Système National Des Données De Santé Research Articles

Incidence of stroke, subsequent clinical outcomes and health care resource utilization in people with type 2 diabetes: a real-world database study in France: “INSIST” study

BackgroundPeople with type 2 diabetes (T2D) are at elevated risk of cardiovascular disease (CVD) including stroke, yet existing real-world evidence (RWE) on the clinical and economic burden of stroke in this population is limited. The aim of this cohort study was to evaluate the clinical and economic burden of stroke among people with T2D in France.MethodsWe conducted a retrospective RWE study using data from the nationally representative subset of the French Système National des Données de Santé (SNDS) database. We assessed the incidence of stroke requiring hospitalization between 2012 and 2018 among T2D patients. Subsequent clinical outcomes including CVD, stroke recurrence, and mortality were estimated overall and according to stroke subtype (ischemic versus hemorrhagic). We also examined the treatment patterns for glucose-lowering agents and CVD agents, health care resource utilization and medical costs.ResultsAmong 45,331 people with T2D without baseline history of stroke, 2090 (4.6%) had an incident stroke requiring hospitalization. The incidence of ischemic stroke per 1000 person-years was 4.9-times higher than hemorrhagic stroke (6.80 [95% confidence interval (CI) 6.47–7.15] versus 1.38 [1.24–1.54]). During a median follow-up of 2.4 years (interquartile range 0.6; 4.4) from date of index stroke, the rate of CVD, stroke recurrence and mortality per 1000 person-years was higher among hemorrhagic stroke patients than ischemic stroke patients (CVD 130.9 [107.7–159.0] versus 126.4 [117.2–136.4]; stroke recurrence: 86.7 [66.4–113.4] versus 66.5 [59.2–74.6]; mortality 291.5 [259.1–327.9] versus 144.1 [134.3–154.6]). These differences were not statistically significant, except for mortality (adjusted hazard ratio 1.95 [95% CI 1.66–2.92]). The proportion of patients prescribed glucagon-like peptide-1 receptor agonists increased from 4.2% at baseline to 6.6% during follow-up. The proportion of patients prescribed antihypertensives and statins only increased slightly following incident stroke (antihypertensives: 70.9% pre-stroke versus 76.7% post-stroke; statins: 24.1% pre-stroke versus 30.0% post-stroke). Overall, 68.8% of patients had a subsequent hospitalization. Median total medical costs were €12,199 (6846; 22,378).ConclusionsThe high burden of stroke among people with T2D, along with the low proportion of patients receiving recommended treatments as per clinical guidelines, necessitates a strengthened and multidisciplinary approach to the CVD prevention and management in people with T2D.

Development and validation of algorithms to predict left ventricular ejection fraction class from healthcare claims data.

The use of large medical or healthcare claims databases is very useful for population-based studies on the burden of heart failure (HF). Clinical characteristics and management of HF patients differ according to categories of left ventricular ejection fraction (LVEF), but this information is often missing in such databases. We aimed to develop and validate algorithms to identify LVEF in healthcare databases where the information is lacking. Algorithms were built by machine learning with a random forest approach. Algorithms were trained and reinforced using the French national claims database [Système National des Données de Santé (SNDS)] and a French HF registry. Variables were age, gender, and comorbidities, which could be identified by medico-administrative code-based proxies, Anatomical Therapeutic Chemical codes for drug delivery, International Classification of Diseases (Tenth Revision) coding for hospitalizations, and administrative codes for any other type of reimbursed care. The algorithms were validated by cross-validation and against a subset of the SNDS that includes LVEF information. The areas under the receiver operating characteristic curve were 0.84 for the algorithm identifying LVEF≤40% and 0.79 for the algorithms identifying LVEF<50% and ≥50%. For LVEF≤40%, the reinforced algorithm identified 50% of patients in the validation dataset with a positive predictive value of 0.88 and a specificity of 0.96. The most important predictive variables were delivery of HF medication, sex, age, hospitalization, and testing for natriuretic peptides with different orders of positive or negative importance according to the LVEF category. The algorithms identify reduced or preserved LVEF in HF patients within a nationwide healthcare claims database with high positive predictive value and low rates of false positives.

