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Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension
- Mantegazza, Renato;
- Wolfe, Gil I.;
- Muppidi, Srikanth;
- Wiendl, Heinz;
- Fujita, Kenji P.;
- ... Kim, Byung-Jo;
- ... Lee, HyeLim;
- 외 550명
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ObjectiveTo evaluate whether eculizumab helps patients with anti-acetylcholine receptor-positive (AChR+) refractory generalized myasthenia gravis (gMG) achieve the Myasthenia Gravis Foundation of America (MGFA) post-intervention status of minimal manifestations (MM), we assessed patients' status throughout REGAIN (Safety and Efficacy of Eculizumab in AChR+ Refractory Generalized Myasthenia Gravis) and its open-label extension.MethodsPatients who completed the REGAIN randomized controlled trial and continued into the open-label extension were included in this tertiary endpoint analysis. Patients were assessed for the MGFA post-intervention status of improved, unchanged, worse, MM, and pharmacologic remission at defined time points during REGAIN and through week 130 of the open-label study.ResultsA total of 117 patients completed REGAIN and continued into the open-label study (eculizumab/eculizumab: 56; placebo/eculizumab: 61). At week 26 of REGAIN, more eculizumab-treated patients than placebo-treated patients achieved a status of improved (60.7% vs 41.7%) or MM (25.0% vs 13.3%; common OR: 2.3; 95% CI: 1.1-4.5). After 130 weeks of eculizumab treatment, 88.0% of patients achieved improved status and 57.3% of patients achieved MM status. The safety profile of eculizumab was consistent with its known profile and no new safety signals were detected.ConclusionEculizumab led to rapid and sustained achievement of MM in patients with AChR+ refractory gMG. These findings support the use of eculizumab in this previously difficult-to-treat patient population.ClinicalTrials.gov IdentifierREGAIN, NCT01997229; REGAIN open-label extension, NCT02301624.Classification of EvidenceThis study provides Class II evidence that, after 26 weeks of eculizumab treatment, 25.0% of adults with AChR+ refractory gMG achieved MM, compared with 13.3% who received placebo. © American Academy of Neurology.
키워드
COMPLEMENT INHIBITOR ECULIZUMAB; EFFICACY; SAFETY
- 제목
- Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension
- 저자
- Mantegazza, Renato; Wolfe, Gil I.; Muppidi, Srikanth; Wiendl, Heinz; Fujita, Kenji P.; O'Brien, Fanny L.; Booth, Heather D.E.; Howard, James F.; Mazia, Claudio Gabriel; Wilken, Miguel; Barroso, Fabio; Saba, Juliet; Rugiero, Marcelo; Bettini, Mariela; Chaves, Marcelo; Vidal, Gonzalo; Garcia, Alejandra Dalila; De Bleecker, Jan; Van Den Abeele, Guy; De Koning, Kathy; De Mey, Katrien; Mercelis, Rudy; Mahieu, Délphine; Wagemaekers, Linda; Van Damme, Philip; Depreitere, Annelies; Schotte, Caroline; Smetcoren, Charlotte; Stevens, Olivier; Van Daele, Sien; Vandenbussche, Nicolas; Vanhee, Annelies; Verjans, Sarah; Vynckier, Jan; D'Hont, Ann; Tilkin, Petra; Alves De Siqueira Carvalho, Alzira; Brockhausen, Igor Dias; Feder, David; Ambrosio, Daniel; César, Gabor Lovasamela; Melo, Ana Paula; Ribeiro, Renata Martins; Rocha, Rosana; Rosa, Bruno Bezerra; Veiga, Thabata; Augusto Da Silva, Luiz; Engel, Murilo Santos; Geraldo, Jordana Gonçalves; Da Penha Ananias Morita, Maria; Coelho, Erica Nogueira; Paiva, Gabriel; Pozo, Marina; Prando, Natalia; Martineli Torres, Debora Dada; Butinhao, Cristiani Fernanda; Duran, Gustavo; Suriane Fialho, Tomás Augusto; Gomes Da Silva, Tamires