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1. Calcitonin gene-related peptide antagonists in pregnancy: a disproportionality analysis in VigiBase®

Author: Noseda, Roberta, Bedussi, Francesca, Gobbi, Claudio, Ceschi, Alessandro, and Zecca, Chiara
Published: 2024
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2. Reporting of late-onset immune-related adverse events with immune checkpoint inhibitors in VigiBase

Author: Alessandro Ceschi, Emanuel Raschi, Roberta Noseda, Michele Fusaroli, Francesca Bedussi, and Valentina Giunchi
Subjects: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract: Background To date, evidence on late-onset immune-related adverse events (irAEs) with immune checkpoint inhibitors (ICIs) is limited to a small number of clinical cases. This study aimed to identify drug- and patient-related characteristics potentially associated with the reporting of late-onset irAEs with ICIs in VigiBase, the WHO global database of individual case safety reports (ICSRs).Methods Observational study comparing deduplicated ICSRs with ICIs reporting late-onset irAEs (occurred >90 days after ICI discontinuation) versus ICSRs with ICIs not reporting late-onset irAEs, collected in VigiBase from 2011 to December 31, 2022. Logistic regression was used to model the relationship between drug-related and patient-related characteristics of ICSRs and the reporting of late-onset irAEs. Significance was determined for variables with the lower bound of the 95% CI of the reporting OR (ROR) higher than 1 and a p value
Published: 2024
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3. Antipsychotic, benzodiazepine and Z-drug prescriptions in a Swiss hospital network in the Choosing Wisely and COVID-19 eras: a longitudinal study

Author: Vanessa Gagliano, Gloria Salemme, Alessandro Ceschi, Angela Greco, Nicola Grignoli, Luca Clivio, Alessandro Merler, Vanessa Feyling Benitez, Jvan Gianini, Martina Zandonà, and Luca Gabutti
Subjects: Medicine
Abstract: AIMS OF THE STUDY: Physicians frequently prescribe antipsychotics off-label to treat, among others, insomnia and anxiety. The Swiss “smarter medicine – Choosing Wisely” campaign has tried to raise awareness about the risks and to limit benzodiazepine and Z-drug prescriptions. In the Italian-speaking part of Switzerland, our network of public hospitals joined the campaign with the aim of avoiding unnecessary benzodiazepine and Z-drug treatments, with prescription monitoring, benchmarking and educational contributions. Considering the risks of a possible shift towards the prescription of antipsychotics, and aware of the potential role of the COVID-19 pandemic, we decided to analyse the prescription trends of antipsychotics and benzodiazepines/Z-drugs before, during (2016–2017) and after the intervention. METHODS: For this longitudinal study, we reactivated a continuous monitoring of inpatient benzodiazepine/Z-drug and antipsychotics prescriptions/deprescriptions, paused in 2018 after the end of the internal Choosing Wisely campaign, based on routinely collected observational health data. We screened all demographic, administrative and prescription data of patients admitted to the internal medicine department of the four teaching hospitals (H1-H4) belonging to the EOC (Ente Ospedaliero Cantonale) network, from the fourth quarter of 2014 to the second quarter of 2023. RESULTS: We analysed 74,659 hospital stays (14,645 / 16,083 / 24,285 / 19,646 at hospitals H1 / H2 / H3 / H4 respectively). The mean (± SD) case mix (a metric that reflects the diversity, complexity and severity of the treated patients) and patient age were 1.08 ± 0.14 and 73 ± 2 years. 10.6% and 12.1% of patients received antipsychotics prior to admission and at discharge respectively (new prescriptions 3.3 ± 0.7%; deprescriptions 13.3 ± 5.2%). New prescriptions showed an upward trend, with +0.20% per year (p
Published: 2024
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4. Lack of association between classical HLA genes and asymptomatic SARS-CoV-2 infection

