Pos1027 apremilast Efficacy in Real World Settings: Results From an Italian Multi-Center Observational Study.

Abstract

BackgroundApremilast, an inhibitor of the phosphodiesterase 4, is indicated for Psoriatic Arthritis (PsA) treatment. The 3 years retention rate, an outcome indirectly related to efficacy, observed in clinical trials [1] is 55,5%. A single subsequent real world setting study [2] suggested a lower efficacy as it reported that the six months retention rate was about 57%.ObjectivesThe main aim of this retrospective observational study is the assessment of apremilast 3 years retention rate in a real world PsA patients’ cohort. Moreover, the secondary objective is reporting the reasons of apremilast suspension and the most relevant factor related to treatment persistence.MethodsIn thirteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history and PsA disease activity (DAPSA) at baseline and after 6 and 12 months were recorded. The Kaplan-Meier curve and the Cox analysis computed the apremilast retention rate and treatment persistence-related risk factors. A p-value < 0.05 was considered statistically significant.ResultsThe three-hundred-twenty-four enrolled patients (median age 60 [InterQuartile Range IQR 52-67] yrs; female prevalence 57,0%) median observation period was 17 [IQR 7-36] months (6848 patients-months). The apremilast retention rate at 6, 12 and 36 months was, respectively, 95%, 86% and 66% (Figure 1). The main discontinuation reasons were: primary inefficacy (40% of interruptions), secondary inefficacy (18%) and gastro-intestinal intolerance (17%%). The oligo-articular onset was the only factor associated to apremilast persistence (Hazard ratio 0.57 IQR 0.34-0.96). Sex, age, and sever comorbidities (cancer, chronic infections etc) were not related to treatment discontinuation. The basal DAPSA (24.1, IQR 18.5-32.0) decreased after 6 and 12 months (respectively 14.5, IQR 10.1-22.6 and 10.5, IQR 8,0-15.2). Remission or minimal disease activity (DAPSA < 15) was achieved after 12 months in 38.0% of patients.ConclusionAlmost two third of PsA patients receiving apremilast were still in treatment after 3 years. The study’s data, confirmed its efficacy and safety profile. Apremilast appear a good treatment choice in patients with oligo articular PsA or burdened by severe comorbidities.References[1]Mease et al. ACR Open Rheumatology (2020)[2]Favalli et al Clin Exp Rheum (2020)Disclosure of InterestsAlarico Ariani Speakers bureau: Zentiva, Consultant of: Boeringher, Amgen, Bristol-Meyers-Squibb, Novartis, Sanofi, Novo Nordisk, Lilly, Janssen, Bruno Farmaceutici, Simone Parisi: None declared, Patrizia Del Medico: None declared, antonella farina: None declared, elisa visalli: None declared, Aldo Molica Colella: None declared, Federica Lumetti Consultant of: Amgen, rosalba caccavale: None declared, Palma Scolieri: None declared, Romina Andracco: None declared, Francesco Girelli: None declared, Elena Bravi: None declared, Matteo Colina: None declared, Veronica Franchina: None declared, Ilaria Platé: None declared, eleonora Di Donato Consultant of: Novartis, Giorgio Amato: None declared, Carlo Salvarani: None declared, Francesco De Lucia: None declared, Daniele Santilli Consultant of: Novartis, eugenio arrigoni: None declared, Flavio Mozzani Consultant of: Novartis, Abbvie, Rosario Foti: None declared, Gilda Sandri: None declared, Vincenzo Bruzzese: None declared, Marino Paroli: None declared, Enrico Fusaro: None declared, Andrea Becciolini: None declared