Pharmacoépidémiologie de la thrombopénie immunologique en France. Suivi de cohorte issue du Système national d'information inter-régimes de l'Assurance maladie et création d'un registre clinique

La thrombopénie immunologique (TI) est une maladie auto-immune rare. Son épidémiologie est mal connue. Le traitement de la TI aiguë repose sur les corticoïdes et les immunoglobulines. Passée la phase aiguë, plusieurs traitements sont possibles, dont la splénectomie, le rituximab et les agonistes du récepteur à la thrombopoiétine. L'exposition aux traitements de la TI en vie réelle n'a jamais été évaluée, et leur risque infectieux jamais comparé. Des vaccinations sont recommandées avant le rituximab et la splénectomie, mais la couverture vaccinale n'est pas connue. Nous avons constitué deux matériels complémentaires : 1) la cohorte French Adult Immune Thrombocytopenia : a pHarmacoepidemiological study (FAITH) est la cohorte des patients adultes incidents ayant une TI primaire traités de façon persistante (plus de 3 mois), bâtie dans le Système National d'Information Inter-régimes de l'Assurance Maladie (SNIIRAM) au niveau national ; 2) le registre Cytopénie Auto-immune : Registre Midi-PyrénéEN (CARMEN) est une étude observationnelle en vie réelle suivant les patients incidents de TI dans la région Midi-Pyrénées. Grâce à ces deux cohortes, nous avons décrit l'épidémiologie de la TI incidente en France, l'exposition aux traitements et la couverture vaccinale chez l'adulte, et évalué le risque infectieux des traitements et l'effet protecteur des vaccins.Immune thrombocytopenia (ITP) is a rare autoimmune bleeding disorder. ITP epidemiology is not well known. ITP treatment is based on glucocorticoids, and intravenous polyvalent immunoglobulin in case of severe bleeding. ITP becomes persistent (lasting more than 3 months) or chronic (more than 12 months) in about 70% of adults. In that case, non-corticosteroid treatments are suggested, mostly splenectomy, rituximab and thrombopoietin receptor agonists. The use of these treatments have never been assessed in the real life practice as well as their effectiveness and safety, particularly as regards the risk of infection. Vaccinations are recommended before splenectomy or rituximab. However, the vaccination rates and their effectiveness has not been assessed. We build two complementary materials: 1) the French Adult Immune Thrombocytopenia: a pHarmacoepidemiological study (FAITH) is the cohort of all incident primary ITP adults persistently treated (more than 3 months), built in the French health Insurance system database (Système national d'information inter-régimes de l'Assurance Maladie, SNIIRAM) at the national level; 2) the Cytopénie Auto-immune : Registre Midi-PyrénéEN (CARMEN) registry that includes and follows all incident ITP adults in the French Midi-Pyrénées region. Thanks to these two cohorts, we could assess the epidemiology of incident ITP in France; describe the exposure ITP treatments; assess the vaccination coverage in rituximab treated and splenectomized patients in France; and assess the risk of infection according to ITP treatments and the protective effect of the vaccines in this population

Registries in immune thrombocytopenia (ITP) in Europe: the European Research Consortium on ITP (ERCI) network

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Br J Haematol

International audienc

Pharmacoepidemiology of immune thrombocytopenia in France : follow-up of a cohort built in the French national health insurance database and creation of a clinical registry

