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2. Characteristics and outcomes of gemcitabine-associated pulmonary hypertension

Author

Pierre Mouillot, Nicolas Favrolt, Charles Khouri, Aurélie Grandvuillemin, Marie-Camille Chaumais, Déborah Schenesse, Andrei Seferian, Xavier Jais, Laurent Savale, Guillaume Beltramo, Olivier Sitbon, Jean-Luc Cracowski, Marc Humbert, Marjolaine Georges, Philippe Bonniaud, and David Montani

Subjects
Medicine
Abstract

Background Despite its known cardiac and lung toxicities, the chemotherapy drug gemcitabine has only rarely been associated with pulmonary hypertension (PH), and the underlying mechanism remains unclear. The objective of the present study was to assess the association between gemcitabine and PH. Methods We identified incident cases of precapillary PH confirmed by right heart catheterisation in patients treated with gemcitabine from the French PH Registry between January 2007 and December 2022. The aetiology, clinical, functional, radiological and haemodynamic characteristics of PH were reviewed at baseline and during follow-up. A pharmacovigilance disproportionality analysis was conducted using the World Health Organization (WHO) pharmacovigilance database. Results We identified nine cases of pulmonary arterial hypertension, either induced (in eight patients) or exacerbated (in one patient) by gemcitabine. Patients exhibited severe precapillary PH, with a median mean pulmonary arterial pressure of 40 (range 26–47) mmHg, a cardiac index of 2.4 (1.6–3.9) L·min−1·m−2 and a pulmonary vascular resistance of 6.3 (3.1–12.6) Wood units. The median time from the initiation of gemcitabine to the onset of PH was 7 (4–50) months, with patients receiving a median of 16 (6–24) gemcitabine injections. Six patients showed clinical improvement upon discontinuation of gemcitabine. In the WHO pharmacovigilance database, we identified a significant signal with 109 cases reporting at least one adverse event related to PH with gemcitabine. Conclusion Both clinical cases and pharmacovigilance data substantiate a significant association between gemcitabine use and the onset or worsening of precapillary PH. The observed improvement following the discontinuation of treatment underscores the importance of PH screening in gemcitabine-exposed patients experiencing unexplained dyspnoea.

Published
2024
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3. Structural Insights into the Activation of Human Aryl Hydrocarbon Receptor by the Environmental Contaminant Benzo[a]pyrene and Structurally Related Compounds

Author

Kwong, Hok-Sau, Paloni, Matteo, Grandvuillemin, Loïc, Sirounian, Savannah, Ancelin, Aurélie, Lai-Kee-Him, Josephine, Grimaldi, Marina, Carivenc, Coralie, Lancey, Claudia, Ragan, Timothy J., Hesketh, Emma L., Balaguer, Patrick, Barducci, Alessandro, Gruszczyk, Jakub, and Bourguet, William

Published
2024
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4. The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report

Author

Crommelynck, Samuel, Grandvuillemin, Aurélie, Ferard, Claire, Mounier, Céline, Gault, Nathalie, Pierron, Evelyne, Jacquot, Baptiste, Vaillant, Tiphaine, Chatelet, Isabelle Parent du, Jacquet, Alexis, Salvo, Francesco, Alt, Martine, Bagheri, Haleh, Micallef, Joëlle, Pariente, Antoine, Gautier, Sophie, Valnet-Rabier, Marie-Blanche, Atzenhoffer, Marina, Lepelley, Marion, Cottin, Judith, Lacroix, Isabelle, Gras, Valérie, Massy, Nathalie, Dhanani, Alban, Vella, Philippe, Shaim, Youssef, Baril, Laurence, Jonville-Béra, Annie-Pierre, and Benkebil, Mehdi

Published
2024
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12. Quelle place pour l’automatisation intelligente et l’intelligence artificielle pour préserver et renforcer l’expertise en vigilance devant l’augmentation des déclarations ?