Generalized pustular psoriasis: A nationwide population-based study using the National Health Data System in France.

GPP is a rare, chronic, neutrophilic skin disease, with limited real-world data characterizing patients with flares and the impact of flares on disease progression and morbidity. Describe the clinical characteristics of patients with GPP, comorbidities, disease epidemiology and frequency and severity of flares, and compare patients with GPP with a matched severe psoriasis population. In this population-based real-world cohort study an algorithm was developed to identify patients with GPP flares. Three cohorts were identified using the Système National des Données de Santé (SNDS) database covering almost the entire French population; a prevalent cohort (2010-2018), an incident cohort (2012-2015). A severe psoriasis cohort was compared with the GPP incident cohort using propensity score matching. The prevalent and incident cohorts comprised 4195 and 1842 patients, respectively. In both cohorts, mean age was 58 years; 53% were male. Comorbidities were significantly more common in the incident cohort versus matched psoriasis cohort, respectively, including hypertension (44% vs. 26%), ischaemic heart disease (26% vs. 18%) and hyperlipidaemia (25% vs. 15%). In the incident cohort, the flare rate was 0.1 flares/person-year and 0.4 flares/person-year among the 569 out of 1842 patients hospitalized with flares. These patients had a mean (±SD) stay of 11.6 ± 10.4 days; 25% were admitted to the intensive care unit. In 2017, the cumulative incidence and cumulative GPP age-sex standardized prevalence were 7.1 and 45.2 per million, respectively. Patients with GPP had a distinct comorbidity profile compared to patients with severe psoriasis, and GPP flares were associated with long hospitalizations.

Use of multiple sclerosis disease-modifying therapies during pregnancy in France: Nationwide study between 2010 and 2021.

Multiple sclerosis (MS) frequently affects women of childbearing age and pregnant women. To assess the use of MS disease-modifying therapies (DMTs) during pregnancy in France over the last decade, marked by an increasing DMTs availability. All pregnancies ended from April 2010 to December 2021 in women with MS were identified based on the nationwide Mother-Child Register EPI-MERES, built from the French National Health Data System (Système National des Données de Santé (SNDS)). Of a total of 20,567 pregnancies in women with MS, 7587 were exposed to DMT. The number of DMT-exposed pregnancies markedly increased from 1079 in 2010-2012 to 2413 in 2019-2021 (+124%), especially those exposed to glatiramer acetate, natalizumab, dimethyl fumarate, and anti-CD20. Among pregnancies of women on DMT 6 months before pregnancy, 78.0% underwent DMT discontinuation and 7.6% switched DMT, generally before (33.0% and 77.0%, respectively) or during the first trimester of pregnancy (58.3% and 17.8%, respectively). DMT discontinuation decreased from 84.0% in 2010-2012 to 72.4% in 2019-2021 and was less frequent among women aged ⩾35 years and those socioeconomically disadvantaged. Despite MS therapeutic management adaptations to pregnancy, exposure during pregnancy to treatments whose safety profile has not yet been clearly established has increased sharply over the last decade.

RWD62 Dupixam: An SNDS (SYSTÈME NATIONAL DES DONNÉES DE SANTÉ) Study to Characterize Patients Treated with Dupilumab for Moderate-to-Severe Atopic Dermatitis in France

RWD62 Dupixam: An SNDS (SYSTÈME NATIONAL DES DONNÉES DE SANTÉ) Study to Characterize Patients Treated with Dupilumab for Moderate-to-Severe Atopic Dermatitis in France

Health status and comorbidities of adult patients with late-diagnosed phenylketonuria (PKU) born before the newborn screening in France – A nationwide study of health insurance claims data

