UMMS Affiliation

Division of Rheumatology, Department of Medicine

Publication Date

2018-06-27

Document Type

Article

Disciplines

Clinical Trials | Musculoskeletal Diseases | Pathological Conditions, Signs and Symptoms | Pharmaceutical Preparations | Rheumatology | Skin and Connective Tissue Diseases | Therapeutics

Abstract

Objective: The Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) clinical trial programme findings demonstrated that apremilast, an oral phosphodiesterase 4 inhibitor, is effective for treating psoriatic arthritis (PsA). Enthesitis and dactylitis are difficult-to-treat features of PsA leading to disability and affecting quality of life. PALACE 1, 2 and 3 data were pooled to assess the efficacy of apremilast on enthesitis and dactylitis outcomes in patients with these conditions at baseline.

Methods: Patients with enthesitis (n=945) or dactylitis (n=633) at baseline were analysed after receiving double-blind treatment with placebo, apremilast 30 mg two times per day or apremilast 20 mg two times per day up to 52 weeks and continuing up to 5 years. Data were analysed through 156 weeks. Enthesitis was evaluated by Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) and dactylitis via dactylitis count.

Results: At week 24, patients receiving apremilast 30 mg two times per day demonstrated a significantly greater mean change in enthesitis (-1.3 vs -0.9; p < 0.05) and dactylitis (-1.8 vs -1.3; p < 0.01) vs placebo. Patients in the 30 mg dose group showed significantly greater mean (-23.6% vs -7.0%; p < 0.05) and median (-50.0% vs -21.1%; p < 0.05) per cent changes in MASES; mean and median per cent changes in dactylitis count were numerically, but not significantly, different for either apremilast dose in patients with dactylitis. In the patient population remaining on apremilast, observed mean and median improvements in both conditions were sustained through 156 weeks.

Conclusion: Apremilast is effective for the treatment of active PsA, including improvements in enthesitis and dactylitis up to 3 years.

Trial registration numbers: NCT01172938, NCT01212757 and NCT01212770.

Keywords

anti-rheumatic agents, apremilast, arthritis, phosphodiesterase 4 inhibitors, psoriatic

Rights and Permissions

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. Open access: This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http:// creativecommons. org/licenses/by-nc/4.0/.

DOI of Published Version

10.1136/rmdopen-2018-000669

Source

RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018. Link to article on publisher's site

Journal/Book/Conference Title

RMD open

Related Resources

Link to Article in PubMed

PubMed ID

30018799

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License

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