Real-world effectiveness and safety of apremilast in psoriatic arthritis: results from the multicenter Italian MAPSI II study.

OBJECTIVE

To assess the effectiveness and safety of apremilast in the treatment of psoriatic arthritis (PsA) in a real-world setting across multiple rheumatology centers in Italy.

METHODS

MAPSI II is a multicenter, observational real-world study including adult patients with active PsA treated with apremilast. Patients were prospectively evaluated at baseline and after 6 and 12 months to assess effectiveness and safety. Clinical assessments included joint, skin, and patient-reported outcomes, namely 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 recording adverse events (AEs) and serious adverse events (SAEs).

RESULTS

Of the 139 enrolled patients, 100 completed the 6-month follow-up and 83 completed the 12-month visit. A significant reduction in PGA-VAS was observed from baseline (60.8 ± 20.5) to 12 months (30.3 ± 23.7; p < 0.001). LEI and CRP levels also improved significantly, while PASI and NAPSI remained unchanged. Apremilast was generally well tolerated; 38 AEs in 38 patients were recorded, mostly gastrointestinal. Two serious AEs were reported. Treatment discontinuation due to AEs occurred in 23 cases (60.5% of AE group).

CONCLUSION

Apremilast demonstrated real-world clinical benefit in reducing disease activity and enthesitis in PsA patients, especially those with moderate disease and limited treatment options. Its safety profile and tolerability support its use in selected patients, potentially even before failure of other DMARDs. Key Points • This multicenter Italian real-world study evaluated the effectiveness of apremilast in patients with psoriatic arthritis. • Treatment with apremilast was associated with improvements in disease activity measures and a favorable safety profile in routine clinical practice. • The MAPSI II study provides additional real-world evidence on the use of apremilast in a heterogeneous psoriatic arthritis population.