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SB2, autorisé dans l'UE en tant que biosimilaire de l'infliximab (IFX), a démontré sa bioéquivalence, ainsi qu'une efficacité, une innocuité et une immunogénicité similaires à l'IFX de référence. Il existe peu de publications démontrant dans la vie réelle la persistance, l'efficacité ou l'innocuité de SB2 chez des patients naïfs d'IFX ou chez ceux en transition depuis la molécule originale ou un autre biosimilaire de l'IFX. PERFUSE est une étude non-interventionnelle en cours comprenant 1374 patients (500 diagnostiqués en rhumatologie, 874 diagnostiqués en gastro-entérologie) recevant SB2 comme traitement de routine ; les objectifs de cette étude sont de décrire les caractéristiques cliniques, l'efficacité, la persistance du traitement et la sécurité chez des patients démarrant SB2 et suivis pendant 24 mois dans 21 sites spécialisés répartis dans toute la France. Les patients adultes éligibles dans les cohortes rhumatologie de cette étude doivent présenter un diagnostic de polyarthrite rhumatoïde (PR), de rhumatisme psoriasique (RPSO) ou de spondyloarthrite ankylosante (SA) ; ils doivent également avoir démarré SB2 comme traitement de routine après septembre 2017, soit comme premier IFX, soit comme transition à partir du produit d'origine d'IFX ou d'un autre biosimilaire de l'IFX. La saisie des données est effectuée à partir des dossiers médicaux des patients. Les paramètres évalués incluent la persistance sous SB2, les caractéristiques cliniques de base (lors de l'initiation de SB2), les scores de la maladie et les événements indésirables graves (EIG). Cette analyse intermédiaire après 12 mois (M12) a inclus 500 patients (99 avec PR, 62 avec RPSO et 339 avec SA). Sous SB2, la persistance M12 pour les patients naïfs d'IFX et en transition était de 73,8 % (IC95 % : 61,5–84,0), 76,2 % (IC95 % : 60,5–87,9) et 71,5 % (IC95 % : 65,6–76,9) pour les patients atteints respectivement de PR, RPSO et SA. Chez les patients préalablement traités par IFX, aucune différence cliniquement significative du score de l'activité de la maladie (DAS) entre le niveau de base et M12 n'a été observée (Tableau 1). La taille restreinte de l'échantillon excluait toute interprétation du score de la maladie pour la cohorte de patients naïfs d'IFX (données non-incluses dans le Tableau 1). Les sept EIG déclarés n'étaient pas associés au traitement SB2 (cohorte PR : carcinome de la prostate et mammaire ; cohorte SA : intoxication alcoolique, néphrostomie, épistaxis, lésion cutanée et fracture de la malléole). Cette analyse intermédiaire indique que, pour les patients présentant une PR, un RPSO ou une SA, la transition entre la molécule d'origine ou un biosimilaire d'IFX vers le SB2 peut s'effectuer avec succès, sans perte de contrôle de la maladie et sans augmentation du nombre d'événements indésirables. Douze mois après son initiation, la majorité des patients ayant effectué cette transition ont continué le traitement SB2. L'étude PERFUSE fournira des informations continues et pertinentes sur les résultats obtenus dans ces populations, ce qui contribuera à éclairer les décisions de traitement fondées sur des données probantes. [ABSTRACT FROM AUTHOR]

Objectives: To describe the real-world use of Elastic Venous Compression Devices (EVCDs) during pregnancy and post-partum using data from a representative subset of the French National Health Insurance Claims Database (the Echantillon Généraliste des Bénéficiaires, EGB)., Study Design: Women aged 15-49 who were pregnant between 1st July 2017 and 15th June 2018 were identified in the EGB using pregnancy-specific acts (certain prenatal examinations or deliveries). Subgroups were defined by age, presence of Venous Thrombo-Embolism (VTE) risk factors, history of VTE, delivery type and time period. EVCD dispensations (format, prescriber, and date) were identified among those for "standard orthotics" using their unique reimbursement tariffs. Dispensation rates were computed for all subgroups, overall and by format and were compared., Results: 15,528 pregnant women were included: 7,252 [46.7 %] deliveries (5,796 vaginal [79.9 %], 482 planned cesarean sections (C-sections) [6.7 %] and 974 unplanned C-Sections [13.4 %]), 2,734 (17.6 %) terminations and 5,542 (35.7 %) unknown outcomes. Overall, 4,919 (31.7 %) women were dispensed at least one EVCD. Ante-partum dispensation occurred in 43.1 % (n = 3,122) of women whose pregnancy led to a delivery. Dispensation rates were 17.3 % (n = 1,005), 46.7 % (n = 225) and 44.1 % (n = 430) after vaginal delivery, planned C-sections or unplanned C-sections, respectively. Overall, dispensation rates significantly increased with age, the presence of VTE risk factors, and a history of VTE (p < 0.01). EVCD dispensation was most frequent (17.0 %) during the 5th month of pregnancy. Among pregnant women who were dispensed at least one EVCD during ante- or post-partum, 69.0 % had one or two units of compression (27.1 % [one unit], 41.9 % [two units]). Stockings (48.6 %, n = 6,038) were dispensed significantly more frequently than socks (36.9 %, n = 4,586) and tights (14.5 %, n = 1,806) (p < 0.01). The main contributors to mechanical VTE prophylaxis were gynecologists (26.3 % of dispensations, n = 2,280), general