Cristina; Maia Gonçalves, Luiz Otavio; Pazetto, Lucas Eduardo; Cubas Volpe, Luciana Renata; Duca, Luciana Souza; Andrégheller Friedrich, Maurício; Guerreiro, Alexandre; Mohr, Henrique; Martins, Maurer Pereira; Da Cruz Pacheco, Daiane; Ferreira, Luciana; MacAgnan, Ana Paula; Pinto, Graziela; De Cassia Santos, Aline; Bulle Oliveira, Acary Souza; Amaral De Andrade, Ana Carolina; Annes, Marcelo; Silva, Liene Duarte; Lino, Valeria Cavalcante; Pinto, Wladimir; Assis, Natália; Carrara, Fernanda; Miranda, Carolina; Souza, Iandra; Fernandes, Patrícia; Siddiqi, Zaeem; Phan, Cecile; Narayan, Jeffrey; Blackmore, Derrick; Mallon, Ashley; Roderus, Rikki; Watt, Elizabeth; Vohanka, Stanislav; Bednarik, Josef; Chmelikova, Magda; Cierny, Marek; Toncrova, Stanislava; Junkerova, Jana; Kurkova, Barbora; Reguliova, Katarina; Zapletalova, Olga; Pitha, Jiri; Novakova, Iveta; Tyblova, Michaela; Jurajdova, Ivana; Wolfova, Marcela; Andersen, Henning; Harbo, Thomas; Vinge, Lotte; Krogh, Susanne; Mogensen, Anita; Vissing, John; Højgaard, Joan; Witting, Nanna; Ostergaard Autzen, Anne Mette; Pedersen, Jane; Erälinna, Juha-Pekka; Laaksonen, Mikko; Oksaranta, Olli; Harrison, Tuula; Eriksson, Jaana; Rozsa, Csilla; Horvath, Melinda; Lovas, Gabor; Matolcsi, Judit; Jakab, Gedeonne; Szabo, Gyorgyi; Szabadosne, Brigitta; Vecsei, Laszlo; Dezsi, Livia; Varga, Edina; Konyane, Monika; Antonini, Giovanni; Di Pasquale, Antonella; Garibaldi, Matteo; Morino, Stefania; Troili, Fernanda; Fionda, Laura; Evoli, Amelia; Alboini, Paolo Emilio; D'Amato, Valentina; Iorio, Raffaele; Inghilleri, Maurizio; Frasca, Vittorio; Giacomelli, Elena; Gori, Maria; Lopergolo, Diego; Onesti, Emanuela; Gabriele, Maria; Saccà, Francesco; Filla, Alessandro; Costabile, Teresa; Marano, Enrico; Fasanaro, Angiola; Marsili, Angela; Puorro, Giorgia; Antozzi, Carlo; Bonanno, Silvia; Camera, Giorgia; Locatelli, Alberta; Maggi, Lorenzo; Pasanisi, Maria; Campanella, Angela; Uzawa, Akiyuki; Kanai, Tetsuya; Kawaguchi, Naoki; Mori, Masahiro; Kaneko, Yoko; Kanzaki, Akiko; Kobayashi, Eri; Murai, Hiroyuki; Masaki, Katsuhisa; Matsuse, Dai; Matsushita, Takuya; Uehara, Taira; Shimpo, Misa; Jingu, Maki; Kikutake, Keiko; Nakamura, Yumiko; Sano, Yoshiko; Utsugisawa, Kimiaki; Nagane, Yuriko; Kamegamori, Ikuko; Tsuda, Tomoko; Fujii, Yuko; Futono, Kazumi; Ozawa, Yukiko; Mizugami, Aya; Saito, Yuka; Samukawa, Makoto; Suzuki, Hidekazu; Morikawa, Miyuki; Kamakura, Sachiko; Miyawaki, Eriko; Okumura, Meinoshin; Funaka, Soichiro; Kawamura, Tomohiro; Nakamori, Masayuki; Takahashi, Masanori; Taichi, Namie; Hasuike, Tomoya; Higuchi, Eriko; Kobayashi, Hisako; Osakada, Kaori; Shiraishi, Hirokazu; Miyazaki, Teiichiro; Motomura, Masakatsu; Mukaino, Akihiro; Yoshimura, Shunsuke; Asada, Shizuka; Yoshida, Seiko; Amamoto, Shoko; Kobashikawa, Tomomi; Koga, Megumi; Yasuko, Maeda; Takada, Kazumi; Takada, Mihoko; Tsurumaru, Masako; Yamashita, Yumi; Suzuki, Yasushi; Akiyama, Tetsuya; Narikawa, Koichi; Tano, Ohito; Tsukita, Kenichi; Kurihara, Rikako; Meguro, Fumie; Fukuda, Yusuke; Sato, Miwako; Imai, Tomihiro; Tsuda, Emiko; Shimohama, Shun; Hayashi, Takashi; Hisahara, Shin; Imai, Tomihiro; Kawamata, Jun; Murahara, Takashi; Saitoh, Masaki; Suzuki, Shuichiro; Yamamoto, Daisuke; Ishiyama, Yoko; Ishiyama, Naoko; Noshiro, Mayuko; Takeyama, Rumi; Uwasa, Kaori; Yasuda, Ikuko; Van Der Kooi, Anneke; De Visser, Marianne; Gibson, Tamar; Kim, Byung-Jo; Lee, Chang Nyoung; Koo, Yong Seo; Seok, Hung Youl; Kang, Hoo Nam; Ra, HyeJin; Kim, Byoung Joon; Cho, Eun Bin; Choi, MiSong; Lee, HyeLim; Min, Ju-Hong; Seok, Jinmyoung; Lee, JiEun; Koh, Da