An observational study of haemophilia A patients without inhibitors using the French national claims (SNDS) database.

OBJECTIVES: To describe clinical characteristics, factor consumption, and events of interest in patients with haemophilia A without inhibitors receiving prophylaxis in France, and the clinical impact of switching to Elocta® in this population. METHODS: This retrospective, observational study using the Système National des Données de Santé database, analysed data from patients with haemophilia A without inhibitors using prophylactic factor VIII (FVIII) replacement therapy during 2016-2019. Clinical characteristics, treatment patterns and switches, factor consumption, and rate of events of interest were determined. In a sub-cohort of patients treated with Elocta®, clinical characteristics, factor consumption, and rate of events of interest before and after switching to Elocta® were compared. RESULTS: For 545 patients, with mean age (standard deviation [SD]) 25.4 (17.8) years, Elocta® was the most used treatment. Bleeding events and articular non-bleeding events leading to hospitalization occurred in 15.4% and 13.9% of patients, respectively, and 9.9% of patients had surgeries or procedures related to haemophilic arthropathy. The mean (SD) FVIII product consumption was 344 (93) IU/kg/month for extended half-life treatment, and 331 (98) IU/kg/month for standard half-life products. For the sub-cohort of 146 patients, bleeding events (SD) decreased from 0.32 (2.2) to 0.09 (0.42) events/patient/year (p = 0.227) after switching to Elocta®. There was no statistically significant difference in rates of factor consumption or articular non-bleeding events before and after initiation of Elocta®. CONCLUSION: This study provides real-world insights that advance the understanding of treatment patterns and events of interest in patients with haemophilia A on prophylactic regimens in France.

Real-World Epidemiology, Clinical and Economic Burden of Chronic Hepatitis B in Japan: A Retrospective Study Using JMDC Claims Database.

INTRODUCTION: Chronic hepatitis B (CHB) is one of the world's major healthcare problems, especially in the Western Pacific regions. This study describes the prevalence, incidence, treatment profiles and clinical and economic burden of chronic hepatitis B patients in Japan using the Japan Medical Data Center (JMDC) Claims Database. METHODS: This is a retrospective observational study. Prevalence cases were identified as patients with ≥ 1 inpatient or ≥ 2 outpatient CHB diagnoses and ≥ 2 records for hepatitis B tests or ≥ 1 prescription for CHB treatment between January 2010 and December 2019. Newly diagnosed CHB patients were defined as patients diagnosed from 2010 to 2018 with no history of the disease up to 2 years prior to the diagnosis. The index date is defined as the first CHB diagnosis day. We only used patients' data with ≥ 1-year post-index date. RESULTS: We identified 13,061 CHB prevalent cases (2010-2019), yielding a crude period prevalence of 0.32%. Newly diagnosed CHB patients (n = 1973; median age 52 years) were followed for a median period of 3.1 years, during which 15% received a CHB treatment. Entecavir was the most common first treatment (66%). During this period, 3.4% of the patients developed compensated cirrhosis (CC), 1.5% decompensated cirrhosis (DC) and 3.0% hepatocellular carcinoma (HCC). Around 43.3% of CHB patients were hospitalized at least once. Hospitalizations, treatment rates, serologic testing and screening for liver diseases increased as the severity of the disease progressed. The average total healthcare cost was 870,568 JPY (7779 USD) per person per year. DC and HCC resulted in the highest management costs. CONCLUSIONS: Chronic hepatitis B represents a high clinical and economic burden for patients and caregivers, given its morbidity and associated costs.

Population norms in France with EQ-5D-5L: health states, value indexes, and VAS.

PURPOSE: To provide EuroQoL EQ-5D-5L French population norms based on a sample of 15,000 responders. METHODS: Based on the National Health and Wellness Survey, an international, annual, selfadministered Internet-based survey, this study extracted data from France for 2018 involving a sample of 15,000 respondents stratified by age and gender. Responses to the EQ-5D-5L questionnaire and the Visual Analog Scale (VAS) score, together with sociodemographic, health behavior, and disease status variables were collected. VAS, value indexes, the level sum score, and the distribution of levels per dimension were described. Multivariate regression analyses were performed to identify covariates with a statistically significant effect on the five dimensions and the three scores. RESULTS: The mean [standard deviation (SD)] VAS was 73.4 (22.2) for the entire sample (male 74.8 vs female 72.2, p < 0.0001). The Mean SD value index was 0.905 (0.158) (male 0.915 vs female 0.895, p < 0.0001). The mean SD level sum score was 7.6 (3.0) (7.4 for males vs. 7.9 for females p < 0.0001). Health state 11,111 (no problem in any dimension) represented 25.1% of all responses. "No problem" responses' proportions were Self Care (91.3%), Usual Activities (74.2%), Mobility (72.4%), Anxiety/Depression (52.6%) and Pain/Discomfort (37.7%). Multivariate regressions revealed a significant relationship for health states, value indexes, and VAS with age, income, employment, marital status, smoking and alcohol consumption, obesity, and the presence of one or more health problems. CONCLUSION: Based on a large sample, this study is the first to report EQ-5D-5L population norms for France.

Correction to: Qualitative Assessment of Adult Patients' Perception of Atopic Dermatitis Using Natural Language Processing Analysis in a Cross-Sectional Study.

The authors would like to correct the images in figures which are in wrong order and require swapping.

Qualitative Assessment of Adult Patients' Perception of Atopic Dermatitis Using Natural Language Processing Analysis in a Cross-Sectional Study.

INTRODUCTION: Atopic dermatitis (AD) is an incurable, inflammatory skin disease characterized by skin barrier disruption and immune dysregulation. Although AD is considered a childhood disease, adult onset is possible, presenting with daily sleep disturbance and functional impairment associated with itch, neuropsychiatric issues (anxiety and depression), and reduced health-related quality of life. Although such aspects of adult AD disease burden have been measured through standardized assessments and based on population-level data, the understanding of the disease experienced at the patient level remains poor. This text-mining study assessed the impact of AD on the lives of adult patients as described from an experiential perspective. METHODS: Natural language processing (NLP) was applied to qualitative patient response data from two large-scale international cross-sectional surveys conducted in the USA and countries outside of the USA (non-USA; Canada, France, Germany, Italy, Spain, and the UK). Descriptive analysis was conducted on patient responses to an open-ended question on how they felt about their AD and how the disease affected their life. Character length, word count, and stop word (common words) count were evaluated; centrality analysis identified concepts that were most strongly interlinked. RESULTS: Patients with AD in all countries were most frequently impacted by itch, pain, and embarrassment across all levels of disease severity. Patients with moderate-to-severe AD were more likely than patients with mild AD to describe sleep disturbances, fatigue, and feelings of depression, anxiety, and a lack of hope that were directly associated with AD. Centrality analysis revealed sleep disturbance was strongly linked with itch. Collectively, these concepts revealed that patients with AD are impacted by both physical and emotional burdens that are intricately connected. CONCLUSIONS: Qualitative data from NLP, being more patient-centric than data from clinical standardized measures, provide a more comprehensive view of the burden of AD to inform disease management.