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In France, Named-Patient Products (NPPs) are used for the treatment of allergic respiratory diseases. Every year, 300,000 patients are treated with NPPs, with 100,000 new patients per year. The French Health Technology Assessment agency requested data to evaluate the effectiveness of sublingual NPPs. To evaluate the impact of sublingual NPPs on patient-reported outcomes. French prospective cohort study of patients with a prescription of NPPs between September 2020 and February 2022 and followed-up at 6 and 12 months. Patients answered an electronic medical questionnaire including the rating of personal importance of 25 treatment needs on a five-point Likert scale (Patient Needs Questionnaire; PNQ) at inclusion, the extent to which these same needs were met by the treatment (Patient Benefit Questionnaire; PBQ) at 6 and 12 months, and other standardized scales. The primary outcome was the Patient Benefit Index (PBI), ranging from 0 to 4, that provides a global weighted benefit parameter (from PNQ and PBQ). A PBI ≥ 1 is admitted to reflect a benefit from treatment. In total, 4,794 patients starting sublingual NPPs were included (3844 adolescents-adults > 12 years old (39.5% men), 950 children (65.8% boys)), with a mean age of 34.2 years and 8.4 years, respectively. At inclusion, most patients had an indication of NPPs for allergic rhinitis (90.2% adolescents-adults and 82.7% children), 19.7% and 27.2% had asthma, 55.7% of adults had a duration of allergy > 10 years. 1,190 adolescents-adults and 387 children had complete data at 6 and 12 months. The mean PBI was 2.0 ± 1.0 (median 2.0) in adults-adolescents, 1.9 ± 1.0 (median 1.8) in children at 6 months, and 2.1 ± 1.0 (median 2.1) and 1.9 ± 1.0 (median 1.8) at 12 months. The PBI was ≥1 in 81.3% of adults-adolescents and 78.0% of children at 6 months, 84.1% and 83.2% at 12 months. Results regarding secondary outcomes suggested no major trends at 6 and 12 months. This study highlights potential benefits of NPPs treatment for allergic respiratory diseases. Further analyses are planned to evaluate the effect of NPPs on trends in healthcare consumption using this cohort matched to the French healthcare insurance system database (SNDS). [ABSTRACT FROM AUTHOR]

Introduction Allergic rhinitis (AR) has been reported to affect between 20% and 40% of the world population. Oralair ® obtained indication for the treatment of grass pollen allergic rhinitis with or without conjunctivitis in adults, adolescents and children (above the age of 5) with clinically relevant symptoms, confirmed by a positive skin test and/or a positive titre of specific grass pollen IgE. The French Health Technology Assessment agency requested to set up a post-authorisation cohort study to describe Oralair ® real-world treatment pattern and patients characteristics. Methods Patients with an initiation of Oralair ® before pollen season in 2015, were included in a cohort study and followed by allergy specialists to the end of the pollen season. Results 90 allergy specialists included 280 adults and 203 children, with a mean age of 33.8 years and 11.8 years at inclusion, 49.6% men and 63.5% boys, age of onset of AR = 15.2 (±10.2) and 4.0 (±2.9) years, 87.1% and 83.7% with conjunctivitis, 41.4% and 34.3% had asthma, 87.9% and 85.2% of AR classified as persistent during the year before, 98.6% and 92.6% as moderate-severe (ARIA classification). A skin test was performed for all patients. Oralair ® was started 3–5 months before pollen season for 85.1% and continued during pollen season for most patients, with a mean duration of 2.5 months. Treatment was discontinued early (< 2 months) in 11.3% of adults and 10.1% of children, generally because of an adverse event (83.7%). At the end of follow-up, AR during pollen season was classified as intermittent for 75.0% of adults and 85.7% of children, and mild severe for 61.8% and 66.0%. The following symptoms reported during the year before were no longer reported during the 2015 pollen season: nasal congestion (52.6% of patients), rhinorrhea (50.1%), repeated sneezing (48.9%), conjunctivitis (48.4%) and nasal pruritus (47.8%). Conclusion This study shows that the conditions of Oralair ® prescriptions by allergy specialists followed the indication recommendations well, and were associated with an improvement of AR severity observed for more than 3 patients out of 5, with a resolution of main previous AR symptoms for about half of the patients. [ABSTRACT FROM AUTHOR]

Background The French HTA agency requested a real-life benefit-risk study of ticagrelor (T) compared to clopidogrel (C) and prasugrel (P) in the secondary prevention of acute coronary syndrome (ACS) (EUPAS5987). Purpose This study aimed to identify the risk factors associated with the primary effectiveness endpoint for patients with antiplatelet agents after a hospitalisation for ACS. Methods Patients hospitalised in 2013 for STEMI, NSTEMI or unstable angina, with intensive care unit (ICU) stay, and followed for 1 year in the nationwide French claims and hospitalisation database, SNIIRAM. Treatment group (T, C, or P ± aspirin) was defined by the first drug dispensed in the month after discharge. The primary effectiveness endpoint was a composite of the first event of ACS with ICU stay, stroke, or all-cause death. Hazard ratios were estimated with Cox proportional hazard risk model (multivariate analysis). Results A total of 41,954 patients were included (19,796 C, 13,916 T, 8242 P) with different characteristics: mean age of 72, 63, 58 years, respectively; 68%, 76%, 86% male; 42%, 55%, 72% STEMI. A Charlson comorbidity index > 5 was associated with a risk increased by at least 50% for the primary effectiveness endpoint; age, a poverty index, ICU stay duration > 5 days and no PCI during index hospitalisation, and congestive heart failure, peripheral arterial disease, ischemic stroke, abnormal renal function, C and P before index hospitalisation were associated with a risk increased by 20–50%; diabetes, hypertension, aspirin before index hospitalisation, and C in the month after discharge (versus T) were associated with a risk increased by 10–20%. Conclusions In this nationwide real-life study, the risk factor most associated with the primary effectiveness endpoint was a Charlson comorbidity index > 5. [ABSTRACT FROM AUTHOR]

