The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229). In this 52-week sub-analysis of the open-label extension of REGAIN (NCT02301624), eculizumab's efficacy and safety were assessed in 11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis. For patients who had received placebo during REGAIN, treatment with open-label eculizumab resulted in generally similar outcomes in the Japanese and Caucasian populations. Rapid improvements were maintained for 52 weeks, assessed by change in score from open-label extension baseline to week 52 (mean [standard error]) using the following scales (in Japanese and Caucasian patients, respectively): Myasthenia Gravis Activities of Daily Living (−2.4 [1.34] and − 3.3 [0.65]); Quantitative Myasthenia Gravis (−2.9 [1.98] and − 4.3 [0.79]); Myasthenia Gravis Composite (−4.5 [2.63] and − 4.9 [1.19]); and Myasthenia Gravis Quality of Life 15-item questionnaire (−8.6 [5.68] and − 6.5 [1.93]). Overall, the safety of eculizumab was consistent with its known safety profile. In this interim sub-analysis, the efficacy and safety of eculizumab in Japanese and Caucasian patients were generally similar, and consistent with the overall REGAIN population.
Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study / H., Murai; A., Uzawa; Y., Suzuki; T., Imai; H., Shiraishi; H., Suzuki; M., Okumura; F., O'Brien; J. -J., Wang; K. P., Fujita; K., Utsugisawa; Gabriel Mazia 11, Claudio; Wilken 11, Miguel; Barroso 11, Fabio; Saba 11, Juliet; Rugiero 12, Marcelo; Bettini 12, Mariela; Chaves 12, Marcelo; Vidal 12, Gonzalo; Dalila Garcia 12, Alejandra; De Bleecker 13, Jan; Van den Abeele 13, Guy; de Koning 13, Kathy; De Mey 13, Katrien; Mercelis 14, Rudy; Mahieu 14, Délphine; Wagemaekers 14, Linda; Van Damme 15, Philip; Depreitere 16, Annelies; Schotte 16, Caroline; Smetcoren 16, Charlotte; Stevens 16, Olivier; Van Daele 16, Sien; Vandenbussche 16, Nicolas; Vanhee 16, Annelies; Verjans 16, Sarah; Vynckier 16, Jan; D'Hondt 16, Ann; Tilkin 16, Petra; Alves de Siqueira Carvalho 17, Alzira; Dias Brockhausen 17, Igor; Feder 17, David; Ambrosio 17, Daniel; César 17, Pamela; Paula Melo 17, Ana; Martins Ribeiro 17, Renata; Rocha 17, Rosana; Bezerra Rosa 17, Bruno; Veiga 17, Thabata; Augusto da Silva 17, Luiz; Santos Engel 17, Murilo; Gonçalves Geraldo 17, Jordana; da Penha Ananias Morita 18, Maria; Nogueira Coelho 18, Erica; Paiva 18, Gabriel; Pozo 18, Marina; Prando 18, Natalia; Dada Martineli Torres 18, Debora; Fernanda Butinhao 18, Cristiani; Duran 18, Gustavo; Cristina Gomes da Silva 18, Tamires; Otavio Maia Gonçalves 18, Luiz; Eduardo Pazetto 18, Lucas; Augusto Suriane Fialho 18, Tomás; Renata Cubas Volpe 18, Luciana; Souza Duca 18, Luciana; Souza Bulle Oliveira 19, Acary; Carolina Amaral Andrade 19, Ana; Annes 19, Marcelo; Duarte Silva 