LONG-TERM real-world data from the German Psoriasis Registry PsoBest suggest that apremilast remains a safe and effective treatment option for patients with moderate-to-severe psoriatic disease, including those with significant comorbidities. The findings provide important insight into treatment outcomes outside the controlled environment of clinical trials.
PsoBest is Germany’s national psoriasis registry, designed to capture real-world data on the safety, tolerability, and effectiveness of systemic therapies for psoriasis and psoriatic arthritis. In this analysis researchers evaluated both baseline characteristics and longitudinal outcomes in patients treated with apremilast, a phosphodiesterase 4 inhibitor widely used in clinical practice.
Patient Characteristics Reflect Routine Apremilast Use
The study included registry data collected between January 2015 and June 2020. In total, 595 patients were exposed to apremilast, with 417 receiving apremilast as monotherapy. Patients treated with apremilast were, on average, older than those receiving other systemic or biologic therapies and had a higher prevalence of comorbid conditions, including cardiovascular and metabolic disease. This reflects real-world prescribing patterns, where apremilast is often considered for patients with complex clinical profiles.
Safety analyses showed that the most commonly reported nonserious adverse events were drug ineffectiveness (14.1%), diarrhoea (9.4%), nausea (7.1%), and headache (6.1%). The highest incidence rates of adverse events of special interest were observed for infections and infestations (8.03 per 100 patient-years) and malignant or unspecified tumours (2.50 per 100 patient-years). Overall, the safety profile of apremilast in routine care was consistent with that previously reported in clinical trials.
Effectiveness outcomes were assessed at 3, 6, and 12 months following treatment initiation. Patients demonstrated sustained improvements across multiple clinical and patient-reported measures, including the Psoriasis Area and Severity Index, body surface area involvement, Dermatology Life Quality Index, and patient-defined treatment benefits measured by the Patient Benefit Index.
Implications for Treating Moderate-to-Severe Psoriatic Disease
The authors conclude that patients treated with apremilast in routine clinical practice experienced meaningful improvements in skin symptoms, disease severity, and quality of life. Importantly, these benefits were observed in a population with substantial comorbidity burden, reinforcing apremilast’s role as a valuable therapeutic option for moderate-to-severe psoriatic disease.
Reference
Augustin M et al. Outcomes in Patients with Psoriasis Following Apremilast Treatment: Results from the German Psoriasis Registry PsoBest. Dermatol Ther (Heidelb). 2026;doi: 10.1007/s13555-025-01631-8
