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1. Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults

Author

Thomas Barbour, Marie Scully, Gema Ariceta, Spero Cataland, Katherine Garlo, Nils Heyne, Yosu Luque, Jan Menne, Yoshitaka Miyakawa, Sung-Soo Yoon, David Kavanagh, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Josep M. Campistol, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Eric Rondeau, Hermann Haller, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, and Edwin K.S. Wong

Subjects
atypical hemolytic uremic syndrome, complement, hemolytic uremic syndrome, kidney failure, ravulizumab, thrombotic microangiopathy, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Introduction: Atypical hemolytic uremic syndrome (aHUS) is a rare, complex, multisystem disease of dysregulated complement activity, characterized by progressive thrombotic microangiopathy (TMA), acute kidney injury, and multiorgan dysfunction, which often progresses to chronic kidney disease. Results from the prospective clinical trial of ravulizumab (NCT02949128) reveal rapid resolution of TMA in patients with aHUS, with sustained efficacy and safety in a 26-week initial evaluation period. Methods: The aim of this analysis was to characterize the long-term efficacy and the safety profile of ravulizumab in adults with aHUS who had completed the initial evaluation period of the trial. Complete TMA response, hematologic and kidney functions, and safety were evaluated for all patients available for follow-up in the extension period (median follow-up: 76.7 weeks; range: 0.6–118.3). This trial included a total of 58 patients, 49 of whom entered the extension period. Results: A total of 4 additional patients achieved complete TMA response during the follow-up period. Normalization of platelet count, serum lactate dehydrogenase (LDH), and hemoglobin observed in the 26-week initial evaluation period was sustained until the last available follow-up, as were the improvements in the estimated glomerular filtration rate (eGFR) and patient quality of life. All efficacy endpoints were correlated with the sustained inhibition of complement C5. Most adverse events (AEs) occurred early during the initial evaluation period and decreased substantially during the extension period. No patient developed a meningococcal infection or died during the extension period. Conclusion: This analysis reveals that ravulizumab administered every 8 weeks is efficacious with an acceptable safety profile for the long-term treatment of adults with aHUS and provides additional clinical benefit beyond 6 months of treatment.

Published
2021
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2. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

