Accès ouvert déclaré 2020 article

Benefits of eculizumab in AQP4+ neuromyelitis optica spectrum disorder: Subgroup analyses of the randomized controlled phase 3 PREVENT trial

Jacqueline Palace, Dean M. Wingerchuk, Kazuo Fujihara, Achim Berthele, Celia Oreja‐Guevara, Ho Jin Kim, Ichiro Nakashima, Michael Levy, Murat Terzi, Natalia A. Totolyan, Shanthi Viswanathan, Kaichen Wang, Amy Pace, Marcus Yountz, Larisa Miller, Róisín Armstrong, Sean Joseph Pittock, Jorge David Amor, Carolina Bocchiardo, Julieta Iourno Danielle, Alfredo Laffue, Carolina Obregon, María Fernanda Páez, Roberto Martin Perez, Viviana Ana Maria Rocchi, Loreley Deborah Teijeiro, Jesica Gómez, Andres Maria Villa, Florencia Aguirre, Victòria Fernández, Ramon F. Goicoechea, Luciana Melamud, A. E. Stillman, Mariana De Virgiliis, Fátima Pagani Cassará, Marta Córdoba, M. Teresa Gutiérrez, Mariana Ingolotti, Natalia Larripa, Anahi Lupinacci, Josefina Arroyo, Alejandra Romano, Mariana Foa Torres, Carlos Ballario, Ana Elisa Chiesa, Hernán Gustavo Gómez, Hernán Gabriel Lattini, Carolina Mainella, Gisel Edith Bolner, María Soledad Eschoyez, Simon Broadley, Saman Heshmat, Arman Sabet, Andrew Swayne, Susan Freeman, Sofia Jimenez Sanchez, Neil Shuey, Linda J. Dalic, Ann French, Guru Kuma, Joshua Laing, Lai Yin Law, Jennifer MacIntyre, Andrew J. Neal, Christopher Plummer, Prashanth Ramachandran, Leslie Sedal, Ian Wilson, Antony Winkel, Wenwen Zhang, Tina Chen, Rani Watts, Michael Harry Barnett, Joshua L. Barton, Heidi N. Beadnall, Justin Garber, Todd A. Hardy, Benjamin Peter Trewin, Marinda Taha, Deleni Walters, Federico Arturo Silva Sieger, Nhora Patricia Ruiz Alfonso, Anna Maria Pinzon Camacho, Alexander Pabón Moreno, Jorge Armando Castellanos Prad, Adriana Paola Duarte Rueda, Tatiana Castillo, Martha Yolanda Moreno Pico, Judith Castill, Mario Habek, Ivan Adamec, Barbara Barun, Luka Crnošija, Tereza Gabelić, Petra Nytrová, Eva Krasulová, Jana Pavlíčková, Michaela Týblová, J. V. Zubkova, Thor Petersen, Gro Helen Dale, Peter Vestergaard Rasmussen, Morten Stilund, Kristina Bacher Svendsen, Vivi Brandt, Nicolas Collongues, Marie‐Céline Fleury, Laurent Kremer, Sandrine Bendele, Valérie Neff, Ricarda Diem, Michael Platten, Anne Berberich, J Jansen, Hannah Jaschoneck, Brigitte Wildemann, Ursula Aures, Tanja Brandenburger, Tanja Haut, Maria-Lourdes Treceno Fernández, Lilian Aly, K. P. Brinkhoff, Dorothea Buck, Daniel Golkowski, Mirjam Hermisson, Muna‐Miriam Hoshi, Miriam Kaminski, Markus Christian Kowarik, Helena C. Kronsbein, Klaus Lehmann‐Horn, Viola Pongratz, Andreas Schweiker, L Leddy, Silvia Melitta Mueller, Kim Obergfell, Marion Wanka, Uwe Klaus Zettl, Jan Klinke, Micha Loebermann, Stefanie Meister, Florian Rimmele, Alexander Winkelmann, Ina Schroeder, Alexander Yuk Lun Lau, Lisa Wing-Chi Au, Florence Sin-Ying Fan, Vincent Hing‐Lung Ip, Sze Ho Ma, Vincent Mok, Cheryl Au, Pauline Wing-Lam Kwan, Francesco Patti, Andrea Caramma, Clara Grazia Chisari, Salvatore Lo Fermo, Silvia Messina, Maria