IQVIA (France)

Tablet formulations of allergen extracts are widely recommended over other formulations for the sublingual immunotherapy (SLIT) of respiratory allergies. However, with adequate clinical trial evidence, SLIT (liquid) drop formulations may be a relevant allergy treatment option. The RHAPSODY multinational, Phase III, parallel-group, double-blind, placebo-controlled, randomised clinical study of adults with moderate-to-severe, grass-pollen-induced allergic rhinoconjunctivitis (ARC) with or without asthma was conducted at 45 investigating centres in six European countries. Participants received 26 months of continuous treatment with active 5-grass-pollen SLIT drops or placebo. The primary efficacy endpoint was the average daily total combined score (TCS, comprising a symptom score and a rescue medication score) during the second peak grass pollen season (PGPS). Of the 445 randomised patients (mean ± standard deviation (range) age: 32.6 ± 9.9 (18-63); males: 55.1%), 389 completed the trial. The primary efficacy endpoint showed a statistically significant difference in favour of active treatment versus placebo (average difference in the daily TCS: 1.88 (95% CI: 0.60-3.17); relative difference 26.51% (95% CI: 9.42-40.55); p = 0.0036). The difference (0.17 points) in the average weekly Rhinitis Quality of Life Questionnaire score during the second PGPS in favour of the active treatment was clinically relevant but not statistically significant. The differences in efficacy were generally driven by the medication score, rather than the symptom score. Most adverse events were mild and local. RHAPSODY was the first well-powered clinical trial to show the positive risk-benefit ratio of 5-grass-pollen SLIT drops in adult participants with moderate-to-severe grass-pollen-induced ARC.

The COVID-19 pandemic significantly worsened mental health (MH) challenges among young people. We aimed to assess changes in mental health-related outpatient care before and after the onset of the pandemic. In this nationwide cross-sectional study, we retrieved visits to general practitioners (GP) resulting in the coding of a MH disorder and/or the prescribing of any psychotropic medication for children aged 6 to 17 years, from January 1, 2016 to May 31, 2022 in France. Interrupted time series analysis of monthly rates of MH-related outpatient visits (per 100,000) was conducted to assess changes in trends overall and by age and sex group (girls/boys- 6 to 11 years; girls/boys- 12 to 17 years). Rate ratios (RR) were also calculated to compare estimated rates after the pandemic onset with expected rates. In total, 5,271,958 MH-related outpatient visits were analyzed. We noted an immediate decrease of the outpatient visit rate by 30.8% in the initial pandemic period (March-May 2020). Hereafter, visit rates increased by 0.4% per month, eventually exceeding expected levels by 6% overall. Notably, outpatient visit rates for adolescent girls (12-17 years) rose 20% above expected levels, while rates for younger girls (6-11 years) declined by 6%. Trends remained stable for other age-sex groups. These findings indicate a persistent increase in outpatient mental healthcare use in children, especially adolescent girls, more than two years after the pandemic onset. Future research should explore the factors contributing to the increased mental health burden in adolescent girls and the potential resilience observed in boys.

IntroductionDiabetes represents an increasing public health challenge in France, yet national data distinguishing type 1 from type 2 diabetes and insulin use remain limited. This study aimed to describe trends in the epidemiology, care pathways and health outcomes of adult individuals living with type 1 or type 2 diabetes in France from 2010 to 2019. It focused on individuals treated or not with insulin and applied a predictive classification algorithm to accurately distinguish between diabetes types using real-world data.MethodsA 10-year retrospective population-based cohort study was conducted from a representative one-tenth sample of the French national healthcare database (i.e. SNDS, Système National des données de Santé), covering nearly the entire French population. Adults (≥ 18 years) affiliated with the general insurance scheme were included. A machine learning algorithm, trained on clinical data from general practitioners, was applied to classify diabetes type. Annual trends in prevalence, incidence, comorbidities, treatments, outpatient care, complications and mortality were assessed.ResultsAmong an extrapolated 5.5 million individuals with diabetes in 2019, 3.5% had type 1 diabetes and 96.5% had type 2 diabetes. The prevalence of type 2 diabetes increased from 6.2% in 2010 to 8.0% in 2019, while type 1 diabetes remained stable. Comorbidity rates were high and increasing in insulin-treated individuals with type 2 diabetes. In 2019, 15.3% of insulin-treated individuals with type 2 diabetes had at least one complication-related hospitalisation. Specialist consultations were underused, especially in type 2 diabetes. The mortality rate in individuals with type 1 diabetes declined from 2.6% to 1.5%, with an increase in mean age at death.ConclusionThis national study provides updated insights into diabetes in France and highlights the need to improve access to specialised care and reinforce long-term surveillance strategies.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-025-01781-0.