19, Liene; Cavalcante Lino 19, Valeria; Pinto 19, Wladimir; Assis 19, Natália; Carrara 19, Fernanda; Miranda 19, Carolina; Souza 19, Iandra; Fernandes 19, Patricia; Siddiqi 20, Zaeem; Phan 20, Cecile; Narayan 20, Jeffrey; Blackmore 20, Derrick; Mallon 20, Ashley; Roderus 20, Rikki; Watt 20, Elizabeth; Junkerova 21, Jana; Kurkova 21, Barbora; Reguliova 21, Katarina; Zapletalova 21, Olga; Pitha 22, Jiri; Novakova 22, Iveta; Tyblova 22, Michaela; Jurajdova 22, Ivana; Wolfova 22, Marcela; Andersen 23, Henning; Harbo 23, Thomas; Vinge 23, Lotte; Krogh 23, Susanne; Mogensen 23, Anita; Vissing 24, John; Højgaard 24, Joan; Witting 24, Nanna; Mette Ostergaard Autzen 24, Anne; Pedersen 24, Jane; Eralinna 25, Juha-Pekka; Laaksonen 25, Mikko; Oksaranta 25, Olli; Harrison 25, Tuula; Eriksson 25, Jaana; Rozsa 26, Csilla; Horvath 26, Melinda; Lovas 26, Gabor; Matolcsi 26, Judit; Szabo 26, Gyorgyi; Jakab 26, Gedeonne; Szabadosne 26, Brigitta; Antonini 27, Giovanni; Di Pasquale 27, Antonella; Garibaldi 27, Matteo; Morino 27, Stefania; Troili 27, Fernanda; Fionda 27, Laura; Filla, Allessandro; Costabile, Teresa; Marano, Enrico; Saccà, Francesco; Fasanaro, Angiola; Marsili, Angela; Puorro, Giorgia; Mantegazza 29, Renato; Antozzi 29, Carlo; Bonanno 29, Silvia; Camera 29, Giorgia; Locatelli 29, Alberta; Maggi 29, Lorenzo; Pasanisi 29, Maria; Campanella 29, Angela; Evoli 30, Amelia; Emilio Alboini 30, Paolo; D'Amato 30, Valentina; Iorio 30, Raffaele; Kanai 31, Tetsuya; Kawaguchi 31, Naoki; Mori 31, Masahiro; Kaneko 31, Yoko; Kanzaki 31, Akiko; Kobayashi 31, Eri; Masaki 32, Katsuhisa; Matsuse 32, Dai; Matsushita 32, Takuya; Uehara 32, Taira; Shimpo 32, Misa; Jingu 32, Maki; Kikutake 32, Keiko; Nakamura 32, Yumiko; Sano 32, Yoshiko; Nagane 33, Yuriko; Kamegamori 33, Ikuko; Tsuda 33, Tomoko; Fujii 33, Yuko; Futono 33, Kazumi; Ozawa 33, Yukiko; Mizugami 33, Aya; Saito 33, Yuka; Morikawa 34, Miyuki; Samukawa 34, Makoto; Kamakura 34, Sachiko; Miyawaki 34, Eriko; Mitazaki 35, Teiichiro; Motomura 35, Masakatsu; Mukaino 35, Akihiro; Yoshimura 35, Shunsuke; Asada 35, Shizuka; Yoshida 35, Seiko; Amamoto 35, Shoko; Kobashikawa 35, Tomomi; Koga 35, Megumi; Maeda 35, Yasuko; Takada 35, Kazumi; Takada 35, Mihoko; Tsurumaru 35, Masako; Yamashita 35, Yumi; Akiyama 36, Tetsuya; Narikawa 36, Koichi; Tano 36, Ohito; Tsukita 36, Kenichi; Kurihara 36, Rikako; Meguro 36, Fumie; Fukuda 36, Yusuke; Sato 36, Miwako; Funaka 37, Soichiro; Kawamura 37, Tomohiro; Makamori 37, Masayuki; Takahashi 37, Masanori; Taichi 37, Namie; Hasuike 37, Tomoya; Higuchi 37, Eriko; Kobayashi 37, Hisako; Osakada 37, Kaori; Tsuda 38, Emiko; Shimohama 38, Shun; Hayashi 38, Takashi; Hisahara 38, Shin; Kawamata 38, Jun; Murahara 38, Takashi; Saitoh 38, Masaki; Suzuki 38, Shuichiro; Yamamoto 38, Daisuke; Ishiyama 