Purpose: This study evaluated real-world clinical and economic outcomes associated with daratumumab-based regimens in patients with multiple myeloma (MM) ineligible for autologous stem cell transplantation (ASCT) in Italy. Differences in healthcare resource use according to daratumumab administration route (intravenous vs subcutaneous) were also explored.
Methods: A retrospective observational analysis was conducted using administrative healthcare databases from Italian Local Health Units covering ~12 million individuals (2018– 2023). Patients with MM receiving daratumumab in first-line (1L) or second-line (2L) therapy were included. Real-world progression-free survival (rwPFS), defined as time to treatment switch or death, was used as a proxy endpoint for disease progression, and healthcare resource utilization were compared between treatment regimens. Propensity score weighting was applied to to improve comparability between treatment groups. Direct healthcare costs captured in administrative databases were analyzed from the perspective of the Italian National Health System.
Results: Among 790 non-ASCT MM patients, 344 received 1L DaraRd and 413 received 2L DaraRd. In the 1L setting, median rwPFS was not reached for DaraRd and was 25.7 months for Rd (p=0.011). In 2L, median rwPFS was 42.9 months for DaraRd versus 19.1 months for Rd (p < 0.001). In 1L, DaraRd was associated with lower hospitalization costs compared with Rd for both all-cause (€ 4324 vs € 7971) and MM-related (€ 2862 vs € 6693) admissions. In 2L, differences in hospitalization costs were smaller and not statistically significant. Conclusion: In this real-world analysis, daratumumab-based regimens were associated with longer rwPFS compared with Rd among transplant-ineligible MM patients, in both 1L and 2 L settings. In 1L treatment, these outcomes were accompanied by lower hospitalization costs. Given the retrospective design and the use of administrative healthcare data, these findings should be interpreted with caution, but they contribute to the growing body of real-world evidence on treatment outcomes and resource utilization in routine clinical practice.

Introduzione
Nonostante i benefici cardiovascolari delle terapie ipolipemizzanti siano comparabili tra i sessi, persistono disparità nella gestione della dislipidemia. Questa analisi valuta differenze negli schemi terapeutici, nell’aderenza e nei costi sanitari tra uomini e donne nella pratica clinica italiana.

Metodi
È stata condotta un’analisi retrospettiva osservazionale su database amministrativi (2017– 2022) coprenti circa 12 milioni di assistibili. Sono stati inclusi adulti con almeno una prescrizione di ipolipemizzanti (statine, ezetimibe). Sono stati analizzati: complessità del trattamento, aderenza (Proportion of Days Covered, PDC ≥80%) e costi, con analisi stratificate per rischio vascolare secondo le linee guida ESC/EAS 2019.

Risultati
Tra i 1.899.894 pazienti inclusi, le donne (51,8%) erano mediamente più anziane (68,9 vs 66,1 anni, p <0,001), ma con un indice di comorbidità di Charlson inferiore (0,5 vs 0,6; p <0,001). Alle donne venivano prescritte meno frequentemente statine ad alta intensità (es. atorvastatina 40/80 mg) o terapie combinate (es. statina + ezetimibe) (p <0,001). I costi annuali erano inferiori nelle donne (2.469 € vs 3.020 €, p <0,001), principalmente per minori ospedalizzazioni e consulti cardiologici. Conclusioni Le evidenze di questa analisi osservazionale suggeriscono che le donne con dislipidemia ricevono trattamenti ipolipemizzanti meno intensi e mostrano minore aderenza, anche dopo aggiustamento per età e rischio cardiovascolare. Queste disparità evidenziano la necessità di strategie di trattamento sensibili al genere per ottimizzare la gestione e gli esiti clinici.

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Introduction: This retrospective observational analysis evaluated the clinical, demographic, and economic burdenof migraine patients in real-world Italian clinical practice.Methods: A retrospective observational analysis was conducted using Italian administrative databases, involvingapproximately 12 million beneficiaries. All adult patients with at least one hospital discharge diagnosis ofmigraine (ICD-9-CM = 346) or at least one prescription for migraine-specific medications (ATC =… Read More »Clinical and economic burden of migraine in Italy: a real-world evidence analysis

ABSTRACTIntroduction: In Italy, real-world data on muscle-invasive bladder cancer (MIBC) are scanty. This analysis exploited administrative databases to describe the clinical characteristics and treatment outcomes of patients with MIBC. Methods: Adults hospitalized for non-metastatic bladder cancer who underwent cystectomy in 2018 were proxied for MIBC. The following variables were examined: demographic and clinical characteristics, number… Read More »Treatment Pathway and Clinical Outcomesof the Population with Muscle‑invasiveBladder Cancer in Italy: A Real‑world Analysiswith Administrative Databases