Apremilast retention rate in clinical practice: observations from an Italian multi-center study

Abstract

Objective There are few real-world setting studies focused on apremilast effectiveness (i.e., retention rate) in psoriatic arthritis (PsA). The main aim of this retrospective observational study is the assessment of apremilast 3-year retention rate in real-world PsA patients. Moreover, the secondary objective is to report the reasons of apremilast discontinuation and the factors related to treatment persistence. Methods In fifteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline 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 356 enrolled patients (median age 60 [interquartile range IQR 52-67] yrs; male prevalence 42.7%) median observation period was 17 [IQR 7-34] months (7218 patients-months). The apremilast retention rate at 12, 24, and 36 months was, respectively, 85.6%, 73.6%, and 61.8%. The main discontinuation reasons were secondary inefficacy (34% of interruptions), gastro-intestinal intolerance (24%), and primary inefficacy (19%). Age and oligo-articular phenotype were related to treatment persistence (respectively hazard ratio 0.98 IQR 0.96-0.99; p = 0.048 and 0.54 IQR 0.31-0.95; p = 0.03). Conclusion Almost three-fifths of PsA patients receiving apremilast were still in treatment after 3 years. This study confirmed its effectiveness and safety profile. Apremilast appears as a good treatment choice in all oligo-articular PsA patients and in those ones burdened by relevant comorbidities. Key Points• Apremilast retention rates in this real-life cohort and trials are comparable.• The oligo-articular phenotype is associated with long-lasting treatment (i.e., 3 years).• No different or more prevalent adverse events were observed.

Sex Differences in the Effectiveness of First‐Line Tumor Necrosis Factor Inhibitors in Psoriatic Arthritis: Results From the European Spondyloarthritis Research Collaboration Network

“…Interestingly, recent studies have discovered similar sex differences in patients treated with IL‐17 inhibitors in a real‐world setting and in post hoc analyses of randomized controlled trials (RCTs) of Janus kinase inhibitors after three months of treatment 8,40 . However, a real‐world study on apremilast did not identify sex differences in retention rates 41 . In addition, the preliminary findings from post hoc analyses of the EXCEED RCT suggested that women receiving an IL‐17 inhibitor experienced a better clinical response than those treated with a TNFi.…”

“…8,40 However, a real-world study on apremilast did not identify sex differences in retention rates. 41 In addition, the preliminary findings from post hoc analyses of the EXCEED RCT suggested that women receiving an IL-17 inhibitor experienced a better clinical response than those treated with a TNFi. This difference was not observed in men.…”

Predictors of DAPSA Response in Psoriatic Arthritis Patients Treated with Apremilast in a Retrospective Observational Multi-Centric Study

“…The analyzed population is part of the BIRRA (Biologics Retention Rate Assessment) project, an observational retrospective study [15]. All PsA consecutive patients from fifteen Italian rheumatological referral centers were screened.…”

“…Among the three-hundred fifty-six PsA patients included in our previous report [15], two-hundred ninety-three with a follow-up period of at least one year were enrolled in the study. One-hundred twenty-six (43%) patients were male.…”

“…Recently, we analyzed the 3-year apremilast retention rate, reasons for discontinuation, and factors related to treatment persistence in a large multicenter observational retrospective study [15].…”