Projetto, Cinzia Caserta, Alessandro Filla, Teresa Costabile, Chiara Pane, Francesco Saccà, Angela Marsili, Giorgia Puorro, Roberto Bergamaschi, Eliana Berra, Giulia Mallucci, Cinzia Fattore, Claudio Gasperini, Simonetta Galgani, Shalom Haggiag, Serena Ruggieri, Claudio Vento, Esmeralda Quartuccio, Carlo Pozzilli, Valeria Teresa Barletta, Giovanna Borriello, Laura De Giglio, Fabiana Marinelli, Miriam Tasillo, Alessandra Amadori, Mariano Fischetti, Flavia Gurreri, Masahiro Mori, Hiroki Masuda, Ryohei Ohtani, Yukari Sekiguchi, Tomohiko Uchida, Akiyuki Uzawa, Hiromi Ito, Emi Kabasawa, Yoko S. Kaneko, Takuya Matsushita, Dai Matsuse, Hiroyuki Murai, Shintaro Hayashi, Katsuhisa Masak, Hidenori Ogata, Koji Shinoda, Taira Uehara, Mitsuru Watanabe, Hiroo Yamaguchi, Ryo Yamasaki, Tomomi Yonekawa, Maki Jingu, M Nagano, Yumiko Nakamura, Yoshiko Sano, Manabu Araki, Youwei Lin, Madoka Mori, Yohei Mukai, Terunori Sano, Wakiro Sato, Naoya Gogun, Yuriko Maeda, A Nishimoto, Sachiko Tsukamoto, Ritsuko Yanagi, Takahiko Saida, Shinichi Nakamura, Tetsuya Nasu, Kyoko Saida, Yuko Shikata, Yoshimi Kodani, Megumi Saeki, Yukako Sawada, Hiroo Yoshikawa, Takashi Kimura, Masamitsu Nishi, Shun Sakamoto, Shinichiro Ukon, Shohei Watanabe, Saori Ebisuya, Nami Kimura, M Matsuura, Yukie Morisaki, Yoshiko Muroi, Kuniko Onishi, Ikuko Oshima, Yuki Washino, Tomomi Yamashita, Tatsuro Misu, Kimihiko Kaneko, Masaaki Kato, Hiroshi Kuroda, Kazuhiro Kurosawa, Shuhei Nishiyama, Hirohiko Ono, Yoshiki Takai, Keiko Abe, Hitomi Hoshi, Mari Jinushi, Azusa Oyama, M. Sakuma, Yuko Sawada, Satoru Ishibashi, Takanori Yokota, Yoichiro Nishida, Kokoro Ozaki, Nobuo Sanjo, Nozomu J. Sato, Fuki Denno, Haruko Hiraki, Yumi Matsubara, Takashi Kanda, Masaaki Abe, Masaya Honda, Motoharu Kawai, Michiaki Koga, Toshihiko Maeda, Jun‐ichi Ogasawara, Masatoshi Omoto, Yasuteru Sano, Ryota Sato, Fumitaka Shimizu, Hideki Arima, Sachie Fukui, Yoshiko Ishikawa, Tomoko Koyama, Shigemi Shimose, Hirokazu Shinozaki, Masanori Watanabe, Sachi Yasuda, Chieko Yoshiwaka, Suffian Adenan, Mohd Azman M Aris, Ahmad Shahir Mawardi, Muhammad Al Hafiz Adnan, Nanthini Munusamy, Siti Nur Omaira Razali, P Somasundram, Jae Won Hyun, In Hye Jeong, Su‐Hyun Kim, Hyun-June Shin, Ji Sung Yoo, Hyunmin Jang, AeRan Joung, Byung‐Jo Kim, Seol‐Hee Baek, Jung Bin Kim, Yoo Hwan Kim, Yong Seo Koo, Chan‐Nyoung Lee, Hung Youl Seok, Jinhee H Hwang, Sung Min Kim, So Hyun Ahn, Kyomin Choi, Seok‐Jin Choi, Jun‐Soon Kim, Young Nam Kwon, Je-Young Shin, 권현주, Byoung Joon Kim, Eun Bin Cho, Hye-Jin Cho, Misong Choi, DongSun Kim, Ju Hyeon Kim, SeungJu Ki, Hye Lim Lee, Kwang Ho Lee, Ju‐Hong Min, Ji-Hyung Park, Jinmyoung Seok, Eun Hwa Choi, Sang Ae Park, Seung Min Kim, Ha-Neul Jeong, Bong Jeongbin, Jin Woo Jung, Seung Woo Kim, Yool-hee Kim, Hyung‐Seok Lee, Ha Young Shin, Yeon Jung, Min Jung Kim, Nou Ri Lee, Miju Shin, Farit A Khabirov, L. A. Aver’yanova, Natalya Nikolaevna Babicheva, Eugenii Granatov, Sergey Kazarov, T I Khaybullin, Alexander