Author: Astrid Marchal, Elizabeth T. Cirulli, Iva Neveux, Evangelos Bellos, Ryan S. Thwaites, Kelly M. Schiabor Barrett, Yu Zhang, Ivana Nemes-Bokun, Mariya Kalinova, Andrew Catchpole, Stuart G. Tangye, András N. Spaan, Justin B. Lack, Jade Ghosn, Charles Burdet, Guy Gorochov, Florence Tubach, Pierre Hausfater, Clifton L. Dalgard, Shen-Ying Zhang, Qian Zhang, Christopher Chiu, Jacques Fellay, Joseph J. Grzymski, Vanessa Sancho-Shimizu, Laurent Abel, Jean-Laurent Casanova, Aurélie Cobat, Alexandre Bolze, Alessandro Aiuti, Saleh Al-Muhsen, Fahd Al-Mulla, Ali Amara, Mark S. Anderson, Evangelos Andreakos, Andrés A. Arias, Lisa M. Arkin, Hagit Baris Feldman, Paul Bastard, Alexandre Belot, Catherine M. Biggs, Dusan Bogunovic, Anastasiia Bondarenko, Alessandro Borghesi, Ahmed A. Bousfiha, Petter Brodin, Yenan Bryceson, Manish J. Butte, Giorgio Casari, John Christodoulou, Roger Colobran, Antonio Condino-Neto, Stefan N. Constantinescu, Megan A. Cooper, Murkesh Desai, Beth A. Drolet, Xavier Duval, Jamila El Baghdadi, Philippine Eloy, Sara Espinosa-Padilla, Carlos Flores, José Luis Franco, Antoine Froidure, Peter K. Gregersen, Bodo Grimbacher, Filomeen Haerynck, David Hagin, Rabih Halwani, Lennart Hammarström, James R. Heath, Elena W.Y. Hsieh, Eystein Husebye, Kohsuke Imai, Yuval Itan, Emmanuelle Jouanguy, Elżbieta Kaja, Timokratis Karamitros, Kai Kisand, Cheng-Lung Ku, Yu-Lung Lau, Yun Ling, Carrie L. Lucas, Tom Maniatis, Davood Mansouri, László Maródi, France Mentré, Isabelle Meyts, Joshua D. Milner, Kristina Mironska, Trine H. Mogensen, Tomohiro Morio, Lisa F.P. Ng, Luigi D. Notarangelo, Antonio Novelli, Giuseppe Novelli, Cliona O'Farrelly, Satoshi Okada, Keisuke Okamoto, Tayfun Ozcelik, Qiang Pan-Hammarström, Jean W. Pape, Rebeca Perez de Diego, Jordi Perez-Tur, David S. Perlin, Graziano Pesole, Anna M. Planas, Carolina Prando, Aurora Pujol, Anne Puel, Lluis Quintana-Murci, Sathishkumar Ramaswamy, Laurent Renia, Igor Resnick, Carlos Rodríguez-Gallego, Anna Sediva, Mikko R.J. Seppänen, Mohammad Shahrooei, Anna Shcherbina, Ondrej Slaby, Andrew L. Snow, Pere Soler-Palacín, Vassili Soumelis, Ivan Tancevski, Ahmad Abou Tayoun, Şehime Gülsün Temel, Christian Thorball, Pierre Tiberghien, Sophie Trouillet-Assant, Stuart E. Turvey, K. M. Furkan Uddin, Mohammed J. Uddin, Diederik van de Beek, Donald C. Vinh, Horst von Bernuth, Joost Wauters, Mayana Zatz, Pawel Zawadzki, Serge Bureau, Yannick Vacher, Anne Gysembergh-Houal, Lauren Demerville, Abla Benleulmi-Chaachoua, Sebastien Abad, Radhiya Abassi, Abdelrafie Abdellaoui, Abdelkrim Abdelmalek, Hendy Abdoul, Helene Abergel, Fariza Abeud, Sophie Abgrall, Noemie Abisror, Marylise Adechian, Nordine Aderdour, Hakeem Farid Admane, Frederic Adnet, Sara Afritt, Helene Agostini, Claire Aguilar, Sophie Agut, Tommaso Francesco Aiello, Marc Ait Kaci, Hafid Ait Oufella, Gokula Ajeenthiravasan, Virginie Alauzy, Fanny Alby-Laurent, Lucie Allard, Marie-Alexandra Alyanakian, Blanca Amador Borrero, Sabrina Amam, Lucile Amrouche, Marc Andronikof, Dany Anglicheau, Nadia Anguel, Djillali Annane, Mohammed Aounzou, Caroline Aparicio, Gladys Aratus, Jean-Benoit Arlet, Jeremy Arzoine, Elisabeth Aslangul, Mona Assefi, Adeline Aubry, Laetitia Audiffred, Etienne Audureau, Christelle Nathalie Auger, Jean-Charles Auregan, Celine Awotar, Sonia Ayllon Milla, Delphine Azan, Laurene Azemar, Billal Azzouguen, Marwa Bachir Elrufaai, Aïda Badsi, Prissile Bakouboula, Coline Balcerowiak, Fanta Balde, Elodie Baldivia, Eliane-Flore Bangamingo, Amandine Baptiste, Fanny Baran-Marszak, Caroline Barau, Nathalie Barget, Flore Baronnet, Romain Barthelemy, Jean-Luc Baudel, Camille Baudry, Elodie Baudry, Laurent Beaugerie, Adel Belamri, Nicolas Belaube, Rhida Belilita, Pierre Bellassen, Rawan Belmokhtar, Isabel Beltran, Ruben Benainous, Mourad Benallaoua, Robert Benamouzig, Amélie Benbara, Jaouad Benhida, Anis Benkhelouf, Jihene Benlagha, Chahinez Benmostafa, Skander Benothmane, Miassa Bentifraouine, Laurence Berard, Quentin Bernier, Enora Berti, Astrid Bertier, Laure Berton, Simon Bessis, Alexandra Beurton, Celine Bianco, Clara Bianquis, Frank Bidar, Philippe Blanche, Clarisse Blayau, Alexandre Bleibtreu, Emmanuelle Blin, Coralie Bloch-Queyrat, Marie-Christophe Boissier, Diane Bollens, Marion Bolzoni, Rudy pierre Bompard, Nicolas Bonnet, Justine Bonnouvrier, Shirmonecrystal Botha, Wissam Boucenna, Fatiha Bouchama, Olivier Bouchaud, Hanane Bouchghoul, Taoueslylia Boudjebla, Noel Boudjema, Catherine Bouffard, Adrien Bougle, Meriem Bouguerra, Leila Bouras, Agnes Bourcier, Anne Bourgarit Durand, Anne Bourrier, Fabrice Bouscarat, Diane Bouvry, Nesrine Bouziri, Ons Bouzrara, Sarah Bribier, Delphine Brugier, Melanie Brunel, Eida Bui, Anne Buisson, Iryna Bukreyeva, Côme Bureau, Jacques Cadranel, Johann Cailhol, Ruxandra Calin, Clara Campos Vega, Pauline Canavaggio, Marta Cancella, Delphine Cantin, Albert Cao, Lionel Carbillon, Nicolas Carlier, Clementine Cassard, Guylaine Castor, Marion Cauchy, Olivier Cha, Benjamin Chaigne, Salima Challal, Karine Champion, Patrick Chariot, Julie Chas, Simon Chauveau, Anthony Chauvin, Clement Chauvin, Nathalie Chavarot, Kamélia Chebbout, Mustapha Cherai, Ilaria Cherubini, Amelie Chevalier, Thibault Chiarabini, Thierry Chinet, Richard Chocron, Pascaline Choinier, Juliette Chommeloux, Christophe Choquet, Laure Choupeaux, Benjamin Chousterman, Dragosmarius Ciocan, Ada Clarke, Gaëlle Clavere, Florian Clavier, Karine Clement, Sebastien Clerc, Yves Cohen, Fleur Cohen, Adrien Cohen, Audrey Coilly, Hester Colboc, Pauline Colin, Magalie Collet, Chloé Comarmond, Emeline Combacon, Alain Combes, Celine Comparon, Jean-Michel Constantin, Hugues Cordel, Anne-Gael Cordier, Adrien Costantini, Nathalie Costedoat Chalumeau, Camille Couffignal, Doriane Coupeau, Alain Creange, Yannie Cuvillier Lamarre, Charlène Da Silveira, Sandrine Dautheville Guibal El Kayani, Nathalie De Castro, Yann De Rycke, Lucie Del Pozo, Quentin Delannoy, Mathieu Delay, Robin Deleris, Juliette Delforge, Laëtitia Delphine, Noemie Demare, Sophie Demeret, Alexandre Demoule, Aurore Deniau, François Depret, Sophie Derolez, Ouda Derradji, Nawal Derridj, Vincent Descamps, Lydia Deschamps, Celine Desconclois, Cyrielle Desnos, Karine Desongins, Robin Dhote, Benjamin Diallo, Morgane Didier, Myriam Diemer, Stephane Diez, Juliette Djadi-Prat, Fatima-Zohra Djamouri Monnory, Siham Djebara, Naoual Djebra, Minette Djietcheu, Hadjer Djillali, Nouara Djouadi, Severine Donneger, Catarina Dos Santos, Nathalie Dournon, Martin Dres, Laura Droctove, Marie Drogrey, Margot Dropy, Elodie Drouet, Valérie Dubosq, Evelyne Dubreucq, Estelle Dubus, Boris Duchemann, Thibault Duchenoy, Emmanuel Dudoignon, Romain Dufau, Florence Dumas, Clara Duran, Emmanuelle Duron, Antoine Durrbach, Claudine Duvivier, Nathan Ebstein, Jihane El Khalifa, Alexandre Elabbadi, Caroline Elie, Gabriel Ernotte, Anne Esling, Martin Etienne, Xavier Eyer, Muriel Sarah Fartoukh, Takoua Fayali, Marion Fermaut, Arianna Fiorentino, Souha Fliss, Marie-Céline Fournier, Benjamin Fournier, Hélène Francois, Olivia Freynet, Yvann Frigout, Isaure Fromont, Axelle Fuentes, Thomas Furet, Joris Galand, Marc Garnier, Agnes Gaubert, Stéphane Gaudry, Samuel Gaugain, Damien Gauthier, Maxime Gautier, Sophie Georgin-Lavialle, Daniela Geromin, Mohamed Ghalayini, Bijan Ghaleh, Myriam Ghezal, Aude Gibelin, Linda Gimeno, Benoit Girard, Bénédicte Giroux Leprieur, Doryan Gomes, Elisabete Gomes-Pires, Anne Gouge, Amel Gouja, Helene Goulet, Sylvain Goupil, Jeanne Goupil De Bouille, Julien Gras, Segolene Greffe, Lamiae Grimaldi, Paul Guedeney, Bertrand Guidet, Matthias Guillo, Mariechristelle Gulczynski, Tassadit Hadjam, Didier Haguenauer, Soumeya Hammal, Nadjib Hammoudi, Olivier Hanon, Anarole Harrois, Coraline Hautem, Guillaume Hekimian, Nicholas Heming, Olivier Hermine, Sylvie Ho, Marie Houllier, Benjamin Huot, Tessa Huscenot, Wafa Ibn Saied, Ghilas Ikherbane, Meriem Imarazene, Patrick Ingiliz, Lina Iratni, Stephane Jaureguiberry, Jean-Francois Jean-Marc, Deleena Jeyarajasingham, Pauline Jouany, Veronique Jouis, Clement Jourdaine, Ouifiya Kafif, Rim Kallala, Sandrine Katsahian, Lilit Kelesyan, Vixra Keo, Flora Ketz, Warda Khamis, Enfel Khelili, Mehdi Khellaf, Christy Gaëlla Kotokpo Youkou, Ilias Kounis, Gaelle Kpalma, Jessica Krause, Vincent Labbe, Karine Lacombe, Jean-Marc Lacorte, Anne Gaelle Lafont, Emmanuel Lafont, Lynda Lagha, Lionel Lamhaut, Aymeric Lancelot, Cecilia Landman, Fanny Lanternier, Cecile Larcheveque, Caroline Lascoux Combe, Ludovic Lassel, Benjamin Laverdant, Christophe Lavergne, Jean-Rémi Lavillegrand, Pompilia Lazureanu, Loïc Le Guennec, Lamia Leberre, Claire Leblanc, Marion Leboyer, Francois Lecomte, Marine Lecorre, Romain Leenhardt, Marylou Lefebvre, Bénédicte Lefebvre, Paul Legendre, Anne Leger, Laurence Legros, Justyna Legrosse, Sébastien Lehuunghia, Julien Lemarec, Jeremie Leporrier-Ext, Manon Lesein, Hubert Lesur, Vincent Levy, Albert Levy, Edwige Lopes, Amanda Lopes, Vanessa Lopez, Julien Lopinto, Olivier Lortholary, Badr Louadah, Bénédicte Loze, Marie-Laure Lucas, Axelle Lucasamichi, Liem Binh Luong, Arouna Magazimama-Ext, David Maingret, Lakhdar Mameri, Philippe Manivet, Cylia Mansouri, Estelle Marcault, Jonathan Marey, Nathalie Marin, Clémence Marois, Olivier Martin, Lou Martineau, Cannelle Martinez-Lopez, Pierre Martyniuck, Pauline Mary De Farcy, Nessrine Marzouk, Rafik Masmoudi, Alexandre Mebazaa, Frédéric Mechai, Fabio Mecozzi, Chamseddine Mediouni, Bruno Megarbane, Mohamed Meghadecha, Élodie Mejean, Arsene Mekinian, Nour Mekki Abdelhadi, Rania Mekni, Thinhinan Sabrina Meliti, Breno Melo Lima, Paris Meng, Soraya Merbah, Fadhila Messani, Yasmine Messaoudi, Baboo-Irwinsingh Mewasing, Lydia Meziane, Carole Michelot-Burger, Françoise Mignot, Fadi Hillary Minka, Makoto Miyara, Pierre Moine, Jean-Michel Molina, Anaïs Montegnies-Boulet, Alexandra Monti, Claire Montlahuc, Anne-Lise Montout, Alexandre Moores, Caroline Morbieu, Helene Mortelette, Stéphane Mouly, Rosita Muzaffar, Cherifa Iness Nacerddine, Marine Nadal, Hajer Nadif, Kladoum Nassarmadji, Pierre Natella, Sandrine Ndingamondze, Stefan Neraal, Caroline Nguyen, Bao N'Guyen, Isabelle Nion Larmurier, Luc Nlomenyengue, Nicolas Noel, Hilario Nunes, Edris Omar, Zineb Ouazene, Elise Ouedraogo, Wassila Ouelaa, Anissa Oukhedouma, Yasmina Ould Amara, Herve Oya, Johanna Oziel, Thomas Padilla, Elena Paillaud, Solenne Paiva, Beatrice Parfait, Perrine Parize, Christophe Parizot, Antoine Parrot, Arthur Pavot, Laetitia Peaudecerf, Frédéric Pene, Marion Pepin, Julie Pernet, Claire Pernin, Mylène Petit, Olivier Peyrony, Marie-Pierre Pietri, Olivia Pietri, Marc Pineton De Chambrun, Michelle Pinson, Claire Pintado, Valentine Piquard, Christine Pires, Benjamin Planquette, Sandrine Poirier, Anne-Laure Pomel, Stéphanie Pons, Diane Ponscarme, Annegaelle Pourcelot, Valérie Pourcher, Anne Pouvaret, Florian Prever, Miresta Previlon, Margot Prevost, Marie-Julie Provoost, Cyril Quemeneur, Cédric Rafat, Agathe Rami, Brigitte Ranque, Maurice Raphael, Jean Herle Raphalen, Anna Rastoin, Mathieu Raux, Amani Rebai, Michael Reby, Alexis Regent, Asma Regrag, Matthieu Resche-Rigon, Quentin Ressaire, Christian Richard, Mariecaroline Richard, Maxence Robert, Benjamin Rohaut, Camille Rolland-Debord, Jacques Ropers, Anne-Marie Roque-Afonso, Charlotte Rosso, Mélanie Rousseaux, Nabila Rousseaux, Swasti Roux, Lorène Roux, Claire Rouzaud, Antoine Rozes, Emma Rubenstein, Jean-Marc Sabate, Sheila Sabet, Sophie-Caroline Sacleux, Nathalie Saidenberg Kermanach, Faouzi Saliba, Dominique Salmon, Laurent Savale, Guillaume Savary, Rebecca Sberro, Anne Scemla, Frederic Schlemmer, Mathieu Schwartz, Saïd Sedfi, Samia Sefir-Kribel, Philippe Seksik, Pierre Sellier, Agathe Selves, Nicole Sembach, Luca Semerano, Marie-Victoire Senat, Damien Sene, Alexandra Serris, Lucile Sese, Naima Sghiouar, Johanna Sigaux, Martin Siguier, Johanne Silvain, Noémie Simon, Tabassome Simon, Lina Innes Skandri, Miassa Slimani, Aurélie Snauwaert, Harry Sokol, Heithem Soliman, Nisrine Soltani, Benjamin Soyer, Gabriel Steg, Lydia Suarez, Tali-Anne Szwebel, Kossi Taffame, Yacine Tandjaoui-Lambiotte, Claire Tantet, Mariagrazia Tateo, Igor Theodose, Pierre clement Thiebaud, Caroline Thomas, Kelly Tiercelet, Julie Tisserand, Carole Tomczak, Krystel Torelino, Fatima Touam-Ext, Lilia Toumi, Gustave Toury, Mireille Toy-Miou, Olivia Tran Dinh Thanh Lien, Alexy Trandinh, Jean-Marc Treluyer, Baptiste Trinque, Jennifer Truchot, Sarah Tubiana, Simone Tunesi, Matthieu Turpin, Agathe Turpin, Tomas Urbina, Rafael Usubillaga Narvaez, Yurdagul Uzunhan, Prabakar Vaittinadaayar, Arnaud Valent, Maelle Valentian, Nadia Valin, Hélène Vallet, Marina Vaz, Miguel-Alejandro Vazquezibarra, Benoit Vedie, Laetitia Velly, Celine Verstuyft, Cedric Viallette, Eric Vicaut, Dorothee Vignes, Damien Vimpere, Myriam Virlouvet, Guillaume Voiriot, Lena Voisot, Emmanuel Weiss, Nicolas Weiss, Anaïs Winchenne, Youri Yordanov, Lara Zafrani, Mohamad Zaidan, Wissem Zaidi, Cathia Zak, Aida Zarhrate-Ghoul, Ouassila Zatout, Suzanne Zeino, Michel Zeitouni, Naïma Zemirli, Lorene Zerah, Ounsa Zia, Marianne Ziol, Oceane Zolario, Julien Zuber, Claire Andrejak, François Angoulvant, Delphine Bachelet, Marie Bartoli, Romain Basmaci, Sylvie Behillil, Marine Beluze, Dehbia Benkerrou, Krishna Bhavsar, Lila Bouadma, Sabelline Bouchez, Maude Bouscambert, Minerva Cervantes-Gonzalez, Anissa Chair, Catherine Chirouze, Alexandra Coelho, Sandrine Couffin-Cadiergues, Eric d’Ortenzio, Marie-Pierre Debray, Laurene Deconinck, Dominique Deplanque, Diane Descamps, Mathilde Desvallée, Alpha Diallo, Alphonsine Diouf, Céline Dorival, François Dubos, Brigitte Elharrar, Vincent Enouf, Hélène Esperou, Marina Esposito-Farese, Manuel Etienne, Eglantine Ferrand Devouge, Nathalie Gault, Alexandre Gaymard, Tristan Gigante, Morgane Gilg, Jérémie Guedj, Alexandre Hoctin, Isabelle Hoffmann, Ikram Houas, Jean-Sébastien Hulot, Salma Jaafoura, Florentia Kaguelidou, Sabrina Kali, Antoine Khalil, Coralie Khan, Cédric Laouénan, Samira Laribi, Minh Le, Quentin Le Hingrat, Soizic Le Mestre, Hervé Le Nagard, François-Xavier Lescure, Sophie Letrou, Yves Levy, Bruno Lina, Guillaume Lingas, Jean-Christophe Lucet, Denis Malvy, Marina Mambert, Amina Meziane, Hugo Mouquet, Jimmy Mullaert, Nadège Neant, Duc Nguyen, Marion Noret, Saad Nseir, Aurélie Papadopoulos, Christelle Paul, Nathan Peiffer-Smadja, Thomas Perpoint, Ventzislava Petrov-Sanchez, Gilles Peytavin, Huong Pham, Olivier Picone, Oriane Puéchal, Christian Rabaud, Manuel Rosa-Calatrava, Bénédicte Rossignol, Patrick Rossignol, Carine Roy, Marion Schneider, Richa Su, Coralie Tardivon, Marie-Capucine Tellier, François Téoulé, Olivier Terrier, Jean-François Timsit, Christelle Tual, Sylvie Van Der Werf, Noémie Vanel, Aurélie Veislinger, Benoit Visseaux, Aurélie Wiedemann, Yazdan Yazdanpanah, Loubna Alavoine, Charlotte Charpentier, Aline Dechanet, Jean-Luc Ecobichon, Wahiba Frezouls, Nadhira Houhou, Jonathan Lehacaut, Pauline Manchon, Mariama Nouroudine, Caroline Quintin, Michael Thy, Sylvie van der Werf, Valérie Vignali, Abir Chahine, Nawal Waucquier, Maria-Claire Migaud, Félix Djossou, Mayka Mergeay-Fabre, Aude Lucarelli, Magalie Demar, Léa Bruneau, Patrick Gérardin, Adrien Maillot, Christine Payet, Bruno Laviolle, Fabrice Laine, Christophe Paris, Mireille Desille-Dugast, Julie Fouchard, Thierry Pistone, Pauline Perreau, Valérie Gissot, Carole L.E. Goas, Samatha Montagne, Lucie Richard, Kévin Bouiller, Maxime Desmarets, Alexandre Meunier, Marilou Bourgeon, Benjamin Lefévre, Hélène Jeulin, Karine Legrand, Sandra Lomazzi, Bernard Tardy, Amandine Gagneux-Brunon, Frédérique Bertholon, Elisabeth Botelho-Nevers, Christelle Kouakam, Leturque Nicolas, Layidé Roufai, Karine Amat, Hélène Espérou, Samia Hendou, Giuseppe Foti, Giuseppe Citerio, Ernesto Contro, Alberto Pesci, Maria Grazia Valsecchi, Marina Cazzaniga, Giacomo Bellani, Jorge Abad, Giulia Accordino, Micol Angelini, Sergio Aguilera-Albesa, Aina Aguiló-Cucurull, Esra Akyüz Özkan, Ilad Alavi Darazam, Jonathan Antonio Roblero Albisures, Juan C. Aldave, Miquel Alfonso Ramos, Taj Ali Khan, Anna Aliberti, Seyed Alireza Nadji, Gulsum Alkan, Suzan A. AlKhater, Jerome Allardet-Servent, Luis M. Allende, Rebeca Alonso-Arias, Mohammed S. Alshahrani, Laia Alsina, Zahir Amoura, Arnau Antolí, Romain Arrestier, Mélodie Aubart, Teresa Auguet, Iryna Avramenko, Gökhan Aytekin, Axelle Azot, Seiamak Bahram, Fanny Bajolle, Fausto Baldanti, Aurélie Baldolli, Maite Ballester, Benoit Barrou, Federica Barzaghi, Sabrina Basso, Gulsum Iclal Bayhan, Liliana Bezrodnik, Agurtzane Bilbao, Geraldine Blanchard-Rohner, Ignacio Blanco, Adeline Blandinières, Daniel Blázquez-Gamero, Marketa Bloomfield, Mireia Bolivar-Prados, Raphael Borie, Elisabeth Botdhlo-Nevers, Aurore Bousquet, David Boutolleau, Claire Bouvattier, Oksana Boyarchuk, Juliette Bravais, M. Luisa Briones, Marie-Eve Brunner, Raffaele Bruno, Maria Rita P. Bueno, Huda Bukhari, Jacinta Bustamante, Juan José Cáceres Agra, Ruggero Capra, Raphael Carapito, Maria Carrabba, Carlos Casasnovas, Marion Caseris, Irene Cassaniti, Martin Castelle, Francesco Castelli, Martín Castillo de Vera, Mateus V. Castro, Emilie Catherinot, Jale Bengi Celik, Alessandro Ceschi, Martin Chalumeau, Bruno Charbit, Cécile Boulanger, Père Clavé, Bonaventura Clotet, Anna Codina, Cloé Comarmond, Patrizia Comoli, Angelo G. Corsico, Taner Coşkuner, Aleksandar Cvetkovski, Cyril Cyrus, David Dalmau, François Danion, David Ross Darley, Vincent Das, Nicolas Dauby, Stéphane Dauger, Paul De Munte, Loic de Pontual, Amin Dehban, Geoffroy Delplancq, Isabelle Desguerre, Antonio Di Sabatino, Jean-Luc Diehl, Stephanie Dobbelaere, Elena Domínguez-Garrido, Clément Dubost, Olov Ekwall, Şefika Elmas Bozdemir, Marwa H. Elnagdy, Melike Emiroglu, Akifumi Endo, Emine Hafize Erdeniz, Selma Erol Aytekin, Maria Pilar Etxart Lasa, Romain Euvrard, Giovanna Fabio, Laurence Faivre, Antonin Falck, Muriel Fartoukh, Morgane Faure, Miguel Fernandez Arquero, Ricard Ferrer, Jose Ferreres, Bruno Francois, Victoria Fumadó, Kitty S.C. Fung, Francesca Fusco, Alenka Gagro, Blanca Garcia Solis, Pierre Garçon, Pascale Gaussem, Zeynep Gayretli, Juana Gil-Herrera, Laurent Gilardin, Audrey Giraud Gatineau, Mònica Girona-Alarcón, Karen Alejandra Cifuentes Godínez, Jean-Christophe Goffard, Nacho Gonzales, Luis I. Gonzalez-Granado, Rafaela González-Montelongo, Antoine Guerder, Belgin Gülhan, Victor Daniel Gumucio, Leif Gunnar Hanitsch, Jan Gunst, Marta Gut, Jérôme Hadjadj, Selda Hancerli, Tetyana Hariyan, Nevin Hatipoglu, Deniz Heppekcan, Elisa Hernandez-Brito, Po-ki Ho, María Soledad Holanda-Peña, Juan P. Horcajada, Sami Hraiech, Linda Humbert, Ivan F.N. Hung, Alejandro D. Iglesias, Antonio Íñigo-Campos, Matthieu Jamme, María Jesús Arranz, Marie-Thérèse Jimeno, Iolanda Jordan, Saliha Kanık-Yüksek, Yalcin Kara, Aydın Karahan, Adem Karbuz, Kadriye Kart Yasar, Ozgur Kasapcopur, Kenichi Kashimada, Sevgi Keles, Yasemin Kendir Demirkol, Yasutoshi Kido, Can Kizil, Ahmet Osman Kılıç, Adam Klocperk, Antonia Koutsoukou, Zbigniew J. Król, Hatem Ksouri, Paul Kuentz, Arthur M.C. Kwan, Yat Wah M. Kwan, Janette S.Y. Kwok, Jean-Christophe Lagier, David S.Y. Lam, Vicky Lampropoulou, Fleur Le Bourgeois, Yee-Sin Leo, Rafael Leon Lopez, Daniel Leung, Michael Levin, Michael Levy, Romain Lévy, Zhi Li, Daniele Lilleri, Edson Jose Adrian Bolanos Lima, Agnes Linglart, Eduardo López-Collazo, José M. Lorenzo-Salazar, Céline Louapre, Catherine Lubetzki, Kwok-Cheung Lung, Charles-Edouard Luyt, David C. Lye, Cinthia Magnone, Enrico Marchioni, Carola Marioli, Majid Marjani, Laura Marques, Jesus Marquez Pereira, Andrea Martín-Nalda, David Martínez Pueyo, Javier Martinez-Picado, Iciar Marzana, Carmen Mata-Martínez, Alexis Mathian, Larissa R.B. Matos, Gail V. Matthews, Julien Mayaux, Raquel McLaughlin-Garcia, Philippe Meersseman, Jean-Louis Mège, Armand Mekontso-Dessap, Isabelle Melki, Federica Meloni, Jean-François Meritet, Paolo Merlani, Özge Metin Akcan, Mehdi Mezidi, Isabelle Migeotte, Maude Millereux, Matthieu Million, Tristan Mirault, Clotilde Mircher, Mehdi Mirsaeidi, Yoko Mizoguchi, Bhavi P. Modi, Francesco Mojoli, Elsa Moncomble, Abián Montesdeoca Melián, Antonio Morales Martinez, Francisco Morandeira, Pierre-Emmanuel Morange, Clémence Mordacq, Guillaume Morelle, Stéphane J. Mouly, Adrián Muñoz-Barrera, Cyril Nafati, Shintaro Nagashima, Yu Nakagama, Bénédicte Neven, João Farela Neves, Yuk-Yung Ng, Hubert Nielly, Yeray Novoa Medina, Esmeralda Nuñez Cuadros, Semsi Nur Karabela, J. Gonzalo Ocejo-Vinyals, Mehdi Oualha, Amani Ouedrani, Tayfun Özçelik, Aslinur Ozkaya-Parlakay, Michele Pagani, Maria Papadaki, Philippe Parola, Tiffany Pascreau, Stéphane Paul, Estela Paz-Artal, Sigifredo Pedraza, Nancy Carolina González Pellecer, Silvia Pellegrini, Rebeca Pérez de Diego, Xosé Luis Pérez-Fernández, Aurélien Philippe, Quentin Philippot, Adrien Picod, Marc Pineton de Chambrun, Antonio Piralla, Laura Planas-Serra, Dominique Ploin, Julien Poissy, Géraldine Poncelet, Garyphallia Poulakou, Marie S. Pouletty, Persia Pourshahnazari, Jia Li Qiu-Chen, Paul Quentric, Thomas Rambaud, Didier Raoult, Violette Raoult, Anne-Sophie Rebillat, Claire Redin, Léa Resmini, Pilar Ricart, Jean-Christophe Richard, Raúl Rigo-Bonnin, Nadia Rivet, Jacques G. Rivière, Gemma Rocamora-Blanch, Mathieu P. Rodero, Carlos Rodrigo, Luis Antonio Rodriguez, Carlos Rodriguez-Gallego, Agustí Rodriguez-Palmero, Carolina Soledad Romero, Anya Rothenbuhler, Damien Roux, Nikoletta Rovina, Flore Rozenberg, Yvon Ruch, Montse Ruiz, Maria Yolanda Ruiz del Prado, Juan Carlos Ruiz-Rodriguez, Joan Sabater-Riera, Kai Saks, Maria Salagianni, Oliver Sanchez, Adrián Sánchez-Montalvá, Silvia Sánchez-Ramón, Laire Schidlowski, Agatha Schluter, Julien Schmidt, Matthieu Schmidt, Catharina Schuetz, Cyril E. Schweitzer, Francesco Scolari, Luis Seijo, Analia Gisela Seminario, Piseth Seng, Sevtap Senoglu, Mikko Seppänen, Alex Serra Llovich, Virginie Siguret, Eleni Siouti, David M. Smadja, Nikaia Smith, Ali Sobh, Xavier Solanich, Jordi Solé-Violán, Catherine Soler, Betül Sözeri, Giulia Maria Stella, Yuriy Stepanovskiy, Annabelle Stoclin, Fabio Taccone, Jean-Luc Taupin, Simon J. Tavernier, Loreto Vidaur Tello, Benjamin Terrier, Guillaume Thiery, Karolina Thorn, Caroline Thumerelle, Imran Tipu, Martin Tolstrup, Gabriele Tomasoni, Julie Toubiana, Josep Trenado Alvarez, Vasiliki Triantafyllia, Jesús Troya, Owen T.Y. Tsang, Liina Tserel, Eugene Y.K. Tso, Alessandra Tucci, Şadiye Kübra Tüter Öz, Matilde Valeria Ursini, Takanori Utsumi, Pierre Vabres, Juan Valencia-Ramos, Ana Maria Van Den Rym, Isabelle Vandernoot, Valentina Velez-Santamaria, Silvia Patricia Zuniga Veliz, Mateus C. Vidigal, Sébastien Viel, Cédric Villain, Marie E. Vilaire-Meunier, Judit Villar-García, Audrey Vincent, Dimitri Van der Linden, Alla Volokha, Fanny Vuotto, Els Wauters, Alan K.L. Wu, Tak-Chiu Wu, Aysun Yahşi, Osman Yesilbas, Mehmet Yildiz, Barnaby E. Young, Ufuk Yükselmiş, Marco Zecca, Valentina Zuccaro, Jens Van Praet, Bart N. Lambrecht, Eva Van Braeckel, Cédric Bosteels, Levi Hoste, Eric Hoste, Fré Bauters, Jozefien De Clercq, Catherine Heijmans, Hans Slabbynck, Leslie Naesens, Benoit Florkin, Mary-Anne Young, Amanda Willis, Paloma Lapuente-Suanzes, Ana de Andrés-Martín, Matilda Berkell, Valerio Carelli, Alessia Fiorentino, Surbhi Malhotra, Alessandro Mattiaccio, Tommaso Pippucci, Marco Seri, Evelina Tacconelli, Michiel van Agtmael, Anne Geke Algera, Brent Appelman, Frank van Baarle, Diane Bax, Martijn Beudel, Harm Jan Bogaard, Marije Bomers, Peter Bonta, Lieuwe Bos, Michela Botta, Justin de Brabander, Godelieve de Bree, Sanne de Bruin, David T.P. Buis, Marianna Bugiani, Esther Bulle, Osoul Chouchane, Alex Cloherty, Mirjam Dijkstra, Dave A. Dongelmans, Romein W.G. Dujardin, Paul Elbers, Lucas Fleuren, Suzanne Geerlings, Theo Geijtenbeek, Armand Girbes, Bram Goorhuis, Martin P. Grobusch, Florianne Hafkamp, Laura Hagens, Jorg Hamann, Vanessa Harris, Robert Hemke, Sabine M. Hermans, Leo Heunks, Markus Hollmann, Janneke Horn, Joppe W. Hovius, Menno D. de Jong, Rutger Koning, Endry H.T. Lim, Niels van Mourik, Jeaninne Nellen, Esther J. Nossent, Frederique Paulus, Edgar Peters, Dan A.I. Pina-Fuentes, Tom van der Poll, Bennedikt Preckel, Jan M. Prins, Jorinde Raasveld, Tom Reijnders, Maurits C.F. J. de Rotte, Michiel Schinkel, Marcus J. Schultz, Femke A.P. Schrauwen, Alex Schuurmans, Jaap Schuurmans, Kim Sigaloff, Marleen A. Slim, Patrick Smeele, Marry Smit, Cornelis S. Stijnis, Willemke Stilma, Charlotte Teunissen, Patrick Thoral, Anissa M. Tsonas, Pieter R. Tuinman, Marc van der Valk, Denise P. Veelo, Carolien Volleman, Heder de Vries, Lonneke A. Vught, Michèle van Vugt, Dorien Wouters, A.H. Zwinderman, Matthijs C. Brouwer, W. Joost Wiersinga, Alexander P.J. Vlaar, Miranda F. Tompkins, Camille Alba, Daniel N. Hupalo, John Rosenberger, Gauthaman Sukumar, Matthew D. Wilkerson, Xijun Zhang, Justin Lack, Andrew J. Oler, Kerry Dobbs, Ottavia M. Delmonte, Jeffrey J. Danielson, Andrea Biondi, Laura Rachele Bettini, Mariella D’Angiò, Ilaria Beretta, Luisa Imberti, Alessandra Sottini, Virginia Quaresima, Eugenia Quiros-Roldan, Camillo Rossi, Riccardo Castagnoli, Daniela Montagna, Amelia Licari, and Gian Luigi Marseglia
Subjects: HLA, association, asymptomatic infection, COVID-19, population stratification, Genetics, QH426-470
Abstract: Summary: Human genetic studies of critical COVID-19 pneumonia have revealed the essential role of type I interferon-dependent innate immunity to SARS-CoV-2 infection. Conversely, an association between the HLA-B∗15:01 allele and asymptomatic SARS-CoV-2 infection in unvaccinated individuals was recently reported, suggesting a contribution of pre-existing T cell-dependent adaptive immunity. We report a lack of association of classical HLA alleles, including HLA-B∗15:01, with pre-omicron asymptomatic SARS-CoV-2 infection in unvaccinated participants in a prospective population-based study in the United States (191 asymptomatic vs. 945 symptomatic COVID-19 cases). Moreover, we found no such association in the international COVID Human Genetic Effort cohort (206 asymptomatic vs. 574 mild or moderate COVID-19 cases and 1,625 severe or critical COVID-19 cases). Finally, in the Human Challenge Characterisation study, the three HLA-B∗15:01 individuals infected with SARS-CoV-2 developed symptoms. As with other acute primary infections studied, no classical HLA alleles favoring an asymptomatic course of SARS-CoV-2 infection were identified.
Published: 2024
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5. Prevalence of SARS-CoV-2 infection and impact of vaccination in dialysis patients over two years of the pandemic

