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FRI0512 Apremilast, an oral phosphodiesterase 4 inhibitor, is associated with long-term (156-week) improvements in basdai in psoriatic arthritis patients: pooled results from 3 phase iii, randomized, controlled trials
  1. PJ Mease1,
  2. H Marzo-Ortega2,
  3. A Poder3,
  4. F Van den Bosch4,
  5. J Wollenhaupt5,
  6. E Lespessailles6,
  7. M McIlraith7,
  8. L Teng7,
  9. S Hall8
  1. 1Swedish Medical Center and University of Washington School of Medicine, Seattle, United States
  2. 2NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals and University of Leeds, Leeds, United Kingdom
  3. 3Clinical Research Centre Ltd, Tartu, Estonia
  4. 4UZ Gent, Gent, Belgium
  5. 5Schön Klinik Hamburg Eilbek, Hamburg, Germany
  6. 6University of Orléans, Orléans, France
  7. 7Celgene Corporation, Summit, United States
  8. 8Monash University, CabriniHealth, Melbourne, Australia

Abstract

Background In PALACE psoriatic arthritis (PsA) studies, the Bath Ankylosing Spondylitis Disease Activity Index score (BASDAI) was used as an exploratory measure in a subset of patients (pts) considered by investigators to have axial involvement, although PsA spondylitis was not confirmed by imaging.

Objectives Report the impact of apremilast 30 mg BID (APR) treatment on BASDAI over 156 wks using pooled PALACE 1–3 data of pts with active PsA despite prior conventional DMARDs and/or biologics.

Methods APR treatment outcomes were evaluated in a subset of pts with baseline (BL) BASDAI ≥4 (“subset”) over 156 wks.

Results BL BASDAI ≥4 was reported for 454/1493 (30%) pts. Mean PsA duration was similar between the subset and rest of the PALACE 1–3 population (n=1039); mean BL psoriasis body surface area (BSA) and percentage of pts with BSA ≥3% were slightly higher. The subset had higher mean BL values vs the rest of PALACE 1–3 pts for C-reactive protein (1.12 vs 0.93), pain VAS (63.6 vs 53.8 mm), pt's global assessment of disease activity (62.2 vs 53.5 mm), and physician's global assessment of disease activity (PhGA; 59.0 vs 53.0 mm) and markedly worse mean HAQ-DI (1.41 vs 1.08), SF-36v2 Physical Functioning (30.6 vs 35.8), and FACIT-F (25.7 vs 31.8) scores. Despite disease activity differences, BL concomitant oral DMARDs were similar in both groups: 1 DMARD in 61.0% (subset) vs 57.8% (rest of PALACE 1–3 pts); methotrexate was the most common DMARD. In the subset, 73.6% had been treated with only oral DMARDs prestudy (44.9% with only 1); 25.1% had prior biologic use. Mean BL BASDAI in the subset was 6.6 with APR and 6.4 with placebo (PBO). Mean BL BASDAI question 2 score, referring directly to spinal and hip pain, was 6.7. APR resulted in greater mean improvement in BASDAI vs PBO at Wk 16 (−1.53 vs −0.91; P=0.0173) and Wk 24 (Table). As early as Wk 16, a 19% mean decrease in the question 2 score was seen with APR vs an increase with PBO. Other disease measures significantly improved early in treatment, including HAQ-DI, fatigue, PhGA, and mPsARC (Table). Long-term improvement was seen across measures, with mean BASDAI reductions of 2.18 at Wk 52 and 2.19 at Wk 156 (Table) and question 2 reductions of 1.94 and 2.28, respectively; treatment resulted in a shift toward lower BASDAI across the subset, with a significant proportion reaching BASDAI <4.

Conclusions In this post hoc analysis of pooled data, pts reporting BASDAI ≥4 at BL appear to experience greater disease burden, including disability, pain, and fatigue; effective treatment strategies may not have been available. APR treatment resulted in long-term improvements in BASDAI and other measures in pts with clinically suspected axial disease.

Disclosure of Interest 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, H. Marzo-Ortega: None declared, A. Poder: None declared, F. Van den Bosch Consultant for: AbbVie, Celgene Corporation, Merck, Pfizer, UCB, Janssen, J. Wollenhaupt Grant/research support from: Abbott, BMS, MSD, Pfizer, UCB, Consultant for: Abbott, BMS, MSD, Pfizer, 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, L. Teng Employee of: Celgene Corporation, 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

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