Real-World Effectiveness and Tolerability of Apremilast in Psoriatic Arthritis in Germany: Results from LAPIS-PsA

Apremilast is approved for psoriasis and psoriatic arthritis (PsA). Although clinical trials demonstrated efficacy and tolerability of apremilast, real-world data for PsA are lacking.

Assess the real-world effectiveness and tolerability of apremilast in German clinical practice.

The multicenter, prospective, non-interventional LAPIS-PsA study (conducted from February 2016 to July 2018) enrolled patients diagnosed with moderate to severe PsA (Physician’s Global Assessment [PhGA] ≥2) and insufficient response or intolerance to ≥1 disease-modifying antirheumatic drug who were initiating apremilast in German clinical practice. Outcomes included, but were not limited to, PhGA improvement ≥1 (scale of 0–4) at ~7 months (primary); PhGA improvement ≥1, Patient Global Assessment (PtGA) improvement ≥1; pain visual analog scale (VAS), pruritus VAS, and the 9-item Psoriatic Arthritis Impact of Disease (PsAID-9) over ~13 months (secondary); and minimal disease activity (MDA) (exploratory) over ~13 months.

A total of 418 patients were analyzed; mean±SD age: 54.9±11.0 years, 59.2% female, 40.8% male. Most (75.6%) patients achieved a PhGA ≥1-point improvement at ~7 months, with responses maintained at ~13 months (72.5%). Over half (58.7%) achieved a PtGA improvement ≥1-point; over one-third (41.5%) achieved MDA at ~13 months. Mean±SD pain and pruritus VAS decreased from 52.1±23.1 and 36.7±30.7 at baseline to 32.6±23.4 and 19.6±21.9 at ~13 months, respectively. Mean (SD) PsAID-9 total score decreased from 5.3±2.1 at baseline to 3.3±2.0 at ~13 months.

Patients with PsA treated with apremilast in German clinical practice experienced improvements in patient- and physician-reported measures of disease activity over 13 months of treatment.