Author: Hitz, Paolo, Pagnamenta, Alberto, Pertusini, Laura, Terrot, Tatiana, Franzosi, Yves, Bassi, Jessica, Silacci-Fregni, Chiara, Gaia, Valeria, Martinetti, Gladys, Keller, Franco, Berwert, Lorenzo, Ogna, Valentina Forni, Lavorato-Hadjeres, Soraya, Giunzioni, Davide, D’Ermo, Andrea, Valnegri, Alan, Ferrari, Paolo, Corti, Davide, Ceschi, Alessandro, Cippà, Pietro, Piccoli, Luca, and Giannini, Olivier
Published: 2023
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6. Neutralization, effector function and immune imprinting of Omicron variants

Author: Addetia, Amin, Piccoli, Luca, Case, James Brett, Park, Young-Jun, Beltramello, Martina, Guarino, Barbara, Dang, Ha, de Melo, Guilherme Dias, Pinto, Dora, Sprouse, Kaitlin, Scheaffer, Suzanne M., Bassi, Jessica, Silacci-Fregni, Chiara, Muoio, Francesco, Dini, Marco, Vincenzetti, Lucia, Acosta, Rima, Johnson, Daisy, Subramanian, Sambhavi, Saliba, Christian, Giurdanella, Martina, Lombardo, Gloria, Leoni, Giada, Culap, Katja, McAlister, Carley, Rajesh, Anushka, Dellota, Jr, Exequiel, Zhou, Jiayi, Farhat, Nisar, Bohan, Dana, Noack, Julia, Chen, Alex, Lempp, Florian A., Quispe, Joel, Kergoat, Lauriane, Larrous, Florence, Cameroni, Elisabetta, Whitener, Bradley, Giannini, Olivier, Cippà, Pietro, Ceschi, Alessandro, Ferrari, Paolo, Franzetti-Pellanda, Alessandra, Biggiogero, Maira, Garzoni, Christian, Zappi, Stephanie, Bernasconi, Luca, Kim, Min Jeong, Rosen, Laura E., Schnell, Gretja, Czudnochowski, Nadine, Benigni, Fabio, Franko, Nicholas, Logue, Jennifer K., Yoshiyama, Courtney, Stewart, Cameron, Chu, Helen, Bourhy, Hervé, Schmid, Michael A., Purcell, Lisa A., Snell, Gyorgy, Lanzavecchia, Antonio, Diamond, Michael S., Corti, Davide, and Veesler, David
Published: 2023
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7. Self-discharge during treatment for acute recreational drug toxicity: an observational study from emergency departments in seven European countries