38, Yoko; Ishiyama 38, Naoko; Noshiro 38, Mayuko; Takeyama 38, Rumi; Uwasa 38, Kaori; Yasuda 38, Ikuko; van der Kooi 39, Anneke; de Visser 39, Marianne; Gibson 39, Tamar; Casasnovas 40, Carlos; Antonia Alberti Aguilo 40, Maria; Homedes-Pedret 40, Christian; Julia Palacios 40, Natalia; Diez Porras 40, Laura; Velez Santamaria 40, Valentina; Lazaro 40, Ana; Diez Tejedor 41, Exuperio; Gomez Salcedo 41, Pilar; Fernandez-Fournier 41, Mireya; Lopez Ruiz 41, Pedro; Javier Rodriguez de Rivera 41, Francisco; Sastre 41, Maria; Gamez 42, Josep; Sune 42, Pilar; Salvado 42, Maria; Gili 42, Gisela; Mazuela 42, Gonzalo; Illa 43, Isabel; Cortes Vicente 43, Elena; Diaz-Manera 43, Jordi; Antonio Querol Gutierrez 43, Luis; Rojas Garcia 43, Ricardo; Vidal 43, Nuria; Arribas-Ibar 43, Elisabet; Piehl 44, Fredrik; Hietala 44, Albert; Bjarbo 44, Lena; Sengun 45, Ihsan; Meherremova 45, Arzu; Ozcelik 45, Pinar; Balkan 45, Bengu; Tuga 45, Celal; Ugur 45, Muzeyyen; Erdem-Ozdamar 46, Sevim; Ebru Bekircan-Kurt 46, Can; Pinar Acar 46, Nazire; Yilmaz 46, Ezgi; Caliskan 46, Yagmur; Orsel 46, Gulsah; Efendi 47, Husnu; Aydinlik 47, Seda; Cavus 47, Hakan; Kutlu 47, Ayse; Becerikli 47, Gulsah; Semiz 47, Cansu; Tun 47, Ozlem; Terzi 48, Murat; Dogan 48, Baki; Kazim Onar 48, Musa; Sen 48, Sedat; Kirbas Cavdar 48, Tugce; Veske 48, Adife; Norwood 49, Fiona; Dimitriou 49, Aikaterini; Gollogly 49, Jakit; Mahdi-Rogers 49, Mohamed; Seddigh 49, Arshira; Sokratous 49, Giannis; Maier 49, Gal; Sohail 49, Faisal; Jacob 50, Saiju; Sadalage 50, Girija; Torane 50, Pravin; Brown 50, Claire; Shah 50, Amna; Sathasivam 51, Sivakumar; Arndt 51, Heike; Davies 51, Debbie; Watling 51, Dave; Amato 52, Anthony; Cochrane 52, Thomas; Salajegheh 52, Mohammed; Roe 52, Kristen; Amato 52, Katherine; Toska 52, Shirli; Wolfe 53, Gil; Silvestri 53, Nicholas; Patrick 53, Kara; Zakalik 53, Karen; Katz 54, Jonathan; Miller 54, Robert; Engel 54, Marguerite; Forshew 54, Dallas; Bravver 55, Elena; Brooks 55, Benjamin; Plevka 55, Sarah; Burdette 55, Maryanne; Cunningham 55, Scott; Sanjak 55, Mohammad; Kramer 55, Megan; Nemeth 55, Joanne; Schommer 55, Clara; Tierney 55, Scott; Juel 56, Vern; Guptill 56, Jeffrey; Hobson-Webb 56, Lisa; Massey 56, Janice; Beck 56, Kate; Carnes 56, Donna; Loor 56, John; Anderson 56, Amanda; Pascuzzi 57, Robert; Bodkin 57, Cynthia; Kincaid 57, John; Snook 57, Riley; Guingrich 57, Sandra; Micheels 57, Angela; Chaudhry 58, Vinay; Corse 58, Andrea; Mosmiller 58, Betsy; Kelley 58, Andrea; Ho 59, Doreen; Srinivasan 59, Jayashri; Vytopil 59, Michal; Jara 59, Jordan; Ventura 59, Nicholas; Scala 59, Stephanie; Carter 59, Cynthia; Donahue 59, Craig; Herbert 59, Carol; Weiner 59, Elaine; Alam 59, Sharmeen; McKinnon 60, Jonathan; Haar 60, Laura; McKinnon 60, Naya; Alcon 60, Karan; McKenna 60, Kaitlyn; Sattar 60, Nadia; Daniels 