BackgroundPhenylketonuria (PKU) is an inborn error of metabolism. When diagnosed late, it causes developmental delay or severe irreversible intellectual disability. This study aimed at evaluating the health status and healthcare consumption of late-diagnosed PKU patients in France. MethodsThis retrospective observational study used health insurance claims data from the French SNDS (Système National des Données de Santé) database, which contains data from over 66 million French inhabitants. Patients with PKU were identified between 2006 and 2018 by ICD-10 diagnosis codes E70.0 / E70.1 documented as a chronic condition (affection de longue durée – ALD) or in the inpatient setting. Patients with PKU were matched to controls by age, sex, and region. Patients with late-diagnosed PKU were defined as patients born before the nationwide implementation of newborn screening in France in 1972. Outcomes were analyzed for the year 2018. ResultsIn total, 3549 patients with PKU were identified in the database on January 1st, 2018. Of those, 3469 patients could be matched to 17,170 controls without PKU. Of these, 2175 patients were at least 16 years old of whom 647 patients were categorized as late-diagnosed. The late-diagnosed PKU patients suffered significantly more often from hypertension (60.9% vs. 50.4%, p < 0.0001), hypercholesterolemia (41.7% vs. 26.9%, p < 0.0001), diabetes (24.4% vs. 14.1%, p < 0.0001), depression (20.6% vs. 13.8%, p < 0.0001), ischemic heart disease (16.1% vs. 6.6%, p < 0.0001), obesity (7.9% vs. 2.5%, inpatient diagnoses only, p < 0.0001), and chronic kidney disease (5.2% vs. 1.3%, inpatient diagnoses only, p < 0.0001) compared with their non-PKU controls. Consequently, significantly more patients with late-diagnosed PKU received medication to treat comorbidities associated with the nervous (82.6% vs 77.0%; p = 0.0021) and cardiovascular system (69.5% vs 58.0%; p < 0.0001). Overall, only 3.4% of patients with late-diagnosed PKU received dietary amino-acid supplements and 0.7% received sapropterin. ConclusionThe results indicate that PKU is associated with a significantly higher risk of comorbidities along with increased pharmaceutical prescriptions in patients with late-diagnosed PKU, compared with non-PKU controls. The increased risk of comorbidities was more pronounced than in patients with early-diagnosed PKU, as shown in previous research, but these patients are older than those with early-diagnosed PKU. Only few late-diagnosed patients were treated specifically for PKU. Patients with late-diagnosed PKU should be referred to specialized centers to prevent and manage comordities and introduce PKU-specific treatment when it is possible.

Real-life omalizumab exposure and discontinuation in a large nationwide population-based study of paediatric and adult asthma patients

This real-life study aimed to assess omalizumab treatment patterns in adult and paediatric asthma patients, and to describe asthma control and healthcare resource use (HCRU) at omalizumab initiation and discontinuation. The French healthcare database system (Système National des Données de Santé (SNDS)) was used to identify asthma patients aged ≥6 years who initiated omalizumab for at least 16 weeks from 2009 to 2019. We examined omalizumab treatment patterns using dispensation records. We identified 16 750 adults and 2453 children initiating omalizumab. Median treatment persistence before discontinuation (TSTOP) was 51.2 (95% CI 49.3-53.4) months in adults and 53.7 (95% CI 50.6-56.4) months in children. At 2 years of omalizumab exposure, rate of hospitalisation for asthma decreased by 75% and use of oral corticosteroids (OCS) by 30%, in adults and children. Among adults who discontinued omalizumab while asthma was controlled, 70%, 39% and 24% remained controlled and did not resume omalizumab at 1, 2 and 3 years after discontinuation, respectively. These proportions were higher in children (76%, 44% and 33%, respectively). Over 2 years of follow-up after discontinuation, HCRU remained stable in adults and children, notably rate of hospitalisations for asthma (none before TSTOP, 1.3% and 0.6% at 2 years) and use of OCS (in adults and children, respectively: 20.0% and 20.2% before TSTOP, 33.3% and 24.6% at 2 years). This is the first large-scale study describing omalizumab real-life exposure patterns in adult and paediatric asthma patients in France with >10 years of follow-up. We showed the long-term maintenance of low HCRU in adults and children who discontinued omalizumab while asthma was controlled, notably for OCS use and hospitalisations for asthma.

Trends in bacterial sepsis incidence and mortality in France between 2015 and 2019 based on National Health Data System (Système National des données de Santé (SNDS)): a retrospective observational study

ObjectiveThis study aims to provide a case definition of sepsis of presumed bacterial aetiology based on 10th revision of the International Classification of Diseases (ICD-10) codes, to assess trends in...

Functional Outcome After Spinal Meningioma Surgery. A Nationwide Population-Based Study.