Rogozhin, Д. В. Похабов, В. Г. Абрамов, A. B. Amelina, Yulia Nesteroca, Tatyana Bozhenkina, Аleksey N. Boyko, Elena G Demyan, Inessa Khoroshilova, Mikhail Vasilyevich Melnikov, Ekaterina Valerievna Popova, Svetlana N. Sharanova, Sergey G Shchur, Denis V Sazonov, Larisa Babenko, Elena Bayandina, Asya Yarmoschuk, В. А. Балязин, Е. В. Балязина, Elena Budaeva, Ирина Васильевна Черникова, Zoya Alexandrovna Goncharova, Vladimir S. Krasnov, Marina Myatleva, Olga V. Rodionova, Iuliana Samulyzhko, Sabas Boyero Durán, Maria Mar Mendibe Bilbao, Irene Díaz Cuervo, J.M. Losada Domingo, Amaia González Eizaguirre, José Eulalio Bárcena, Roberto Valverde Moyano, Carmen Bahamonde, Fernando Sánchez López, Raquel Piñar Morales, Eduardo Agüera, Carmen Bahamonde Roman, Juan Jose Ochoa Sepulveda, Maria del Carmen Blanco Valero, Nazaret Peláez Viña, Cristina Conde Gavilán, Ana Maria Jover Sanchez, Sara Vila Bedmar, Nuria González García, Aida Orviz García, Inés González‐Suarez, Elena Miñano Guillamon, Miguel Kawiorski, Elena Guerra Schulz, Alba Garcia Alonso, Francisco Jesus Lopez Perez, Marta Palacios Sarmiento, Guillermo Izquierdo Ayuso, Guillermo Navarro Mascarell, Cristina Páramo Camino, A García, Y.M. Mendoza, Veronica Ines Vargas Muñoz, Patricia Torres Tonda, Ching‐Piao Tsai, Jiu‐Haw Yin, Mei‐Jung Chen, Shanni Li, Fei-Ti Wang, Suwat Srisuwannanukorn, Thanatat Boonmongkol, Duangporn Borisutbuathip, Duangkamol Singwicha, Krittika Siritanan, Chidchanoke Thearapati, Kwanmuang Sornda, Metha Apiwattanakul, Saharat Aungsumart, Narupat Suanprasert, Kaona Suksuchano, Nittaya Parkinsee, Kongkiat Kulkantrakorn, Praween Lolekha, Artit Potigumjon, Puchit Sukphulloprat, Dararat Suksasunee, Chankawee Komaratat, Sunattana Luangtong, Arkhom Arayawichanont, Phanpaphon Konpan, Nathapol Riablershirun, Thaddao Wiroteurairuang, Panadda Jantaweesirirat, Aslı Tuncer Kurne, İrem Erkent, Ebru Bekircan Kurt, Ezgi Saylam, Yagmur Caliskan, Gulsah Orsel, Yahya Çelik, Canan Çelebi, Aslan Tekataş, Tugce Banbal, Gülşen Akman Demir, Burcu Altunrende, Zeliha Matur, Barış Topçular, Tules Elmas, Aysenur Gulo, Selin Ozdemir, Cansu Özkökleşen, Mahinur Ozturk, Mertkan Yanik, Elif Yıldırım, Melih Tütüncü, Ayse Gul Kocak Altintas, Abdulsamet Cam, Ayşe Deniz Elmalı, Sabahattin Saip, Aksel Sıva, Uygur Tanrıverdi, Uğur Uygunoğlu, Sinem Caliskan, Pinar Gulo, Esra Kozig, Sakine Sakiz, İhsan Şükrü Şengün, Egemen İdıman, Duygu Arslan, Utku Bulut, Yasemin Karakaptan, Derya Kaya, Zaur Mehdiyev, Bengu Balkan, Berfu Kuku, Mujgan Ozhun, Celal Tuga, Müzeyyen Ugur, Hüsnü Efendi, Sena Destan Bünül, Hakan Çavuş, Yunus Emre Gorke, Ayşe Kutlu, Seda Duman Öztürk, Cansu Eğilmez Sarıkaya, Gulsah Becerikli, Cansu Semiz, Ozlem Tun, Sehriban Ayer, Musa Kazım Onar, Mehlika Berra Ozberk, Sedat Şen, Tugce Kirbas Cavdar, Adife Veske, Cavit Boz, Didem Altiparmak, Cigdem Ozen Aydin, Sibel Gazioğlu, Duygu Bekircan, Anu Sam Jacob, Heike Arndt, Liene Elsone, Shahd Hassan Mahmoud Hamid, Daniel Hugh Whittam, Martin Wilson, Imelda O'Brien, Maria Isabel