The objective of this study was to assess the cost-effectiveness of mavacamten in combination with the standard of care (SoC), composed of beta-blockers and calcium channel blocker monotherapy, compared to the SoC alone in the treatment of patients with obstructive hypertrophic cardiomyopathy with persistent symptoms, from a French collective perspective. A four state Markov model defined by NYHA classification levels I to III/IV and death was developed to simulate the evolution of disease severity over a lifetime horizon. Clinical inputs and utilities were derived from EXPLORER-HCM trial. According to HAS recommendations, costs, life-years (LYs) and quality-adjusted LYs (QALYs) per patient, incremental costs and LYs/QALYs, incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR) were estimated. Model uncertainty was assessed through deterministic, probabilistic sensitivity analyses and scenario analyses. Mavacamten in combination with SoC was associated with a QALY gain of 1.52, driven by an improved NYHA distribution of mavacamten patients. Incremental discounted costs were €122,651, owing to increased treatment acquisition costs, partly offset by savings in healthcare resource utilization, resulting in an ICUR of €80,799/QALY. The sensitivity analyses showed the results of the model were relatively robust. The probabilistic sensitivity analysis confirmed base-case ICUR, with 80% probability of mavacamten being cost effective at a willingness-to-pay of €93,750/QALY. The scenario analysis simulating a limited societal perspective highlighted the potential benefit of mavacamten treatment on productivity loss costs. On a public list price basis, mavacamten in combination with SoC is a cost-effective strategy for symptomatic obstructive HCM compared to SoC alone.

Objective Patients with immunological diseases exhibit distinct comorbidity patterns, categorized into low comorbidity, polyautoimmunity, and polyinflammation clusters. This retrospective cohort study aimed to validate these profiles in rheumatoid arthritis (RA), examine their longitudinal trajectories, and assess their impact on treatment persistence. Methods RA patients receiving targeted therapies, and their associated treatments, were identified from the French pharmacy dispensing database LRx. Comorbidity clusters were assigned using a multinomial regression model, and state sequence analysis with hierarchical clustering was used to define temporal trajectories. Cox regression models evaluated DMARD persistence across trajectories. Results Among 15,189 RA patients (maximum follow-up: 10 years), initial comorbidity profiles included low comorbidity (61.9%), polyautoimmunity (24.7%), and polyinflammation (13.4%). Four trajectory patterns emerged: stable low comorbidity (50%), dominant polyautoimmune (31%), stable polyinflammatory (9%), and low comorbidity switching to polyinflammation (polyinflammation switchers, 10%). The prevalence of polyautoimmunity and polyinflammation increased with age by 2.5% and 3.8% per decade, respectively. Patients with stable polyinflammation had the lowest classical synthetic DMARD persistence (HR: 1.79 [1.33-2.42], reference: polyinflammation switchers). Stable low comorbidity patients had the highest biological and targeted synthetic DMARD persistence (polyinflammation switchers aHR: 1.32 [1.09-1.60], reference: stable low comorbidity). Conclusion Comorbidity trajectories in RA influence DMARD persistence, reflecting distinct etiopathological subgroups with potential theranostic relevance.