ObjectiveTo describe and analysed the functional outcome (FO) after spinal meningioma (SM) surgery. MethodsWe processed the système national des données de santé (SNDS) i.e. , the French national administrative medical database to retrieve appropriate cases. We analysed the International Classification of Diseases 10 codes to assess the FO. Logistic models were implemented to search for variables associated with a favourable FO i.e. , a patient being independent at home without disabling symptom. ResultsA total of 2,844 patients were identified of which 79.1% were female. Median age at surgery was 66 years, interquartile range (IQR) (56–75). Ninety-five point nine percent of the SMs were removed through a posterior ± lateral approach and 0.7% need an associated stabilisation. Benign meningioma represented 92.9% and malignant 2.1%. Median follow-up was 5.5 years, IQR (2.1–8), and at data collection 9% had died. The FO was good and increased along the follow-up: 84.3% of the patients were alive and had not associated symptoms at one year, 85.9% at 2 and 86.8% at 3 years. Nonetheless, 3 years after the surgery 9.8% of the alive patients still presented at least one disabling symptom of which 2.7% motor deficit, 3.3% bladder control problem, and 2.5% gait disturbance. One point seven percent were care-provider dependent and 2.1% chair or bedfast. In the multivariable logistic regression an older age at surgery (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.29–0.47, p<0.001), a high level of comorbidities (OR, 0.71; 95% CI, 0.66–0.75, p<0.001), and an aggressive tumor (OR, 0.49; 95% CI, 0.33–0.73; p<0.001) were associated with a worse FO. ConclusionFO after meningioma surgery is favourable but, may be impaired for older patients with a high level of comorbidities and aggressive tumor.

Risk of first ischaemic stroke and use of antidopaminergic antiemetics: nationwide case-time-control study

ObjectiveTo estimate the risk of ischaemic stroke associated with antidopaminergic antiemetic (ADA) use.DesignCase-time-control study.SettingData from the nationwide French reimbursement healthcare system database Système National des Données de Santé (SNDS).ParticipantsEligible participants...

Relationship Between CPAP Termination and All-Cause Mortality: A French Nationwide Database Analysis

BackgroundRandomized controlled trials have failed to demonstrate an effect of CPAP therapy on mortality. However, these studies have a number of important limitations, including low CPAP adherence, patient selection, and a small number of mortality events.Research QuestionWhat are the effects of CPAP therapy termination in the first year on all-cause mortality in patients with OSA from the Nationwide Claims Data Lake for Sleep Apnea study?Study Design and MethodsData from the Système National des Données de Santé (SNDS) database, the French national health insurance reimbursement system, for all new CPAP users ≥ 18 years of age were analyzed. The SNDS contains comprehensive, individualized, and anonymized data on health spending reimbursements for > 99% of all individuals living in France. OSA diagnosis was based on specific disease codes, whereas CPAP prescription was identified using specific treatment method codes. CPAP therapy termination was defined as the cessation of CPAP reimbursements triggered by the respiratory physician or sleep specialist in charge of follow-up. Patients who terminated therapy in the first year were propensity score matched with those who continued to use CPAP. The primary outcome was all-cause mortality. Three-year survival was visualized using Kaplan-Meier curves. Contributors to mortality also were determined.ResultsData from two matched groups each including 88,007 patients were included (mean age, 60 years; 64% men). Continuation of CPAP therapy was associated with a significantly lower risk of all-cause death compared with CPAP therapy termination (hazard ratio [HR], 0.61; 95% CI, 0.57-0.65; P < .01, log-rank test). Incident heart failure also was less common in patients who continued vs terminated CPAP therapy (HR, 0.77; 95% CI, 0.71-0.82; P < .01).InterpretationThese real-world data from a comprehensive, unbiased database highlight the potential for ongoing use of CPAP treatment to reduce all-cause mortality in patients with OSA.

Epidemiology and Survival after Spinal Meningioma Surgery: A Nationwide Population-Based Study.