Author

Hiddo J L Heerspink, Jai Radhakrishnan, Charles E Alpers, Jonathan Barratt, Stewart Bieler, Ulysses Diva, Jula Inrig, Radko Komers, Alex Mercer, Irene L Noronha, Michelle N Rheault, William Rote, Brad Rovin, Howard Trachtman, Hernán Trimarchi, Muh Geot Wong, Vlado Perkovic, Eric Alarmartine, Dong Wan Chae, Lucia Del Vecchio, Jurgen Floege, Shang-Jyh Hwang, Bojan Jelakovic, Bart Maes, Robert Malecki, Marius Miglinas, Fernando Eduardo Barbosa Nolasco, Manual Praga, Kannaiyan Rabindranath, Mai Rosenberg, Sydney Chi Wai Tang, Vladmir Tesar, Bhadran Bose, Muralikrishna Gangadharan, Stephen McDonald, Chen Peh, Sadia Jahan, Chii Yeap, Philip Clayton, Georgina Irish, Nikhil Thyagarajan, Peter Hollett, Rathika Krishnasamy, Robert Carroll, Shilpanjali Jesudason, Susan Crail, Toby Coates, Jane Waugh, Euan Noble, Kumaradevan Mahadevan, Victoria Campbell, Tania Salehi, Wai Lim, Neil Boudville, Aron Chakera, Doris Chan, Anoushka Krishnan, Yusuf Eqbal, Alastair Gillies, Eswari Vilayur, Thida Maung Maung Myint, Nicholas Gray, Melissa Cheetham, Carol Pollock, Bruce Cooper, Amanda Mather, Sarah Roxburgh, Yvonne Shen, Stefanie Stangenberg, Amanda Siriwardana, Emma O'Lone, Susan Wan, Brendon Neuen, Jeffrey Tsun Kit Ha, Dana Kim, Lauren Heath, Arunima Jain, Elaine Phua, Yan Li, Martin Gallagher, Meg Jardine, Angus Ritchie, Mona Razavian, Celine Foote, Roger Wyndham, Shaundeep Sen, Zoltan Endre, Jonathan Erlich, Mangalee Fernando, Kenneth Yong, Grant Luxton, Sradha Kotwal, Simon Roger, Vidu Wijeratne, David Packham, Ian Fraser, Bert Vandewiele, Margo Laute, Wim Lemahieu, Sofie Jamar, Sara Ombelet, Gert Meeus, Marc Decupere, Olivier Schockaert, Peter Doubel, Liesbeth Viaene, Luc Radermacher, Catherine Masset, Martial Moonen, Eric Firre, Martina Milicevic, Xavier Warling, An Vanacker, Thomas Malfait, Ivan Durlen, Ivica Horvatic, Ana Savuk, Lana Gellineo, Sandra Karanovic, Zivka Dika, Djuro Plavljanic, Ivana Mikacic, Dubravka Trajbar Kentric, Dunja Barisic, Marija Stankovic, Karolina Majstorovic Barac, Ivan Kruljac, Drasko Pavlovic, Martin Drinkovic, Ingrid Prkacin, Jerko Barbic, Zvonimir Sitas, Dunja Vujcic, Ivan Rychlik, Anna Benesova, Klara Drinovska, Karolina Kratka, Dita Maixnerova, Madis Ilmoja, Kristin Unt, Kadri Lilienthal, Asta Auerbach, Liisi Leis, Julia Piel, Annika Adoberg, Kulli Kolvald, Kristi Veermae, Kadri Telling, Elviira Seppet, Jana Uhlinova, Philippe Zaoui, Pierre-Louis Carron, Ingrid Masson, Miriana Dinic, Damien Thibaudin, Christian Broyet, Nicolas Maillard, Hesham Mohey, Christophe Mariat, Guillaume Claisse, Eric Alamartine, Bertrand Dussol, Stephane Burtey, Noemie Chiche-Jourde, Jean-Emmanuel Serre, Guillaume Jeantet, Leila Chenine, Anne Blanchard, Stephane Roueff, Eric Thervet, David Fouassier, Alexandre Buffet, Marine Livrozet, Roxane Gaisset, Alexandre Karras, Anne-Elisabeth Heng, Cyril Garrouste, Carole Philipponnet, Clementine Nicolo, Alba Atenza, Camille Lanaret, Clarisse Greze, Valentin Mayet, Clement Dumond, Yahsou Delmas, Christian Combe, Claire Rigothier, Laure Burguet, Aurore Labat, Simon Mucha, Valérie de Précigout, Thomas Weinreich, Helmut Reichel, Diliana Draganova, Lothar Wolf, Bernd Hohenstein, Sven Heinrichs, Simone Kulka, Sebahat Sat, Lea Weiland, Thilo Krueger, Gunter Wolf, Christiane Kettner, Mandy Schlosser, Johann Konstantin Herfurth, Annegret Koch, Martin Busch, Stephan Christian Werth, Martin Nitschke, Figen Cakiroglu, Franziska Sarnow, Lisa Schulz, Stefan Weiner, Nikolaus Wirtz, Eric Koester, Marcus Moeller, Eleni Stamellou, Silja Sanden, Hans Schmidt-Guertler, Wanja Bernhardt, Margret Patecki, Georg Schlieper, Kevin Schulte, Annette Girardet, Ulrich Kunzendorf, Lorraine Pui Yuen Kwan, Maggie Ming Yee Mok, Gary Chi Wang Chan, Mingyao Ma, Davina Ngoi Wah Lie, Anthony Ting Pong Chan, Cheuk Chun Szeto, Kit Chung Jack Ng, Siu Fai Cheung, Tak Tai Andrew Yue, Ka Shun Samuel Fung, Hon Tang, Ka Fai Yim, Wai Ping Law, Yick Hei Wong, Chi Kwan Darwin Lam, Sze Ho Sunny Wong, Carmelita Marcantoni, Roberta