Author: Odd Martin Vallersnes, Alison M. Dines, David M. Wood, Fridtjof Heyerdahl, Knut Erik Hovda, Christopher Yates, Isabelle Giraudon, Blazena Caganova, Alessandro Ceschi, Miguel Galicia, Evangelia Liakoni, Matthias E. Liechti, Òscar Miró, Roberta Noseda, Per Sverre Persett, Kristiina Põld, Yasmin Schmid, Irene Scholz, Federico Vigorita, and Paul I. Dargan
Subjects: Recreational drug toxicity, Self-discharge, Leaving against medical advice, Discharge against medical advice, Leaving without being seen, Substance use, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract: Abstract Background Self-discharge is a risk factor for readmission and excess mortality. We assess the rate of self-discharge from the emergency department (ED) among presentations for acute recreational drug toxicity and identify factors associated with self-discharge. Methods From the Euro-DEN Plus database of presentations to the ED with acute recreational drug toxicity, we extracted data from 11 centres in seven European countries from 2014 to 2017. Self-discharge was defined as taking one’s own discharge or escaping from the ED before being medically cleared. We used multiple logistic regression analyses to look for factors associated with self-discharge. Results Among 15,135 included presentations, 1807 (11.9%) self-discharged. Self-discharge rates varied from 1.7 to 17.1% between centres. Synthetic cannabinoids were associated with self-discharge, adjusted odds ratio 1.44 (95% confidence interval 1.10–1.89), as were heroin, 1.44 (1.26–1.64), agitation, 1.27 (1.10–1.46), and naloxone treatment, 1.27 (1.07–1.51), while sedation protected from self-discharge, 0.38 (0.30–0.48). Conclusion One in eight presentations self-discharged. There was a large variation in self-discharge rates across the participating centres, possibly partly reflecting different discharge procedures and practices. Measures to improve the management of agitation and cautious administration of naloxone to avoid opioid withdrawal symptoms may be approaches worth exploring to reduce self-discharge.
Published: 2023
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8. Validation of sTREM-1 and IL-6 based algorithms for outcome prediction of COVID-19

Author: Mathias Van Singer, Thomas Brahier, Jana Koch, Pr. Olivier Hugli, Andrea M. Weckman, Kathleen Zhong, Taylor J. Kain, Aleksandra Leligdowicz, Enos Bernasconi, Alessandro Ceschi, Sara Parolari, Danielle Vuichard-Gysin, Kevin C. Kain, Werner C. Albrich, and Noémie Boillat-Blanco
Subjects: Biomarkers, Validation study, COVID-19, sTREM-1, Clinical support decision tool, Infectious and parasitic diseases, RC109-216
Abstract: Abstract Background A prospective observational cohort study of COVID-19 patients in a single Emergency Department (ED) showed that sTREM-1- and IL-6-based algorithms were highly predictive of adverse outcome (Van Singer et al. J Allergy Clin Immunol 2021). We aim to validate the performance of these algorithms at ED presentation. Methods This multicentric prospective observational study of PCR-confirmed COVID-19 adult patients was conducted in the ED of three Swiss hospitals. Data of the three centers were retrospectively completed and merged. We determined the predictive accuracy of the sTREM-1-based algorithm for 30-day intubation/mortality. We also determined the performance of the IL-6-based algorithm using data from one center for 30-day oxygen requirement. Results 373 patients were included in the validation cohort, 139 (37%) in Lausanne, 93 (25%) in St.Gallen and 141 (38%) in EOC. Overall, 18% (93/373) patients died or were intubated by day 30. In Lausanne, 66% (92/139) patients required oxygen by day 30. The predictive accuracy of sTREM-1 and IL-6 were similar compared to the derivation cohort. The sTREM-1-based algorithm confirmed excellent sensitivity (90% versus 100% in the derivation cohort) and negative predictive value (94% versus 100%) for 30-day intubation/mortality. The IL-6-based algorithm performance was acceptable with a sensitivity of 85% versus 98% in the derivation cohort and a negative predictive value of 60% versus 92%. Conclusion The sTREM-1 algorithm demonstrated good reproducibility. A prospective randomized controlled trial, comparing outcomes with and without the algorithm, is necessary to assess its safety and impact on hospital and ICU admission rates. The IL-6 algorithm showed acceptable validity in a single center and need additional validation before widespread implementation.
Published: 2023
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9. Circulating SARS-CoV-2 spike N439K variants maintain fitness while evading antibody-mediated immunity

Author: Thomson, Emma C, Rosen, Laura E, Shepherd, James G, Spreafico, Roberto, da Silva Filipe, Ana, Wojcechowskyj, Jason A, Davis, Chris, Piccoli, Luca, Pascall, David J, Dillen, Josh, Lytras, Spyros, Czudnochowski, Nadine, Shah, Rajiv, Meury, Marcel, Jesudason, Natasha, De Marco, Anna, Li, Kathy, Bassi, Jessica, O’Toole, Aine, Pinto, Dora, Colquhoun, Rachel M, Culap, Katja, Jackson, Ben, Zatta, Fabrizia, Rambaut, Andrew, Jaconi, Stefano, Sreenu, Vattipally B, Nix, Jay, Zhang, Ivy, Jarrett, Ruth F, Glass, William G, Beltramello, Martina, Nomikou, Kyriaki, Pizzuto, Matteo, Tong, Lily, Cameroni, Elisabetta, Croll, Tristan I, Johnson, Natasha, Di Iulio, Julia, Wickenhagen, Arthur, Ceschi, Alessandro, Harbison, Aoife M, Mair, Daniel, Ferrari, Paolo, Smollett, Katherine, Sallusto, Federica, Carmichael, Stephen, Garzoni, Christian, Nichols, Jenna, Galli, Massimo, Hughes, Joseph, Riva, Agostino, Ho, Antonia, Schiuma, Marco, Semple, Malcolm G, Openshaw, Peter JM, Fadda, Elisa, Baillie, J Kenneth, Chodera, John D, Investigators, The ISARIC4C, Consortium, the COVID-19 Genomics UK, Rihn, Suzannah J, Lycett, Samantha J, Virgin, Herbert W, Telenti, Amalio, Corti, Davide, Robertson, David L, and Snell, Gyorgy
Subjects: Medical Microbiology, Biomedical and Clinical Sciences, Biological Sciences, Immunology, Biotechnology, Coronaviruses Therapeutics and Interventions, Coronaviruses, Vaccine Related, Infectious Diseases, Immunization, Emerging Infectious Diseases, Prevention, 5.1 Pharmaceuticals, 2.1 Biological and endogenous factors, Infection, Good Health and Well Being, Angiotensin-Converting Enzyme 2, Antibodies, Neutralizing, Antibodies, Viral, COVID-19, Genetic Fitness, Humans, Immune Evasion, Mutation, Phylogeny, SARS-CoV-2, Spike Glycoprotein, Coronavirus, Virulence, ISARIC4C Investigators, COVID-19 Genomics UK (COG-UK) Consortium, N439K, Spike, monoclonal antibody escape, mutation, protein structure, receptor binding motif, variant, Medical and Health Sciences, Developmental Biology, Biological sciences, Biomedical and clinical sciences
Abstract: SARS-CoV-2 can mutate and evade immunity, with consequences for efficacy of emerging vaccines and antibody therapeutics. Here, we demonstrate that the immunodominant SARS-CoV-2 spike (S) receptor binding motif (RBM) is a highly variable region of S and provide epidemiological, clinical, and molecular characterization of a prevalent, sentinel RBM mutation, N439K. We demonstrate N439K S protein has enhanced binding affinity to the hACE2 receptor, and N439K viruses have similar in vitro replication fitness and cause infections with similar clinical outcomes as compared to wild type. We show the N439K mutation confers resistance against several neutralizing monoclonal antibodies, including one authorized for emergency use by the US Food and Drug Administration (FDA), and reduces the activity of some polyclonal sera from persons recovered from infection. Immune evasion mutations that maintain virulence and fitness such as N439K can emerge within SARS-CoV-2 S, highlighting the need for ongoing molecular surveillance to guide development and usage of vaccines and therapeutics.
Published: 2021

10. Sex Differences in Outcomes of Intravenous Thrombolysis in Acute Ischemic Stroke Patients with Preadmission Use of Antiplatelets

Author: Noseda, Roberta, Rea, Federico, Pagnamenta, Alberto, Agazzi, Pamela, Bianco, Giovanni, Sihabdeen, Shairin, Seiffge, David, Michel, Patrik, Nedeltchev, Krassen, Bonati, Leo, Kägi, Georg, Niederhauser, Julien, Nyffeler, Thomas, Luft, Andreas, Wegener, Susanne, Schelosky, Ludwig, Medlin, Friedrich, Rodic, Biljana, Peters, Nils, Renaud, Susanne, Mono, Marie-Luise, Carrera, Emmanuel, Fischer, Urs, Ceschi, Alessandro, and Cereda, Carlo Walter
Published: 2023
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11. Mapping Neutralizing and Immunodominant Sites on the SARS-CoV-2 Spike Receptor-Binding Domain by Structure-Guided High-Resolution Serology

Author: Piccoli, Luca, Park, Young-Jun, Tortorici, M Alejandra, Czudnochowski, Nadine, Walls, Alexandra C, Beltramello, Martina, Silacci-Fregni, Chiara, Pinto, Dora, Rosen, Laura E, Bowen, John E, Acton, Oliver J, Jaconi, Stefano, Guarino, Barbara, Minola, Andrea, Zatta, Fabrizia, Sprugasci, Nicole, Bassi, Jessica, Peter, Alessia, De Marco, Anna, Nix, Jay C, Mele, Federico, Jovic, Sandra, Rodriguez, Blanca Fernandez, Gupta, Sneha V, Jin, Feng, Piumatti, Giovanni, Lo Presti, Giorgia, Pellanda, Alessandra Franzetti, Biggiogero, Maira, Tarkowski, Maciej, Pizzuto, Matteo S, Cameroni, Elisabetta, Havenar-Daughton, Colin, Smithey, Megan, Hong, David, Lepori, Valentino, Albanese, Emiliano, Ceschi, Alessandro, Bernasconi, Enos, Elzi, Luigia, Ferrari, Paolo, Garzoni, Christian, Riva, Agostino, Snell, Gyorgy, Sallusto, Federica, Fink, Katja, Virgin, Herbert W, Lanzavecchia, Antonio, Corti, Davide, and Veesler, David
Subjects: Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Coronaviruses Vaccines, Coronaviruses, Prevention, Coronaviruses Therapeutics and Interventions, Vaccine Related, Biotechnology, Immunization, Emerging Infectious Diseases, Infectious Diseases, Infection, Good Health and Well Being, Angiotensin-Converting Enzyme 2, Antibodies, Monoclonal, Antibodies, Neutralizing, Antibodies, Viral, Antigen-Antibody Reactions, Betacoronavirus, Binding Sites, COVID-19, Coronavirus Infections, Epitope Mapping, Epitopes, Humans, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Kinetics, Molecular Dynamics Simulation, Pandemics, Peptidyl-Dipeptidase A, Pneumonia, Viral, Protein Binding, Protein Domains, Protein Structure, Quaternary, SARS-CoV-2, Spike Glycoprotein, Coronavirus, coronaviruses, effector functions, immunity, neutralizing antibodies, Biological Sciences, Medical and Health Sciences, Developmental Biology, Biological sciences, Biomedical and clinical sciences
Abstract: Analysis of the specificity and kinetics of neutralizing antibodies (nAbs) elicited by SARS-CoV-2 infection is crucial for understanding immune protection and identifying targets for vaccine design. In a cohort of 647 SARS-CoV-2-infected subjects, we found that both the magnitude of Ab responses to SARS-CoV-2 spike (S) and nucleoprotein and nAb titers correlate with clinical scores. The receptor-binding domain (RBD) is immunodominant and the target of 90% of the neutralizing activity present in SARS-CoV-2 immune sera. Whereas overall RBD-specific serum IgG titers waned with a half-life of 49 days, nAb titers and avidity increased over time for some individuals, consistent with affinity maturation. We structurally defined an RBD antigenic map and serologically quantified serum Abs specific for distinct RBD epitopes leading to the identification of two major receptor-binding motif antigenic sites. Our results explain the immunodominance of the receptor-binding motif and will guide the design of COVID-19 vaccines and therapeutics.
Published: 2020

12. REPLY TO GREMESE ET AL. : Statistical reasoning to evaluate treatment effects when data are collected with lack of design: Covid-19 experience

Author: Di Serio, Clelia, Cippà, Pietro, Ceschi, Alessandro, and Ferrari, Paolo
Published: 2022

13. Maturation of SARS-CoV-2 Spike-specific memory B cells drives resilience to viral escape

Author: Marzi, Roberta, Bassi, Jessica, Silacci-Fregni, Chiara, Bartha, Istvan, Muoio, Francesco, Culap, Katja, Sprugasci, Nicole, Lombardo, Gloria, Saliba, Christian, Cameroni, Elisabetta, Cassotta, Antonino, Low, Jun Siong, Walls, Alexandra C., McCallum, Matthew, Tortorici, M. Alejandra, Bowen, John E., Dellota, Exequiel A., Jr., Dillen, Josh R., Czudnochowski, Nadine, Pertusini, Laura, Terrot, Tatiana, Lepori, Valentino, Tarkowski, Maciej, Riva, Agostino, Biggiogero, Maira, Franzetti-Pellanda, Alessandra, Garzoni, Christian, Ferrari, Paolo, Ceschi, Alessandro, Giannini, Olivier, Havenar-Daughton, Colin, Telenti, Amalio, Arvin, Ann, Virgin, Herbert W., Sallusto, Federica, Veesler, David, Lanzavecchia, Antonio, Corti, Davide, and Piccoli, Luca
Published: 2023
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14. Observational cross-sectional case study of toxicities of antifungal drugs

Author: Andrea M. Burden, Lucy Hausammann, Alessandro Ceschi, Hugo Kupferschmidt, and Stefan Weiler
Subjects: Azole, Polyene, Echinocandin, Adverse reaction, Overdose, Intoxication, Microbiology, QR1-502
Abstract: ABSTRACT: Objectives: In this study, we examined the toxicities, including poisoning and overdoses, with polyene, azole, flucytosine and echinocandin antifungals reported to the Swiss National Poison Centre. Methods: An observational cross-sectional study on antifungals was performed based on reports between 1995 and 2016 to Tox Info Suisse. Patient demographic and clinical characteristics were summarised among all reported calls, stratified by age group. In secondary analyses, we evaluated cases with clinical follow-up information. Results: In total, 149 cases were reported to the National Poison Centre during the study period, of which 49 (32.9%) were male and 91 (61.1%) were female, and 95 (63.8%) were adults and 54 (36.2%) were children (age ≤16 years). The most frequently reported drug class was azoles (136; 91.3%). In 31 cases (20.8%) reported by treating physicians, further clinical follow-up information was available. Nearly one-half of these patients were asymptomatic (15/31; 48.4%). In 11 patients (35.5%) among those with symptoms, the symptoms of toxicity were categorised with a strong causality to the respective antifungal. Clinical findings caused by triazoles were effects in the gastrointestinal tract, hallucinations and predelirium state. Clinical findings caused by polyenes were mostly minor symptoms with infusion-related effects or hypokalaemia. The severity was categorised as minor in 6 (54.5%) of 11 cases and as moderate in 5 cases (45.5%). Conclusion: Despite high administered doses, no severe or fatal cases occurred within the study period. Although various toxicities can occur with antifungal administration and overdoses, they showed a favourable safety profile.
Published: 2022
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15. Integrating joint latent class mixed models and Bayesian network for uncovering clinical subgroups of COVID-19 patients.