This is a cross-sectional nationwide descriptive observational and analytic retrospective study. This study aims to describe and assess survival after spinal meningioma (SM) surgery. A few studies report a reduced survival after SM surgery. The current study processed the Système National des Données de Santé (SNDS), the French national administrative medical database, to retrieve appropriate cases. This study identified 2,844 patients (79.1% females) between 2008 and 2017. The median age at surgery was 66 years (interquartile range [IQR], 56-75 years). Moreover, 95.9% of SMs were removed through posterior or posterolateral approaches, and 6.9% were epidural and 0.7% needed an associated spine stabilization. Benign meningioma represented 92.9%, with 5% and 2.1% atypical and malignant, respectively. The median follow-up was 3.3 years (IQR, 3.1-3.5 years). Of the patients, 0.25% and 1.2% expired within a month and a year of surgery, respectively. At data collection, 225 patients (7.9%) expired. The 5-year overall survival (OS) probability was 90.1% (95% CI, 88.6%-91.7%). However, absolute excess risk of mortality after SM surgery was null, and the related standardized mortality ratio was 1 (95% CI, 0.9-1.2; p =0.565). In the adjusted regression, age at surgery (hazard ratio [HR], 1.06; 95% CI, 1.04-1.07; p <0.001), level of comorbidities (HR, 1.44; 95% CI, 1.34-1.54; p <0.001), neurofibromatosis type 2 (NF2; HR, 3.65; 95% CI, 1.28-10.39; p =0.0152), epidural SM (HR, 1.73; 95% CI, 1.09-2.75; p =0.0206), and malignant meningioma (HR, 2.64; 95% CI, 1.51-4.61; p <0.001) remained significantly associated to a reduced OS. The SNDS is of great value in assessing SM incidence, associated mortality, and its predictors. OS after meningioma surgery is favorable but may be impaired for NF2 or older patients with a high level of comorbidities, epidural tumor, and malignant histopathology. SM surgery is not associated with an increased absolute excess mortality risk despite being performed on even more senior patients compared with intracranial meningioma.

POSA412 Using French National Healthcare Databases (SNDS) to Estimate Economic Burden of Diseases: A Literature Review

The French national medico-administrative database called SNDS (“Système National des Données de Santé”) contains hospital records, primary and secondary care for 66 million people. All dispensed and reimbursed drug prescriptions are collected and these data are individualized and anonymized. The General Beneficiaries Sample (EGB) is a representative sample (1/97) of the SNDS. We aim to provide an overview of cost of illness assessment from medico-administrative databases, focusing on data extracted from SNDS and EGB. A literature review of French and English language publications from 2011 to 2021 was conducted in PubMed, searching keywords related to the SNDS database studies. Only human studies were selected. All publications including a cost analysis conducted through these databases were included. We excluded studies without any cost analysis and studies with cost data extracted from other databases or retrieved from PMSI (hospital database) only. Overall, 43 articles were selected after screening 121 publications, which most of them were published in clinical journals (54%). The EGB database was used more frequently to estimate costs than the SNDS (63% vs 37%). Cardiovascular diseases (16%), cancers (16%) and diabetes (16%) were the three pathologies most studied. Almost half of the studies considered costs over only a 1-year period or less (46.5%). Cost analyses were performed from the French health Insurance System (47%) or societal (35%) perspective, rarely both (9%), when the information was provided. Direct medical (hospitalizations and ambulatory care) or non-medical costs (transportation) were retrieved from French administrative databases, and 8 publications also considered some indirect costs (sick leaves, daily allowances, disability pensions). Discounting was not applied in most cases (79%). The SNDS is an exhaustive medical-administrative database which can provide real world cost data to assess burden of diseases, but also to provide inputs for medico-economic and budget impact models.

POSC52 Cost-Effectiveness of Atezolizumab in Association with Bevacizumab for Patients with Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Using a French Real-World Evidence Database

In most cost-effectiveness analyses, data are sourced from clinical trials and/or clinical guidelines. The objective of this study was to evaluate the impact on the cost-effectiveness of Tecentriq+Bevacizumab (T+A) in hepatocellular carcinoma (HCC) in a model populated with real-world evidence from the French Système National des Données de Santé (SNDS). Sensitivity analyses using adjusted extrapolations based on the Guyot’s method and macrocosting were considered in this French-based cost-effectiveness analysis.

