ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1561

Apremilast, an Oral Phosphodiesterase 4 Inhibitor, and the Impact of Baseline Weight and BMI on ACR20 and HAQ-DI Response: Pooled Results from 3 Phase 3, Randomized, Controlled Trials

Georg A. Schett1, Philip J. Mease2, Dafna D. Gladman3, Arthur Kavanaugh4, Adewale O. Adebajo5, Juan J. Gomez-Reino6, Jurgen Wollenhaupt7, Maurizio Cutolo8, Eric Lespessailles9, ChiaChi Hu10, Randall M. Stevens10, Christopher J. Edwards11 and Charles A. Birbara12, 1Dept of Medicine 3, Rheumatology and Clinical Immunology, University of Erlangen-Nuremberg, Erlangen, Germany, 2Swedish Medical Center and University of Washington, Seattle, WA, 3University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, 4University of California San Diego, La Jolla, CA, 5University of Sheffield, Sheffield, United Kingdom, 6Rheumatology, Hospital Clinico Universitario, Santiago, Spain, 7Schoen-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, 8Research Laboratory and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Genoa, Italy, 9University of Orléans, Orléans, France, 10Celgene Corporation, Warren, NJ, 11University Hospital Southampton, Southampton, United Kingdom, 12University of Massachusetts Medical School, Worcester, MA

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords:

Session Information

Title: Spondyloarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment II

Session Type: Abstract Submissions (ACR)

Background/Purpose: Apremilast (APR) is a phosphodiesterase 4 inhibitor that helps to regulate the immune response that causes inflammation and skin disease associated with psoriatic arthritis (PsA). PALACE 1, 2, and 3 compared the efficacy and safety of APR with placebo in patients with active PsA despite prior disease-modifying antirheumatic drugs (DMARDs) and/or biologics, including biologic failures. We assessed the impact of baseline weight and body mass index (BMI) on clinical response to APR over 24 weeks in a pooled analysis.

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 apremilast dose. At Week 24, all remaining placebo patients were re-randomized to APR20 or APR30.

Results: 1,493 patients were randomized, received ≥1 dose of study medication (placebo: n=496; APR20: n=500; APR30: n=497), and were comparable across treatment groups for demographics, disease characteristics, and prior/concurrent therapy. At baseline, mean (SD) weight was 85.7 (20.6) kg and mean (SD) BMI was 29.9 (6.5) kg/m2. At Week 16, a significantly greater proportion of patients receiving APR20 or APR30 achieved a modified ACR20 response vs placebo (primary endpoint) in all 3 PALACE trials. APR30 was associated with significant improvements in Health Assessment Questionnaire-Disability Index (HAQ-DI) score vs placebo at Week 16 (key secondary endpoint) across all 3 trials. At Week 16, similar ACR20 response rates and improvements in HAQ-DI scores were observed across all weight and BMI ranges (Table). A favorable treatment effect for both APR treatment groups vs placebo was observed, irrespective of baseline body weight or BMI. Overall, the treatment effect was dose-dependent, with greater effects generally observed in APR30 patients over APR20 patients. These treatment effects were generally maintained at Week 24.

Conclusion: APR demonstrated a favorable treatment effect in patients with active PsA. Comparable improvements in the signs and symptoms of PsA and physical function were observed across a broad range of baseline weight and BMI values. Results suggest that no dose adjustment is required to account for baseline body weight or BMI.

 

Disclosure:

G. A. Schett,

Abbott, Celgene Corporation, Roche, and UCB,

2,

Abbott, Celgene Corporation, Roche, and UCB,

5;

P. J. Mease,

Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB, Celgene Corporation, Novartis, and Roche,

2,

Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCBCelgene Corporation, Novartis, and Roche ,

5,

Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, and UCB,

8;

D. D. Gladman,

AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB,

2,

AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB,

5;

A. Kavanaugh,

Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB,

2;

A. O. Adebajo,
None;

J. J. Gomez-Reino,

Bristol-Myers Squibb, Pfizer Inc, Roche, Schering-Plough, and UCB SA,

9,

Bristol-Myers Squibb, Roche, Schering-Plough, and Wyeth,

9,

Roche and Schering-Plough,

2;

J. Wollenhaupt,

Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB,

2,

Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB,

5;

M. Cutolo,

Actelion, Bristol-Myers Squibb, and Sanofi-Aventis,

2,

Actelion, Bristol-Myers Squibb, and Sanofi-Aventis,

5;

E. Lespessailles,

Amgen, Eli Lilly, Novartis, and Servier,

2,

Amgen, Eli Lilly, Novartis, and Servier,

8;

C. Hu,

Celgene Corporation,

3,

Celgene Corporation,

1;

R. M. Stevens,

Celgene Corporation,

1,

Celgene Corporation,

3;

C. J. Edwards,

Celgene Corporation, Pfizer Inc, Roche, and Samsung,

2,

Celgene Corporation, Pfizer Inc, Roche, and Samsung,

5,

Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche,

8;

C. A. Birbara,

Amgen, Bristol-Myers Squibb, Incyte, Eli Lilly, Merck, and Pfizer Inc,

2.

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