Author: Cugnata, Federica, Brombin, Chiara, Cippà, Pietro E., Ceschi, Alessandro, Ferrari, Paolo, and Di Serio, Clelia
Subjects: COVID-19 pandemic, BAYESIAN analysis, COVID-19, INDIVIDUALIZED medicine, STATISTICAL models
Abstract: When modelling the dynamics of biomarkers in biomedical studies, it is essential to identify homogeneous clusters of patients and analyse them from a precision medicine perspective. This need has emerged as crucial and urgent during the COVID-19 pandemic: early understanding of symptoms and patient heterogeneity has significant implications for prevention, early diagnosis, effective management, and treatment. Additionally, biomarker progression may be associated with clinically relevant time-toevent data. Therefore, statistical models are necessary to gain insight into complex disease mechanisms by properly accounting for unobservable heterogeneity in patients while jointly modelling longitudinal and time-to-event data. In this study, we leverage the key features of Latent Class modelling and Bayesian Network approaches and propose a unified framework to (a) uncover homogeneous subgroups of patients concerning their longitudinal and survival data and (b) describe patient subgroups within a multivariate framework. [ABSTRACT FROM AUTHOR]
Published: 2025
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16. A data-driven approach to identify risk profiles and protective drugs in COVID-19

Author: Cippà, Pietro E., Cugnata, Federica, Ferrari, Paolo, Brombin, Chiara, Ruinelli, Lorenzo, Bianchi, Giorgia, Beria, Nicola, Schulz, Lukas, Bernasconi, Enos, Merlani, Paolo, Ceschi, Alessandro, and Di Serio, Clelia
Published: 2021

17. Broadly neutralizing antibodies overcome SARS-CoV-2 Omicron antigenic shift

Author: Cameroni, Elisabetta, Bowen, John E., Rosen, Laura E., Saliba, Christian, Zepeda, Samantha K., Culap, Katja, Pinto, Dora, VanBlargan, Laura A., De Marco, Anna, di Iulio, Julia, Zatta, Fabrizia, Kaiser, Hannah, Noack, Julia, Farhat, Nisar, Czudnochowski, Nadine, Havenar-Daughton, Colin, Sprouse, Kaitlin R., Dillen, Josh R., Powell, Abigail E., Chen, Alex, Maher, Cyrus, Yin, Li, Sun, David, Soriaga, Leah, Bassi, Jessica, Silacci-Fregni, Chiara, Gustafsson, Claes, Franko, Nicholas M., Logue, Jenni, Iqbal, Najeeha Talat, Mazzitelli, Ignacio, Geffner, Jorge, Grifantini, Renata, Chu, Helen, Gori, Andrea, Riva, Agostino, Giannini, Olivier, Ceschi, Alessandro, Ferrari, Paolo, Cippà, Pietro E., Franzetti-Pellanda, Alessandra, Garzoni, Christian, Halfmann, Peter J., Kawaoka, Yoshihiro, Hebner, Christy, Purcell, Lisa A., Piccoli, Luca, Pizzuto, Matteo Samuele, Walls, Alexandra C., Diamond, Michael S., Telenti, Amalio, Virgin, Herbert W., Lanzavecchia, Antonio, Snell, Gyorgy, Veesler, David, and Corti, Davide
Published: 2022
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18. Spikevax booster and delayed urticaria: a Swiss signal with diagnostic uncertainties due to a high proportion of direct patient reports

Author: Noseda, Roberta, Müller, Laura, Stammschulte, Thomas, Bertoli, Raffaela, and Ceschi, Alessandro
Published: 2022
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19. Risk assessment and seroprevalence of SARS-CoV-2 infection in healthcare workers of COVID-19 and non-COVID-19 hospitals in Southern Switzerland

Author: Piccoli, Luca, Ferrari, Paolo, Piumatti, Giovanni, Jovic, Sandra, Rodriguez, Blanca Fernandez, Mele, Federico, Giacchetto-Sasselli, Isabella, Terrot, Tatiana, Silacci-Fregni, Chiara, Cameroni, Elisabetta, Jaconi, Stefano, Sprugasci, Nicole, Bartha, Istvan, Corti, Davide, Uguccioni, Mariagrazia, Lanzavecchia, Antonio, Garzoni, Christian, Giannini, Olivier, Bernasconi, Enos, Elzi, Luigia, Albanese, Emiliano, Sallusto, Federica, and Ceschi, Alessandro
Published: 2021
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20. The Contribution of Clinical Pharmacologists in Precision Medicine: An Opportunity for Health Care Improvement

Author: Grisafi, Davide, Ceschi, Alessandro, Avalos Clerici, Veronica, and Scaglione, Francesco
Published: 2021
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21. P1245 Polymorphic Variants of HSD3B1 Gene Confer Different Outcome in Specific Subgroups of Patients Infected With SARS-CoV-2

Author: Samantha Epistolio, Giulia Ramelli, Margaret Ottaviano, Emanuele Crupi, Laura Marandino, Maira Biggiogero, Pier Andrea Maida, Lorenzo Ruinelli, Ursula Vogl, Dylan Mangan, Mariarosa Pascale, Marco Cantù, Alessandro Ceschi, Enos Bernasconi, Luca Mazzucchelli, Carlo Catapano, Andrea Alimonti, Christian Garzoni, Silke Gillessen Sommer, Federico Mattia Stefanini, Alessandra Franzetti-Pellanda, Milo Frattini, and Ricardo Pereira Mestre
Subjects: SARS-CoV-2, HSD3B1 gene polymorphism, androgen receptor, direct sequencing, Likelihood-ratio tests, Medicine (General), R5-920
Abstract: Introduction: Severe respiratory syndrome coronavirus 2 (SARS-CoV-2) uses the androgen receptor (AR), through ACE2 receptor and TMPRSS2, to enter nasal and upper airways epithelial cells. Genetic analyses revealed that HSD3B1 P1245C polymorphic variant increases dihydrotestosterone production and upregulation of TMPRSS2 with respect to P1245A variant, thus possibly influencing SARS-CoV-2 infection. Our aim was to characterize the HSD3B1 polymorphism status and its potential association with clinical outcomes in hospitalized patients with COVID-19 in Southern Switzerland.Materials and Methods: The cohort included 400 patients hospitalized for COVID-19 during the first wave between February and May 2020 in two different hospitals of Canton Ticino. Genomic DNA was extracted from formalin-fixed paraffin-embedded tissue blocks, and HSD3B1 gene polymorphism was evaluated by Sanger sequencing. Statistical associations were verified using different test.Results:HSD3B1 polymorphic variants were not associated with a single classical factor related to worse clinical prognosis in hospitalized patients with SARS-CoV-2. However, in specific subgroups, HSD3B1 variants played a clinical role: intensive care unit admission was more probable in patients with P1245C diabetes compared with P1245A individuals without this comorbidity and death was more associated with hypertensive P1245A>C cases than patients with P1245A diabetes without hypertension.Discussion: This is the first study showing that HSD3B1 gene status may influence the severity of SARS-CoV-2 infection. If confirmed, our results could lead to the introduction of HSD3B1 gene status analysis in patients infected with SARS-CoV-2 to predict clinical outcome.
Published: 2022
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22. Clinical effect of ethanol co-use in patients with acute drug toxicity involving the use of central nervous system depressant recreational drugs

Author: Heier, Eva-Carina, Eyer, Florian, Rabe, Christian, Geith, Stefanie, Dargan, Paul I., Wood, David M., Heyerdahl, Fridtjof, Dines, Alison M., Giraudon, Isabelle, Erik Hovda, Knut, Yates, Chris, Vallersnes, Odd Martin, Miró, Òscar, Liechti, Matthias E., Zellner, Tobias, Anand, Lukasz, Waldman, Wojciech, Anseeuw, Kurt, Gillebeert, Johan, Badaras, Robertas, Laubner, Gabija, Bonnici, Jeffrey, Brvar, Miran, Grenc, Damjan, Burke, Rachel, Moughty, Adrian, Caganova, Blazena, Galicia, Miguel, Gorozia, Ketevan, Kutubidze, Soso, Jaffal, Karim, Mégarbane, Bruno, Jürgens, Gesche, Konstari, Jutta, Liguts, Viesturs, Stašinskis, Roberts, Lyphout, Cathelijne, Toth, Ibolya, Noseda, Roberta, Ceschi, Alessandro, O’Connor, Niall, Sopirala, Radhika, Paasma, Raido, Perez, Juan Ortega, Puiguriguer, Jordi, Perminas, Marius, Surkus, Jonas, Persett, Per Sverre, Põld, Kristiina, Radenkova-Saeva, Julia, Rulisek, Jan, Vigorita, Federico, Waldman, Wojciech, Waring, W. Stephen, Zacharov, Sergej, Schmid, Yasmin, Liakoni, Evangelia, Scholz, Irene, Gesnigt, Femke MJ., Sandel, Maro H., Nitescu, Gabriela Viorela, Calýskan, Feriyde, Hengel-Koot, Irma van den, and Hondebrink, Laura
Published: 2022
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23. Clinical effects of cannabis compared to synthetic cannabinoid receptor agonists (SCRAs): a retrospective cohort study of presentations with acute toxicity to European hospitals between 2013 and 2020

Author: NVIC bedrijfsvoering, Brain, Waters, Mitchell L., Dargan, Paul I., Yates, Christopher, Dines, Alison M., Eyer, Florian, Giraudon, Isabelle, Heyerdahl, Fridtjof, Hovda, Knut Erik, Liechti, Matthias E., Miró, Òscar, Vallersnes, Odd Martin, Anseeuw, Kurt, Badaras, Robertas, Bitel, Marcin, Bonnici, Jeffrey, Brvar, Miran, Caganova, Blazena, Calýskan, Feriyde, Ceschi, Alessandro, Chamoun, Karam, Daveloose, Laurence, Galicia, Miguel, Gartner, Birgit, Gorozia, Ketevan, Grenc, Damjan, Gresnigt, Femke M.J., Hondebrink, Laura, Jürgens, Gesche, Konstari, Jutta, Kutubidze, Soso, Laubner, Gabija, Liakoni, Evangelia, Liguts, Viesturs, Lyphout, Cathelijne, McKenna, Roy, Mégarbane, Bruno, Moughty, Adrian, Nitescu, Gabriela Viorela, Noseda, Roberta, O'Connor, Niall, Paasma, Raido, Ortega Perez, Juan, Perminas, Marius, Persett, Per Sverre, Põld, Kristiina, Puchon, Erik, Puiguriguer, Jordi, Radenkova-Saeva, Julia, Rulisek, Jan, Samer, Caroline, Schmid, Yasmin, Scholz, Irene, Stašinskis, Roberts, Surkus, Jonas, Van den Hengel-Koot, Irma, Vigorita, Federico, Vogt, Severin, Waldman, Wojciech, Waring, William Stephen, Zacharov, Sergej, Zellner, Tobias, Wood, David M., NVIC bedrijfsvoering, Brain, Waters, Mitchell L., Dargan, Paul I., Yates, Christopher, Dines, Alison M., Eyer, Florian, Giraudon, Isabelle, Heyerdahl, Fridtjof, Hovda, Knut Erik, Liechti, Matthias E., Miró, Òscar, Vallersnes, Odd Martin, Anseeuw, Kurt, Badaras, Robertas, Bitel, Marcin, Bonnici, Jeffrey, Brvar, Miran, Caganova, Blazena, Calýskan, Feriyde, Ceschi, Alessandro, Chamoun, Karam, Daveloose, Laurence, Galicia, Miguel, Gartner, Birgit, Gorozia, Ketevan, Grenc, Damjan, Gresnigt, Femke M.J., Hondebrink, Laura, Jürgens, Gesche, Konstari, Jutta, Kutubidze, Soso, Laubner, Gabija, Liakoni, Evangelia, Liguts, Viesturs, Lyphout, Cathelijne, McKenna, Roy, Mégarbane, Bruno, Moughty, Adrian, Nitescu, Gabriela Viorela, Noseda, Roberta, O'Connor, Niall, Paasma, Raido, Ortega Perez, Juan, Perminas, Marius, Persett, Per Sverre, Põld, Kristiina, Puchon, Erik, Puiguriguer, Jordi, Radenkova-Saeva, Julia, Rulisek, Jan, Samer, Caroline, Schmid, Yasmin, Scholz, Irene, Stašinskis, Roberts, Surkus, Jonas, Van den Hengel-Koot, Irma, Vigorita, Federico, Vogt, Severin, Waldman, Wojciech, Waring, William Stephen, Zacharov, Sergej, Zellner, Tobias, and Wood, David M.
Published: 2024

24. Calcitonin gene-related peptide antagonists in pregnancy: a disproportionality analysis in VigiBase®

Author: Noseda, Roberta; https://orcid.org/0000-0002-4946-7926, Bedussi, Francesca; https://orcid.org/0000-0002-8584-7408, Gobbi, Claudio; https://orcid.org/0000-0002-7554-0664, Ceschi, Alessandro; https://orcid.org/0000-0002-4308-0405, Zecca, Chiara; https://orcid.org/0000-0002-9990-3431, Noseda, Roberta; https://orcid.org/0000-0002-4946-7926, Bedussi, Francesca; https://orcid.org/0000-0002-8584-7408, Gobbi, Claudio; https://orcid.org/0000-0002-7554-0664, Ceschi, Alessandro; https://orcid.org/0000-0002-4308-0405, and Zecca, Chiara; https://orcid.org/0000-0002-9990-3431
Abstract: Background Current evidence on the safety of calcitonin gene–related peptide antagonists (CGRP-A) in pregnancy for the treatment of both episodic and chronic migraine is scarce and does not yet provide definitive information. By querying VigiBase$^{®}$, the World Health Organization global pharmacovigilance database, this study aimed to detect differences in the reporting frequency between CGRP-A and triptans in relation to pregnancy. Methods Disproportionality analyses on de-duplicated safety reports collected in VigiBase$^{®}$ as of 31.05.2023 reporting exposure to CGRP-A in pregnancy with or without pregnancy outcomes. A Reporting Odds Ratio (ROR) with a 95% confidence interval (CI) was used as a measure of disproportionality and the threshold for the detection of a signal of disproportionate reporting was set with a 95% CI lower limit > 1. Findings Four hundred sixty-seven safety reports reported exposure to CGRP-A in pregnancy, mostly originating from the United States of America (360/467, 77%), more frequently reported by patients (225/467, 48%), who were mainly females (431/467, 92%), and more frequently reported exposure to CGRP-A during pregnancy (400/467, 86%). Compared to triptans, no signals of disproportionate reporting were detected with CGRP-A either for the overall reporting of pregnancy-related safety reports (ROR 0.91, 95% CI 0.78–1.06), for the reporting of pregnancy outcomes (maternal and/or foetal/neonatal, ROR 0.54, 95% CI 0.45–0.66), or for the reporting of foetal/neonatal outcomes (ROR 0.53, 95% CI 0.41–0.68). Conclusions This study showed that, to date, there are no signals of increased reporting with CGRP-A compared to triptans in relation to pregnancy in VigiBase$^{®}$. Future pharmacovigilance studies are needed to confirm these findings.
Published: 2024

25. Diabetes mellitus is a risk factor for prolonged SARS-CoV-2 viral shedding in lower respiratory tract samples of critically ill patients

Author: Buetti, Niccolò, Trimboli, Pierpaolo, Mazzuchelli, Timothy, Lo Priore, Elia, Balmelli, Carlo, Trkola, Alexandra, Conti, Marco, Martinetti, Gladys, Elzi, Luigia, Ceschi, Alessandro, Consonni, Vera, Ogna, Adam, Forni-Ogna, Valentina, and Bernasconi, Enos
Published: 2020
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26. Poor neutralization and rapid decay of antibodies to SARS-CoV-2 variants in vaccinated dialysis patients.