Aliotta, Francesca Deodato, Gemma Patella, Nicolino Comi, Caterina Vita, Nazareno Carullo, Davide Bolignano, Michela Musolino, Matias Trillini, Norberto Perico, Giuseppe Remuzzi, Erica Daina, Luigi Biancone, Loredana Colla, Manuel Burdese, Chiara Cogno, Elena Boaglio, Isabella Abbasciano, Carlotta Federica Zizzi, Paolo Randone, Pietro Napodano, Anna Ricchiuto, Matthias Cassia, Simone Accarino, Mario Cozzolino, Rocco Baccaro, Stefano Costanzi, Federica Di Maio, Maria Arena, Federica Urciuolo, Sara Vigano, Andrea Cavalli, Monica Limardo, Monica Bordoli, Serena Ponti, Selena Longhi, Andrea Solazzo, Francesco Giaroni, Gabriele Donati, Massimo Torreggiani, Davide Catucci, Marco Colucci, Vittoria Esposito, Ciro Esposito, Loreto Gesualdo, Flavia Capaccio, Emma Diletta Stea, Carmen Sivo, Francesca Annese, Federica Papadia, Piergiorgio Messa, Mirco Belingheri, Patrizia Passerini, Silvia Malvica, Alvita Vickiene, Urte Zakauskiene, Egle Asakiene, Inga Arune Bumblyte', Asta Stankuviene, Lina Santockiene, Ashik Hayat, Allister Williams, Peter Sizeland, Eddie Tan, Gerald Waters, Lai Wan Chan, Andrew Henderson, Angus Turnbull, Andrew McNally, Annie Reynolds, Helen Pilmore, Ian Dittmer, Paul Manley, Elizabeth Stallworthy, Tze Goh, David Semple, Michael Collins, Elizabeth Curry, Jafar Ahmed, Thu Nguyen, Agata Winiarska, Justyna Zbrzezniak, Tomasz Stompor, Magdalena Krajewska, Hanna Augustyniak-Bartosik, Dorota Zielinska, Anna Jander, Malgorzata Stanczyk, Marcin Tkaczyk, Przemyslaw Miarka, Dariusz Aksamit, Piotr Jaskowski, Wladyslaw Sulowicz, Dominik Cieniawski, Julita Gontarek-Kacprzak, Elzbieta Felicjanczuk, Norbert Kwella, Bogna Kwella, Ewa Satora, João Carlos Fernandes, Ana Marta Gomes, Marina Reis, Daniela Lopes, Catarina Almeida, Helena Sá, Ana Carolina Figueiredo, Clara Pardinhas, Edgar Almeida, Mario Raimundo, Ana Cortesão Costa, Luis Pedro Falcao Goncalves, Sara Fernandes, Sónia Silva, Catarina Teixeira, Adriana Fernandes, Fernando Nolasco, Patricia Alves, Mario Gois, Nuno Fonseca, Ana Messias, Maria Menezes, Filipa Cardoso, Helena Sousa, Joana Marques, Rui Barata, Jose Antonio Lopes, Sofia Jorge, Joana Gameiro, Jose Nuno de Almeida Agapito Fonseca, Sara Goncalves, Ana Farinha, Patricia Valerio Santos, Ana Natario, Jose Carlos de Jesus Barreto, Catarina Abrantes, Elsa Sofia Quadrado Soares, Joana de Sousa Soares Felgueiras, Liliana Cunha, Lucia Parreira, Teresa Furtado, Alvaro Vaz, Kook-Hwan Oh, Hajeong Lee, Se Joong Kim, Jong Cheol Jeong, Yeong Hoon Kim, Yunmi Kim, Hyeong Cheon Park, Hoon Young Choi, Hyung Wook Kim, Moon Hyoung Lee, Songuk Yoon, Kyu-Beck Lee, YoungYoul Hyun, Tae-Hyun Yoo, Seung Hyeok Han, Jung Tak Park, Sunggyun Kim, Young Rim Song, Jwa-Kyung Kim, Hyung-seok Lee, Narae Joo, JungEun Lee, Hye Ryoun Jang, Junseok Jeon, Wookyung Chung, HyunHee Lee, Jae Hyun Chang, Ka Yeong Chun, Ji Yong Jung, Han Ro, Aejin Kim, Sang-Kyung Jo, Jihyun Yang, Myung-Gyu Kim, SeWon Oh, Caridad Martinez Villanueva, Ana Vilar Gimeno, Gustavo Andres Useche Bonilla, Esther Tamarit, Antonio Galan Serrano, Eduardo Verde Moreno, Jose Luño Fernandez, Maria Angeles Goicoechea Diezhandino, Ursula Verdalles Guzman, Ana Perez de Jose, Alberto Ortiz Arduan, María Vanessa Pérez Gómez, Catalina Martín Cleary, Raul Fernandez Prado, Elena Goma, Jose Ballarin, Montserrat Diaz Encarnacion, Iara Da Silva Santos, Helena Marco Rusinol, Monica Furlano, Carlos Arias, Clara Barrios, Eva Rodriguez Garcia, Adriana Sierra Ochoa, Belen Vizcaino Castillo, Jonay Pantoja Perez, Mercedes Gonzalez Moya, Mari Sargsyan, Emma Calatayud Aristoy, Ana Avila Bernabeu, Leticia Perez Lluna, Tamara Malek Marin, Maria Antonia Munar Vila, Ivon Maritza Bobadilla Rico, Natalia Allende Burgos, Eduardo Gutierrez Martinez, Elena Gutierrez Solis, Angel Sevillano, Evangelina Merida Herrero, Josep Miquel Blasco Pelicano, Lida Maria Rodas Marin, Luis F Quintana, Maria Antonieta Azancot Rivero, Natalia Ramos Terrades, Clara Garcia Carro, Irene Agraz Pamplona, Mercedes Salgueira Lazo, Francisco de la