved a count of 0 and the mean percent change was −83.6%; for MASES, 55.0% of APR pts achieved a score of 0 and the mean percent change was −65.2%.

Conclusions The majority of pts (63%) in PALACE 1–3 had active enthesitis and 42% had dactylitis at BL. APR30 demonstrated early and long-term benefit (up to 156 wks) in treating dactylitis and enthesitis, including resolution of BL disease in many pts.

Disclosure of Interest 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, A. Kavanaugh Grant/research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, UCB, J. Gomez-Reino Grant/research support from: Roche and Schering-Plough, Consultant for: BMS, Pfizer, Roche, Schering-Plough, UCB, J. Wollenhaupt Grant/research support from: Abbott, BMS, MSD, Pfizer, UCB, Consultant for: Abbott, BMS, MSD, Pfizer, UCB, M. Cutolo Grant/research support from: Actelion, BMS, Sanofi-Aventis, Consultant for: Actelion, BMS, Sanofi-Aventis, G. Schett Grant/research support from: Abbott, Celgene Corporation, Roche, UCB, Consultant for: Abbott, Celgene Corporation, Roche, UCB, E. Lespessailles Grant/research support from: Amgen, Eli Lilly, Novartis, Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, Servier, M. McIlraith Employee of: Celgene Corporation, C. Hu Employee of: Celgene Corporation, C. Edwards Grant/research support from: Celgene Corporation, Pfizer, Roche, Samsung, Consultant for: Celgene Corporation, Pfizer, Roche, Samsung, Speakers bureau: Abbott, GSK, Pfizer, Roche, C. Birbara Grant/research support from: Amgen, BMS, Incyte, Eli Lilly, Merck, Pfizer, 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

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