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AB0805 Long-Term Impact of Apremilast on Physical Function in Patients with Psoriatic Arthritis Using the HAQ-DI Assessment
  1. F. Zhang1,
  2. Z. Clancy1,
  3. S. Li1,
  4. A. Kavanaugh2,
  5. A. Adebajo3,
  6. J. Wollenhaupt4
  1. 1Celgene Corporation, Warren
  2. 2University of California, San Diego, United States
  3. 3University of Sheffield, Sheffield, United Kingdom
  4. 4Schön Klinik Hamburg Eilbek, Hamburg, Germany

Abstract

Background The safety and efficacy of apremilast (APR), including improvements in physical disability, were compared with placebo in the PALACE 1 study of patients who had active psoriatic arthritis despite prior conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics. Physical function is a substantial burden in patients with psoriatic arthritis, and the Health Assessment Questionnaire-Disability Index (HAQ-DI) is commonly used in clinical trials to assess this impairment.1

Objectives Assess the long-term (104-week) impact of APR therapy on physical function in patients enrolled in the PALACE 1 study.

Methods Patients were randomized (1:1:1) to receive placebo, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no). Patients whose swollen and tender joint counts had not improved by ≥20% at Week 16 were considered non-responders and were required to be re-randomized (1:1) to APR20 or APR30 if they were initially randomized to placebo, or continued on their initial APR dose. At Week 24, all patients remaining on placebo were re-randomized to APR20 or APR30. Treatment efficacy analysis at Week 16 was performed based on the intent-to-treat population, and analyses at Week 52 and Week 104 were based on data as observed. Physical function, a prespecified secondary end point, was measured in patients using the Health Assessment Questionnaire-Disability Index (HAQ-DI) scores. Proportion of patients achieving minimal clinically important differences (MCID) in the HAQ-DI score (improvements of ≥0.13 or ≥0.30 from baseline) were collected.

Results At Week 16, the change from baseline in physical function was significantly improved with APR30 vs. placebo, as measured by the HAQ-DI score (Table). Improvements in physical function were maintained at Weeks 52 and 104. At Week 52, 59.8% (APR30) and 60.0% (APR20) of patients achieved HAQ-DI MCID ≥0.13 and 44.7% (APR30) and 45.8% (APR20) achieved MCID ≥0.30. At Week 104, 62.4% (APR30) and 57.7% (APR20) achieved HAQ-DI MCID ≥0.13 and 54.5% (APR30) and 51.5% (APR20) achieved MCID ≥0.30.

Conclusions Patients treated with APR30 reported clinically meaningful improvements in physical function compared with those treated with placebo, as measured by the HAQ-DI scores at Week 16. Improvements in physical function were maintained long term at Weeks 52 and 104

References

  1. Lee S, et al. The burden of psoriatic arthritis. P&T 2010;35:680-689.

  2. Kwok T, Pope JE. J Rheumatol 2010;37:1024-1028.

  3. Mease PJ, et al. Ann Rheum Dis 2004;63(Suppl 1):391.9.

Disclosure of Interest F. Zhang Employee of: Celgene Corporation, Z. Clancy Employee of: Celgene Corporation, S. Li Employee of: Celgene Corporation, 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, A. Adebajo: None declared, 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

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