Prada Alvarez, Fabiola Alonso Garcia, Wenceslao Adrian Aguilera Morales, Salia Virxinia Pol Heres, Angel Forcen, Eduardo Parra Moncasi, Cristina Medrano Villarroya, Alejandro Soria Villen, Olga Gracia Garcia, Mercedes Velo Plaza, Maria Dolores Sánchez de la Nieta, Marta Calvo Arevalo, Antolina Moreno, Secundino Cigarran Guldris, Manuel Pereira de Vicente, Bang-Gee Hsu, Chih-Hsien Wang, Cheng-Hsu Chen, Tung-Min Yu, Ming-Ju Wu, Shang-Feng Tsai, Chia-Tien Hsu, Hsien-Fu Chiu, Kang-Ju Chou, Hua-Chang Fang, Po-Tsang Lee, Hsin-Yu Chen, Chien-Liang Chen, Chien-Wei Huang, Shih-Hsiang Ou, Tzung-Yo Ho, Chih-Yang Hsu, Ming-Shan Chang, Yen-Ling Chiu, Yu-Sen Peng, Kai-Hsiang Shu, Szu-Yu Pan, Shih-Ping Hsu, Ju-Yeh Yang, Mei-Fen Pai, Po-Yu Tseng, Hon-Yen Wu, Wan-Chuan Tsai, Kuei-Ting Tung, Hung-Yuan Chen, Hung-Chun Chen, Mei-Chuan Kuo, Daw-Yang Hwang, Yi-Wen Chiu, Chi-Chih Hung, Hung-Tien Kuo, Jer-Chia Tsai, Kieran McCafferty, Suzanne Forbes, Indranil Dasgupta, Mark Thomas, Amar Mahdi, Bamidele Ajayi, Paramit Chowdhury, Theodoros Kasimatis, Dimitrios Moutzouris, Caroline Dudreuilh, Rishi Pruthi, Nick Mansfield, Gabriel Doctor, Sapna Shah, Sui Kon, Priscilla Smith, Patrick Hamilton, Durga Kanigicherla, Omar Sherin Ibrahim Ragy, Bassam Alchi, Oliver Flossmann, Farid Ghalli, Sarah Lawman, Smeeta Sinha, Constantina Chrysochou, Chukwuma Chukwu, Aine Maire De Bhailis, Saif Al Chalabi, Amy Hudson, Arun Gopu, Olivia Wickens, Joshua Storrar, Mona Wahba, Nathan Lorde, Mohammad Rony, Sian Griffin, Farah Latif, Mohammad Ali, Louise DaSilva, Jonathan Ayling-Smith, Eamon Mahdi, Lisa Willcocks, Rachel Jones, Chee Kay Cheung, Haresh Selvaskandan, Dan Pugh, Matthew Sayer, Neeraj Dhaun, Fiona Chapman, Patrick Mark, Colin Geddes, Emily McQuarrie, Rajan Patel, Laurence Solomon, Arvind Ponnusamy, Adam Morris, Pedro Okoh, Lauren Floyd, Ajay Dhaygude, Janson Leung, Christopher Goldsmith, Bhavna Pandya, Didem Tez, Ashraf Mikhail, Karen Brown, Thomas Bucknall, Mark Lambie, Roderick Comunale, Donald Brandon, Stacy Martinez, Amanda Hall, Amy Henderson, Aaron Fearday, Nicole Douthit, Brian Snow, Arnold Silva, Cathylee Sly, Christopher Keller, Robert Davidson, Jerry Meng, Robert Haws, Siddhartha Kattamanchi, Javad Mojarrab, Unnikrishnan Pillai, Richard Lafayette, Michelle O'Shaughnessy, Fahameedah Kamal, Kshama Mehta, Bruce Baker, Mario Ruiz, Praveena Jyothinagaram, Usha Peri, William Paxton, James Tumlin, Kerri McGreal, Ellen McCarthy, Cassandra Kimber, Archana Gautam, Kassem Khalil, Viet Nguyen, Raffi Minasian, Dariush Arfaania, Sam Daneshvari, Michel Zakari, Artashes Patrikyan, Rouzbeh Afsari, Christine Ayvazyan, Faisal Fakih, Mark Lagatta, Alfred Rodriguez, Jorge Enrique Monroy Avella, Ramachandra Patak, Jigar Kadakia, Gerald Appel, Wooin Ahn, Bradley Nelson, Allyson Medina, Syeda Ahmad, Yonatan Peleg, Nisha Clement, Ian Chiu, Elizabeth Hendren, Andrew Bomback, Pietro Canetta, Bruce Spinowitz, Chaim Charytan, Nishita Parikh, Sheng Kuo, Ritesh Raichoudhury, Mirela Dobre, Lavinia Negrea, Aparna Padiyar, Arksarapuk Jittirat, Nishigandha Pradhan, Ranjit Dhelaria, Saravanan Balamuthusamy, Machaiah Madhrira, Thomas Powell, Howard Lifland, Asha Bailey, Sarah Ashley Ford Sightler, Meera Patel Suthar, Heather Green, Samir Parikh, Isabelle Ayoub, Salem Almaani, Gabriel Contreras, Alessia Fornoni, Yelena Drexler, Abdallah Geara, Brittany Sheridan, Gaia Coppock, Jonathan Hogan, Carlos Gonzalez, Shamik Bhadra, Pradip Chowdhury, Kay Kyaw, May Tan, Lathika Raakesh, Elder Mendoza, Veronica Viramontes, Asghar Chaudhry, Juan Carbonell, Rajdeep Gadh, Victor Fernandez, Mohamad Kassem, Radu Jacob, Karen Wilder, Britt Newsome, Kathryn Klamm, Irina Suyumova, Laura Ann Kooienga, Catherine Janko, Dana Rizk, Bruce Julian, Dawn Caster, Erika Perez, Gunjan Garg, Nayan Gowda, Suneel Udani, Sreedhar Mandayam, Biruh Workeneh, Ali Assefi, Barbara Greco, Michael Germain, Jusmin Patel, Sarah Quinn, James Sullivan, Jeffrey Glaze, Phillip Madonia, Kellyn McMahon, Harold Giles, Sharon Adler, and Tiane Dai