practitioners (20.2 %, n = 1,749) and midwives (15.1 %, n = 1,314)., Conclusions: Low observed dispensation rates highlight a discrepancy between the French National Authority for Health (Haute Autorité de Santé, HAS), recommending EVCDs use during pregnancy and after delivery, and the real-life use of EVCD. Prescription sensitization combined with targeted information campaigns for pregnant women would be beneficial to contribute to the prevention of VTE, a health problem for pregnant women., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: To estimate prevalence, incidence and mortality rates, and annual healthcare costs of primary Sjögren's syndrome (pSS) and SS associated with other autoimmune disorders (SS+AID) in France., Methods: French national healthcare claims-based study within the prospective Système National des Données de Santé database that includes the majority of the French population. An algorithm was developed to identify patients with SS and SS-related healthcare claims were analysed between 2011 and 2018., Results: Overall, 23 848 patients with pSS and 14 809 with SS+AID were identified. From 2011 to 2018, the prevalence rate increased slightly for pSS (23-32 per 100000) and SS+AID (16-20 per 100 000), with females comprising 90%-91% and 92%-93% of cases, respectively. The incidence rate of SS per 100 000 persons decreased from 2012 (pSS: 4.3; SS+AID: 2.0) to 2017 (pSS: 0.7; SS+AID: 0.3). Mortality rates per 100 000 persons increased from 2012 to 2018 in patients with pSS (0.2-0.8) or SS+AID (0.1-0.5); mean age of death also increased. Artificial tears and hydroxychloroquine were the most common drug reimbursements. Less than half of patients received annual specialist care from a dentist or ophthalmologist. Healthcare costs associated with SS increased from 2011 to 2018 and exceeded the national estimate of expected costs for chronic diseases., Conclusion: In this large French population database study, the low prevalence of pSS confirms that it is an orphan disease. SS is clinically and economically burdensome; these findings may help clinicians better understand routine healthcare received by patients., Competing Interests: Competing interests: RS is a consultant for Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Fresenius Kabi, GlaxoSmithKline, Janssen, Pfizer and Roche. LC is a consultant for Bristol Myers Squibb. GD is a consultant for Bristol Myers Squibb and a consultant with no fees for Roche. JZ and VV-M are employees of and shareholders in Bristol Myers Squibb. VD-P is a consultant for AbbVie, Bristol Myers Squibb and Novartis, and has received grant/research support from Bristol Myers Squibb, Eli Lilly and Roche-Chugai. MB declares no conflicts of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Interstitial lung disease (ILD) is a severe extra-articular manifestation of rheumatoid arthritis (RA). The objectives of this study were to estimate mortality rate in patients with RA-ILD and identify factors affecting mortality., Methods: Data from a French national claims database (Système National des Données de Santé) from 2013 to 2018 were analysed. Adults with an RA diagnosis (International Classification of Diseases (ICD)-10 codes M05, M06.0, M06.8 and M06.9) were included. ILD diagnosis was defined with ICD-10 code J84. Mortality rates were compared between patients with RA with and without ILD, using Cox proportional hazards regression, after matching 1:1 for age, sex, age at RA-ILD onset and RA duration., Results: Among 173 132 patients with RA, 4330 (3%) also had ILD (RA-ILD). After matching, RA-ILD was associated with an increased mortality rate (HR 3.4, 95% CI 3.1 to 3.9). The HR for mortality was greater for: patients aged <75 years (HR 4.8, 95% CI 3.9 to 5.9) versus ≥75 years (HR 3.0, 95% CI 2.6 to 3.5); patients with ILD onset occurring before RA onset (HR 8.4, 95% CI 5.5 to 13.0) versus ILD onset occurring after RA onset (HR 2.9, 95% CI 2.6 to 3.3); and men (HR 5.2, 95% CI 4.4 to 6.2) versus women (HR 3.6, 95% CI 3.0 to 4.2)., Conclusion: In this nationwide cohort study, RA-ILD was associated with increased mortality rate (vs in patients with RA without ILD), notably for those aged <75 years, those whose ILD preceded RA onset and men., Competing Interests: Competing interests: PA-J has received grant/research support from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Medac, Novartis, Roche Chugai and Societe Francaise de Rhumatologie; and consultancy fees from Bristol Myers Squibb. LW has received consultancy fees from Boehringer Ingelheim, Bristol Myers Squibb, Roche and Sanofi. SO has received consultancy fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Roche-Chugai, SOBI and UCB. GD has received consultancy fees from Bristol Myers Squibb. JZ and VV-M are employees of and shareholders in Bristol Myers Squibb. R-MF has received speakers bureau fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Medac, Merck Sharp & Dohme, Novartis, Pfizer and Roche-Chugai; and grant/research support from Amgen, Janssen, Novartis and Pfizer. BC has received consultancy fees from Apellis, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, Roche and Sanofi; and grant/research support from Boehringer Ingelheim, Bristol Myers Squibb and Roche. PD has