Author

Pariente, Antoine, Micallef, Joëlle, Lahouegue, Amir, Molimard, Mathieu, Auffret, Marine, Chouchana, Laurent, Denis, Bernard, Faillie, Jean Luc, Grandvuillemin, Aurelie, Letinier, Louis, Pierron, Evelyne, Pons, Catherine, Pujade, Iris, Rubino, Heather, and Salvo, Francesco

Published
2023
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13. Cryo-EM structure of the agonist-bound Hsp90-XAP2-AHR cytosolic complex

Author

Jakub Gruszczyk, Loïc Grandvuillemin, Josephine Lai-Kee-Him, Matteo Paloni, Christos G. Savva, Pierre Germain, Marina Grimaldi, Abdelhay Boulahtouf, Hok-Sau Kwong, Julien Bous, Aurélie Ancelin, Cherine Bechara, Alessandro Barducci, Patrick Balaguer, and William Bourguet

Subjects
Science
Abstract

Aryl hydrocarbon receptor (AHR) is a sensor of the chemical environment including pollutants, diet components and metabolites. Here, authors determine the structure of the indirubin-bound AHR cytosolic complex providing mechanistic insights into ligand-binding promiscuity and selectivity.

Published
2022
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16. Impact of cardiac surgical timing on the neurodevelopmental outcomes of newborns with Complex congenital heart disease (CHD)

Author

Marien Lenoir, Thibault Beretti, Benoit Testud, Noémie Resseguier, Kim Gauthier, Virginie Fouilloux, Célia Gran, Florent Paoli, Fedoua El-Louali, Philippe Aldebert, Julie Blanc, Camille Soulatges, Sarab Al-dybiat, Guillaume Carles, Chloe Wanert, William Rozalen, Stéphane Lebel, Sophie Arnaud, Dominique Santelli, Chloé Allary, Marianne Peyre, Isabelle Grandvuillemin, Clotilde Desroberts, Myriem Belghiti Alaoui, Farid Boubred, Fabrice Michel, Caroline Ovaert, Mathieu Milh, Clément François, and Béatrice Desnous

Subjects
bayley IV, congenital heart disease, white matter injuries, cardiac surgical timing, neonates, neurodevetlopmental outcomes, Pediatrics, RJ1-570
Abstract

BackgroundMore than half of infants with complex congenital heart disease (CHD) will have a neurodevelopmental disorder of multifactorial causes. The preoperative period represents a time-window during which neonates with complex CHD are in a state of hypoxia and hemodynamic instability, which fosters the emergence of brain injuries and, thus, affects early brain networks and neurodevelopmental outcomes. Currently, there is no consensus regarding the optimal age for cardiac surgery in terms of neurodevelopmental outcomes, and its definition is a real challenge. Our aim is to determine the relationship between cardiac surgical timing and long-term neurodevelopmental outcomes for various types of complex CHD.MethodsWe hypothesize that earlier surgical timing could represent a neuroprotective strategy that reduces perioperative white matter injuries (WMIs) and postoperative morbidity, leading to improved neurodevelopmental outcomes in infants with complex CHD. Firstly, our prospective study will allow us to determine the correlation between age at the time of surgery (days of life) and neurodevelopmental outcomes at 24 months. We will then analyze the correlation between age at surgery and (i) the incidence of WMIs (through pre- and postoperative MRIs), (ii) postoperative morbidity, and (iii) the duration of the hospital stay.Implications and DisseminationThis research protocol was registered in the Clinical Trial Registry (National Clinical Trial: NCT04733378). This project aims to help launch the first Neurocardiac Investigation Clinic in Marseille — AP-HM — to propose an overall personalized monitoring and treatment program for patients operated on for complex CHD.

Published
2023
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18. Adverse drug effect in the context of drug shortage: the CIRUPT prospective study from the French pharmacovigilance network

Author

Bourneau-Martin, Delphine, primary, Grandvuillemin, Aurelie, additional, Babin, Marina, additional, Mullet, Charlotte, additional, Said, Hillary, additional, Cellier, Morgane, additional, Geniaux, Helene, additional, Gautier, Sophie, additional, Beurrier, Mathilde, additional, Veyrac, Gwenaelle, additional, Lagarce, Laurence, additional, Laroche, Marie-Laure, additional, and Briet, Marie, additional

Published
2024
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22. Liquid formulation of ifosfamide increased risk of encephalopathy: A case-control study in a pediatric population

