Article
Apremilast, an Oral Phophodiesterase 4 Inhibitor, Is Associated With Long-term (52-Week) Improvements in Enthesitis and Dactylitis in Patients With Psoriatic Arthritis: Results From the PALACE 4 Phase 3, Randomized, Controlled Trial
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Authors
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Christopher Edwards
- Southampton University Hospitals NHS Trust, Southampton General Hospital, Department of Rheumatology, Southampton, United Kingdom
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Jürgen Wollenhaupt
- Schön Klinik Hamburg Eilbek, Klinik für Rheumatologie und klinische Immunologie, Hamburg
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Adewale Adebajo
- University of Sheffield, Sheffield, United Kingdom
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Alan Kivitz
- Altoona Center for Clinical Research, Duncansville, United States of America
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Paul Bird
- University of New South Wales, Kogarah, Australia, Kogarah, Australia
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ChiaChi Hu
- Celgene Corporation,, Warren, USA
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Jacob A. Aelion
- West Tennessee Research Institute, Jackson, TN, USA, Jackson, USA
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Alvin F. Wells
- Rheumatology and Immunotherapy Center, Franklin, WI, USA, Franklin, USA
| Published: | September 1, 2015 |
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Outline
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Introduction: Apremilast (APR), an oral phosphodiesterase 4 inhibitor, helps regulate immune responses in psoriatic arthritis (PsA). PALACE 4 compared the efficacy and safety of APR with placebo in patients with active PsA who were DMARD-naïve. We evaluated the impact of APR treatment over 52 weeks on enthesitis and dactylitis.
Methods: Patients were randomized (1:1:1) to placebo, APR 30 mg BID (APR30), or APR 20 mg BID (APR20). The placebo-controlled phase continued to Week 24, with an early escape option at Week 16. Double-blind APR treatment continued to Week 52. Enthesitis was evaluated based on MASES (0-13), indicating the number of painful entheses out of 13 sites. The dactylitis count (0-20) is the number of digits (hands/feet) with dactylitis present.
Results: At Week 16, significantly more APR-treated patients achieved a modified ACR20 response vs. placebo (primary endpoint). Patients initially randomized to APR with enthesitis or dactylitis at baseline and continuing on APR over 52 weeks demonstrated improvements in enthesitis and dactylitis over 52 weeks, as evidenced by reductions in MASES and dactylitis count. At Week 16, mean percent changes in MASES were 13.3% (placebo), -32.2% (APR30; P=0.0052), and -6.7% (APR20; P=0.2806). At Week 52, mean percent changes in MASES were -43.2% (APR30) and -35.5% (APR20) in patients initially randomized to APR; 45.9% (APR30) and 39.6% (APR20) of patients achieved a MASES of 0, indicating no pain at any entheses. At Week 16, mean percent changes in dactylitis count were -22.4% (placebo), -46.7% (APR30; P=0.0795), and -49.7% (APR20; P=0.0394). At Week 52, mean decreases in dactylitis count were 75.0% (APR30) and 52.8% (APR20) in patients initially randomized to APR; 68.8% (APR30) and 68.6% (APR20) of patients achieved a dactylitis count of 0. The safety profile of APR for up to 52 weeks was similar to that observed for up to 24 weeks of treatment (placebo-controlled period).
Conclusion: Among patients treated with APR through 52 weeks, sustained improvements in enthesitis and dactylitis were observed in DMARD-naive patients with active PsA who had enthesitis or dactylitis at baseline. APR demonstrated an acceptable safety profile and was generally well tolerated for up to 52 weeks.
