Estimating the counterfeit markets in Europe

Counterfeiting is a global phenomenon that threatens the economic stability and sustainable growth of countries. A growing number of researchers, stakeholders, and public or private institutions have been producing a wide variety of studies and estimates on counterfeit markets. However, these studies are varied in scope and sometimes based on unclear methodologies. This prevents comparisons across time and space. In recent decades, Transcrime has contributed to the development of transparent and rigorous methodologies for the analysis of illegal activities. This study presents an update of the approach used by Transcrime to estimate the size of the various counterfeit markets at EU level. It starts with a brief review of what is known about counterfeiting in the EU (i.e. routes, products, consumers and previous studies). It then proposes new estimates of the expenditures for ten different counterfeit markets in the 28 EU Member States using a demand-size approach. Finally, it discusses policy and research implications

Primary Analysis and 4-Year Follow-Up of the Phase III NIBIT-M2 Trial in Melanoma Patients With Brain Metastases

Purpose: Phase II trials have shown encouraging activity with ipilimumab plus fotemustine and ipilimumab plus nivolumab in melanoma brain metastases. We report the primary analysis and 4-year follow-up of the NIBIT-M2 study, the first phase III trial comparing these regimens with fotemustine in patients with melanoma with brain metastases. Patients and methods: This phase III study recruited patients 18 years of age and older with BRAF wild-type or mutant melanoma, and active, untreated, asymptomatic brain metastases from nine centers, randomized (1:1:1) to fotemustine, ipilimumab plus fotemustine, or ipilimumab plus nivolumab. The primary endpoint was overall survival (OS). Results: From January, 2013 to September, 2018, 27, 26, and 27 patients received fotemustine, ipilimumab plus fotemustine, and ipilimumab plus nivolumab. Median OS was 8.5 months [95% confidence interval (CI), 4.8-12.2] in the fotemustine arm, 8.2 months (95% CI, 2.2-14.3) in the ipilimumab plus fotemustine arm (HR vs. fotemustine, 1.09; 95% CI, 0.59-1.99; P = 0.78), and 29.2 months (95% CI, 0-65.1) in the ipilimumab plus nivolumab arm (HR vs. fotemustine, 0.44; 95% CI, 0.22-0.87; P = 0.017). Four-year survival rate was significantly higher for ipilimumab plus nivolumab than fotemustine [(41.0%; 95% CI, 20.6-61.4) vs. 10.9% (95% CI, 0-24.4; P = 0.015)], and was 10.3% (95% CI, 0-22.6) for ipilimumab plus fotemustine. In the fotemustine, ipilimumab plus fotemustine, and ipilimumab plus nivolumab arms, respectively, 11 (48%), 18 (69%), and eight (30%) patients had treatment-related grade 3 or 4 adverse events, without treatment-related deaths. Conclusions: Compared with fotemustine, ipilimumab plus nivolumab significantly improved overall and long-term survival of patients with melanoma with asymptomatic brain metastases

Nivolumab plus ipilimumab in melanoma patients with asymptomatic brain metastases: 7-year outcomes and quality of life from the multicenter phase III NIBIT-M2 trial

Background: The primary analysis of the phase III NIBIT-M2 study showed a 41% 4-year overall survival (OS) of melanoma patients with asymptomatic brain metastases treated with ipilimumab plus nivolumab. Methods: Here, we report the 7-year efficacy outcomes and the Health-Related Quality of Life (HRQoL) analyses of the NIBIT-M2 study. Results: As of May 1, 2023, at a median follow-up of 67 months (mo), the median OS was 8.5 (95% CI: 6.6-10.3), 8.2 (95% CI: 2.1-14.3) and 29.2 (95% CI: 0-69.9) mo for the fotemustine (F) Arm A, ipilimumab plus fotemustine Arm B, and ipilimumab plus nivolumab Arm C, respectively. The 7-year OS rate was 10.0% (95% CI: 0-22.5) in Arm A, 10.3% (95% CI: 0-22.6) in Arm B, and 42.8% (95% CI: 23.4-62.2) in Arm C. HRQoL was preserved in all treatment arms. Most functional scales evaluated from baseline to W12 were preserved, with a lower mean score decrease for EORTC Quality of Life Questionnaire (QLQ)-C30 and an increase for EORTC QLQBrain neoplasm (BN20) in patients receiving ipilimumab plus nivolumab. Conclusions: With the longest follow-up available to date in melanoma patients with asymptomatic brain metastases, the NIBIT-M2 study continues to show persistent therapeutic efficacy of I ipilimumab plus nivolumab while preserving HRQoL