Author

Hillaire-Buys, Dominique, Mousset, Mégane, Allouchery, Marion, Azzouz, Brahim, Babin, Marina, Bellet, Florelle, Béné, Johana, Default, Anne, Durrieu, Geneviève, Géniaux, Hélène, Grandvuillemin, Aurélie, Gras-Champel, Valérie, Jantzem, Hélène, Lambert, Aude, Lepelley, Marion, Massy, Nathalie, Petitpain, Nadine, Rocher, Fanny, Sanchez-Pena, Paola, Sassier, Marion, Simon, Corinne, Triquet, Louise, Valnet-Rabier, Marie-Blanche, Veyrac, Gwenaëlle, Faillie, Jean-Luc, and Zenut, Marie-Christine

Published
2020
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25. Hypertension pulmonaire associée à la gemcitabine : caractéristiques et évolution

Author

Mouillot, P., primary, Khoury, C., additional, Favrolt, N., additional, Grandvuillemin, A., additional, Chaumais, M.-C., additional, Schenesse, D., additional, Seferian, A., additional, Jais, X., additional, Savale, L., additional, Beltramo, G., additional, Sitbon, O., additional, Cracowski, J.-L., additional, Humbert, M., additional, Georges, M., additional, Bonniaud, P., additional, and Montani, D., additional

Published
2024
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26. Case Report: Clostridium neonatale Bacteremia in a Preterm Neonate With Necrotizing Enterocolitis

Author

Nadim Cassir, Isabelle Grandvuillemin, Manon Boxberger, Priscilla Jardot, Farid Boubred, and Bernard La Scola

Subjects
case report, necrotizing enterocolitis, preterm neonate, Clostridium neonatale, gut microbiota, Pediatrics, RJ1-570
Abstract

Necrotizing enterocolitis is a life-threatening acquired gastrointestinal disorder among preterm neonates and is associated with a high mortality rate and long-term neurodevelopmental morbidity. No etiologic agent has been definitively established; nonetheless, the most implicated bacteria include members of the Clostridium genus. We reported here on a case of Clostridium neonatale bacteremia in a preterm neonate with necrotizing enterocolitis, providing more information regarding the potential role of this bacterium in pathogenesis of necrotizing enterocolitis. We emphasized the sporulating form of C. neonatale that confers resistance to disinfectants usually applied for the hospital environmental cleaning. Further works are needed to establish the causal relationship between the occurrence of NEC and the isolation of C. neonatale, with promising perspectives in terms of diagnostic and therapeutic management.

Published
2021
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29. Structural insights into the activation of human aryl hydrocarbon receptor by the environmental contaminant benzo[a]pyrene and structurally related compounds

Author

Kwong, Hok-Sau, primary, Paloni, Matteo, additional, Grandvuillemin, Loïc, additional, Sirounian, Savannah, additional, Ancelin, Aurélie, additional, Lai-Kee-Him, Josephine, additional, Grimaldi, Marina, additional, Carivenc, Coralie, additional, Lancey, Claudia, additional, Ragan, Timothy J., additional, Hesketh, Emma L., additional, Balaguer, Patrick, additional, Barducci, Alessandro, additional, Gruszczyk, Jakub, additional, and Bourguet, William, additional

Published
2023
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34. What place for intelligent automation and artificial intelligence to preserve and strengthen vigilance expertise in the face of increasing declarations?

Author

Antoine, Pariente, Joëlle, Micallef, Amir, Lahouegue, Mathieu, Molimard, Marine, Auffret, Laurent, Chouchana, Bernard, Denis, Jean Luc, Faillie, Aurelie, Grandvuillemin, Louis, Letinier, Evelyne, Pierron, Catherine, Pons, Iris, Pujade, Heather, Rubino, and Francesco, Salvo

Subjects
Pharmacology (medical)
Abstract

In 2018, the "Ateliers de Giens" (Giens Workshops) devoted a workshop to artificial intelligence (AI) and led its experts to confirm the potential contribution and theoretical benefit of AI in clinical research, pharmacovigilance, and in improving the efficiency of care. The 2022 workshop is a continuation of this reflection on AI and intelligent automation (IA) by focusing on its contribution to pharmacovigilance and the applications and tasks could be optimized to preserve and strengthen medical and pharmacological expertise in pharmacovigilance. The evolution of pharmacovigilance work is characterized by many tasks with low added value, a growing volume of pharmacovigilance reporting of suspected side effects, and a scarcity of medical staff with expertise in clinical pharmacology and pharmacovigilance and human resources to support this growing need. Together, these parameters contribute to an embolization of the pharmacovigilance system at risk of missing its primary mission: to identify and characterize a risk or even a health alert on a drug. The participants of the workshop (representatives of the Regional Pharmacovigilance Centres (CRPV), the French National Agency for Safety of Medicinal Products (ANSM), patients, the pharmaceutical industry, or start-ups working in the development of AI in the field of medicine) shared their experiences, their pilot projects and their expectations on the expected potential, theoretical or proven, AI and IA. This work has made it possible to identify the needs and challenges that AI or IA represent, in the current or future modes of organization of pharmacovigilance activities. This approach led to the development of a SWOT matrix (strengths, weaknesses, opportunities, threats), a basis for reflection to identify critical points and consider four main recommendations: (1) preserve and develop business expertise in pharmacovigilance (including research and development in methods) with the integration of new technologies; (2) improve the quality of pharmacovigilance reports; (3) adapt technical and regulatory means; (4) implement a development strategy for AI and IA tools at the service of expertise.