Subjects
General Medicine
Published
2023

3. Successful treatment of a Streptococcus pneumoniae-associated haemolytic uraemic syndrome by eculizumab

Author

Georges Mourad, Guillaume Jeantet, Vincent Brunot, Vincent Pernin, Kada Klouche, Arnaud Roccabianca, Chantal Loirat, Véronique Frémeaux-Bacchi, Moglie Le Quintrec, Ilan Szwarc, Anouk Macombe, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Néphrologie Dialyse Saint Guilhem (NDSG), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Service de néphrologie pédiatrique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Robert Debré-Université Paris Diderot - Paris 7 (UPD7), Hôpital Robert Debré, Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), MORNET, Dominique, and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)

Subjects
medicine.medical_specialty, Thrombotic microangiopathy, 030232 urology & nephrology, urologic and male genital diseases, medicine.disease_cause, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, haemolytic uraemic syndrome, hemic and lymphatic diseases, Internal medicine, Streptococcus pneumoniae, medicine, complement, Transplantation, biology, Streptococcus, business.industry, [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, Eculizumab, medicine.disease, Haemolysis, [SDV.MHEP.UN] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, female genital diseases and pregnancy complications, thrombotic microangiopathy, 3. Good health, Nephrology, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, biology.protein, eculizumab, [SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy, Antibody, Haemolytic-uraemic syndrome, Complication, business, medicine.drug
Abstract

International audience; Haemolytic uraemic syndrome (HUS) is a rare complication of invasive infection by Streptococcus pneumoniae (SP-HUS), especially in adults. Here we report an unusual case of a 53-year-old man presenting SP-HUS with severe multivisceral involvement. After failure of supportive care and plasma exchanges, eculizumab (anti-C5 antibody) resulted in a favourable outcome.

Published
2018
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4. Stricturing Crohn’s disease-like colitis in a patient treated with belatacept

Author

Guillaume Jeantet, Guillaume Pineton de Chambrun, Benjamin Rivière, Natalie Funakoshi, Jeanne Ramos, Moglie Le Quintrec, Sylvie Delmas, Jean Emmanuel Serre, Gaspard Dufour, Jean-Christophe Valats, Michael Bismuth, Roman Combes, Pierre Blanc, Anne Bozon, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), KARLI, Mélanie, and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)

Subjects
Crohn’s disease, Graft Rejection, Male, Case Report, Constriction, Pathologic, 030230 surgery, Gastroenterology, Inflammatory bowel disease, 0302 clinical medicine, Intestinal mucosa, CTLA-4 Antigen, Intestinal Mucosa, Kidney transplantation, Crohn's disease, Crohn\textquoterights disease, hemic and immune systems, Belatacept, General Medicine, Colonoscopy, Middle Aged, Colitis, 3. Good health, 030211 gastroenterology & hepatology, [SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy, Immunosuppressive Agents, medicine.drug, medicine.medical_specialty, medicine.drug_class, Colon, chemical and pharmacologic phenomena, Monoclonal antibody, HHV-6, Abatacept, 03 medical and health sciences, Internal medicine, medicine, Humans, Glucocorticoids, business.industry, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, medicine.disease, Kidney Transplantation, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Withholding Treatment, Kidney Failure, Chronic, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) modifying agents have been involved in the development of intestinal inflammation, especially therapeutic monoclonal antibodies directed against CTLA-4. Here we report the appearance of a severe stricturing Crohn's disease-like colitis in a patient with a kidney allograft who was treated with belatacept, a recombinant CTLA-4-Ig fusion protein.