CHRONIC INFLAMMATION AND END-DIALYSIS OVERWEIGHT. A 36 MONTH PROSPECTIVE OBSERVATIONAL STUDY

Introduction and Aims: Attaining dry body weight is paramount in dialysis practice, but this goal is not always reached.We hypothesized that the amount of end-dialysis overweight (edOW), could be associated to increased chronic inflammation and mortality. Aim of the study: to evaluate the effect of edOWon serum C-reattive protein (hsCRP) concentrations and on survival in a cohort of 182 prevalent HD patients ( pts) followed for 36 months. Methods: In 182 pts (117 men, age 65±12 years, vintage 48 months; range 6-336), edOWwas present in 98/182 (54%) pts. Mean value was 0.4±0.2 Kg (range: 0.1-1.4). In the 98 pts with edOW(Group 1) and in the other 84 (Group 2) we evaluated: Ultrafiltration rate(UFR), hsCRPdry body weight (dBW), Kt/V, protein catabolic rate (PCRn), interdialytic weight gain (IDWG), mean arterial pressure (MAP). Unpaired Student’s t test was employed to compare groups, linear regression analysis to test correlations, log-rank test and Kaplan-Meier curves to evaluate survival. Results: Mean UFR was 11.7±2.8 ml/Kg/hour, dBW 64±12 Kg, hsCRP 6.6 (0.2-36) mg/L, Kt/V 1.27±0.09, PCRn 1.06±0.10 g/Kg/day, IDWG 2.8±0.4 Kg, MAP 97±6.5 mmHg. edOWand hsCRP were directly and significantly correlated (r= 0.67; p<0.0001). Comparison between pts with (Group 1) and without (Group 2) edOW showed significant differences in: UFR (12.7±2.6 vs 10.9±2.6 ml/Kg/hour; p< 0.0001), hsCRP (13.0±8.1 vs 5.2±5.3 mg/L; p< 0.0001), and PCRn (1.03±0.09 vs 1.08±0.10 g/Kg/day; p<0.004). 98 pts (54%) died during follow-up for cardiovascular complications in 69% of cases. Survival curves showed significantly greater mortality in Group 1 vs Group 2 in relation to the amount of edOW, and hsCRP (p<0.0001). Conclusions: edOWand chronic inflammation are directly correlated in HD pts, and both are associated to a greater long-term risk of mortality

Grand banditisme traditionnel and foreign groups: Organised crime infiltration in France

By relying on police records and reports, data from the French asset recovery agency, and qualitative analysis of case studies, this chapter provides an unprecendented analysis of the infiltration by organised crime groups of legitimate businesses in France. Individuals related to the traditional local 'Grand Banditisme' control firms in key sectors of the French economy, especially in the south of the country; at the same time foreign organised crime groups (e.g. North-African, Balkanic, Russian-speaking) invest widely in companies in the entire country

Trafficking in human beings

The contribution provides a short overview of the trafficking in human beings, the actors involved and the existing estimates

Italy

This chapter provides the results of the assessment of money laundering risk in Italy. It develops a composite risk indicator at territorial level (for the 110 Italian provinces) and at sectoral level, and discusses the reasons underpinning the distribution of money laundering risk across Italian territories and economic activities

Assessing Money Laundering Risk across Regions. An Application in Italy

Most money laundering (ML) risk assessments carried out in Europe and abroad are qualitative analyses at national aggregate level. To complement current knowledge, this paper – based on the findings of the European co-funded project IARM (Identifying and Assessing the Risk of Money laundering in Europe -www.transcrime.it/iarm) – proposes a new quantitative methodology to measure ML risk across regions in a country and tests it on the 110 Italian provinces. In particular, it develops a composite indicator of ML risk, which combines a variety of risk factors (classified as threats and vulnerabilities), such as organised crime, tax evasion, cash-intensiveness and opacity of business structure. The application of the methodology to Italy reveals that the areas with the highest (relative) ML risk are in the south of the country, in particular Calabria, with some exceptions in the centre (e.g. province of Prato) and in the north (e.g. Imperia). The developed risk indicator can support policy-makers and investigators in allocating anti-money laundering (AML) resources more effectively, but it can also be helpful for obliged entities such as banks and professionals to improve their “risk based” customer due diligence activities