Non-tuberculous mycobacterial pulmonary diseases in France: an 8\xa0years nationwide study

BackgroundThe objective of the study was to describe the epidemiology, management and cost of non-tuberculous mycobacteria pulmonary disease (NTM-PD) in France.MethodsA retrospective analysis was performed using the SNDS (“Système national des données de santé”) database over 2010–2017. Patients with NTM-PD were identified based on the ICD10 codes during hospitalizations and/or specific antibiotics treatment regimens. The study population was matched (age, sex and region) to a control group (1:3) without NTM-PD.Results5628 patients with NTM-PD (men: 52.9%, mean age = 60.9 years) were identified over the study period and 1433 (25.5%) were treated with antibiotics. The proportion of patients still receiving treatment at 6 and 12 months was 40% and 22%, respectively. The prevalence of NTM-PD was estimated at 5.92 per 100,000 inhabitants and the incidence rate of NTM-PD remained stable over time between 1.025/100,000 in 2010 and 1.096/100,000 in 2017. Patients with NTM-PD had more co-morbidities compared to controls: corticoids (57.3% vs. 33.8%), chronic lower respiratory disease (34.4% vs. 2.7%), other infectious pneumonia (24.4% vs. 1.4%), malnutrition (based on hospitalization with the ICD-10 code reported during a hospital stay as a main or secondary diagnosis) (22.0% vs. 2.0%), history of tuberculosis (14.1% vs. 0.1%), HIV (8.7% vs. 0.2%), lung cancer and lung graft (5.7% vs. 0.4%), cystic fibrosis (3.2% vs. 0.0%), gastro-esophageal reflux disease (2.9% vs. 0.9%) and bone marrow transplant (1.3% vs. 0.0%) (p < 0.0001). The mean Charlson comorbidity index score was 1.6 (vs. 0.2 for controls; p < 0.0001). NTM-PD was independently associated with an increased mortality rate with a hazard ratio of 2.8 (95% CI: 2.53; 3.11). Mortality was lower for patients treated with antibiotics compared to untreated patients (HR = 0.772 (95% CI [0.628; 0.949]). Annual total expenses the year following the infection in a societal perspective were € 24,083 (SD: 29,358) in NTM-PD subjects vs. € 3402 (SD: 8575) in controls (p < 0.0001). Main driver of the total expense for NTM-PD patients was hospital expense (> 50% of the total expense).ConclusionPatients with NTM-PD in France were shown to have many comorbidities, their mortality risk is high and mainly driven by NTM-PD, and their management costly. Only a minority of patients got treated with antibiotics and of those patients treated, many stopped their therapy prematurely. These results underline the high burden associated with NTM-PD and the need for improvement of NTM-PD management in France.

Risk of Hospitalization for Vaso-Occlusive Episode in Patients with Sickle Cell Disease after out-Patient Exposure to Systemic Corticosteroids

