anti-rheumatic agents; apremilast; arthritis; phosphodiesterase 4 inhibitors; psoriatic
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
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.
Orthopedics & Sports Medicine
Gladman, Dafna D; Kavanaugh, Arthur; Gómez-Reino, Juan J; Wollenhaupt, Jürgen; Cutolo, Maurizio; Schett, Georg; Lespessailles, Eric; Guerette, Benoit; Delev, Nikolay; Teng, Lichen; Edwards, Christopher J; Birbara, Charles A; and Mease, Philip J, "Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies." (2018). Articles, Abstracts, and Reports. 522.