Apremilast in psoriatic disease: therapeutic outcomes and cardiometabolic trajectories from a multicenter real-world study
Riccardo Terribili, Emanuele Trovato, Carla Gaggiano, Antonella Di Cesare, Martina Dragotto, Elia Rosi, Gemma Lepri, Maurizio Benucci, Federica Ricceri, Andrea Delle Sedie, Caterina Baldi, Pietro Rubegni, Bruno Frediani, Serena Guiducci, Francesca Prignano, Stefano GentileschiAbstract
Objectives
To evaluate real-world effectiveness, safety, drug retention, and cardiometabolic effects of apremilast (APR) in psoriatic disease (PD).
Methods
This multicenter retrospective study included adults with psoriatic arthritis (PsA) or psoriasis (PsO) treated with APR. Disease activity and cardiometabolic parameters were assessed at baseline and at approximately 3, 6 and 12 months using mixed linear models. Adverse events (AEs), discontinuations, and drug retention rates (DRRs) up to 48 months were analyzed using Kaplan–Meier methods.
Results
145 patients (mean age 66.5 years; 60.7% female sex) were included, 56 (38.6%) with PsO and 89 (61.4%) with PsA. The cohort had a high comorbidity burden, including malignancy in 91 patients (62.8%). Over 12 months, median Disease Activity in PsA decreased from 13.1 (IQR 13.3) to 6.0 (IQR 8.9)(p = 0.015), PsO Area and Severity Index from 8.0 (7.0) to 2.0 (IQR 3.0)(p ≤ 0.001), and pain Visual Analogue Scale from 6.0 (IQR 3.0) to 4.0 (IQR 3.0)(p < 0.001). Median BMI decreased from 27.0 (IQR 5.9) to 25.4 (IQR 6.0)(p = 0.003). Improvements were observed in total cholesterol (p < 0.001), HDL-C (p = 0.003), and triglycerides (p = 0.023), but not LDL-C (p = 0.087) in patients with untreated dyslipidemia. DRRs were 82.9% at 6 months, 65.5% at 12 months, 60.4% at 24 months, and 47.9% at 48 months. Lower DRRs were observed in patients with scalp or inverse PsO (p = 0.006 and p = 0.003). The most frequent AE was diarrhea (27, 18.6%).
Conclusion
APR appears to be a valid option for selected patients with PD when comorbidities and cardiometabolic risk influence treatment choice.