▪Introduction : Sickle cell disease (SCD) is an inherited disorder which affects 300,000 newborns per year. Vaso-occlusive episodes (VOEs) cause an important morbi-mortality and a decreased quality of life in patients with SCD. Some risk factors of VOE are well known, like infection, cold exposure, stress, pulmonary diseases and dehydration. Exposure to systemic corticosteroids has been suspected to increase the occurrence of VOEs in few case reports or series. However, no comparative study has been conducted to demonstrate this risk which is still debated, resulting in discrepancies among guidelines on SCD management. This study aimed to assess the risk of hospitalization for VOE associated with out-hospital exposure to systemic corticosteroids in patients with SCD in France.Methods : Data source was the French national health insurance system database, named SNDS (Système National des Données de Santé) between 2010 and 2018. The SNDS links sociodemographic, out- and in-hospital data for the entire French population (>66 million inhabitants). The study population consisted in all patients with SCD with at least one hospitalization for VOE during the study period, identified with a primary discharge diagnosis of VOE (D57.0 code of the international classification of disease, 10 th version; positive predictive value: 98.6%). All genotypes (homozygous SS-SCD and double-heterozygous SCD) were included. Because we assessed out-hospital exposure to corticosteroids, patients hospitalized during the three months before the first VOE were excluded. We performed a case-case-time-control study (Figure 1). This self-controlled design results in self-adjustment for time-independent confounders, including genotype. The outcome was the first hospitalization for VOE. The exposure to oral and injectable corticosteroids, identified using out-hospital reimbursement data, was assessed during a case period (28 days before the outcome) compared to the exposure during a control period (28 days, starting 84 days before the outcome). The same comparison was made among future cases (matched patients hospitalized for VOE the year after the given case), in order to adjust for the trend of exposure to corticosteroids (calendar variations of corticosteroid exposure).Results : Overall, 5,151 cases of VOEs were included in the main analysis. Median age at first VOE was 16.9 years; 317 (6.2%) patients were exposed to corticosteroids during the case period. In the main analysis, corticosteroid exposure was significantly associated with the occurrence of hospitalizations for VOEs: adjusted Odds Ratio (aOR): 3.81, 95% confidence interval (95% CI): 2.44 to 5.61. In patients exposed to hydroxyurea, the aOR was 2.61, 95% CI: 1.07 to 6.39, compared with an aOR of 4.00, 95% CI: 2.53 to 6.30 in unexposed patients. In the subgroup analysis by age, the aOR was 2.81, 95% CI: 1.49 to 5.30 in children, and 4.45, 95% CI: 2.37 to 8.37 in adults. The results were consistent in all sensitivity analyses.Conclusion : This study showed an association between outpatient exposure to systemic corticosteroids with an increased risk of hospitalization for VOE, in both adults and children. Hydroxyurea may reduce this risk in adults. [Display omitted] DisclosuresBartolucci: GBT: Consultancy; Emmaus: Consultancy; Fabre Foundation: Research Funding; AGIOS: Consultancy; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Lecture fees, Steering committee, Research Funding; Jazz Pharma: Other: Lecture fees; INNOVHEM: Other: Co-founder; Bluebird: Consultancy, Research Funding; F. Hoffmann-La Roche Ltd: Consultancy; Hemanext: Consultancy; Addmedica: Consultancy, Other: Lecture fees, Research Funding. Moulis: Argenx: Membership on an entity's Board of Directors or advisory committees; Sobi: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Grifols: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding.

OAB-016: Treatment pathways for patients with multiple myeloma: a real-life study based on the French National Claim database from 2014 to 2019

<h3>Background</h3> Multiple Myeloma (MM) disease course is a succession of remissions and relapses, which define lines of treatment. For each line, several regimens can be used. This study provides a comprehensive overview of the evolution through treatment lines of MM patients, based on the nationwide French National Health Insurance (NHI) databases, called SNDS ("Système National des Données de Santé"). These databases include hospital records, primary and secondary care, and death records of 66 million people. <h3>Methods</h3> This is a retrospective observational cohort study including all cases of multiple myeloma from 2014 to 2019 identified through the French NHI databases (SNDS). Cases were detected using a validated algorithm which was expanded to consider recent evolution of MM therapeutic management. Incident patients of 2014 and 2015 were extracted and followed up until December 31st, 2019. Treatment lines were reconstructed from 2014 to 2019 through ATLAS, an artificial intelligence algorithm adapted from the Smith-Waterman alignment sequence. Time To Next Treatment (TTNT) for each line has been estimated with a Kaplan Meier method. <h3>Results</h3> 40,747 prevalent treated patients with MM were identified in the SNDS from 2014 to 2019. This analysis involved more specifically 7,118 of these patients, including 3,557 incident patients from 2014 and 3,561 from 2015. Patients were followed until December 31st, 2019, or death. For the frontline treatment, 76% [N=5,409] had a frontline without transplant (L1 NTE) and 24% [N=1,709] had a frontline with transplant (L1 TE). Among patients with L1 NTE (resp. TE), 15% [N=827] (resp. 33% [N=560]) stayed in frontline until the end of the follow-up, 31% [N=1,682] (resp. 4% [N=71]) died after their frontline, and 54% [N=2,900] (resp. 63% [N=1,078]) switched to L2. Among patients with a L1 NTE (resp. TE) and a L2, 26% [N=764] (resp. 35% [N=378]) stayed in L2 until the end of the follow-up, 29% [N=841] (resp. 12% [N=124]) died after their L2, and 45% [N=1,295] (resp. 53% [N=576]) switched to L3. Among patients with a L1 NTE (resp. TE) and a L3, 24% [N=316] (resp. 28% [N=159]) stayed in L3 until the end of the follow-up, 28% [N=367] (resp. 19% [N=111]) died after their L3, and 47% [N=612] (resp. 53% [N=306]) switched to L4. The median TTNT for L1 NTE (resp. TE) was 2.4 (resp. 3.3) years. The overall survival rate at 5 years for patients with a L1 NTE (resp. TE) was 41% (resp. 75%). Regarding treatment sequencing, the main course of patients was as follows: frontline: V-based regimen (VMP for NTE, VTd for TE); L2: Rd; L3: Pom-dex; L4: Dara mono. <h3>Conclusions</h3> This study shows the flow of patients from frontline to L4+ and their survival rates. The study also showed that real-world data are a powerful tool to study treatment lines at a national scale and lead the way to more precise analyses of optimal therapeutic sequences, including their impact on the overall survival.

