作者
James F Howard, Kimiaki Utsugisawa, Michael Benatar, Hiroyuki Murai, Richard J Barohn, Isabel Illa, Saiju Jacob, John Vissing, Ted M Burns, John T Kissel, Srikanth Muppidi, Richard J Nowak, Fanny O'Brien, Jing-Jing Wang, Renato Mantegazza, Claudio Gabriel Mazia, Miguel Wilken, Carolina Ortea, Juliet Saba, Marcelo Rugiero, Mariela Bettini, Gonzalo Vidal, Alejandra Dalila Garcia, Phillipa Lamont, Wai-Kuen Leong, Heidi Boterhoven, Beverly Fyfe, Leslie Roberts, Mahi Jasinarachchi, Natasha Willlems, Julia Wanschitz, Wolfgang Löscher, Jan De Bleecker, Guy Van den Abeele, Kathy de Koning, Katrien De Mey, Rudy Mercelis, Linda Wagemaekers, Delphine Mahieu, Philip Van Damme, Charlotte Smetcoren, Olivier Stevens, Sarah Verjans, Ann D'Hondt, Petra Tilkin, Alzira Alves de Siqueira Carvalho, Rosa Hasan, Igor Dias Brockhausen, David Feder, Daniel Ambrosio, Ana Paula Melo, Rosana Rocha, Bruno Rosa, Thabata Veiga, Luiz Augusto da Silva, Jordana Gonçalves Geraldo, Maria da Penha Morita Ananias, Erica Nogueira Coelho, Gabriel Paiva, Marina Pozo, Natalia Prando, Debora Dada Martineli Torres, Cristiani Fernanda Butinhao, Erica Coelho, Luciana Renata Cubas Volpe, Gustavo Duran, Tamires Cristina Gomes da Silva, Luiz Otavio Maia Gonçalves, Lucas Eduardo Pazetto, Luciana Souza Duca, Tomás Augusto Suriane Fialho, Maurício André Gheller Friedrich, Alexandre Guerreiro, Henrique Mohr, Maurer Pereira Martins, Daiane da Cruz Pacheco, Ana Paula Macagnan, Aline de Cassia Santos, Acary Souza Bulle Oliveira, Ana Carolina Amaral de Andrade, Marcelo Annes, Valeria Cavalcante Lino, Wladimir Pinto, Carolina Miranda, Fernanda Carrara, Iandra Souza, Angela Genge, Rami Massie, Natasha Campbell, Vera Bril, Hans Katzberg, Mehran Soltani, Eduardo Ng, Zaeem Siddiqi, Celile Phan, Derrick Blackmore, Stanislav Vohanka, Josef Bednarik, Magda Chmelikova, Marek Cierny, Stanislava Toncrova, Jana Junkerova, Barbora Kurkova, Katarina Reguliova, Olga Zapletalova, Jiri Pitha, Iveta Novakova, Michaela Tyblova, Marcela Wolfova, Ivana Jurajdova, Henning Andersen, Thomas Harbo, Lotte Vinge, Anita Mogensen, Joan Højgaard, Nanna Witting, Anne Mette Autzen, Jane Pedersen, Markus Färkkilä, Sari Atula, Anne Nyrhinen, Juha-Pekka Erälinna, Mikko Laaksonen, Olli Oksaranta, Jaana Eriksson, Tuula Harrison, Claude Desnuelle, Sabrina Sacconi, Marie-Hélène Soriani, Sonia Decressac, Julie Moutarde, Pauline Lahaut, Guilhem Solé, Gwendal Le Masson, Anne-Cécile Wielanek-Bachelet, Morgane Gaboreau, Caroline Moreau, Amy Wilson, Christophe Vial, Françoise Bouhour, Helene Gervais-Bernard, Hélène Merle, Caroline Hourquin, Arnaud Lacour, Olivier Outteryck, Patrick Vermersch, Hélène Zephir, Edouard Millois, Michel Deneve, Fabienne Deruelle
发表日期
2017/12/1
期刊
The Lancet Neurology
卷号
16
期号
12
页码范围
976-986
出版商
Elsevier
简介
Background
Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial.
Methods
We did a phase 3, randomised, double-blind, placebo-controlled, multicentre study (REGAIN) in 76 hospitals and specialised clinics in 17 countries across North America, Latin America, Europe, and Asia. Eligible patients were aged at least 18 years, with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of 6 or more, Myasthenia Gravis Foundation of America (MGFA) class II–IV disease, vaccination against …
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JF Howard, K Utsugisawa, M Benatar, H Murai… - The Lancet Neurology, 2017