60, Kevin; Jeffery 60, Dennis; Freimer 61, Miriam; Chad Hoyle 61, Joseph; Kissel 61, John; Agriesti 61, Julie; Chelnick 61, Sharon; Mezache 61, Louisa; Pineda 61, Colleen; Muharrem 61, Filiz; Karam 62, Chafic; Khoury 62, Julie; Marburger 62, Tessa; Kaur 62, Harpreet; Dimitrova 62, Diana; Gilchrist 63, James; Agrawal 63, Brajesh; Elsayed 63, Mona; Kohlrus 63, Stephanie; Andoin 63, Angela; Darnell 63, Taylor; Golden 63, Laura; Lokaitis 63, Barbara; Seelback 63, Jenna; Muppidi 64, Srikanth; Goyal 64, Neelam; Sakamuri 64, Sarada; T So 64, Yuen; Paulose 64, Shirley; Pol 64, Sabrina; Welsh 64, Lesly; Bhavaraju-Sanka 65, Ratna; Tobon Gonzales 65, Alejandro; Dishman 65, Lorraine; Jones 65, Floyd; Gonzalez 65, Anna; Padilla 65, Patricia; Saklad 65, Amy; Silva 65, Marcela; Kazamel 66, Mohamed; Alsharabati 66, Mohammad; Lu 66, Liang; Nozaki 66, Kenkichi; Mumfrey-Thomas 66, Sandi; Woodall 66, Amy; Mozaffar 67, Tahseen; Cash 67, Tiyonnoh; Goyal 67, Namita; Roy 67, Gulmohor; Mathew 67, Veena; Maqsood 67, Fatima; Minton 67, Brian; James Jones 68, H; Rosenfeld 68, Jeffrey; Garcia 68, Rebekah; Echevarria 68, Laura; Garcia 68, Sonia; Pulley 69, Michael; Aranke 69, Shachie; Ross Berger 69, Alan; Shah 69, Jaimin; Shabbir 69, Yasmeen; Smith 69, Lisa; Varghese 69, Mary; Gutmann 70, Laurie; Gutmann 70, Ludwig; Jerath 70, Nivedita; Nance 70, Christopher; Swenson 70, Andrea; Olalde 70, Heena; Kressin 70, Nicole; Sieren 70, Jeri; Barohn 71, Richard; Dimachkie 71, Mazen; Glenn 71, Melanie; McVey 71, April; Pasnoor 71, Mamatha; Statland 71, Jeffery; Wang 71, Yunxia; Liu 71, Tina; Emmons 71, Kelley; Jenci 71, Nicole; Locheke 71, Jerry; Fondaw 71, Alex; Johns 71, Kathryn; Rico 71, Gabrielle; Walsh 71, Maureen; Herbelin 71, Laura; Hafer-Macko 72, Charlene; Kwan 72, Justin; Zilliox 72, Lindsay; Callison 72, Karen; Young 72, Valerie; DiSanzo 72, Beth; Naunton 72, Kerry; Benatar 73, Michael; Bilsker 73, Martin; Sharma 73, Khema; Cooley 73, Anne; Reyes 73, Eliana; Michon 73, Sara-Claude; Sheldon 73, Danielle; Steele 73, Julie; Howard Jr 74, James; Karam 74, Chafic; Chopra 74, Manisha; Traub 74, Rebecca; Vu 75, Tuan; Katzin 75, Lara; McClain 75, Terry; Harvey 75, Brittany; Hart 75, Adam; Huynh 75, Kristin; Beydoun 76, Said; Chilingaryan 76, Amaiak; Doan 76, Victor; Droker 76, Brian; Gong 76, Hui; Karimi 76, Sanaz; Lin 76, Frank; McClain 76, Terry; Pokala 76, Krishna; Shah 76, Akshay; Tran 76, Anh; Akhter 76, Salma; Malekniazi 76, Ali; Tandan 77, Rup; Hehir 77, Michael; Waheed 77, Waqar; Lucy 77, Shannon; Weiss 78, Michael; Distad 78, Jane; Strom 78, Susan; Downing 78, Sharon; Kim 78, Bryan; Nowak 79, Richard; Dicapua 79, Daniel; Keung 79, Benison; Kumar 79, Aditya; Patwa 79, Huned; Robeson 79, Kimberly; Yang 79, Irene; Nye 79, Joan; ., Hong Vu. - In: JOURNAL OF THE NEUROLOGICAL SCIENCES. - ISSN 0022-510X. - 407:(2019), p. 116419. [10.1016/j.jns.2019.08.004]
Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study
Murai H.; Uzawa A.; Suzuki Y.; Imai T.; Shiraishi H.; Suzuki H.; Okumura M.; O'Brien F.; Wang J. -J.; Fujita K. P.; Utsugisawa K.; Claudio Gabriel Mazia 11; Miguel Wilken 11; Fabio Barroso 11; Juliet Saba 11; Marcelo Rugiero 12; Mariela Bettini 12; Marcelo Chaves 12; Gonzalo Vidal 12; Alejandra Dalila Garcia 12; Jan De Bleecker 13; Guy Van den Abeele 13; Kathy de Koning 13; Katrien De Mey 13; Rudy Mercelis 14; Délphine Mahieu 14; Linda Wagemaekers 14; Philip Van Damme 15; Annelies Depreitere 16; Caroline Schotte 16; Charlotte Smetcoren 16; Olivier Stevens 16; Sien Van Daele 16; Nicolas Vandenbussche 16; Annelies Vanhee 16; Sarah Verjans 16; Jan Vynckier 16; Ann D'Hondt 16; Petra Tilkin 16; Alzira Alves de Siqueira Carvalho 17; Igor Dias Brockhausen 17; David Feder 17; Daniel Ambrosio 17; Pamela César 17; Ana Paula Melo 17; Renata Martins Ribeiro 17; Rosana Rocha 17; Bruno Bezerra Rosa 17; Thabata Veiga 17; Luiz Augusto da Silva 17; Murilo Santos Engel 17; Jordana Gonçalves Geraldo 17; Maria da Penha Ananias Morita 18; Erica Nogueira Coelho 18; Gabriel Paiva 18; Marina Pozo 18; Natalia Prando 18; Debora Dada Martineli Torres 18; Cristiani Fernanda Butinhao 18; Gustavo Duran 18; Tamires Cristina Gomes da Silva 18; Luiz Otavio Maia Gonçalves 18; Lucas Eduardo Pazetto 18; Tomás Augusto Suriane Fialho 18; Luciana Renata Cubas Volpe 18; Luciana Souza Duca 18; Acary Souza Bulle Oliveira 19; Ana Carolina Amaral Andrade 19; Marcelo Annes 19; Liene Duarte Silva 19; Valeria Cavalcante Lino 19; Wladimir Pinto 19; Natália Assis 19; Fernanda Carrara 19; Carolina Miranda 19; Iandra Souza 19; Patricia Fernandes 19; Zaeem Siddiqi 20; Cecile Phan 20; Jeffrey Narayan 20; Derrick Blackmore 20; Ashley Mallon 20; Rikki Roderus 20; Elizabeth Watt 20; Jana Junkerova 21; Barbora Kurkova 21; Katarina Reguliova 21; Olga Zapletalova 21; Jiri Pitha 22; Iveta Novakova 22; Michaela Tyblova 22; Ivana Jurajdova 22; Marcela Wolfova 22; Henning Andersen 23; Thomas Harbo 23; Lotte Vinge 23; Susanne Krogh 23; Anita Mogensen 23; John Vissing 24; Joan Højgaard 24; Nanna Witting 24; Anne Mette Ostergaard Autzen 24; Jane Pedersen 24; Juha-Pekka Eralinna 25; Mikko Laaksonen 25; Olli Oksaranta 25; Tuula Harrison 25; Jaana Eriksson 25; Csilla Rozsa 26; Melinda Horvath 26; Gabor Lovas 26; Judit Matolcsi 26; Gyorgyi Szabo 26; Gedeonne Jakab 26; Brigitta Szabadosne 26; Giovanni Antonini 27; Antonella Di Pasquale 27; Matteo Garibaldi 27; Stefania Morino 27; Fernanda Troili 27; Laura Fionda 27; Allessandro Filla; Teresa Costabile ;Enrico Marano ;Francesco Saccà ;Angiola Fasanaro; Angela Marsili ;Giorgia Puorro ;Renato Mantegazza 29; Carlo Antozzi 29; Silvia Bonanno 