received consultancy fees from Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Eli Lilly, Medac, Novartis, Pfizer and Sanofi; and grant/research support from Bristol Myers Squibb, GlaxoSmithKline and Pfizer., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Rheumatoid arthritis (RA) is considered a major risk factor for fragility fractures. We examined the quality of management of bone fragility in RA patients in a real-life setting., Methods: We performed a longitudinal case-control retrospective study in a 1/97th random sample of French health care claims database from 2014 to 2016 to determine the extent of bone fragility management in patients with RA compared with non-RA matched controls., Results: Compared to their non-RA controls (n=4652), RA patients (n=1008; mean age: 61.1years; methotrexate: 69.7%; other conventional disease-modifying antirheumatic drugs (cDMARDs): 26.8%; biologic: 26.0%; corticosteroids: 36.9%) had more reimbursements for bone mineral density (BMD) measurements (21.6 vs. 9.2%; OR=2.7 [2.3; 3.3]; P<0.01) and for bisphosphonates (7.1 vs. 3.6%, OR=2.0 [1.5; 2.7]; P<0.05). In patients exposed to corticosteroids, RA patients underwent more BMD assessments than non-RA controls (28.0 vs. 18.8%; OR=1.7 [1.3; 2.2]; P<0.05). RA patients exposed to corticosteroids were more likely to sustain fracture than non-exposed RA patients (5.7 vs. 2.4%, P<0.01). In addition, only when comparing patients exposed to corticosteroids, was there statistical evidence of an association between RA and an increased fracture rate (6.2 vs. 3.5%, P<0.05)., Conclusion: Patients with RA exposed to corticosteroids are at high risk of fracture. Patients with RA had more bone fragility management than controls., (Copyright © 2022 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

Objective: Epidemiological surveillance of malaria in France is based on a hospital laboratory sentinel surveillance network. There is no comprehensive population surveillance. The objective of this study was to assess the ability of the French National Health Insurance Information System to support nationwide malaria surveillance in continental France., Materials and Methods: A case identification algorithm was built in a 2-step process. First, inclusion rules giving priority to sensitivity were defined. Then, based on data description, exclusion rules to increase specificity were applied. To validate our results, we compared them to data from the French National Reference Center for Malaria on case counts, distribution within subgroups, and disease onset date trends., Results: We built a reusable automatized tool. From July 1, 2013, to June 30, 2014, we identified 4077 incident malaria cases that occurred in continental France. Our algorithm provided data for hospitalized patients, patients treated by private physicians, and outpatients for the entire population. Our results were similar to those of the National Reference Center for Malaria for each of the outcome criteria., Discussion: We provided a reliable algorithm for implementing epidemiological surveillance of malaria based on the French National Health Insurance Information System. Our method allowed us to work on the entire population living in continental France, including subpopulations poorly covered by existing surveillance methods., Conclusion: Traditional epidemiological surveillance and the approach presented in this paper are complementary, but a formal validation framework for case identification algorithms is necessary., (© The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com)

Rationale and Objectives: To evaluate the quality of images of the aorta and visceral arteries made at a high level of spatial resolution with thin slices and an optimized acquisition time by three-dimensional contrast-enhanced magnetic resonance angiography (3D CE-MRA)., Materials and Methods: 3D CE-MRA with a 1.4-mm slice thickness and 512-pixel base matrix was done on 62 consecutive patients with a 1.5-T magnetic resonance imaging MRI unit. A bolus test with a power injector was used to calculate the optimal scan delay time. For quantitative evaluation, the signal-to-noise ratio (SNR) was measured in 3 regions of interest. Qualitative image analysis was evaluated independently by two radiologists and graded on a scale of 0-3. Separate analyses were done for the aorta and distal visceral arterial branches., Results: The means SNR values were respectively 56.2 +/- 15.2 (mean +/- SD) for the aorta, 59.2 +/- 15.1 for the celiac trunk, and 57 +/- 15.2 for the superior mesenteric artery, with a homogeneous distribution (P = .99). Consistent enhancement was confirmed by the lack of statistically significant differences between the SNR values. The average score for vessel visualization on source images ranged from good to excellent for different segments. After post-processing of images, the average score for distal arterial segments was significantly improved. The overall agreement between the 2 reviewers in the visualization of definite artery segments was excellent (k = .91)., Conclusion: 3D CE-MRA with a 512-pixel base matrix and thin slices can be applied in a reproducible way with excellent depiction and delineation of small vessels. Such a protocol could be used routinely.