Published
2017
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5. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment

Author

Sunil Babu, Guilia Antognoli, Elena Gutierréz, Yoshitaka Miyakawa, Moglie Le Quintrec, Jan Menne, David J. Kavanagh, Tatiana Kirsanova, Edwin K.S. Wong, Maria Vinogradova, Philip Campbell, Guillaume Favre, Michael Fischereder, Spero R. Cataland, Iino Fumie, Hermann Haller, Vladimir A. Dobronravov, Paramit Chowdhury, Guillaume Jeantet, Marie Scully, Sonia Boyer-Suavet, Thomas D. Barbour, Yosu Luque, Leonardo Caroti, Stephan Ortiz, Shashi K. Nagaraj, Cyril Garrouste, Masayoshi Okumi, Anja Gaeckler, Maria Cappuccilli, Chiu-Ching Huang, Anja Muhlfeld, Gema Ariceta, Gaetano La Manna, Eric Rondeau, Nils Heyne, Giorgia Comai, Natalia Ramos Terrada, Eric Goffin, Paola Rodriguez, Gregory Greenwood, Eugene Swenson, Barbara Seitz-Polski, Nilufer Broeders, Gowthami M. Arepally, Manuel Praga Terente, Marc Vallee, Johan Morelle, Siân V. Griffin, Nicole Lietar, Doyeun Oh, Theo Kasimatis, I-Ru Chen, Ulf Schönermarck, Susan Huang, Jin Seok Kim, Fiona G. Brown, François Provôt, Lino Cirami, Sung-Soo Yoon, Yahsou Delmas, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, Sorbonne Université (SU), The Ohio State University Press, and Hannover Medical School [Hannover] (MHH)

Subjects
0301 basic medicine, Adult, medicine.medical_specialty, Thrombotic microangiopathy, [SDV]Life Sciences [q-bio], 030232 urology & nephrology, Renal function, Antibodies, Monoclonal, Humanized, Gastroenterology, 03 medical and health sciences, Complement inhibitor, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Atypical hemolytic uremic syndrome, medicine, Clinical endpoint, Humans, complement, Adverse effect, Atypical Hemolytic Uremic Syndrome, Creatinine, business.industry, Thrombotic Microangiopathies, atypical hemolytic uremic syndrome, Complement System Proteins, Eculizumab, medicine.disease, ravulizumab, 3. Good health, thrombotic microangiopathy, 030104 developmental biology, Complement Inactivating Agents, chemistry, Nephrology, hemolytic uremic syndrome, eculizumab, business, medicine.drug
Abstract

Ravulizumab is a long-acting C5 inhibitor engineered from eculizumab with increased elimination half-life, allowing an extended dosing interval from two to eight weeks. Here we evaluate the efficacy and safety of ravulizumab in adults with atypical hemolytic uremic syndrome presenting with thrombotic microangiopathy. In this global, phase 3, single arm study in complement inhibitor-naive adults (18 years and older) who fulfilled diagnostic criteria for atypical hemolytic uremic syndrome, enrolled patients received ravulizumab through a 26-week initial evaluation period. The primary endpoint was complete thrombotic microangiopathy response defined as normalization of platelet count and lactate dehydrogenase and 25% or more improvement in serum creatinine. Secondary endpoints included changes in hematologic variables and renal function. Safety was also evaluated. Ravulizumab treatment resulted in an immediate, complete, and sustained C5 inhibition in all patients. Complete thrombotic microangiopathy response was achieved in 53.6% of patients. Normalization of platelet count, lactate dehydrogenase and 25% or more improvement in serum creatinine was achieved in 83.9%, 76.8% and 58.9% of patients, respectively. Improvement in estimated glomerular filtration rate by one or more stage was achieved in 68.1% of patients by day 183. No unexpected adverse events were reported across a safety analysis set of 58 patients. Four deaths occurred (three within one month of study initiation, including one in a patient excluded based on eligibility criteria after the first dose) with none considered treatment-related by the study investigator. Thus, treatment with ravulizumab once every eight weeks resulted in rapidly improved hematologic and renal endpoints with no unexpected adverse events in adults with atypical hemolytic uremic syndrome.