Bien que les médicaments indiqués dans l'ostéoporose aient déjà fait preuve de leur efficacité dans les essais cliniques contre placebo, les données sur leur efficacité en situation réelle de soins sont à ce jour limitées. Une étude de cohorte a été réalisée à partir des données de l'Assurance maladie française, le SNDS, incluant toute femme de 55 ans et plus initiant un traitement pour l'ostéoporose (i.e., dénosumab, acide zolédronique (AZ), bisphosphonates oraux (BPO), estrogènes, tériparatide et raloxifène) entre le 1er janvier 2014 et le 31 décembre 2016 selon une approche hiérarchique qui suit l'ordre de commercialisation de ces médicaments en France. Les patientes incluses étaient traitées pendant au moins 6 mois par le traitement index et étaient suivies au moins 2 ans. L'incidence des fractures était comparée au sein d'un même groupe de traitement, en comparant le taux d'incidence des 3 mois suivant la date d'initiation (risque fracturaire de référence), avec celui des 12, 18 et 24 mois suivants. Les résultats des analyses autocontrôlées « sous traitement » ont été présentés en termes d'Incidence Rate Ratio (IRR) et de son intervalle de confiance à 95 % (IC95 %). Parmi les 200 496 patientes inclues, 33 % avaient initié du dénosumab, 26 % des BPO, 21 % de l'AZ, 10 % des estrogènes, 6 % du raloxifène et 4 % du tériparatide. Les patientes avaient en moyenne entre 63 ans (SD ± 8 ans) dans le groupe estrogène et 76 ans (±9 ans) dans le groupe tériparatide. Un traitement préalable par un médicament anti-ostéoporotique était plus fréquemment retrouvé dans le groupe dénosumab (55 %). Le risque fracturaire de référence était variable entre les groupes de traitement ; il était le plus élevé dans les groupes AZ (fracture de la hanche) et tériparatide (fractures vertébrales) et le plus bas dans le groupe estrogène. En comparaison avec les 3 mois suivant l'initiation, les fractures vertébrales faisant l'objet d'une hospitalisation étaient significativement réduites dans les 12, 18 et 24 mois suivants avec le dénosumab (IRRs : 0,7 [0,5 ; 0,8], 0,6 [0,5 ; 0,7] et 0,6 [0,5 ; 0,7]), l'AZ (IRR : 0,4 [0,3 ; 0,4] pour les 3 périodes), le tériparatide (IRRs : 0,4 [0,3 ; 0,6], 0,4 [0,2 ; 0,5] et 0,3 [0,2 ; 0,5]) et les BPO (IRRs : 0,6 [0,4 ; 0,8] pour les 3 périodes). Comparativement aux 3 premiers mois suivant la date index, l'incidence de fracture de la hanche était significativement plus faible avec le dénosumab dans les 18 et 24 mois suivants (IRRs : 0,8 [0,6 ; 0,9]) mais significativement plus élevée pour les BPO pour l'ensemble des 3 périodes (IRRs : 1,6 [1,1 ; 2,2] dans les 12 mois suivants, et 1,7 [1,2 ; 2,3] dans les 18 et les 24 mois suivants), alors qu'aucune différence significative n'était observée avec l'AZ et le tériparatide. Une diminution significative de l'incidence des fractures périphériques était observée uniquement dans le groupe dénosumab pour les 3 périodes (IRRs : 0,85 [0,75 ; 0,96] dans les 12 mois suivants, 0,83 [0,73 ; 0,94] dans les 18 mois suivants et 0,82 [0,73 ; 0,92] dans les 24 mois suivants). L'incidence des fractures vertébrales a été réduite par le traitement avec des thérapies contre l'ostéoporose. Une diminution significative des fractures de hanche et périphériques a été observée uniquement avec le dénosumab. Le traitement avec des médicaments contre l'ostéoporose est efficace dans en situation réelle. [ABSTRACT FROM AUTHOR]

Although the main limitation of the French nationwide claims database (SNDS) is the absence of clinical information, relapse is an outcome that can be identified to assess effects of disease modifying therapies in multiple sclerosis (MS) in real word setting. A random sample of 200 patients - 100 with at least one relapse and 100 without relapse screened by the algorithm - were randomly selected from a cohort of 37,986 MS patients previously identified in the SNDS. [Extracted from the article]