Author: Jessica Bassi, Olivier Giannini, Chiara Silacci-Fregni, Laura Pertusini, Paolo Hitz, Tatiana Terrot, Yves Franzosi, Francesco Muoio, Christian Saliba, Marcel Meury, Exequiel A Dellota, Josh R Dillen, Patrick Hernandez, Nadine Czudnochowski, Elisabetta Cameroni, Nicola Beria, Mariangela Ventresca, Alberto Badellino, Soraya Lavorato-Hadjeres, Elisabetta Lecchi, Tecla Bonora, Matteo Mattiolo, Guido Trinci, Daniela Garzoni, Giuseppe Bonforte, Valentina Forni-Ogna, Davide Giunzioni, Lorenzo Berwert, Ravindra K Gupta, Paolo Ferrari, Alessandro Ceschi, Pietro Cippà, Davide Corti, Antonio Lanzavecchia, and Luca Piccoli
Subjects: Medicine, Science
Abstract: Patients on dialysis are at risk of severe course of SARS-CoV-2 infection. Understanding the neutralizing activity and coverage of SARS-CoV-2 variants of vaccine-elicited antibodies is required to guide prophylactic and therapeutic COVID-19 interventions in this frail population. By analyzing plasma samples from 130 hemodialysis and 13 peritoneal dialysis patients after two doses of BNT162b2 or mRNA-1273 vaccines, we found that 35% of the patients had low-level or undetectable IgG antibodies to SARS-CoV-2 Spike (S). Neutralizing antibodies against the vaccine-matched SARS-CoV-2 and Delta variant were low or undetectable in 49% and 77% of patients, respectively, and were further reduced against other emerging variants. The fraction of non-responding patients was higher in SARS-CoV-2-naïve hemodialysis patients immunized with BNT162b2 (66%) than those immunized with mRNA-1273 (23%). The reduced neutralizing activity correlated with low antibody avidity. Patients followed up to 7 months after vaccination showed a rapid decay of the antibody response with an average 21- and 10-fold reduction of neutralizing antibodies to vaccine-matched SARS-CoV-2 and Delta variant, which increased the fraction of non-responders to 84% and 90%, respectively. These data indicate that dialysis patients should be prioritized for additional vaccination boosts. Nevertheless, their antibody response to SARS-CoV-2 must be continuously monitored to adopt the best prophylactic and therapeutic strategy.
Published: 2022
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27. Seizures as a complication of recreational drug use: Analysis of the Euro-DEN Plus data-set

Author: Anseeuw, Kurt, Badaras, Robertas, Bonnici, Jeffrey, Brvar, Miran, Caganova, Blazena, Ceschi, Alessandro, Eyer, Florian, Galicia, Miguel, Geith, Stefanie, Gillebeert, Johan, Grenc, Damjan, Gorozia, Ketevan, Jaffal, Karim, Jürgens, Gesche, Kabata, Piotr Maciej, Kennedy, Iarlaith, Konstari, Jutta, Kutubidze, Soso, Laubner, Gabija, Liakoni, Evangelia, Liechti, Matthias E., Lyphout, Cathelijne, Mégarbane, Bruno, Miró, Òscar, Moughty, Adrian, Müller, Laura, O'Connor, Niall, Paasma, Raido, Perez, Juan Ortega, Perminas, Marius, Persett, Per Sverre, Põld, Kristiina, Puiguriguer, Jordi, Radenkova-Saeva, Julia, Rulisek, Jan, Schmid, Yasmin, Scholz, Irene, Sopirala, Radhika, Surkus, Jonas, Toth, Ibolya, Vallersnes, Odd Martin, Vigorita, Federico, Waldman, Wojciech, Waring, W. Stephen, Zacharov, Sergej, Wolfe, Caitlin E., Wood, David M., Dines, Alison, Whatley, Benjamin P., Yates, Christopher, Heyerdahl, Fridtjof, Hovda, Knut Erik, Giraudon, Isabelle, and Dargan, Paul I.
Published: 2019
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28. Safety of Monoclonal Antibodies Inhibiting PCSK9 in Pregnancy: Disproportionality Analysis in VigiBase®.

Author: Noseda, Roberta, Bedussi, Francesca, Panchaud, Alice, and Ceschi, Alessandro
Subjects: MONOCLONAL antibodies, MISCARRIAGE, PREGNANCY outcomes, PREGNANCY, MEDICAL personnel, DATABASES, HUMAN abnormalities
Abstract: Safety data on the use of monoclonal antibodies inhibiting proprotein convertase subtilisin/kexin type 9 in pregnancy are scarce. This study queried VigiBase®, the World Health Organization global pharmacovigilance database, to search for signals of disproportionate reporting for pregnancy outcomes with alirocumab and evolocumab. As of November 22, 2023, there were 45 safety reports of exposure to evolocumab (N = 31) and alirocumab (N = 14) in pregnancy. Most of them originated from Europe (N = 25, 55.6%) and were more frequently reported by healthcare professionals (N = 35, 77.8%). Median patient age was 37 years (25th–75th percentiles; 32–41 years). Drug exposure occurred during pregnancy in 36 (80.0%) safety reports, via paternal exposure during pregnancy in four (8.9%), during lactation in three (6.7%), and in two safety reports the time of drug exposure remained unknown. Twenty safety reports (57.8%) merely reported drug exposure, while 19 (42.2%) also reported pregnancy outcomes, however, without specific maternal toxicities or patterns of birth defects. Spontaneous abortion was reported in eight safety reports without representing a signal of disproportionate reporting compared with either the full database (reporting odds ratio, ROR, 0.06 95% confidence interval, CI 0.03–0.12) or statins (ROR 0.16, 95% CI 0.08–0.32). In conclusion, this study showed that, currently, there are no signals of increased reporting of spontaneous abortion with alirocumab and evolocumab compared with the full database and statins in VigiBase®. Notwithstanding, lack of disproportionality is not synonymous with safety and, as disproportionality analyses depend on the number of safety reports that progressively accumulate in VigiBase®, they should be repeated at regular intervals to confirm the results of the present study. [ABSTRACT FROM AUTHOR]
Published: 2024
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29. Clinical effects of cannabis compared to synthetic cannabinoid receptor agonists (SCRAs): a retrospective cohort study of presentations with acute toxicity to European hospitals between 2013 and 2020.

Author: Waters, Mitchell L., Dargan, Paul I., Yates, Christopher, Dines, Alison M., Eyer, Florian, Giraudon, Isabelle, Heyerdahl, Fridtjof, Hovda, Knut Erik, Liechti, Matthias E., Miró, Òscar, Vallersnes, Odd Martin, Anseeuw, Kurt, Badaras, Robertas, Bitel, Marcin, Bonnici, Jeffrey, Brvar, Miran, Caganova, Blazena, Calýskan, Feriyde, Ceschi, Alessandro, and Chamoun, Karam
Subjects: CANNABINOID receptors, SYNTHETIC receptors, ACUTE toxicity testing, EMERGENCY room visits, SYNTHETIC marijuana, WEEDS
Abstract: Cannabis is the most common recreational drug worldwide and synthetic cannabinoid receptor agonists are currently the largest group of new psychoactive substances. The aim of this study was to compare the clinical features and outcomes of lone acute cannabis toxicity with lone acute synthetic cannabinoid receptor agonist toxicity in a large series of presentations to European emergency departments between 2013-2020. Self-reported drug exposure, clinical, and outcome data were extracted from the European Drug Emergencies Network Plus which is a surveillance network that records data on drug-related emergency department presentations to 36 centres in 24 European countries. Cannabis exposure was considered the control in all analyses. To compare the lone cannabis and lone synthetic cannabinoid receptor agonist groups, univariate analysis using chi squared testing was used for categorical variables and non-parametric Mann-Whitney U- testing for continuous variables. Statistical significance was defined as a P value of <0.05. Between 2013-2020 there were 54,314 drug related presentations of which 2,657 were lone cannabis exposures and 503 lone synthetic cannabinoid receptor agonist exposures. Synthetic cannabinoid receptor agonist presentations had statistically significantly higher rates of drowsiness, coma, agitation, seizures and bradycardia at the time of presentation. Cannabis presentations were significantly more likely to have palpitations, chest pain, hypertension, tachycardia, anxiety, vomiting and headache. Emergency department presentations involving lone synthetic cannabinoid receptor agonist exposures were more likely to have neuropsychiatric features and be admitted to a psychiatric ward, and lone cannabis exposures were more likely to have cardiovascular features. Previous studies have shown variability in the acute toxicity of synthetic cannabinoid receptor agonists compared with cannabis but there is little comparative data available on lone exposures. There is limited direct comparison in the current literature between lone synthetic cannabinoid receptor agonist and lone cannabis exposure, with only two previous poison centre series and two clinical series. Whilst this study is limited by self-report being used to identify the drug(s) involved in the presentations, previous studies have demonstrated that self-report is reliable in emergency department presentations with acute drug toxicity. This study directly compares presentations with acute drug toxicity related to the lone use of cannabis or synthetic cannabinoid receptor agonists. It supports previous findings of increased neuropsychiatric toxicity from synthetic cannabinoid receptor agonists compared to cannabis and provides further data on cardiovascular toxicity in lone cannabis use. [ABSTRACT FROM AUTHOR]
Published: 2024
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30. Multifaceted intervention to curb in-hospital over-prescription of proton pump inhibitors: A longitudinal multicenter quasi-experimental before-and-after study

Author: Del Giorno, Rosaria, Ceschi, Alessandro, Pironi, Michela, Zasa, Anna, Greco, Angela, and Gabutti, Luca
Published: 2018
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31. Immune Checkpoint Inhibitor-Related Cytokine Release Syndrome: Analysis of WHO Global Pharmacovigilance Database

Author: Alessandro Ceschi, Roberta Noseda, Karine Palin, and Katia Verhamme
Subjects: immune checkpoint inhibitors, cytokine release syndrome, VigiBase, adverse drug reaction, pharmacovigilance, Therapeutics. Pharmacology, RM1-950
Abstract: Immune checkpoint inhibitors (ICIs) have proven effective in the treatment of numerous cancers; however, they have been associated with immune-related adverse events (irAEs), among which cytokine release syndrome (CRS) has been reported in a few case reports. To describe the burden of ICI-related CRS and raise awareness of CRS as irAE, we queried VigiBase, the World Health Organization global database of spontaneously reported suspected adverse drug reactions (ADRs), and retrieved safety reports of suspected CRS associated with ICIs, gathered in the database through January 12th 2020. We assessed ICI-related CRS safety reports in terms of geographical and temporal patterns of reporting, patient demographics and clinical features, treatment characteristics, CRS clinical presentation, timing, seriousness, and outcome. We retrieved 58 cases of whom 43 (74%) reported CRS with anti-programmed death-1/anti-programmed death-ligand 1 agents. Melanoma (n=17, 29%) and hematologic malignancies (n=16, 28%) were the most common underlying cancers. ICIs were the solely suspected drugs in 37 (64%) cases. Typical signs and symptoms of CRS were reported in 25 (43%) patients. ICI-related CRS developed a median of 4 weeks after ICI initiation (IQR 1–18 weeks, n=9, 16%). Besides two fatal cases, CRS recovered/was recovering at the time of reporting in 35 (60%) cases. We observed differences in the geographical pattern of ICI-related CRS reporting, with a high proportion of ICI-related CRS cases in Australia and North America (0.14 and 0.10% respectively). Due to ICI expanding indications, clinicians should be aware that ICIs could contribute to CRS onset in cancer patients as pharmacological triggers.
Published: 2020
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32. Self-discharge during treatment for acute recreational drug toxicity: an observational study from emergency departments in seven European countries

Author: Vallersnes, Odd Martin, primary, Dines, Alison M., additional, Wood, David M., additional, Heyerdahl, Fridtjof, additional, Hovda, Knut Erik, additional, Yates, Christopher, additional, Giraudon, Isabelle, additional, Caganova, Blazena, additional, Ceschi, Alessandro, additional, Galicia, Miguel, additional, Liakoni, Evangelia, additional, Liechti, Matthias E., additional, Miró, Òscar, additional, Noseda, Roberta, additional, Persett, Per Sverre, additional, Põld, Kristiina, additional, Schmid, Yasmin, additional, Scholz, Irene, additional, Vigorita, Federico, additional, and Dargan, Paul I., additional
Published: 2023
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33. Validation of sTREM-1 and IL-6 based algorithms for outcome prediction of COVID-19

Author: Van Singer, Mathias, primary, Brahier, Thomas, additional, Koch, Jana, additional, Hugli, Pr. Olivier, additional, Weckman, Andrea M., additional, Zhong, Kathleen, additional, Kain, Taylor J., additional, Leligdowicz, Aleksandra, additional, Bernasconi, Enos, additional, Ceschi, Alessandro, additional, Parolari, Sara, additional, Vuichard-Gysin, Danielle, additional, Kain, Kevin C., additional, Albrich, Werner C., additional, and Boillat-Blanco, Noémie, additional
Published: 2023
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34. Evaluation of the safety profile of rotavirus vaccines: a pharmacovigilance analysis on American and European data