Published
2023
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35. Quelle place pour l’automatisation intelligente et l’intelligence artificielle pour préserver et renforcer l’expertise en vigilance devant l’augmentation des déclarations ?

Author

Antoine Pariente, Joëlle Micallef, Amir Lahouegue, Mathieu Molimard, Marine Auffret, Laurent Chouchana, Bernard Denis, Jean Luc Faillie, Aurelie Grandvuillemin, Louis Letinier, Evelyne Pierron, Catherine Pons, Iris Pujade, Heather Rubino, and Francesco Salvo

Subjects
Pharmacology (medical)
Published
2023
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36. Moderate-to-severe eosinophilia induced by treatment with immune checkpoint inhibitors: 37 cases from a national reference center for hypereosinophilic syndromes and the French pharmacovigilance database

Author

Quentin Scanvion, Johana Béné, Sophie Gautier, Aurélie Grandvuillemin, Christine Le Beller, Chouki Chenaf, Nicolas Etienne, Solenn Brousseau, Alexis B. Cortot, Laurent Mortier, Delphine Staumont-Sallé, Franck Morschhauser, Alexandra Forestier, Matthieu Groh, David Launay, Eric Hachulla, Myriam Labalette, Jean-Emmanuel Kahn, and Guillaume Lefèvre

Subjects
eosinophilia, immune-related adverse events, emergent adverse event, immune checkpoint inhibitors, Immunologic diseases. Allergy, RC581-607, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

A better understanding of immune-related adverse events is essential for the early detection and appropriate management of these phenomena. We conducted an observational study of cases recorded at the French reference center for hypereosinophilic syndromes and in the French national pharmacovigilance database. Thirty-seven reports of eosinophilia induced by treatment with immune checkpoint inhibitors (ICIs) were included. The median [range] time to the absolute eosinophil count (AEC) peak was 15 [4─139] weeks. The median AEC was 2.7 [0.8─90.9] G/L. Eosinophil-related manifestations were reported in 21 of the 37 cases (57%). If administered, corticosteroids were always effective (n = 10 out of 10). Partial or complete remission of eosinophilia was obtained in some patients not treated with corticosteroids, after discontinuation (n = 12) or with continuation (n = 4) of the ICI. The AEC should be monitored in ICI-treated patients. If required by oncologic indications, continuation of ICI may be an option in asymptomatic hypereosinophilic patients, and in corticosteroid responders.

Published
2020
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38. Adverse drug reaction related to drug shortage: A retrospective study on the French National Pharmacovigilance Database

Author

Bourneau-Martin, Delphine, Babin, Marina, Grandvuillemin, Aurelie, Mullet, Charlotte, Salvo, Francesco, Singier, Allison, Cellier, Morgane, Fresse, Audrey, de Canecaude, Claire, Pietri, Tessa, Drablier, Guillaume, Geniaux, Helene, Lagarce, Laurence, Laroche, Marie-Laure, Briet, Marie, Admin, Oskar, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Régional de Pharmacovigilance, de Renseignement sur le Médicament et de Pharmaco épidémiologie de Bourgogne [Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Dijon, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Centre Régional de PharmacoVigilance de Lorraine (CRPV Lorraine), CRHU Nancy, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service Pharmacologie Clinique [CHU Toulouse], Pôle Santé publique et médecine publique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Centre régional de pharmacovigilance, de pharmaco-épidémiologie et d'information sur les médicaments [Limoges], CHU Limoges, Vieillissement Fragilité Prévention e-Santé (VieSanté), OmégaHealth (ΩHealth), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Laboratoire de Biologie Neurovasculaire Intégrée [Angers] (CNRS UMR6214 - INSERM U771), and Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Faculté de Médecine d'Angers