29; Giorgia Camera 29; Alberta Locatelli 29; Lorenzo Maggi 29; Maria Pasanisi 29; Angela Campanella 29; Amelia Evoli 30; Paolo Emilio Alboini 30; Valentina D'Amato 30; Raffaele Iorio 30; Tetsuya Kanai 31; Naoki Kawaguchi 31; Masahiro Mori 31; Yoko Kaneko 31; Akiko Kanzaki 31; Eri Kobayashi 31; Katsuhisa Masaki 32; Dai Matsuse 32; Takuya Matsushita 32; Taira Uehara 32; Misa Shimpo 32; Maki Jingu 32; Keiko Kikutake 32; Yumiko Nakamura 32; Yoshiko Sano 32; Yuriko Nagane 33; Ikuko Kamegamori 33; Tomoko Tsuda 33; Yuko Fujii 33; Kazumi Futono 33; Yukiko Ozawa 33; Aya Mizugami 33; Yuka Saito 33; Miyuki Morikawa 34; Makoto Samukawa 34; Sachiko Kamakura 34; Eriko Miyawaki 34; Teiichiro Mitazaki 35; Masakatsu Motomura 35; Akihiro Mukaino 35; Shunsuke Yoshimura 35; Shizuka Asada 35; Seiko Yoshida 35; Shoko Amamoto 35; Tomomi Kobashikawa 35; Megumi Koga 35; Yasuko Maeda 35; Kazumi Takada 35; Mihoko Takada 35; Masako Tsurumaru 35; Yumi Yamashita 35; Tetsuya Akiyama 36; Koichi Narikawa 36; Ohito Tano 36; Kenichi Tsukita 36; Rikako Kurihara 36; Fumie Meguro 36; Yusuke Fukuda 36; Miwako Sato 36; Soichiro Funaka 37; Tomohiro Kawamura 37; Masayuki Makamori 37; Masanori Takahashi 37; Namie Taichi 37; Tomoya Hasuike 37; Eriko Higuchi 37; Hisako Kobayashi 37; Kaori Osakada 37; Emiko Tsuda 38; Shun Shimohama 38; Takashi Hayashi 38; Shin Hisahara 38; Jun Kawamata 38; Takashi Murahara 38; Masaki Saitoh 38; Shuichiro Suzuki 38; Daisuke Yamamoto 38; Yoko Ishiyama 38; Naoko Ishiyama 38; Mayuko Noshiro 38; Rumi Takeyama 38; Kaori Uwasa 38; Ikuko Yasuda 38; Anneke van der Kooi 39; Marianne de Visser 39; Tamar Gibson 39; Carlos Casasnovas 40; Maria Antonia Alberti Aguilo 40; Christian Homedes-Pedret 40; Natalia Julia Palacios 40; Laura Diez Porras 40; Valentina Velez Santamaria 40; Ana Lazaro 40; Exuperio Diez Tejedor 41; Pilar Gomez Salcedo 41; Mireya Fernandez-Fournier 41; Pedro Lopez Ruiz 41; Francisco Javier Rodriguez de Rivera 41; Maria Sastre 41; Josep Gamez 42; Pilar Sune 42; Maria Salvado 42; Gisela Gili 42; Gonzalo Mazuela 42; Isabel Illa 43; Elena Cortes Vicente 43; Jordi Diaz-Manera 43; Luis Antonio Querol Gutierrez 43; Ricardo Rojas Garcia 43; Nuria Vidal 43; Elisabet Arribas-Ibar 43; Fredrik Piehl 44; Albert Hietala 44; Lena Bjarbo 44; Ihsan Sengun 45; Arzu Meherremova 45; Pinar Ozcelik 45; Bengu Balkan 45; Celal Tuga 45; Muzeyyen Ugur 45; Sevim Erdem-Ozdamar 46; Can Ebru Bekircan-Kurt 46; Nazire Pinar Acar 46; Ezgi Yilmaz 46; Yagmur Caliskan 46; Gulsah Orsel 46; Husnu Efendi 47; Seda Aydinlik 47; Hakan Cavus 47; Ayse Kutlu 47; Gulsah Becerikli 47; Cansu Semiz 47; Ozlem Tun 47; Murat Terzi 48; Baki Dogan 48; Musa Kazim Onar 48; Sedat Sen 48; Tugce Kirbas Cavdar 48; Adife Veske 48; Fiona Norwood 49; Aikaterini Dimitriou 49; Jakit Gollogly 49; Mohamed Mahdi-Rogers 