Leite, Pedro M. Rodríguez Cruz, Damian Jenkins, George W Tackley, Ana Cavey, Rosie Everett, Joy Hodder, Ellen M. Mowry, Walter Royal, Robert Kang Shin, Christopher T. Bever, Daniel M. Harrison, Horea Rus, Wei Xing Zheng, Karen Callison, Kerry Naunton, Benjamin M. Frishberg, Andrew M. Blumenfeld, Andrew Inocelda, Kalyani Korabathina, Michael Lobatz, Melissa M Mortin, Irene J Oh, Jay H. Rosenberg, Mark Sadoff, Gregory A. Sahagian, Anchi Wang, Yasmin Camberos, Guadalupe Sánchez, Estela Soto, Jacqueline A. Nicholas, Aaron Lee Boster, Geoffrey Eubank, Katy Groezinger, Meghan Lauf, Annette F. Okai, Rashedul Hasan, Chaouki Khoury, Victoria J. Stokes, Stacey Lynn Clardy, Melissa M. Cortez, John Greenlee, JOHN W. ROSE, M. Mateo Paz Soldán, Amanda Emett, Lawanda Esquibel, Lilly Fagatele, Ka-Ho Wong, James C. Stevens, Thomas M Banas, Marlene C Bultemeyer, Andrea Haller, Natalie C. Manalo, Keri Aeschliman, Debi Kocks, Michael Racke, Michelle R. Bowman, Jaime Imitola, Yasushi Y. Kisanuki, Misty Green, Stephanie Scarberry, SHARON G. LYNCH, Heather S. Anderson, Gary Gronseth, Nancy E Hammond, Yasir N. Jassam, Manoj Kumar Mittal, Muhammed M Nashatizadeh, Nicholas A. Levine, Lisa F. Schmidt, Jill Sibley, Vonda Whitley, James Winkley, Timothy Coleman, Gregory M. Cooper, S Sheffield, Keri Turner, Dana Galloway, Robert S Tillett, Geeta A Ganesh, Brian M. Plato, Tad Seifert, Diana Godwin, Deborah Lockridge, Kottil W Rammohan, William A. Sheremata, Silvia R. Delgado, José Luís Calvo González, Alexis Lizarraga, Janice Y. Maldonado, Melissa R Ortega, Leticia Tornes, Yanet Babcock, Osmara Cailam, Yesica Campos, Irlisse Couvertier, Bettina Daneri, Jeremy Deni, Jeffrey Hernandez, Tatiana Jaramillo, Tenita Morris, Daniel Nobel, Anjelis Oliveira, R Richardson, Gloria Martha Palomar Rodríguez, Ana Dolores Gómez Romero, Carlos Sandova, Ruta Sawant, Lissett Tueros, Eric Scott Zetka, Chao Zheng, Daniel H. Jacobs, Constance Easterling, Jennifer Fairbank, Revathi Iyengar, Mark Klafter, Justin Lindquist, Ahmed H Sadek, Elizabeth Carmona Toro, Navin Verma, Brigith Patino Castro, Nadia Sukhraj-Singh, Joseph R. Berger, Eric M. L. Williamson, Salim Chahin, Dina A. Jacobs, Clyde Markowitz, Jessica M. Dobbins, Lauren Mace, María Elena Martín, Ashley Pinckney, Amber Roberts, Islam Zaydan, Galen W. Mitchell, Rock A. Heyman, Ryan L. Orie, Valerie R. Suski, Kerry Oddis, Darlene Punjack, Eoin P. Flanagan, Avi Gadoth, Andrew McKeon, William Oliver Tobin, Anastasia Zekeridou, Katie Dunlay, Jessica A. Sagen, Jonathan L Carter, Bachir Estephan, Brent P. Goodman, Charlene R. Hoffman Snyder, Andrea Francone, Irene Galasky, Martha Thomas, Pavle Repovic, James David Bowen, Angeli S. Mayadev, Peiqing Qian, Yuriko Courtney, Lauren Lennox, Robert T. Naismith, Anne Haney Cross, Emily M. Evans, Erin E. Longbrake, M Orchard, Gregory F. Wu, Linda Heinrich, S. R. Sommers, Faria S. Amjad, Erika Mitchell, Carlos A. Mora, Bethany Schreiber, Carlo Tornatore, Alexis Carlson, Sacha McCarthy, Alexandria L. Oliver