Published
2020
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6. Corrigendum to 'Rondeau E, Scully M, Ariceta G, Barbour T, Cataland S, Heyne N, Miyakawa Y, Ortiz S, Swenson E, Vallee M, Yoon S-S, Kavanagh D and Haller H; on behalf of the 311 Study Group. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment.' Kidney Int. 2020;97:1287–1296

Author

Eric Rondeau, Marie Scully, Gema Ariceta, Tom Barbour, Spero Cataland, Nils Heyne, Yoshitaka Miyakawa, Stephan Ortiz, Eugene Swenson, Marc Vallee, Sung-Soo Yoon, David Kavanagh, Hermann Haller, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Josep M. Campistol, Miquel Blasco, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Giorgia Comai, Maria Cappuccilli, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Yosu Luque, Jan Menne, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Elena Gutierréz, Paola Rodriguez, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Rondeau E., Scully M., Ariceta G., Barbour T., Cataland S., Heyne N., Miyakawa Y., Ortiz S., Swenson E., Vallee M., Yoon S.-S., Kavanagh D., Haller H., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Campistol J.M., Blasco M., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Comai G., Cappuccilli M., Le Quintrec M., Jeantet G., Fumie I., Luque Y., Menne J., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Gutierrez E., Rodriguez P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., and Wong E.K.S.

Subjects
Kidney, medicine.medical_specialty, Adult patients, business.industry, INT, medicine.disease, Gastroenterology, Complement inhibitor, medicine.anatomical_structure, Long acting, Nephrology, Internal medicine, Atypical hemolytic uremic syndrome, Medicine, Ravulizumab, Thrombotic microangiopathy, Pregnancy microangiopathies, Atypical hemolytic uremic syndrome, business
Abstract

The authors regret that 2 investigators were not included in the 311 Study Group. Members of the 311 Study Group are listed in the Appendix. The authors would like to apologize for any inconvenience caused.

Published
2021
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7. Erratum to 'Rondeau E, Scully M, Ariceta G, Barbour T, Cataland S, Heyne N, Miyakawa Y, Ortiz S, Swenson E, Vallee M, Yoon S-S, Kavanagh D, Haller H; on behalf of the 311 Study Group. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment' Kidney Int. 2020;97:1287–1296

Author

Eric Rondeau, Marie Scully, Gema Ariceta, Tom Barbour, Spero Cataland, Nils Heyne, Yoshitaka Miyakawa, Stephan Ortiz, Eugene Swenson, Marc Vallee, Sung-Soo Yoon, David Kavanagh, Hermann Haller, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Giorgia Comai, Maria Cappuccilli, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Yosu Luque, Jan Menne, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Elena Gutierréz, Paola Rodriguez, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Rondeau E., Scully M., Ariceta G., Barbour T., Cataland S., Heyne N., Miyakawa Y., Ortiz S., Swenson E., Vallee M., Yoon S.-S., Kavanagh D., Haller H., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Comai G., Cappuccilli M., Le Quintrec M., Jeantet G., Fumie I., Luque Y., Menne J., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Gutierrez E., Rodriguez P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., and Wong E.K.S.

Subjects
N.A, Nephrology
Abstract

The publisher regrets that the members of the 311 Study Group were not included as collaborative authors. Members of the 311 Study Group are listed in the Appendix. The publisher would like to apologize for any inconvenience caused.

Published
2020
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8. Successful treatment of a

Author

Guillaume, Jeantet, Vincent, Pernin, Vincent, Brunot, Arnaud, Roccabianca, Anouk, Macombe, Ilan, Szwarc, Kada, Klouche, Chantal, Loirat, Georges, Mourad, Véronique, Frémeaux-Bacchi, and Moglie, Le Quintrec

Subjects
Streptococcus pneumoniae, hemic and lymphatic diseases, haemolytic uraemic syndrome, complement, eculizumab, urologic and male genital diseases, Infection, female genital diseases and pregnancy complications, thrombotic microangiopathy
Abstract

Haemolytic uraemic syndrome (HUS) is a rare complication of invasive infection by Streptococcus pneumoniae (SP-HUS), especially in adults. Here we report an unusual case of a 53-year-old man presenting SP-HUS with severe multivisceral involvement. After failure of supportive care and plasma exchanges, eculizumab (anti-C5 antibody) resulted in a favourable outcome.

Published
2017

9. Traitement par éculizumab des récidives cliniques de gc3/ig-gnmp idiopathiques après transplantation rénale

Author

Dominique Bertrand, Philippe Gatault, Julien Zuber, M. Le Quintrec, Bertrand Dussol, Fadi Fakhouri, Guillaume Jeantet, Véronique Frémeaux-Bacchi, Hélène Perrochia, and Arnaud Lionet

