Analysis of the Pharmacoutilization of Biological Drugs in Psoriatic Arthritis Patients: A Real-World Retrospective Study Among an Italian Population.

INTRODUCTION: Real-world pharmacoutilization analysis of biological drugs in psoriatic arthritis (PsA) patients with the aim to evaluate biologic treatment patterns and pharmacoutilization among patients with PsA in Italy. METHODS: A retrospective study was conducted using administrative databases of Italian Entities. PsA patients were included and diagnosed by hospitalization and/or an active exemption code. Two analyses were performed: a cross-sectional for treatment patterns in patients enrolled among 2017-2020, and a longitudinal study during 2015 to investigate the pharmacoutilization, in terms of persistence and monthly maintenance dosage of biological/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). Patients with or without b/tsDMARDs prescriptions before inclusion were defined as bioexperienced or naïve, respectively. An analysis on ixekizumab-treated patients (IXE patients) from the 2017-to study ending was performed. RESULTS: PsA was diagnosed in 24,786 (2017), 27,221 (2018), 28,889 (2019), and 29,292 (2020) patients. Across 2017-2020, 31.1-40.5% of PsA patients were untreated with systemic medications, and 16.4-18.8% were under biological therapies. Among b/tsDMARD-treated patients, decreasing use of TNF-inhibitors (77.6-57.1%) and increasing IL-inhibitors (19.6-33.2%) was found across 2017-2020, respectively. Persistence to TNF-inhibitors and IL inhibitors as first-line ranged, respectively, 74.9-83.0% and 73.0-84.6%; specifically, 73.1-76.9% and 73.0-83.8% among bio-naïve, 83.3-90.0%, and 87.0% among bio-experienced. Among IXE-patients (N = 178), 55.6% were bio-naïve, while 21.9% previously used secukinumab, 12.9% adalimumab, 10.1% etanercept. During a 1-year follow-up, 6.8% of IXE patients switched therapy. CONCLUSIONS: This real-world study of PsA pharmacoutilization in Italy showed that more than one-third of patients were systemically untreated, and almost 20% were receiving biological medications. Among biological users, increasing use of IL-inhibitors and a decrease in TNF-inhibitors prescriptions over the years were found. A rather-high extent of persistency in treatment was observed. A focused analysis on IXE patients revealed over half of them to be bio-naïve, while around one-fourth were bio-experienced to IL inhibitors.

Analysis of the prevalence of ankylosing spondylitis and treatment patterns and drug utilization among affected patients: an Italian real-world study.

OBJECTIVES: To evaluate the prevalence of ankylosing spondylitis (AS) and associated treatment patterns and drug utilization in real-world clinical practice in Italy. METHODS: This observational study used data from administrative databases of selected Italian entities and included patients with AS diagnosis identified by ICD-9-CM and/or exemption codes. Patients without biologic disease-modifying antirheumatic drug (bDMARD) prescriptions prior to inclusion were defined bio-naïve. A cross-sectional analysis identified treatment patterns from 2016 to 2018. A longitudinal analysis investigated bDMARD utilization (persistence, switch, discontinuing treatment) among bio-naïve patients, with 2014 and 2017 as inclusion periods. Follow-up extended from first bDMARD prescription (index date) to end of data availability. RESULTS: The prevalence of AS was 75.5 per 100,000 (88.3 per 100,000 in adults) in 2018. In total, 5,942 AS patients were identified in 2016, 6,554 in 2017, and 7,146 in 2018. bDMARDs were prescribed to 21.4% (2016), 22.0% (2017), and 16.9% (2018) of the patients. Among the 349 patients included in 2014, 9.5% switched therapies, 13.8% discontinued treatment. In 2017, 12.2% of the 262 patients included switched therapies, 27.1% discontinued treatment. CONCLUSIONS: This study provided an up-to-date prevalence of AS diagnosis in Italy. Bio-naïve patients showed an increasing tendency toward switch of therapy and discontinuation.

Pattern of drug use in patients with psoriatic arthritis in Italy: study in a real-world setting.

Background: The aim of this study is to assess treatment patterns and pharmaco-utilization in patients with psoriatic arthritis (PsA) in Italy.Methods: A retrospective analysis using administrative databases of six Local Health Units was performed. All adult patients with PsA diagnosis and ≥1 prescription for biologic/targeted-synthetic (b/ts) disease-modifying antirheumatic drugs (DMARDs) from January 2010 to March 2017 were included. The date of first b/tsDMARD prescription was defined index-date. Follow-up lasted 1-year post index-date. Patients without b/tsDMARDs prescription pre index-date were defined bionaïve.Results: Of the 1,056 patients included, 33% received adalimumab, 30% etanercept, 10% golimumab, 9% secukinumab, 7% infliximab, 6% ustekinumab, 4% certolizumab, and 1% apremilast. During follow-up, persistence with b/tsDMARDs was observed in 79.8% of patients, 10.8% switched therapies, dose change occurred in 15.8% of patients, 47.4% received an add-on. Among bionaïve patients (n = 591), 67.0% were persistent with b/tsDMARDs, 10.1% switched therapy, 14.5% required a dose change and 45.8% an add-on. Discontinuation was observed in 10.6% of total PsA population and in 24.8% of bionaïve patients.Conclusion: This analysis provided insights on drug utilization patterns for PsA in an Italian real-world setting. Our results show that treatment regimen changes occur in a high proportion of PsA patients.

[Extent of platelet aggregation inhibition and clinical events: new evidence with prasugrel]. / Entità dell'inibizione dell'aggregazione piastrinica ed eventi clinici: nuove evidenze ottenute con prasugrel.

Clopidogrel in combination with aspirin is the recommended standard of care for reducing the occurrence of cardiovascular events in patients presenting with acute coronary syndromes; these protective effects of clopidogrel have been shown both in patients undergoing percutaneous coronary intervention (PCI) and in those treated with medical therapy alone. However, significant shortcomings still exist, including a delayed onset of action in platelet inhibition, individual response variability (with some patients being frankly hyporesponsive), and a prolonged time to recovery of platelet function following cessation of treatment. Among these, clopidogrel hyporesponsiveness seems to be particularly important, as a growing body of evidence suggests that residual platelet reactivity on clopidogrel is associated with a significant increase in the risk of developing adverse clinical events. Prasugrel is a novel, third-generation oral thienopyridine that is a specific, irreversible antagonist of the platelet adenosine 5'-diphosphate P2Y12 receptor. Prasugrel has more potent antiplatelet activity, faster onset of action, and less interpatient variability as compared to clopidogrel. These pharmacodynamic properties led prasugrel to be more effective in preventing ischemic events in patients with acute coronary syndromes undergoing PCI in the setting of the recent TRITON-TIMI 38 study. However, the greater protective effects toward ischemic events were partially counterbalanced by an increased risk of bleeding, particularly in patients with history of transient ischemic attack/stroke, in those with body weight <60 kg and in those older than 74 years. A favorable net clinical benefit of prasugrel compared with clopidogrel has been shown.