42Citations signalées, ce qui n’est pas une note de qualité

25Institutions déclarées

10Pays d’affiliation déclarés

Rattachement africain : gb, us, jp, de, es, kr, tr, ru, my, tw. Niveau de preuve : code pays fourni par la source.

Le résumé fourni par la source

BACKGROUND: Antibodies to the aquaporin-4 (AQP4) water channel in neuromyelitis optica spectrum disorder (NMOSD) are reported to trigger the complement cascade, which is implicated in astrocyte damage and subsequent neuronal injury. The PREVENT study demonstrated that the terminal complement inhibitor eculizumab reduces adjudicated relapse risk in patients with anti-AQP4 immunoglobulin G-positive (AQP4+) NMOSD. The objective of this analysis was to evaluate the efficacy of eculizumab in reducing relapse risk and its safety in AQP4+ NMOSD across clinically relevant subgroups in PREVENT. METHODS: In the randomized, double-blind, time-to-event, phase 3 PREVENT trial, 143 adults received eculizumab (maintenance dose, 1200 mg/2 weeks) or placebo (2:1), with stable-dose concomitant immunosuppressive therapy (IST) permitted (except rituximab and mitoxantrone). Post hoc analyses of relapses and adverse events were performed for prespecified and post hoc subgroups based on concomitant IST and prior rituximab use, demographic and disease characteristics, and autoimmune comorbidity. RESULTS: The significant reduction in relapse risk observed for eculizumab versus placebo in the overall PREVENT population was consistently maintained across subgroups based on concomitant IST and previous rituximab use, age, sex, region, race, time since clinical onset of NMOSD, historical annualized relapse rate, baseline Expanded Disability Status Scale score, and history of another autoimmune disorder. The serious infection rate was lower with eculizumab than placebo regardless of rituximab use in the previous year, concomitant IST use, or history of another autoimmune disorder. CONCLUSION: Across a wide range of clinically relevant AQP4+ NMOSD patient subgroups in PREVENT, eculizumab therapy was consistently effective versus placebo in reducing relapse risk, with no apparent increase in serious infection rate. TRIAL REGISTRATION: NCT01892345 (ClinicalTrials.gov).

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.

Le contrôle bibliographique ouvert

DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref: Benefits of eculizumab in AQP4+ neuromyelitis optica spectrum disorder: Subgroup analyses of the randomized controlled phase 3 PREVENT trial
Date Crossref: 01/01/2021
Éditeur: Elsevier BV
Type: journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.

Où se fait cette recherche

John Radcliffe Hospital pays non établi dans la notice
Établissement de santé
University of Oxford Nuffield Department of Clinical Neurosciences pays non établi dans la notice
Université ou école supérieure
Mayo Clinic in Arizona pays non établi dans la notice
Établissement de santé
Fukushima Medical University Department of Multiple Sclerosis Therapeutics pays non établi dans la notice
Université ou école supérieure
Tohoku University Department of Neurology pays non établi dans la notice
Université ou école supérieure
Southern Tohoku General Hospital pays non établi dans la notice
Établissement de santé
TUM Klinikum pays non établi dans la notice
Établissement de santé
Technical University of Munich pays non établi dans la notice
Université ou école supérieure
Universidad Complutense de Madrid pays non établi dans la notice
Université ou école supérieure
Hospital Clínico San Carlos pays non établi dans la notice
Établissement de santé
Instituto de Investigación Sanitaria del Hospital Clínico San Carlos pays non établi dans la notice
Établissement de santé
National Cancer Center pays non établi dans la notice
Organisation à but non lucratif

John Radcliffe Hospital, Nuffield Department of Clinical Neurosciences — University of Oxford et Mayo Clinic in Arizona, avec 9 autres affiliations.

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Les sujets associés

Multiple Sclerosis Research StudiesVestibular and auditory disordersPeripheral Neuropathies and Disorders

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