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THU0449 Assessment of Disability Levels in A Cohort of 1,489 Patients with Active Psoriatic Arthritis, and The Effect of Apremilast Treatment: Pooled Data from 3 Phase III, Randomized, Controlled Trials
  1. P.J. Mease1,
  2. J. Wollenhaupt2,
  3. S. Hall3,
  4. F. Van den Bosch4,
  5. E. Lespessailles5,
  6. M. McIlraith6,
  7. L. Teng6,
  8. C.J. Edwards7
  1. 1Swedish Medical Center and University of Washington School of Medicine, Seattle, United States
  2. 2Schön Klinik Hamburg Eilbek, Hamburg, Germany
  3. 3Monash University, CabriniHealth, Melbourne, Australia
  4. 4UZ Gent, Gent, Belgium
  5. 5University of Orléans, Orléans, France
  6. 6Celgene Corporation, Summit, United States
  7. 7University Hospital Southampton, Southampton, United Kingdom

Abstract

Background Psoriatic arthritis (PsA) reduces physical function and QoL; a treatment goal is to improve/maintain functionality. PALACE 1 (NCT01172938), 2 (NCT01212757), and 3 (NCT01212770) compared apremilast (APR) efficacy/safety with placebo (PBO) in patients (pts) with active PsA despite prior conventional DMARDs and/or biologics, providing one of the largest databases (N=1,489) examining physical disability in pts with moderate/severe PsA.

Objectives Assess APR 30 mg BID (APR30) treatment impact on disability using the HAQ-DI over 104 wks with PALACE 1–3 pooled data.

Methods Pts were randomized (1:1:1) to PBO, APR30, or APR 20 mg BID (APR20) stratified by baseline (BL) DMARD use (yes/no). At Wk 24, all remaining PBO pts were re-randomized to APR30 or APR20. HAQ-DI scores were collected at BL and Wks 16, 24, 40, 52 65, 78, 91, and 104. Mean change, proportion reaching MCID, and disability levels were calculated; HAQ-DI cutoff levels were ≤1.0 (clinically significant disability1), ≤0.5 (MDA criteria2), and ≤0.25. Score shift categories were examined in 0.25 increments to clarify pt disability level. Wk 16 data, compared with PBO, are analyzed by intent-to-treat/LOCF methodology. Other data shown are as observed to Wk 104. Mean change and MCID outcomes are for all pts receiving treatment with APR30 at any time during the study; for disability level and category shift assessments, data are shown for pts randomized to APR at BL.

Results Pts exhibited significant BL physical disability (mean HAQ-DI=1.2); 60% of APR30 pts had a score >1.0, and 31% >1.5, noting marked difficulty/need for assistive devices in performing activities of daily living. Major disability was noted in 19% with BL HAQ-DI >1.75. As early as Wk 16, physical function improved with APR30; pts exhibited a mean HAQ-DI change of −0.23 (vs −0.08 PBO; P<0.0001), 56% achieved HAQ-DI ≤1.0 at Wk 16 (vs 48% PBO pts), and 29% achieved HAQ-DI ≤0.5 (vs 25% PBO pts). Fewer PBO vs APR30 pts reached the MCID of −0.13 (prespecified analysis; 37% vs 47%; P<0.005) or −0.30 (prespecified analysis)/−0.353 (post hoc analysis) (26% vs 36% for both; P<0.005). At Wk 52, decreases in disability were maintained (APR30 mean change in HAQ-DI=−0.33); 48% of APR30 pts achieved MCID −0.30 and −0.35. Importantly, at Wk 52, 58% of all APR30 pts achieved HAQ-DI ≤1.0, 34% ≤0.5, and 24% ≤0.25 (Table). Among pts with greater BL disability (HAQ-DI ≥1.5), 64% improved by ≥1 shift category and 47% by ≥2. At Wk 104, 50% of APR30 pts achieved MCID of −0.30 and −0.35, with 64% achieving HAQ-DI ≤1.0, 38% ≤0.5, and 28% ≤0.25; LOCF analysis confirmed Wk 104 results.

Conclusions In APR30 pts, physical function improved at Wk 16 and was sustained with long-term treatment. Most pts achieved HAQ-DI MCID −0.30 or −0.35 and HAQ-DI scores ≤1.0, with many obtaining HAQ-DI ≤0.5, defined as minimal disease in recent criteria. These data indicate improvement and long-term maintenance of functionality with APR treatment.

  1. Arthritis Rheum. 2003;48:59–63.

  2. Ann Rheum Dis. 2010;69:48–53.

  3. J Rheumatol. 2011;38:2461–5.

Disclosure of Interest P. Mease Grant/research support from: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB, Celgene Corporation, Novartis, Roche, Consultant for: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB, Celgene Corporation, Novartis, Roche, J. Wollenhaupt Grant/research support from: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB, Consultant for: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB, S. Hall Grant/research support from: Celgene Corporation, Pfizer, UCB, Bristol-Myers Squibb, Glaxo-Smith Kline, Roche, Janssen, Novartis, Merck, Consultant for: Celgene Corporation, Pfizer, UCB, Bristol-Myers Squibb, Glaxo-Smith Kline, Roche, Janssen, Novartis, Merck, F. Van den Bosch Grant/research support from: Celgene Corporation, E. Lespessailles Grant/research support from: Amgen, Celgene, Eli Lilly, Novartis, and Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, and Servier, M. McIlraith Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, C. Edwards Grant/research support from: Celgene Corporation, Pfizer Inc, Roche, Samsung, Consultant for: Celgene Corporation, Pfizer Inc, Roche, Samsung, Speakers bureau: Abbott, Glaxo-SmithKline, Pfizer Inc, Roche

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