Article Text

PDF
THU0432 Apremilast, An Oral Phosphodiesterase 4 Inhibitor, Is Associated with Long-Term (104-Week) Improvement in Fatigue in Patients with Psoriatic Arthritis: Pooled Results from 3 Phase III, Randomized, Controlled Trials
  1. A. Kavanaugh1,
  2. D.D. Gladman2,
  3. C.J. Edwards3,
  4. A. Poder4,
  5. F. Lioté5,
  6. P. Bird6,
  7. G. Schett7,
  8. D. Nguyen8,
  9. L. Teng8,
  10. P.J. Mease9
  1. 1University of California, San Diego, School of Medicine, La Jolla, United States
  2. 2Toronto Western Research Institute, Toronto, Canada
  3. 3University Hospital Southampton, Southampton, United Kingdom
  4. 4Clinical Research Centre Ltd, Tartu, Estonia
  5. 5University Paris Diderot, Paris, France
  6. 6University of New South Wales, Kogarah, Australia
  7. 7University of Erlangen-Nuremberg, Erlangen, Germany
  8. 8Celgene Corporation, Summit
  9. 9Swedish Medical Center and University of Washington School of Medicine, Seattle, United States

Abstract

Background Fatigue, a common symptom affecting individuals with psoriatic arthritis (PsA), is associated with decreased quality of life and loss of work productivity.1 The 2014 OMERACT PsA Working Group identified fatigue measurement as an important outcome to consider including in PsA core assessments.2 The PALACE 1 (NCT01172938), 2 (NCT01212757), and 3 (NCT01212770) studies compared apremilast (APR) efficacy/safety, including fatigue level, with placebo (PBO) in patients (pts) with active PsA despite prior conventional DMARDs and/or biologics.

Objectives Report APR treatment impact on fatigue over 104 wks in a pooled analysis of the PALACE 1–3 studies.

Methods Pts were randomized (1:1:1) to PBO, APR 30 mg BID (APR30), or APR 20 mg BID (APR20) stratified by baseline DMARD use. The PBO-controlled phase continued to Wk 24, with a Wk 16 early escape option. At Wk 24, all remaining PBO pts were re-randomized to APR30 or APR20. Double-blind APR treatment continued to Wk 52; pts could then continue to receive open-label APR up to an additional 4 years. Fatigue was assessed using FACIT-F v4 and SF-36v2 Vitality domain (VT).3 Total FACIT-F scores range from 0–52; lower scores denote higher fatigue levels. As a point of reference, mean fatigue scores of 40.1–43.6 in the general population,4,5 35.8 in PsA pts,6 and 23.9 in anemic cancer pts5 have been reported, and FACIT-F MCID in PsA has not been determined; this analysis used FACIT-F MCID in rheumatoid arthritis pts (3–4).7 SF-36v2 VT, a subscale of SF-36v2, measures physical and mental impact of fatigue on individuals.8 Scores are norm-based; group values <47 represent a below-average range vs the general population.9

Results Baseline mean FACIT-F (29.4–30.9) and SF-36v2 VT (40.6–40.8) scores were below population norms. Long-term improvement in fatigue was seen in APR pts at Wks 52 and 104 (mean FACIT-F=35.0), marking a shift toward population FACIT-F norms (Table). APR30 mean change was 5.6, with 50.9% of pts achieving FACIT-F MCID. Similarly, improvements in SF-36v2 VT scores were observed at Wks 52 and 104 with $≈ $60% of pts achieving MCID. Over 104 wks, most AEs were mild/moderate; in general, no increase was seen in AE incidence/severity with longer term exposure.

Conclusions APR-treated pts experienced improvements in fatigue, as measured by FACIT-F and SF-36 VT scores. Over 104 wks, clinically meaningful improvements were maintained. APR demonstrated an acceptable safety profile and was generally well tolerated up to 104 wks.

  1. Swain. Clin Sci (Lond). 2000;99:1–8.

  2. Tillett. J Rheumatol. 2015;42:2198–2203.

  3. Yellen. J Pain Symptom Manage. 1997;13:63–74.

  4. Webster. Health Qual Life Outcomes. 2003;179.

  5. Cella. Cancer. 2002;94:528–38.

  6. Chandran. Ann Rheum Dis. 2007;66:936–9.

  7. Cella. J Rheumatol. 2005;32:811–9.

  8. Ware. Med Care. 1992;30:473–83.

  9. Advantages of norm-based scoring. In Ware, ed. User's Manual for the SF-36v2 Health Survey. 2nd ed. Lincoln, RI: QualityMetric Incorporated; 2007.

Disclosure of Interest A. Kavanaugh Grant/research support from: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB, Consultant for: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB, D. Gladman Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, 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. Poder Grant/research support from: Celgene Corporation, F. Lioté: None declared, P. Bird Grant/research support from: Celgene Corporation, G. Schett Grant/research support from: Abbott, Celgene Corporation, Roche, UCB, Consultant for: Abbott, Celgene Corporation, Roche, UCB, D. Nguyen Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, P. Mease Grant/research support from: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, and UCB, Consultant for: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, and UCB, Speakers bureau: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, and UCB

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.