La thrombopénie immunologique (TI) est une maladie auto-immune rare. Son épidémiologie est mal connue. Le traitement de la TI aiguë repose sur les corticoïdes et les immunoglobulines. Passée la phase aiguë, plusieurs traitements sont possibles, dont la splénectomie, le rituximab et les agonistes du récepteur à la thrombopoiétine. L'exposition aux traitements de la TI en vie réelle n'a jamais été évaluée, et leur risque infectieux jamais comparé. Des vaccinations sont recommandées avant le rituximab et la splénectomie, mais la couverture vaccinale n'est pas connue. Nous avons constitué deux matériels complémentaires : 1) la cohorte French Adult Immune Thrombocytopenia : a pHarmacoepidemiological study (FAITH) est la cohorte des patients adultes incidents ayant une TI primaire traités de façon persistante (plus de 3 mois), bâtie dans le Système National d'Information Inter-régimes de l'Assurance Maladie (SNIIRAM) au niveau national ; 2) le registre Cytopénie Auto-immune : Registre Midi-PyrénéEN (CARMEN) est une étude observationnelle en vie réelle suivant les patients incidents de TI dans la région Midi-Pyrénées. Grâce à ces deux cohortes, nous avons décrit l'épidémiologie de la TI incidente en France, l'exposition aux traitements et la couverture vaccinale chez l'adulte, et évalué le risque infectieux des traitements et l'effet protecteur des vaccins.Immune thrombocytopenia (ITP) is a rare autoimmune bleeding disorder. ITP epidemiology is not well known. ITP treatment is based on glucocorticoids, and intravenous polyvalent immunoglobulin in case of severe bleeding. ITP becomes persistent (lasting more than 3 months) or chronic (more than 12 months) in about 70% of adults. In that case, non-corticosteroid treatments are suggested, mostly splenectomy, rituximab and thrombopoietin receptor agonists. The use of these treatments have never been assessed in the real life practice as well as their effectiveness and safety, particularly as regards the risk of infection. Vaccinations are recommended before splenectomy or rituximab. However, the vaccination rates and their effectiveness has not been assessed. We build two complementary materials: 1) the French Adult Immune Thrombocytopenia: a pHarmacoepidemiological study (FAITH) is the cohort of all incident primary ITP adults persistently treated (more than 3 months), built in the French health Insurance system database (Système national d'information inter-régimes de l'Assurance Maladie, SNIIRAM) at the national level; 2) the Cytopénie Auto-immune : Registre Midi-PyrénéEN (CARMEN) registry that includes and follows all incident ITP adults in the French Midi-Pyrénées region. Thanks to these two cohorts, we could assess the epidemiology of incident ITP in France; describe the exposure ITP treatments; assess the vaccination coverage in rituximab treated and splenectomized patients in France; and assess the risk of infection according to ITP treatments and the protective effect of the vaccines in this population

Comparaison de la splénectomie première et du rituximab premier dans la thrombopénie immunologique primaire persistante ou chronique (étude dans une cohorte monocentrique de 105 patients)

TOULOUSE3-BU Santé-Centrale (315552105) / SudocSudocFranceF

Impact of previous exposure to systemic corticosteroids on unfavorable outcome in patients hospitalized for COVID-19

International audienceBackground: The impact of prior exposure to systemic corticosteroids on COVID-19 severity in patients hospitalized for a SARS-CoV-2 pneumonia is not known. The present study was designed to answer to this question. Methods: The population study was the Covid-Clinic-Toul cohort which records data about all hospitalized patients with a positive reverse transcriptase polymerase chain reaction for a SARS-CoV-2 infection at Toulouse University hospital, France. Exposure to systemic corticosteroids was assessed at hospital admission. A propensity score (PS) according to corticosteroid exposure was calculated including comorbidities, clinical, radiological and biological variables that impact COVID-19 severity. The primary outcome was composite, including admission to intensive care unit, need of mechanical ventilation and death occurring during the 14 days after hospital admission. Logistic regression models adjusted for the PS (overlap weighting) provided odds ratios (ORs) and their 95% confidence intervals (95% CIs). Results: Overall, 253 patients were included in the study. Median age was 64 years, 140 patients (59.6%) were men and 218 (86.2%) had at least one comorbidity. Seventeen patients (6.7%) were exposed to corticosteroids before hospital admission. Chronic inflammatory disease (n = 8) was the most frequent indication. One hundred and twenty patients (47.4%) met the composite outcome. In the crude model, the OR of previous exposure to systemic corticosteroids was 1.64; 95% CI: 0.60-4.44. In the adjusted model, it was 1.09 (95% CI: 0.65-1.83). Conclusion: Overall, this study provide some evidences for an absence of an increased risk of unfavorable outcome with previous exposure to corticosteroids in the general setting of patients hospitalized for COVID-19

Pharmacoepidemiology of Immune Thrombocytopenia: Protocols of FAITH and CARMEN Studies

Immune thrombocytopenia (ITP) is a rare condition. Its epidemiology is not well-known. First-line treatment is based on corticosteroids. ITP leads to persistency (lasting more than 3 months) in 70% of adult cases. Then, several second-line treatments (SLTs) are available, mainly splenectomy, rituximab (off-label) and thrombopoietin-receptor agonists. Their efficacy and safety have not been compared, particularly in the long-term. FAITH (French Adult primary Immune Thrombocytopenia: a pHarmacoepidemiological study) is dedicated to the building and follow-up of the cohort of all adults with primary ITP in France persistently treated (>3 months) through the database of French Health Insurance system (système national d’information interrégimes d’Assurance maladie, SNIIRAM), in order to assess the benefit-to-risk balance of SLTs in real-life practice. CARMEN (Cytopénies Auto-immunes : Registre Midi-PyrénéEN) is a clinical registry of all incident adult ITP patients in the Midi-Pyrénées region. It is aimed at describing ITP clinical features, assessing SLT benefit-to-risk balance and adherence to guidelines for ITP management. FAITH is registered n°ENCEPP/SDPP/4574