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Abstract Number: 1564

Long-Term (104-Week) Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Results from a Phase 3, Randomized, Controlled Trial and Open-Label Extension

Philip J. Mease1, Adewale O. Adebajo2, Dafna D. Gladman3, Juan J. Gomez-Reino4, Stephan Hall5, Arthur Kavanaugh6, Eric Lespessailles7, Georg A. Schett8, Kamal Shah9, Randall M. Stevens9, Lichen Teng9 and Jürgen Wollenhaupt10, 1Swedish Medical Center and University of Washington, Seattle, WA, 2University of Sheffield, Sheffield, United Kingdom, 3University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, 4Rheumatology, Hospital Clinico Universitario, Santiago, Spain, 5Cabrini Health and Monash University, Melbourne, Australia, 6University of California San Diego, La Jolla, CA, 7University of Orléans, Orléans, France, 8Dept of Medicine 3, Rheumatology and Clinical Immunology, University of Erlangen-Nuremberg, Erlangen, Germany, 9Celgene Corporation, Warren, NJ, 10Schön Klinik Hamburg Eilbek, Hamburg, Germany

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Psoriatic arthritis

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Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: Apremilast (APR), a phosphodiesterase 4 inhibitor, helps regulate the immune response that causes inflammation and skin disease associated with psoriatic arthritis (PsA). PALACE 1, a phase 3 randomized trial with an open-label extension, compared the efficacy/safety of APR with placebo (PBO) in pts with active PsA despite prior conventional DMARDs and/or biologics.

Methods: Pts were randomized (1:1:1) to receive PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no). Pts whose swollen/tender joint counts had not improved ≥20% at Wk 16 were considered non-responders and were re-randomized (1:1) to APR20 or APR30 (PBO pts) or continued on their initial dose (APR pts). At Wk 24, all remaining PBO pts were re-randomized to APR20 or APR30. Double-blind APR treatment continued to Wk 52; pts could continue to receive APR during an open-label, long-term treatment phase. The analysis reports safety findings from the APR-exposure period (Wks 0 to ≤104).

Results: 504 pts were randomized and received ≥1 dose of study medication (PBO: n=168; APR20: n=168; APR30: n=168). A total of 490 (410.3 pt-years) and 344 (306.2 pt-years) pts received APR in the Wk 0 to ≤52 and Wk >52 to ≤104 APR-exposure periods, respectively. During the Wk >52 to ≤104 period, AEs occurring in ≥5% of APR-exposed pts were nasopharyngitis and URTI (Table). Most AEs were mild/moderate in severity between Wks >52 to ≤104 and in general, no increase was seen in the incidence or severity of AEs with longer term exposure. During the Wk >52 to ≤104 exposure period, diarrhea and nausea occurred at lower rates (1.7% and 1.2%, respectively) than in the Wk 0 to ≤52 period (15.3% and 12.4%, respectively). Serious AEs occurred in 6.4% (APR20 ) and 4.7% (APR30) over the Wk >52 to ≤104 APR-exposure period.Through Wk 104, serious infections were reported by 5 pts receiving APR during Wks 0 to ≤52 and 3 pts receiving APR during Wks >52 to ≤104; none were opportunistic infections. No cases of tuberculosis (new or reactivation) were reported with either APR dose. Discontinuations due to AEs occurred at a lower rate in the combined APR-exposure pts during the Wk >52 to ≤104 (1.5%) APR-exposure period than in Wks 0 to ≤52 (8.2%). Discontinuation rates due to diarrhea and nausea also decreased over the Wk >52 to ≤104 APR-exposure period. Marked laboratory abnormalities were generally infrequent and returned to baseline with continued treatment or were associated with a concurrent medical condition.

Conclusion: APR demonstrated an acceptable safety profile and was generally well tolerated for up to 104 wks, with no new safety concerns identified with long-term exposure. These data continue to support that specific laboratory monitoring is not needed with APR.

 

APR-Exposure Period*

Wks 0 to ≤52

APR-Exposure Period*

Wks >52 to ≤104

Patients, n (%)

APR20

n=245

APR30

n=245

APR20

n=173

APR30

n=171

≥1 AE

171 (69.8)

178 (72.7)

108 (62.4)

101 (59.1)

≥1 serious AE

14 (5.7)

21 (8.6)

11 (6.4)

8 (4.7)

≥1 serious infection

2 (0.8)

3 (1.2)

2 (1.2)

1 (0.6)

AE leading to drug withdrawal

17 (6.9)

23 (9.4)

2 (1.2)

3 (1.8)

Death

1 (0.4)µ

0 (0.0)

0 (0.0)

1 (0.6)‡

AEs in ≥5% of patients, any treatment group, n (%)

Diarrhea

28 (11.4)

47 (19.2)

3 (1.7)

3 (1.8)

Nausea

24 (9.8)

37 (15.1)

3 (1.7)

1 (0.6)

Headache

22 (9.0)

24 (9.8)

6 (3.5)

8 (4.7)

URTI

20 (8.2)

15 (6.1)

15 (8.7)

8 (4.7)

Nasopharyngitis

18 (7.3)

16 (6.5)

7 (4.0)

12 (7.0)

*Includes all patients who received APR during the time interval relative to the start of APR. µMultiorgan failure not suspected to be treatment related. ‡Patient died in a motor vehicle accident on study day 489 while receiving APR 30.

 



Disclosure:

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;

A. O. Adebajo,
None;

D. D. Gladman,

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

2,

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

5;

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;

S. Hall,

Celgene Corporation, Pfizer, UCB, Bristol-Myers Squibb, Glaxo-Smith Kline, Roche, Janssen, Novartis, Merck,

2,

Celgene Corporation, Pfizer, UCB, Bristol-Myers Squibb, Glaxo-Smith Kline, Roche, Janssen, Novartis, Merck,

5;

A. Kavanaugh,

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

2;

E. Lespessailles,

Amgen, Eli Lilly, Novartis, and Servier,

2,

Amgen, Eli Lilly, Novartis, and Servier,

8;

G. A. Schett,

Abbott, Celgene Corporation, Roche, and UCB,

2,

Abbott, Celgene Corporation, Roche, and UCB,

5;

K. Shah,

Celgene Corporation,

1,

Celgene Corporation,

3;

R. M. Stevens,

Celgene Corporation,

1,

Celgene Corporation,

3;

L. Teng,

Celgene Corporation,

1,

Celgene Corporation,

3;

J. Wollenhaupt,

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

2,

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

5.

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