49; Arshira Seddigh 49; Giannis Sokratous 49; Gal Maier 49; Faisal Sohail 49; Saiju Jacob 50; Girija Sadalage 50; Pravin Torane 50; Claire Brown 50; Amna Shah 50; Sivakumar Sathasivam 51; Heike Arndt 51; Debbie Davies 51; Dave Watling 51; Anthony Amato 52; Thomas Cochrane 52; Mohammed Salajegheh 52; Kristen Roe 52; Katherine Amato 52; Shirli Toska 52; Gil Wolfe 53; Nicholas Silvestri 53; Kara Patrick 53; Karen Zakalik 53; Jonathan Katz 54; Robert Miller 54; Marguerite Engel 54; Dallas Forshew 54; Elena Bravver 55; Benjamin Brooks 55; Sarah Plevka 55; Maryanne Burdette 55; Scott Cunningham 55; Mohammad Sanjak 55; Megan Kramer 55; Joanne Nemeth 55; Clara Schommer 55; Scott Tierney 55; Vern Juel 56; Jeffrey Guptill 56; Lisa Hobson-Webb 56; Janice Massey 56; Kate Beck 56; Donna Carnes 56; John Loor 56; Amanda Anderson 56; Robert Pascuzzi 57; Cynthia Bodkin 57; John Kincaid 57; Riley Snook 57; Sandra Guingrich 57; Angela Micheels 57; Vinay Chaudhry 58; Andrea Corse 58; Betsy Mosmiller 58; Andrea Kelley 58; Doreen Ho 59; Jayashri Srinivasan 59; Michal Vytopil 59; Jordan Jara 59; Nicholas Ventura 59; Stephanie Scala 59; Cynthia Carter 59; Craig Donahue 59; Carol Herbert 59; Elaine Weiner 59; Sharmeen Alam 59; Jonathan McKinnon 60; Laura Haar 60; Naya McKinnon 60; Karan Alcon 60; Kaitlyn McKenna 60; Nadia Sattar 60; Kevin Daniels 60; Dennis Jeffery 60; Miriam Freimer 61; Joseph Chad Hoyle 61; John Kissel 61; Julie Agriesti 61; Sharon Chelnick 61; Louisa Mezache 61; Colleen Pineda 61; Filiz Muharrem 61; Chafic Karam 62; Julie Khoury 62; Tessa Marburger 62; Harpreet Kaur 62; Diana Dimitrova 62; James Gilchrist 63; Brajesh Agrawal 63; Mona Elsayed 63; Stephanie Kohlrus 63; Angela Andoin 63; Taylor Darnell 63; Laura Golden 63; Barbara Lokaitis 63; Jenna Seelback 63; Srikanth Muppidi 64; Neelam Goyal 64; Sarada Sakamuri 64; Yuen T So 64; Shirley Paulose 64; Sabrina Pol 64; Lesly Welsh 64; Ratna Bhavaraju-Sanka 65; Alejandro Tobon Gonzales 65; Lorraine Dishman 65; Floyd Jones 65; Anna Gonzalez 65; Patricia Padilla 65; Amy Saklad 65; Marcela Silva 65; Mohamed Kazamel 66; Mohammad Alsharabati 66; Liang Lu 66; Kenkichi Nozaki 66; Sandi Mumfrey-Thomas 66; Amy Woodall 66; Tahseen Mozaffar 67; Tiyonnoh Cash 67; Namita Goyal 67; Gulmohor Roy 67; Veena Mathew 67; Fatima Maqsood 67; Brian Minton 67; H James Jones 68; Jeffrey Rosenfeld 68; Rebekah Garcia 68; Laura Echevarria 68; Sonia Garcia 68; Michael Pulley 69; Shachie Aranke 69; Alan Ross Berger 69; Jaimin Shah 69; Yasmeen Shabbir 69; Lisa Smith 69; Mary Varghese 69; Laurie Gutmann 70; Ludwig Gutmann 70; Nivedita Jerath 70; Christopher Nance 70; Andrea Swenson 70; Heena Olalde 70; Nicole Kressin 70; Jeri Sieren 70; Richard Barohn 71; Mazen Dimachkie 71; Melanie Glenn 71; April McVey 71; Mamatha Pasnoor 71; Jeffery Statland 