P-221: Evolution of Dara-based regimen use along treatment lines from 2016 to 2019: a real-life study based on the French national claim database

P-221: Evolution of Dara-based regimen use along treatment lines from 2016 to 2019: a real-life study based on the French national claim database

Epidemiology, Mortality and Healthcare Resource Utilization Associated With Systemic Sclerosis-Associated Interstitial Lung Disease in France.

Objectives: To investigate the clinical characteristics, epidemiology, survival estimates and healthcare resource utilization and associated costs in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) in France.Methods: The French national administrative healthcare database, the Système National des Données de Santé (SNDS), includes data on 98.8% of the French population, including data relating to ambulatory care, hospitalizations and death. In our study, claims data from the SNDS were used to identify adult patients with SSc-ILD between 2010 and 2017. We collected data on clinical features, incidence, prevalence, survival estimates, healthcare resource use and costs.Results: In total, 3,333 patients with SSc-ILD were identified, 76% of whom were female. Patients had a mean age [standard deviation (SD)] of 60.6 (14.4) years and a mean (SD) individual study duration of 3.9 (2.7) years. In 2016, the estimated overall incidence and prevalence were 0.69/100,000 individuals and 5.70/100,000 individuals, respectively. The overall survival estimates of patients using Kaplan–Meier estimation were 93, 82, and 55% at 1, 3, and 8 years, respectively. During the study, 98.7% of patients had ≥1 hospitalization and 22.3% of patients were hospitalized in an intensive care unit. The total annual mean healthcare cost per patient with SSc-ILD was €25,753, of which €21,539 was related to hospitalizations.Conclusions: This large, real-world longitudinal study provides important insights into the epidemiology of SSc-ILD in France and shows that the disease is associated with high mortality, healthcare resource utilization and costs. SSc-ILD represents a high burden on both patients and healthcare services.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03858842.

Impact of the COVID-19 pandemic on the burden of chronic heart failure patients in France

ContextThe COVID-19 pandemic in France has led to the implementation of containment measures, limiting medical activity to urgent care. Heart Failure (HF) patients should have particularly been concerned. During the pandemic, movement restrictions and fear of contamination could have worsened HF patients. MethodsWe conducted two dedicated anonymous questionnaire completed at the end of the first lockdown period in France about the HF patients'symptoms and the cardiologists'pratice. In parallel, data from the SNDS (Système National des Données de Santé) were collected concerning the practices of cardiologists. ResultsRegarding HF patients, 1156 participated and filled the questionnaire. 53% were men, aged 61± 15 yo in men and 53±12 yo in women; 13% declared feeling bad during the pandemic period. 36% declared they had more dyspnea, 14% more oedema, 45% a gain of weight and 57% were more tired. 45% of patients declared having spent more than 4 weeks without any appointment with a medical doctor. Regarding Cardiologists, they proposed to perform a remotely follow-up (teleconsultation including visio, phone call management) in 23% of cases. In parallel, data from the SNDS showed that 19% of cardiologist used teleconsultations. ConclusionThrough this original survey, it emerges that despite the HF patients being more symptomatic, cardiological follow-up was difficult and challenging. We suggest that during pandemic, teleconsultations could improve the efficiency and quality of care, reduce demands on patients, and reduce healthcare costs.