Background: French troops are exposed to tick-borne encephalitis (TBE) during their tours of duty in the Balkans. This disease, potentially serious because of its lethality and morbidity, has an effective vaccination. The epidemiological characteristics of TBE in the Balkans are not well known., Objective: In order to provide the French Department of Defence with arguments on the utility of vaccinating troops on missions in this area of Europe, we conducted a cost-benefit study., Design and Setting: Through a decision analysis, we estimated the net benefit of a three-injection vaccination programme for all French military personnel in the Balkans versus no vaccination during a period from 2004 to 2014. We used a review of the literature to estimate the parameters necessary for the present study: the disease's morbidity and death incidence rate; the disease's sequelae; and the adverse effects of the vaccination. The initial hypothesis of the seroconversion rate of TBE in the Balkans was 834 per 100,000 person-years. Human life was valued in Euro (year 2004 values) by calculating the amounts paid by the French Department of Defence to military personnel in case of disabling sequelae and to their heirs in case of death., Main Results: The net benefit was negative: -5.68 million Euro. The vaccination programme's cost was 10.05 million Euro. 121 cases of TBE could be prevented by this vaccination; however, the sensitivity analysis showed that the results are closely related to the incidence of the disease., Conclusion: Very high incidence rates of TBE were initially hypothesised compared with what has actually been reported. As a result, the vaccination programme against TBE for French military personnel should not be implemented unless the objective of the armed forces is to prevent all cases of TBE and they are willing to assume the cost of doing so.

Several states, of whom France, have been alarmed about suicide in the military. An observational longitudinal cohort study was conducted to check whether the suicide risk in the French army was higher than in the general population and to find out the more prone to self-harm destruction personnel categories. From 1997 to 2000 inclusive, 230 suicides occurred among 315,934 person.years; i.e., the overall annual crude suicide rate was 18.2 per 100,000 active-duty personnel. With the National data for 1999 as reference, army men had a lower suicide risk than men in the overall population of similar age categories (standardised mortality ratio = 67). A Poisson regression model showed that the incidence rate in the Gendarmerie was twice as high as in the Land Forces (incidence rate ratio = 2.15), that the incidence relative risk increased threefold over 4 years, and that the incidence rate ratio amongst under 25 and from 40 to 44-year-old personnel was almost twice as high as in the 25-29-year-old category. The main suicide methods were use of a firearm (51%) and hanging (28%). Despite a global lower risk than in the general population, certain army categories, i.e., Gendarmerie personnel and young men, deserve specific surveillance and preventive measures.

Background: To describe the preoperative clinical, echocardiographic and biological findings in patients with acute aortic dissection and attempt to specify high risk factors of preoperative mortality., Methods: A retrospective, monocentric study of 148 patients admitted for acute type A aortic dissection. All patients underwent a clinical, echocardiographic and biological evaluation on admission. In 75 patients, we measured serum cardiac troponin I (cTnI)., Results: In hospital mortality was 25.9% and 15.6% presented with preoperative cardiac circulatory arrest (POCCA). Patients with POCCA were more likely than others to have hypotension (97+/-56 vs 144+/-24 mmHg, p<0.01) or shock (52% vs 3%, p<0.01) on admission. Pericardial effusion (65% vs 35%, p=0.01) and tamponade (61% vs 8%, p<0.01) were also significantly linked to POCCA but not the aortic ascendant diameter. Detection of cTnI was more frequent in patients with POCCA (24% vs 7%, p=0.051) and was found to be a good predictor of in hospital mortality (47% vs 14%, p<0.01)., Conclusions: For patients with acute type A aortic dissection, hypotension or shock on admission, pericardial effusion or tamponade, as well as cTnI detection, were the main predictors for POCCA and imply immediate surgery.