A multicenter real-world study published in Clinical Rheumatology has reported that apremilast is associated with significant improvements in disease activity and enthesitis, while demonstrating a favorable safety profile in patients with psoriatic arthritis (PsA) treated in routine clinical practice.
Psoriatic arthritis is a chronic inflammatory disease characterized by musculoskeletal and skin manifestations that substantially affect patients’ quality of life. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, exerts its anti-inflammatory effects by increasing intracellular cyclic adenosine monophosphate (cAMP) levels, thereby modulating multiple inflammatory pathways implicated in psoriasis and PsA. It has been shown to reduce the expression of pro-inflammatory mediators, including inducible nitric oxide synthase, interleukin (IL)-23, and tumor necrosis factor-alpha (TNF-α), while enhancing the production of the anti-inflammatory cytokine IL-10.
The Italian MAPSI II study was a prospective, multicenter, observational study conducted across rheumatology centers to evaluate the effectiveness and safety of apremilast in adults with active PsA receiving routine clinical care. Patients were assessed at baseline and after 6 and 12 months of treatment. Clinical outcomes included the Disease Activity Index for Psoriatic Arthritis based on 28 joint counts and C-reactive protein (DAPSA28-CRP), Leeds Enthesitis Index (LEI), dactylitis count, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Visual Analogue Scale (VAS) for pain and patient global assessment (PGA), Psoriatic Arthritis Impact of Disease questionnaire (PsAID-9), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and C-reactive protein (CRP). Safety was evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs).
A total of 139 patients were enrolled in the study, of whom 100 completed the 6-month follow-up and 83 completed the 12-month assessment. Treatment with apremilast was associated with a significant reduction in patient global assessment scores, with PGA-VAS improving from 60.8 ± 20.5 at baseline to 30.3 ± 23.7 at 12 months (p<0.001). Significant improvements were also observed in enthesitis, as measured by the Leeds Enthesitis Index, and in C-reactive protein levels during follow-up. In contrast, psoriasis severity and nail involvement, assessed using PASI and NAPSI scores, remained largely unchanged over the study period.
Apremilast demonstrated a favorable safety profile in routine clinical practice. Thirty-eight adverse events were reported in 38 patients, with gastrointestinal events being the most common. Two serious adverse events were documented, and treatment discontinuation because of adverse events occurred in 23 patients, representing 60.5% of those who experienced an adverse event.
The investigators concluded that the MAPSI II study provides additional real-world evidence supporting the effectiveness and safety of apremilast in a heterogeneous population of patients with psoriatic arthritis. The observed improvements in disease activity and enthesitis, together with its acceptable tolerability profile, reinforce the role of apremilast as a valuable treatment option for patients with active PsA in routine clinical practice.
References
- Schenone C, Serban T, Tramontano G, Pendolino M, Foti R, Foti R, Bergamini A, Faggioli P, Iannone F, De Andres I, Favero M, Pirone C, Delle Sedie A, Camellino D, Bianchi G. Real-world effectiveness and safety of apremilast in psoriatic arthritis: results from the multicenter Italian MAPSI II study. Clin Rheumatol. 2026 Jul;45(7):4287-4295.
- Reed M, Crosbie D. Apremilast in the treatment of psoriatic arthritis: a perspective review. Ther Adv Musculoskelet Dis. 2017 Feb;9(2):45-53.