Subjects
Pharmacology, Pharmacovigilance, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Adverse drug reaction, Drug shortage, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Pharmacology (medical), Medication error
Abstract

International audience; AIM: Drug shortage is a growing global health issue. The aim of the study was to evaluate the consequences of drug shortages on patient safety based on data recorded in the French Pharmacovigilance Database. METHODS: All cases involving drug shortages reported from 1985 to the end of 2019 were extracted from the database. RESULTS: Following the selection process, 462 cases were included. The number of cases increased significantly from 2004 to 2019. Cases mainly involved drugs from the nervous system (22.1%, CI95[17.5;27.0]), the cardiovascular system (16.4%, CI95[11.9;21.4]), and anti-infectives for systemic use (14.3%, CI95[9.7;19.2]) ATC classes. Most of the cases reported an adverse drug reaction (ADR) belonging to the SOC nervous system (21%, CI95[18;24]), skin and subcutaneous (14%, CI95[11;17]), general (13%, CI95[10;17]), and gastrointestinal (8%, CI95[5;11]) disorders. Disease worsening was observed in 15.9% of the cases, mostly related to a lack of efficacy of the replacement drug. Half of the cases were considered as serious. Evolution was favourable in 79.4% of the cases. Death and/or life-threatening situations were reported in 5.8% of the cases. Medication errors (ME) were identified in 51 cases (11%), mostly occurring at the administration step and involving a human factor. CONCLUSION: This study emphasises the clinical impact of drug shortage in terms of ADRs, ME and inefficiency. These observations underline the importance of a global health policy programme to limit the occurrence of drug shortages and to reinforce the information provided to patients and health care professionals in this context to limit risk.

Published
2022
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40. Impact of cardiac surgical timing on the neurodevelopmental outcomes of newborns with Complex congenital heart disease (CHD)

Author

Lenoir, Marien, primary, Beretti, Thibault, additional, Testud, Benoit, additional, Resseguier, Noémie, additional, Gauthier, Kim, additional, Fouilloux, Virginie, additional, Gran, Célia, additional, Paoli, Florent, additional, El-Louali, Fedoua, additional, Aldebert, Philippe, additional, Blanc, Julie, additional, Soulatges, Camille, additional, Al-dybiat, Sarab, additional, Carles, Guillaume, additional, Wanert, Chloe, additional, Rozalen, William, additional, Lebel, Stéphane, additional, Arnaud, Sophie, additional, Santelli, Dominique, additional, Allary, Chloé, additional, Peyre, Marianne, additional, Grandvuillemin, Isabelle, additional, Desroberts, Clotilde, additional, Alaoui, Myriem Belghiti, additional, Boubred, Farid, additional, Michel, Fabrice, additional, Ovaert, Caroline, additional, Milh, Mathieu, additional, François, Clément, additional, and Desnous, Béatrice, additional

Published
2023
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41. Epidermal necrolysis after COVID −19 vaccination: An exploratory analysis using World Health Organization VigiBase

Author

Ahouach, Btisseme, primary, Diaz, Emmanuelle, additional, Bertin, Blandine, additional, Ben Said, Benoit, additional, Combret, Sandrine, additional, Grandvuillemin, Aurélie, additional, Petitpain, Nadine, additional, Rabier, Marie Blanche, additional, Thomas, Laure, additional, Trenque, Thierry, additional, Ingen‐Housz‐Oro, Saskia, additional, and Lebrun‐Vignes, Bénédicte, additional

Published
2023
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47. Analyse de classification des uvéites secondaires aux inhibiteurs de check-points et aux inhibiteurs de la voie MAP-kinase (inhibiteurs de BRAF et MEK) à partir des cas issus de la base nationale de pharmacovigilance

Author

Thibault, T., primary, Auvens, C., additional, Rogier, T., additional, Muller, G., additional, Turcu, A., additional, Lecluse, J., additional, Mouries-Martin, S., additional, El Hssaini, N., additional, Rajillah, A., additional, Besancenot, J.F., additional, Dautriche, A., additional, Grandvuillemin, A., additional, and Devilliers, H., additional

Published
2022
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