71; Yunxia Wang 71; Tina Liu 71; Kelley Emmons 71; Nicole Jenci 71; Jerry Locheke 71; Alex Fondaw 71; Kathryn Johns 71; Gabrielle Rico 71; Maureen Walsh 71; Laura Herbelin 71; Charlene Hafer-Macko 72; Justin Kwan 72; Lindsay Zilliox 72; Karen Callison 72; Valerie Young 72; Beth DiSanzo 72; Kerry Naunton 72; Michael Benatar 73; Martin Bilsker 73; Khema Sharma 73; Anne Cooley 73; Eliana Reyes 73; Sara-Claude Michon 73; Danielle Sheldon 73; Julie Steele 73; James Howard Jr 74; Chafic Karam 74; Manisha Chopra 74; Rebecca Traub 74; Tuan Vu 75; Lara Katzin 75; Terry McClain 75; Brittany Harvey 75; Adam Hart 75; Kristin Huynh 75; Said Beydoun 76; Amaiak Chilingaryan 76; Victor Doan 76; Brian Droker 76; Hui Gong 76; Sanaz Karimi 76; Frank Lin 76; Terry McClain 76; Krishna Pokala 76; Akshay Shah 76; Anh Tran 76; Salma Akhter 76; Ali Malekniazi 76; Rup Tandan 77; Michael Hehir 77; Waqar Waheed 77; Shannon Lucy 77; Michael Weiss 78; Jane Distad 78; Susan Strom 78; Sharon Downing 78; Bryan Kim 78; Richard Nowak 79; Daniel Dicapua 79; Benison Keung 79; Aditya Kumar 79; Huned Patwa 79; Kimberly Robeson 79; Irene Yang 79; Joan Nye 79; Hong Vu .
2019
Abstract
The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229). In this 52-week sub-analysis of the open-label extension of REGAIN (NCT02301624), eculizumab's efficacy and safety were assessed in 11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis. For patients who had received placebo during REGAIN, treatment with open-label eculizumab resulted in generally similar outcomes in the Japanese and Caucasian populations. Rapid improvements were maintained for 52 weeks, assessed by change in score from open-label extension baseline to week 52 (mean [standard error]) using the following scales (in Japanese and Caucasian patients, respectively): Myasthenia Gravis Activities of Daily Living (−2.4 [1.34] and − 3.3 [0.65]); Quantitative Myasthenia Gravis (−2.9 [1.98] and − 4.3 [0.79]); Myasthenia Gravis Composite (−4.5 [2.63] and − 4.9 [1.19]); and Myasthenia Gravis Quality of Life 15-item questionnaire (−8.6 [5.68] and − 6.5 [1.93]). Overall, the safety of eculizumab was consistent with its known safety profile. In this interim sub-analysis, the efficacy and safety of eculizumab in Japanese and Caucasian patients were generally similar, and consistent with the overall REGAIN population.
Citazione
Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study / H., Murai; A., Uzawa; Y., Suzuki; T., Imai; H., Shiraishi; H., Suzuki; M., Okumura; F., O'Brien; J. -J., Wang; K. 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[10.1016/j.jns.2019.08.004]
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Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande. La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.