Subjects
Nephrology
Abstract

Introduction La recidive clinique de glomerulopathie a depot de C3 (GC3) ou de glomerulonephrite membranoproliferative a complexes immuns (Ig-GNMP) survient chez 50 % des patients apres transplantation renale et est la premiere cause de perte du greffon chez ces patients. Aucun traitement n’a montre son efficacite en post-transplantation. L’eculizumab (ECZ), a ete utilise dans des cas severes sur rein natif ou sur greffon avec une efficacite variable. L’objectif de ce travail etait d’etudier la reponse et d’identifier des facteurs associes a la reponse a l’ECZ chez les patients traites pour une recidive clinique de GC3/Ig-GNMP. Patients/Materiels et methodes Il s’agit d’une etude retrospective multicentrique nationale francaise, incluant les patients transplantes pour une GC3/Ig-GNMP. La recidive clinique etait definie par une augmentation de la creatininemie > 30 % du nadir et/ou l’apparition d’une proteinurie > 0,5 g/g. Elle devait etre confirmee par la presence de depots de C3 glomerulaires a la biopsie du greffon, sans signes de rejet. La reponse complete (RC) a l’ECZ etait definie par la baisse de la creatininemie au nadir et de la proteinurie ≤ 0,5 g/g, la reponse partielle (RP) par la stabilisation de la creatininemie (± 25 %) et la regression de plus de > 50 % de la proteinurie. Observation/Resultats Nous avons identifie 66 recidives de GC3/Ig-GNMP entre 1986 et 2016, dont 39 recidives cliniques. Quatorze patients sur 39 ont ete traites par ECZ (11 GC3, 3 Ig-GNMP). La recidive survenait apres un delai median de 58 jours dans le groupe ECZ contre 556 jours dans le groupe non traites (p = 0,0017). Le delai median d’introduction de l’ECZ etait de 35 jours apres le diagnostic. A 6 mois de traitement par ECZ, 9/14 (64 %) patients etaient repondeurs (6 RC, 3 RP). Au dernier follow-up, 3/5 non repondeurs avaient perdu leur greffon contre 0/9 repondeurs (p = 0,027). Les repondeurs avaient une fonction renale stable. Le principal facteur associe a une reponse a l’ECZ etait la presence de depots glomerulaires de C5b-9 (7/7 repondeurs ; 2/5 non-repondeurs ; p = 0,045). La survie du greffon semblait meilleure dans le groupe ECZ sans toutefois de difference significative (p = 0,123) Discussion/Conclusion L’ECZ a ete efficace chez 64 % des patients traites pour une recidive clinique de GC3/Ig-GNMP. Les depots de C5b-9 glomerulaires etaient significativement associes a une reponse au traitement. Des essais prospectifs sont necessaires pour confirmer ces resultats.

Published
2018
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10. Rehydration behaviour and ageing of dairy powders assessed by calorimetric measurements

Author

Jean-François willart, Bruno Richard, Romain Jeantet, Marc Descamps, Guillaume Delaplace, Ousmane Syll, Pierre Schuck, Science et Technologie du Lait et de l'Oeuf (STLO), Institut National de la Recherche Agronomique (INRA)-AGROCAMPUS OUEST, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro), and ISI Document Delivery No.: 937AOTimes Cited: 0Cited Reference Count: 19Syll, Ousmane Richard, Bruno Willart, Jean Francois Descamps, Marc Schuck, Pierre Delaplace, Guillaume Jeantet, RomainScientific Committee of CNIEL Recherche (Paris, France)The authors thank the Scientific Committee of CNIEL Recherche (Paris, France) for stimulating discussions and financial support.Elsevier sci ltdOxfordJeantet, R (reprint author), UMR STLO, 65 Rue St Brieuc, F-35042 Rennes, France.romain.jeantet@agrocampus-ouest.fr

Subjects
Exothermic reaction, Enthalpy, Thermodynamics, Calorimetry, Powder, Endothermic process, Industrial and Manufacturing Engineering, Dairy, 0404 agricultural biotechnology, enthalpy, Dissolution, réhydratation, FOOD SCIENCE & TECHNOLOGY, Manufacturing process, Chemistry, Metallurgy, 0402 animal and dairy science, 04 agricultural and veterinary sciences, General Chemistry, Rehydration, 040401 food science, 040201 dairy & animal science, Ageing, ageing, [SDV.IDA.SMA]Life Sciences [q-bio]/Food engineering/domain_sdv.ida.sma, Food Science
Abstract

On the basis of dissolution enthalpy measurements, the aims of this study were i) to investigate the feasibility of lassifying the dissolvability of various dairy powders, and ii) to establish whether a change in rehydration behaviour that occurs with ageing could be predicted. No clear correlations could be established between the exothermic or endothermic nature of the calorimetric response and the rehydration ability of the powders studied. Dissolution enthalpy cannot thus be considered an absolute parameter that could be used to classify one dairy powder among others. On the contrary, it is experimentally shown that dissolution enthalpy is very sensitive both to the composition and the physical state of the powder. Consequently, dissolution enthalpy value can be considered as a marker representative of the manufacturing process and storage conditions. Evidence is made that following dissolution enthalpy over time could be a way to detect changes in powders due to ageing.

Published
2012
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