Author: Bonaldo, Giulia, Noseda, Roberta, Ceschi, Alessandro, Vaccheri, Alberto, and Motola, Domenico
Published: 2020
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35. Reporting of Acute Inflammatory Neuropathies with COVID-19 Vaccines: Subgroup Disproportionality Analyses in VigiBase

Author: Roberta Noseda, Paolo Ripellino, Sara Ghidossi, Raffaela Bertoli, and Alessandro Ceschi
Subjects: acute inflammatory neuropathy, COVID-19 vaccines, VigiBase, safety, disproportionality, Medicine
Abstract: Since marketing authorization, cases of neuralgic amyotrophy (NA), facial paralysis/Bell’s palsy (FP/BP), and Guillain-Barré syndrome (GBS) were reported with COVID-19 vaccines of different technologies. This study aimed to assess whether NA, FP/BP, and GBS were more frequently reported in VigiBase with COVID-19 vaccines (of any technologies) than with other viral vaccines, over the full database and across potential risk groups by sex and age. The reporting odds ratio (ROR) with 95% confidence interval (95% CI) was used as the measure of disproportionality and subgroup disproportionality analyses were performed by sex and age. Out of 808,906 safety reports with COVID-19 vaccines, 57 (0.01%) reported NA, 3320 (0.4%) FP/BP, and 632 (0.1%) GBS. There were not signals of disproportionate reporting for NA and GBS with COVID-19 vaccines against other viral vaccines. FP/BP was disproportionately more frequently reported with COVID-19 vaccines than with other viral vaccines over the full database (ROR 1.12, 95%CI 1.07–1.17), in males (ROR 1.65, 95%CI 1.54–1.78) and in age subgroups 65–74 years (ROR 1.21, 95%CI 1.05–1.39) and ≥75 years (ROR 1.84, 95%CI 1.52–2.22). Albeit not proving causation, these findings might support clinicians in decision-making for patients potentially at risk for developing an acute inflammatory neuropathy with COVID-19 vaccines.
Published: 2021
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36. Reconsidering clinical pharmacology frameworks as a necessary strategy for improving the health care of patients: a systematic review

Author: Grisafi, Davide, Ceschi, Alessandro, Sava, Gianni, Avalos Clerici, Veronica, and Scaglione, Francesco
Published: 2018
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37. Chronic conditions and multimorbidity in a primary care population: a study in the Swiss Sentinel Surveillance Network (Sentinella)

Author: Gnädinger, Markus, Herzig, Lilli, Ceschi, Alessandro, Conen, Dieter, Staehelin, Alfred, Zoller, Marco, and Puhan, Milo A.
Published: 2018
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38. Haemophagocytic lymphohistiocytosis in patients treated with immune checkpoint inhibitors: analysis of WHO global database of individual case safety reports

Author: Alessandro Ceschi, Roberta Noseda, Raffaela Bertoli, and Laura Müller
Subjects: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract: Background Immune checkpoint inhibitor (ICI) use in clinical practice has unravelled a spectrum of immune-related adverse events (irAEs) due to immune system hyper-activation. ICI-related haemophagocytic lymphohistiocytosis (HLH) has been recently outlined in single case reports, raising a concern about the need of increasing our knowledge on this rare yet life threatening ICI haematological toxicity.Methods To determine ICI-related HLH clinical, haematological, and coagulation features, its timing and outcome, concurrent irAEs and concomitant infections, we performed a retrospective observational cross-sectional study and queried VigiBase, the WHO global database of suspected adverse drug reactions (ADRs), on September 30th, 2018. We retrieved the individual case safety reports reporting HLH in association with ipilimumab, nivolumab, pembrolizumab, atezolizumab, avelumab or durvalumab, gathered in the database starting from the ICIs’ approval dates by the US Food and Drug Administration. The main outcome measures were co-suspected drugs, concurrent irAEs, HLH clinical, haematological and coagulation features, concomitant infections, HLH median time to onset and outcome.Results Among 49′883 ICI-related ADRs collated in VigiBase as of September 30th, 2018, HLH was reported in 38 cases of which 34 (90%) mentioned ICIs as the solely suspected drugs. ICI-related HLH showed clinical, haematological and coagulation features similar to those of HLH with different etiology. Concurrent irAEs occurred in 5 (13%) patients and 6 (16%) reported concomitant viral infections. 31 (82%) cases defined ICI-related HLH outcome, which resolved in 19 (61%) cases. HLH developed a median of 6.7 weeks after initiation of ICI treatment (IQR 2.9–15.4, n = 18, 47%).Conclusions By evaluating the largest cohort of ICI-related HLH cases, we observed that ICI-related HLH arises with a delayed timing with respect to initiation of ICI treatment, and usually presents without other irAEs and concomitant infections. Keeping in mind these findings, clinicians should consider ICIs’ involvement in the onset of HLH whenever they diagnose a disease of this group of syndromes in cancer patients treated with ICIs.
Published: 2019
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39. ACE2-binding exposes the SARS-CoV-2 fusion peptide to broadly neutralizing coronavirus antibodies

Author: Jun Siong Low, Josipa Jerak, M. Alejandra Tortorici, Matthew McCallum, Dora Pinto, Antonino Cassotta, Mathilde Foglierini, Federico Mele, Rana Abdelnabi, Birgit Weynand, Julia Noack, Martin Montiel-Ruiz, Siro Bianchi, Fabio Benigni, Nicole Sprugasci, Anshu Joshi, John E. Bowen, Cameron Stewart, Megi Rexhepaj, Alexandra C. Walls, David Jarrossay, Diego Morone, Philipp Paparoditis, Christian Garzoni, Paolo Ferrari, Alessandro Ceschi, Johan Neyts, Lisa A. Purcell, Gyorgy Snell, Davide Corti, Antonio Lanzavecchia, David Veesler, Federica Sallusto, University of Zurich, Low, Jun Siong, Veesler, David, and Sallusto, Federica
Subjects: 1000 Multidisciplinary, Multidisciplinary, SARS-CoV-2, Antibodies, Monoclonal, COVID-19, 610 Medicine & health, Antibodies, Viral, Antibodies, Neutralizing, 10199 Clinic for Clinical Pharmacology and Toxicology, Spike Glycoprotein, Coronavirus, Animals, Humans, Angiotensin-Converting Enzyme 2, Peptides, Broadly Neutralizing Antibodies, Protein Binding
Abstract: The coronavirus spike glycoprotein attaches to host receptors and mediates viral fusion. Using a broad screening approach, we isolated seven monoclonal antibodies (mAbs) that bind to all human-infecting coronavirus spike proteins from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immune donors. These mAbs recognize the fusion peptide and acquire affinity and breadth through somatic mutations. Despite targeting a conserved motif, only some mAbs show broad neutralizing activity in vitro against alpha- and betacoronaviruses, including animal coronaviruses WIV-1 and PDF-2180. Two selected mAbs also neutralize Omicron BA.1 and BA.2 authentic viruses and reduce viral burden and pathology in vivo. Structural and functional analyses showed that the fusion peptide-specific mAbs bound with different modalities to a cryptic epitope hidden in prefusion stabilized spike, which became exposed upon binding of angiotensin-converting enzyme 2 (ACE2) or ACE2-mimicking mAbs. ispartof: SCIENCE vol:377 issue:6607 pages:735-741 ispartof: location:United States status: published
Published: 2022
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40. Sex Differences in Outcomes of Intravenous Thrombolysis in Acute Ischemic Stroke Patients with Preadmission Use of Antiplatelets

Author: Noseda, R, Rea, F, Pagnamenta, A, Agazzi, P, Bianco, G, Sihabdeen, S, Seiffge, D, Michel, P, Nedeltchev, K, Bonati, L, Kägi, G, Niederhauser, J, Nyffeler, T, Luft, A, Wegener, S, Schelosky, L, Medlin, F, Rodic, B, Peters, N, Renaud, S, Mono, M, Carrera, E, Fischer, U, Ceschi, A, Cereda, C, Noseda, Roberta, Rea, Federico, Pagnamenta, Alberto, Agazzi, Pamela, Bianco, Giovanni, Sihabdeen, Shairin, Seiffge, David, Michel, Patrik, Nedeltchev, Krassen, Bonati, Leo, Kägi, Georg, Niederhauser, Julien, Nyffeler, Thomas, Luft, Andreas, Wegener, Susanne, Schelosky, Ludwig, Medlin, Friedrich, Rodic, Biljana, Peters, Nils, Renaud, Susanne, Mono, Marie-Luise, Carrera, Emmanuel, Fischer, Urs, Ceschi, Alessandro, Cereda, Carlo Walter, Noseda, R, Rea, F, Pagnamenta, A, Agazzi, P, Bianco, G, Sihabdeen, S, Seiffge, D, Michel, P, Nedeltchev, K, Bonati, L, Kägi, G, Niederhauser, J, Nyffeler, T, Luft, A, Wegener, S, Schelosky, L, Medlin, F, Rodic, B, Peters, N, Renaud, S, Mono, M, Carrera, E, Fischer, U, Ceschi, A, Cereda, C, Noseda, Roberta, Rea, Federico, Pagnamenta, Alberto, Agazzi, Pamela, Bianco, Giovanni, Sihabdeen, Shairin, Seiffge, David, Michel, Patrik, Nedeltchev, Krassen, Bonati, Leo, Kägi, Georg, Niederhauser, Julien, Nyffeler, Thomas, Luft, Andreas, Wegener, Susanne, Schelosky, Ludwig, Medlin, Friedrich, Rodic, Biljana, Peters, Nils, Renaud, Susanne, Mono, Marie-Luise, Carrera, Emmanuel, Fischer, Urs, Ceschi, Alessandro, and Cereda, Carlo Walter
Abstract: Aim: To compare safety and functional outcomes of intravenous thrombolysis (IVT) between females and males with acute ischaemic stroke (AIS) in relation to preadmission use of antiplatelets. Methods: Multicentre cohort study of patients admitted from 1 January 2014 to 31 January 2020 to hospitals participating in the Swiss Stroke Registry, presenting with AIS and receiving IVT. Primary safety outcome was in-hospital symptomatic intracerebral haemorrhage (sICH). Primary functional outcome was functional independence at 3 months after discharge. Multivariable logistic regression models were fitted to assess the association between sex and each outcome according to preadmission use of antiplatelets. Results: The study included 4996 patients (42.51 % females, older than males, median age 79 vs 71 years, p < 0.0001). Comparable proportions of females (39.92 %) and males (40.39 %) used antiplatelets before admission (p = 0.74). In total, 3.06 % females and 2.47 % males developed in-hospital sICH (p = 0.19), with similar odds (adjusted odds ratio, [AOR] 0.93, 95 % confidence interval, [CI] 0.63–1.39). No interaction was found between sex and preadmission use of either single or dual antiplatelets in relation to in-hospital sICH (p = 0.94 and p = 0.23). Males had higher odds of functional independence at 3 months (AOR 1.34, 95 % CI 1.09–1.65), regardless of preadmission use of antiplatelets (interaction between sex and preadmission use of either single or dual antiplatelets p = 0.41 and p = 0.58). Conclusion: No sex differences were observed in the safety of IVT regarding preadmission use of antiplatelets. Males showed more favourable 3-month functional independence than females; however, this sex difference was apparently not explained by a sex-specific mechanism related to preadmission use of antiplatelets.
Published: 2023

41. Safety profile of monoclonal antibodies targeting the calcitonin gene-related peptide system in pregnancy: Updated analysis in VigiBase®

Author: Noseda, Roberta; https://orcid.org/0000-0002-4946-7926, Bedussi, Francesca, Gobbi, Claudio; https://orcid.org/0000-0002-7554-0664, Ceschi, Alessandro; https://orcid.org/0000-0002-4308-0405, Zecca, Chiara; https://orcid.org/0000-0002-9990-3431, Noseda, Roberta; https://orcid.org/0000-0002-4946-7926, Bedussi, Francesca, Gobbi, Claudio; https://orcid.org/0000-0002-7554-0664, Ceschi, Alessandro; https://orcid.org/0000-0002-4308-0405, and Zecca, Chiara; https://orcid.org/0000-0002-9990-3431
Abstract: Background: Safety data on the use of migraine preventive monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) system in pregnancy are limited. Methods: Updated pharmacovigilance assessment of the safety reports related to pregnancy associated with erenumab, galcanezumab, fremanezumab and eptinezumab, retrieved from VigiBase® as of 31 December 2021. As primary outcome, the whole group of monoclonal antibodies targeting the CGRP system was considered and sex and age subgroup disproportionality analyses using the reporting odds ratio (ROR) were conducted. Results: 286 safety reports were found: 116 (40.6%) on erenumab, 125 (43.7%) on galcanezumab, 39 (13.6%) on fremanezumab, 6 (2.1%) on eptinezumab. One hundred and forty-nine (52.1%) safety reports reported only drug exposure in relation to pregnancy while 137 (47.9%) also included ≥1 pregnancy outcomes: maternal outcomes (n = 64), spontaneous abortion (n = 63), foetal growth restriction (n = 1), prematurity (n = 8), neonatal outcomes (n = 13), and poor breastfeeding (n = 1). No specific patterns of maternal, foetal and neonatal toxicity were observed. Spontaneous abortion was not disproportionally more frequently reported with erenumab, galcanezumab, fremanezumab and eptinezumab compared with the entire database (ROR 1.1, 95% confidence interval, CI, 0.8–1.5), the entire database since 2018 (ROR 1.3, 95% CI 1.0–1.8), and triptans (ROR 1.2, 95% CI 0.8–1.9). Conclusions: This updated safety analysis on erenumab, galcanezumab, fremanezumab and eptinezumab in pregnancy showed no signals of foeto-maternal toxicity according to VigiBase® safety reports.
Published: 2023

