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Abstract Number: 1565

Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated with Improvement of Pain, Fatigue, and Disability in Patients with Psoriatic Arthritis: Results from 3 Phase 3, Randomized, Controlled Trials

Dafna D. Gladman1, Vibeke Strand2, Arthur Kavanaugh3, Philip J. Mease4, Christopher J. Edwards5, Maurizio Cutolo6, Frédéric Lioté7, Paul Bird8, Randall M. Stevens9, Lichen Teng9, Marla Hochfeld9 and Georg A. Schett10, 1University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, 2Stanford University, Portola Valley, CA, 3University of California San Diego, La Jolla, CA, 4Swedish Medical Center and University of Washington, Seattle, WA, 5University Hospital Southampton, Southampton, United Kingdom, 6Research Laboratory and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Genoa, Italy, 7Rheumatology Department, University Paris Diderot, Paris, France, 8Combined Rheumatology Practice, Kogarah, Australia, 9Celgene Corporation, Warren, NJ, 10Dept of Medicine 3, Rheumatology and Clinical Immunology, University of Erlangen-Nuremberg, Erlangen, Germany

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Psoriatic arthritis

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Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: Apremilast (APR) is an oral phosphodiesterase 4 inhibitor that helps regulate the immune response that causes inflammation and skin disease associated with psoriatic arthritis (PsA). The PALACE 1, 2, and 3 trials compared the efficacy and safety of APR with placebo in patients with active PsA despite prior conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics, including biologic failures.

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. This analysis reports data over 52 weeks.

Results: In the pooled PALACE 1-3 population, a significantly greater proportion of patients receiving APR20 and APR30 achieved a modified ACR20 response vs placebo at Week 16 (placebo: 18.8%; APR20: 32.0% [P<0.0001]; APR30: 37.0% [P<0.0001]) (primary endpoint). At Week 16, significant improvements were observed with APR20 and APR30 (PALACE 1-3, pooled) for multiple patient-reported outcomes compared with placebo (placebo; APR20; and APR30, respectively): least-squares (LS) mean changes in Health Assessment Questionnaire-Disability Index (HAQ-DI) (-0.07; -0.16 [P=0.0009]; and -0.21 [P<0.0001), pain visual analog scale (VAS) (-5.8; -10.7 [P=0.0009]; and -12.7 [P <0.0001]), 36-item Short-Form Health Survey version 2 (SF-36v2) physical component summary (PCS) (1.9; 3.3 [P=0.0016]; and 3.9 [P<0.0001]), and SF-36v2 Physical Functioning (PF) domain (1.3; 2.7 [P=0.0057]; and 3.6 [P<0.0001]) scores. APR30 also significantly improved the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 16 (1.1; 1.5 [P=NS]; and 3.5 [P<0.0001]). In patients initially randomized to APR who completed Week 52, improvements were sustained at Week 52 across the individual studies (Table). The most common adverse events reported for up to 24 weeks of APR treatment were diarrhea (12.2%), nausea (10.1%), and headache (8.0%) (PALACE 1-3; pooled). The safety profile of APR through 52 weeks was similar to that observed with APR for up to 24 weeks of treatment.

Conclusion: Among patients continuously treated with APR, sustained clinically meaningful improvements in patient-reported outcome measures of pain, physical function, and fatigue were observed through Week 52. APR demonstrated an acceptable safety profile and was generally well tolerated through 52 weeks.

 

Impact of APR on Parameters of Pain, Disability, and Fatigue at Week 52
(Data as Observed)

 

PALACE 1

PALACE 2

PALACE 3

Mean Change From Baseline

APR20

n=124

APR30

n=130

APR20

n=125

APR30

n=114

APR20

n=120

APR30

n=126

HAQ-DI (0-3)*

-0.37

-0.32

-0.19

-0.33

-0.33

-0.35

Pain VAS
(0-100 mm)*

-17.8

-20.3

-13.5

-12.9

-14.9

-18.7

SF-36v2 PCS (0-100 mm)µ

7.8

6.5

5.1

6.4

6.3

5.9

SF-36v2 PF
(0-100 mm)µ

7.0

5.7

4.1

5.0

5.7

5.9

FACIT-fatigue (0-52)µ

4.3

3.7

2.5

4.4

4.8

6.2

Note: The n reflects the number of patients who completed 52 weeks; actual number of patients available for each endpoint may vary. *Decrease indicates improvement. µIncrease indicates improvement.

 



Disclosure:

D. D. Gladman,

Abbvie, Amgen, Celgene, Janssen, Pfizer, UCB,

2,

Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB,

5;

V. Strand,

Afferent Pharmaceuticals, Inc.,

5;

A. Kavanaugh,

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

2;

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;

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;

M. Cutolo,

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

2,

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

5;

F. Lioté,

Celgene Corporation,

2,

Celgene Corporation,

5;

P. Bird,

Celgene Corporation,

2;

R. M. Stevens,

Celgene Corporation,

1,

Celgene Corporation,

3;

L. Teng,

Celgene Corporation,

1,

Celgene Corporation,

3;

M. Hochfeld,

Celgene Corporation,

1,

Celgene Corporation,

3;

G. A. Schett,

Abbott, Celgene Corporation, Roche, and UCB,

2,

Abbott, Celgene Corporation, Roche, and UCB,

5.

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