Real-World Progression-Free Survival and Healthcare Resource Utilization Associated with Daratumumab Use in Transplant-Ineligible Multiple Myeloma Patients in Italy
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.
Characteristics, therapeutic pathway and the economicburden of patients with drug-resistantepilepsy: A real-world analysis following the introduction of cenobamate inItaly
Abstract Objectives: Drug-resistant epilepsy (DRE) remains a major clinical challenge, affecting approximately one-thirdof patients with epilepsy. Cenobamate, a novel antiseizure medication (ASM) approved in Italy in 2022, has shown promisein clinical trials. However, real-world data on its use, especially economic evaluations, remain limited. This analysis assessed the impact of cenobamate in Italian clinical practice, focusing… Read More »Characteristics, therapeutic pathway and the economicburden of patients with drug-resistantepilepsy: A real-world analysis following the introduction of cenobamate inItaly
Evaluation of biochemical and economic outcomes in patients treated with PCSK9 inhibitors in a real clinical practice setting
BACKGRO UND : PCSK9 inhibitors (PCSK9i) in combination with high-dose statins can reduce LDL -cholesterol (LDL-C) levels by 50-60% over statin monotherapy. This analysis investigated biochemical (LDL-C reduction) and economic outcomes in Italian patients treated with PCSK9i or potentially eligible but untreated.METHOD S: Administrative databases of healthcare institutions covering around 5 million residents were used… Read More »Evaluation of biochemical and economic outcomes in patients treated with PCSK9 inhibitors in a real clinical practice setting
Profile, Healthcare Resource Consumption and Related Costs in ANCA-Associated Vasculitis Patients: a Real-World Analysis in Italy
Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV) are rare autoimmune diseases triggeringinflammation of small vessels. This real-world analysis was focused on the most common AAV forms, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), to describe patients’ demographic and clinical characteristics,therapeutic management, disease progression, and the related economic burden. A retrospective analysis was conducted on administrative… Read More »Profile, Healthcare Resource Consumption and Related Costs in ANCA-Associated Vasculitis Patients: a Real-World Analysis in Italy
Real-world analysis of outcomes and economic burden in patients with Chronic Kidney Disease with and without Secondary Hyperparathyroidism among a sample of the Italian population
This real-world analysis evaluated the clinical and economic burden of non-dialysis-dependent CKD patients with and without secondary hyperparathyroidism (sHPT) in Italy. An observational retrospective study was conducted using administrative databases containing a pool of healthcare entities covering 2.45 million health-assisted individuals. Adult patients with hospitalization discharge diagnoses for CKD stages 3, 4, and 5 were… Read More »Real-world analysis of outcomes and economic burden in patients with Chronic Kidney Disease with and without Secondary Hyperparathyroidism among a sample of the Italian population