42. Maturation of SARS-CoV-2 Spike-specific memory B cells drives resilience to viral escape

Author: Marzi, Roberta; https://orcid.org/0000-0001-6025-6735, Bassi, Jessica; https://orcid.org/0000-0002-4723-6892, Silacci-Fregni, Chiara, Bartha, Istvan; https://orcid.org/0000-0003-3360-1999, Muoio, Francesco; https://orcid.org/0000-0003-4963-8665, Culap, Katja; https://orcid.org/0000-0002-0956-0018, Sprugasci, Nicole; https://orcid.org/0000-0003-3258-5552, Lombardo, Gloria, Saliba, Christian; https://orcid.org/0000-0003-0100-6976, Cameroni, Elisabetta, Cassotta, Antonino; https://orcid.org/0000-0001-8674-4294, Low, Jun Siong; https://orcid.org/0000-0002-1775-0778, Walls, Alexandra C; https://orcid.org/0000-0002-9636-8330, McCallum, Matthew; https://orcid.org/0000-0001-8398-8330, Tortorici, M Alejandra; https://orcid.org/0000-0002-2260-2577, Bowen, John E; https://orcid.org/0000-0003-3590-9727, Dellota, Exequiel A, Dillen, Josh R, Czudnochowski, Nadine; https://orcid.org/0000-0002-3146-4110, Pertusini, Laura, Terrot, Tatiana, Lepori, Valentino, Tarkowski, Maciej, Riva, Agostino, Biggiogero, Maira, Franzetti-Pellanda, Alessandra, Garzoni, Christian, Ferrari, Paolo; https://orcid.org/0000-0002-9619-3104, Ceschi, Alessandro; https://orcid.org/0000-0002-4308-0405, Giannini, Olivier, et al, Marzi, Roberta; https://orcid.org/0000-0001-6025-6735, Bassi, Jessica; https://orcid.org/0000-0002-4723-6892, Silacci-Fregni, Chiara, Bartha, Istvan; https://orcid.org/0000-0003-3360-1999, Muoio, Francesco; https://orcid.org/0000-0003-4963-8665, Culap, Katja; https://orcid.org/0000-0002-0956-0018, Sprugasci, Nicole; https://orcid.org/0000-0003-3258-5552, Lombardo, Gloria, Saliba, Christian; https://orcid.org/0000-0003-0100-6976, Cameroni, Elisabetta, Cassotta, Antonino; https://orcid.org/0000-0001-8674-4294, Low, Jun Siong; https://orcid.org/0000-0002-1775-0778, Walls, Alexandra C; https://orcid.org/0000-0002-9636-8330, McCallum, Matthew; https://orcid.org/0000-0001-8398-8330, Tortorici, M Alejandra; https://orcid.org/0000-0002-2260-2577, Bowen, John E; https://orcid.org/0000-0003-3590-9727, Dellota, Exequiel A, Dillen, Josh R, Czudnochowski, Nadine; https://orcid.org/0000-0002-3146-4110, Pertusini, Laura, Terrot, Tatiana, Lepori, Valentino, Tarkowski, Maciej, Riva, Agostino, Biggiogero, Maira, Franzetti-Pellanda, Alessandra, Garzoni, Christian, Ferrari, Paolo; https://orcid.org/0000-0002-9619-3104, Ceschi, Alessandro; https://orcid.org/0000-0002-4308-0405, Giannini, Olivier, and et al
Published: 2023

43. Determinants of Admission to Critical Care Following Acute Recreational Drug Toxicity: A Euro-DEN Plus Study

Author: Noseda, Roberta; https://orcid.org/0000-0002-4946-7926, Franchi, Matteo; https://orcid.org/0000-0001-9620-8057, Pagnamenta, Alberto, Müller, Laura, Dines, Alison M, Giraudon, Isabelle, Heyerdahl, Fridtjof; https://orcid.org/0000-0001-9602-4370, Eyer, Florian; https://orcid.org/0000-0002-4753-2747, Hovda, Knut Erik; https://orcid.org/0000-0001-6341-8699, Liechti, Matthias E; https://orcid.org/0000-0002-1765-9659, Miró, Òscar, Vallersnes, Odd Martin; https://orcid.org/0000-0003-1213-392X, Yates, Christopher, Dargan, Paul I, Wood, David M, Ceschi, Alessandro; https://orcid.org/0000-0002-4308-0405, Noseda, Roberta; https://orcid.org/0000-0002-4946-7926, Franchi, Matteo; https://orcid.org/0000-0001-9620-8057, Pagnamenta, Alberto, Müller, Laura, Dines, Alison M, Giraudon, Isabelle, Heyerdahl, Fridtjof; https://orcid.org/0000-0001-9602-4370, Eyer, Florian; https://orcid.org/0000-0002-4753-2747, Hovda, Knut Erik; https://orcid.org/0000-0001-6341-8699, Liechti, Matthias E; https://orcid.org/0000-0002-1765-9659, Miró, Òscar, Vallersnes, Odd Martin; https://orcid.org/0000-0003-1213-392X, Yates, Christopher, Dargan, Paul I, Wood, David M, and Ceschi, Alessandro; https://orcid.org/0000-0002-4308-0405
Abstract: This study aimed to characterize patients admitted to critical care following Emergency Department (ED) presentation with acute recreational drug toxicity and to identify determinants of admission to critical care. A retrospective multicenter matched case-control study was conducted by the European Drug Emergency Network Plus (Euro-DEN Plus) over the period 2014–2021. The cases were ED presentations with acute recreational drug toxicity admitted to critical care, the controls consisted of ED presentations with acute recreational drug toxicity medically discharged directly from the ED. The potential determinants of admission to critical care were assessed through multivariable conditional stepwise logistic regression analysis and multiple imputation was used to account for the missing data. From 2014 to 2021, 3448 Euro-DEN Plus presentations involved patients admitted to critical care (76.9% males; mean age 33.2 years; SD 10.9 years). Patient age ≥35 years (as compared to ≤18 years) was a determinant of admission to critical care following acute recreational drug toxicity (adjusted odds ratio, aOR, 1.51, 95% confidence interval, CI, 1.15–1.99), along with polydrug use (aOR 1.39, 95% CI 1.22–1.59), ethanol co-ingestion (aOR 1.44, 95% CI 1.26–1.64), and the use of gamma-hydroxybutyrate/gamma-butyrolactone (GHB/GBL, aOR 3.08, 95% CI 2.66–3.57). Conversely, lower odds of admission to critical care were associated with the use of cocaine (aOR 0.85, 95% CI 0.74–0.99), cannabis (aOR 0.44, 95% CI 0.37–0.52), heroin (aOR 0.80, 95% CI 0.69–0.93), and amphetamine (aOR 0.65, 95% CI 0.54–0.78), as was the arrival to the ED during the night (8 p.m.–8 a.m., aOR 0.88, 95% CI 0.79–0.98). These findings, which deserve confirmation and further investigation, could contribute to a more complete understanding of the decision-making process underlying the admission to critical care of patients with acute recreational drug toxicity.
Published: 2023

44. Calcitonin gene-related peptide antagonists in pregnancy: a disproportionality analysis in VigiBase®.

Author: Noseda, Roberta, Bedussi, Francesca, Gobbi, Claudio, Ceschi, Alessandro, and Zecca, Chiara
Subjects: DATABASES, CONFIDENCE intervals, NEUROPEPTIDES, PHARMACOLOGY, CALCITONIN, PREGNANCY outcomes, DESCRIPTIVE statistics, SEROTONIN receptors, ODDS ratio, PATIENT safety, CHEMICAL inhibitors, PREGNANCY
Abstract: Background: Current evidence on the safety of calcitonin gene–related peptide antagonists (CGRP-A) in pregnancy for the treatment of both episodic and chronic migraine is scarce and does not yet provide definitive information. By querying VigiBase®, the World Health Organization global pharmacovigilance database, this study aimed to detect differences in the reporting frequency between CGRP-A and triptans in relation to pregnancy. Methods: Disproportionality analyses on de-duplicated safety reports collected in VigiBase® as of 31.05.2023 reporting exposure to CGRP-A in pregnancy with or without pregnancy outcomes. A Reporting Odds Ratio (ROR) with a 95% confidence interval (CI) was used as a measure of disproportionality and the threshold for the detection of a signal of disproportionate reporting was set with a 95% CI lower limit > 1. Findings: Four hundred sixty-seven safety reports reported exposure to CGRP-A in pregnancy, mostly originating from the United States of America (360/467, 77%), more frequently reported by patients (225/467, 48%), who were mainly females (431/467, 92%), and more frequently reported exposure to CGRP-A during pregnancy (400/467, 86%). Compared to triptans, no signals of disproportionate reporting were detected with CGRP-A either for the overall reporting of pregnancy-related safety reports (ROR 0.91, 95% CI 0.78–1.06), for the reporting of pregnancy outcomes (maternal and/or foetal/neonatal, ROR 0.54, 95% CI 0.45–0.66), or for the reporting of foetal/neonatal outcomes (ROR 0.53, 95% CI 0.41–0.68). Conclusions: This study showed that, to date, there are no signals of increased reporting with CGRP-A compared to triptans in relation to pregnancy in VigiBase®. Future pharmacovigilance studies are needed to confirm these findings. [ABSTRACT FROM AUTHOR]
Published: 2024
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45. Safety profile of monoclonal antibodies targeting the calcitonin gene-related peptide system in pregnancy: Updated analysis in VigiBase®

Author: Noseda, Roberta, primary, Bedussi, Francesca, additional, Gobbi, Claudio, additional, Ceschi, Alessandro, additional, and Zecca, Chiara, additional
Published: 2023
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46. Four cases of audio-vestibular disorders related to immunisation with SARS-CoV-2 mRNA vaccines

Author: Pierre Ekobena, Laura E. Rothuizen, Francesca Bedussi, Pierre Guilcher, Sylvain Meylan, Alessandro Ceschi, François Girardin, and Kim Dao
Subjects: Speech and Hearing, Linguistics and Language, Humans, SARS-CoV-2/genetics, COVID-19 Vaccines/adverse effects, BNT162 Vaccine, COVID-19/prevention & control, Immunization, Vestibular Diseases/etiology, Vestibular Diseases/genetics, Deafness, RNA, Messenger, Adverse event, COVID-19 mRNA vaccines, hearing loss, immunisation, sensorineural, vestibular neuritis, otorhinolaryngologic diseases, Language and Linguistics
Abstract: To gain medical insight into the clinical course and safety of otolaryngologic disorders following immunisation with severe acute respiratory coronavirus (SARS-CoV-2) mRNA-based vaccines. Case description. We report four cases of transient audio-vestibular symptoms, which occurred shortly after inoculation of two BNT162b2 (Pfizer-BioNTech ® ) and mRNA-1273 (Moderna®) vaccines. Hearing loss was unilateral in all cases and recovered at least partially: it was associated with persistent gait instability in two cases, after 1 and 7 months. Trigger mechanisms underpinning audio-vestibular impairment remain uncertain. Immune tolerance mechanisms with off-target innate activation of T-lymphocytes may be involved in vestibulocochlear nerve disorders, as for other cranial nerves involvement. The occurrence of audio-vestibular manifestations following mRNA-based vaccines needs ENT monitoring to support their causality in such rare vaccine-related adverse events. Audio-vestibular disorders appeared of transitory nature, including hearing loss, and should not deter further efforts in large-scale vaccination campaigns against SARS-CoV-2.
Published: 2022
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47. Lifestyle factors, psychiatric and neurologic comorbidities, and drug use associated with incident seizures among adult patients with depression: a population-based nested case—control study

Author: Bloechliger, Marlene, Ceschi, Alessandro, Rüegg, Stephan, Jick, Susan Sara, Meier, Christoph Rudolf, and Bodmer, Michael
Published: 2016

48. Safety of monoclonal antibodies targeting PCSK9 in pregnancy: Analysis of the WHO's global pharmacovigilance database

Author: Noseda, Roberta, Bedussi, Francesca, Panchaud, Alice, and Ceschi, Alessandro
Published: 2023
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49. Therapeutic and vaccine-induced cross-reactive antibodies with effector function against emerging Omicron variants

Author: Amin Addetia, Luca Piccoli, James Brett Case, Young-Jun Park, Martina Beltramello, Barbara Guarino, Ha Dang, Dora Pinto, Suzanne M. Scheaffer, Kaitlin Sprouse, Jessica Bassi, Chiara Silacci-Fregni, Francesco Muoio, Marco Dini, Lucia Vincenzetti, Rima Acosta, Daisy Johnson, Sambhavi Subramanian, Christian Saliba, Martina Giurdanella, Gloria Lombardo, Giada Leoni, Katja Culap, Carley McAlister, Anushka Rajesh, Exequiel Dellota, Jiayi Zhou, Nisar Farhat, Dana Bohan, Julia Noack, Florian A. Lempp, Elisabetta Cameroni, Bradley Whitener, Olivier Giannini, Alessandro Ceschi, Paolo Ferrari, Alessandra Franzetti-Pellanda, Maira Biggiogero, Christian Garzoni, Stephanie Zappi, Luca Bernasconi, Min Jeong Kim, Gretja Schnell, Nadine Czudnochowski, Nicholas Franko, Jennifer K. Logue, Courtney Yoshiyama, Cameron Stewart, Helen Chu, Michael A. Schmid, Lisa A. Purcell, Gyorgy Snell, Antonio Lanzavecchia, Michael S. Diamond, Davide Corti, and David Veesler
Subjects: Article
Abstract: Currently circulating SARS-CoV-2 variants acquired convergent mutations at receptor-binding domain (RBD) hot spots1. Their impact on viral infection, transmission, and efficacy of vaccines and therapeutics remains poorly understood. Here, we demonstrate that recently emerged BQ.1.1. and XBB.1 variants bind ACE2 with high affinity and promote membrane fusion more efficiently than earlier Omicron variants. Structures of the BQ.1.1 and XBB.1 RBDs bound to human ACE2 and S309 Fab (sotrovimab parent) explain the altered ACE2 recognition and preserved antibody binding through conformational selection. We show that sotrovimab binds avidly to all Omicron variants, promotes Fc-dependent effector functions and protects mice challenged with BQ.1.1, the variant displaying the greatest loss of neutralization. Moreover, in several donors vaccine-elicited plasma antibodies cross-react with and trigger effector functions against Omicron variants despite reduced neutralizing activity. Cross-reactive RBD-directed human memory B cells remained dominant even after two exposures to Omicron spikes, underscoring persistent immune imprinting. Our findings suggest that this previously overlooked class of cross-reactive antibodies, exemplified by S309, may contribute to protection against disease caused by emerging variants through elicitation of effector functions.
Published: 2023

50. sj-pdf-3-cep-10.1177_03331024231158083 - Supplemental material for Safety profile of monoclonal antibodies targeting the calcitonin gene-related peptide system in pregnancy: Updated analysis in VigiBase®

Author: Noseda, Roberta, Bedussi, Francesca, Gobbi, Claudio, Ceschi, Alessandro, and Zecca, Chiara
Subjects: FOS: Psychology, FOS: Clinical medicine, 170199 Psychology not elsewhere classified, 110319 Psychiatry (incl. Psychotherapy), 110306 Endocrinology, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 110904 Neurology and Neuromuscular Diseases, Neuroscience
Abstract: Supplemental material, sj-pdf-3-cep-10.1177_03331024231158083 for Safety profile of monoclonal antibodies targeting the calcitonin gene-related peptide system in pregnancy: Updated analysis in VigiBase® by Roberta Noseda, Francesca Bedussi, Claudio Gobbi, Alessandro Ceschi and Chiara Zecca in Cephalalgia
Published: 2023
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