Yoon; Kwon, JuYoung; Park, SangAe; Choi, Eun Haw; Hong, Yoon-Ho; Ahn, So-Hyun; Koo, Dae Lim; Lim, Jae-Sung; Shin, Chae Won; Hwang, Ji Ye; Kim, Miri; Kim, Seung Min; Jeong, Ha-Neul; Jung, JinWoo; Kim, Yool-Hee; Lee, Hyung Seok; Shin, Ha Young; Hwang, Eun Bi; Shin, Miju; Casasnovas, Carlos; Alberti Aguilo, Maria Antonia; Homedes-Pedret, Christian; Palacios, Natalia Julia; Porras, Laura Diez; Santamaria, Valentina Velez; Lazaro, Ana; Carbonell, Josep Gamez; Sune, Pilar; Figueras, Maria Salvado; Gili, Gisela; Mazuela, Gonzalo; Illa, Isabel; Vicente, Elena Cortes; Diaz-Manera, Jordi; Querol Gutiérrez, Luis Antonio; Garcia, Ricardo Rojas; Vidal, Nuria; Arribas-Ibar, Elisabet; Tejedor, Exuperio Diez; Salcedo, Pilar Gomez; Fernandez-Fournier, Mireya; Lopez Ruiz, Pedro; Rodriguez De Rivera, Francisco Javier; Sastre, Maria; Piehl, Fredrik; Hietala, Albert; Bjarbo, Lena; Sengun, Ihsan; Meherremova, Arzu; Ozcelik, Pinar; Balkan, Bengu; Tuga, Celal; Ugur, Muzeyyen; Erdem-Ozdamar, Sevim; Bekircan-Kurt, Can Ebru; Acar, Nazire Pinar; Yilmaz, Ezgi; Caliskan, Yagmur; Orsel, Gulsah; Efendi, Husnu; Aydinlik, Seda; Cavus, Hakan; Kutlu, Ayse; Becerikli, Gulsah; Semiz, Cansu; Tun, Ozlem; Terzi, Murat; Dogan, Baki; Onar, Musa Kazim; Sen, Sedat; Cavdar, Tugce Kirbas; Veske, Adife; Norwood, Fiona; Dimitriou, Aikaterini; Gollogly, Jakit; Mahdi-Rogers, Mohamed; Seddigh, Arshira; Sokratous, Giannis; Maier, Gal; Sohail, Faisal; Jacob, Saiju; Sadalage, Girija; Torane, Pravin; Brown, Claire; Shah, Amna; Sathasivam, Sivakumar; Arndt, Heike; Davies, Debbie; Watling, Dave; Amato, Anthony; Cochrane, Thomas; Salajegheh, Mohammed; Roe, Kristen; Amato, Katherine; Toska, Shirli; Silvestri, Nicholas; Patrick, Kara; Zakalik, Karen; Katz, Jonathan; Miller, Robert; Engel, Marguerite; Forshew, Dallas; Bravver, Elena; Brooks, Benjamin; Sanjak, Mohammed; Plevka, Sarah; Burdette, Maryanne; Cunningham, Scott; Kramer, Megan; Nemeth, Joanne; Schommer, Clara; Scott, Tierney; Juel, Vern; Guptill, Jeffrey; Hobson-Webb, Lisa; Massey, Janice; Beck, Kate; Carnes, Donna; Loor, John; Anderson, Amanda; Pascuzzi, Robert; Bodkin, Cynthia; Kincaid, John; Snook, Riley; Guingrich, Sandra; Micheels, Angela; Chaudhry, Vinay; Corse, Andrea; Mosmiller, Betsy; Kelley, Andrea; Ho, Doreen; Srinivasan, Jayashri; Vytopil, Michal; Jara, Jordan; Ventura, Nicholas; Carter, Cynthia; Donahue, Craig; Herbert, Carol; Scala, Stephanie; Weiner, Elaine; Alam, Sharmeen; McKinnon, Jonathan; Haar, Laura; McKinnon, Naya; Alcon, Karan; McKenna, Kaitlyn; Sattar, Nadia; Daniels, Kevin; Jeffery, Dennis; Freimer, Miriam; Hoyle, Joseph Chad; Kissel, John; Agriesti, Julie; Chelnick, Sharon; Mezache, Louisa; Pineda, Colleen; Muharrem, Filiz; Karam, Chafic; Khoury, Julie; Marburger, Tessa; Kaur, Harpreet; Dimitrova, Diana; Gilchrist, James; Agrawal, Brajesh; Elsayed, Mona; Kohlrus, Stephanie; Ardoin, Angela; Darnell, Taylor; Golden, Laura; Lokaitis, Barbara; Seelbach, Jenna; Goyal, Neelam; Sakamuri, Sarada; So, Yuen T; Paulose, Shirley; Pol, Sabrina; Welsh, Lesly; Bhavaraju-Sanka, Ratna; Gonzalez, Alejandro Tobon; Dishman, Lorraine; Jones, Floyd; Gonzalez, Anna; Padilla, Patricia; Saklad, Amy; Silva, Marcela; Nations, Sharon; Trivedi, Jaya; Hopkins, Steve; Kazamel, Mohamed; Alsharabati, Mohammad; Lu, Liang; Nozaki, Kenkichi; Mumfrey-Thomas, Sandi; Woodall, Amy; Mozaffar, Tahseen; Cash, Tiyonnoh; Goyal, Namita; Roy, Gulmohor; Mathew, Veena; Maqsood, Fatima; Minton, Brian; Jones, H. James; Rosenfeld, Jeffrey; Garcia, Rebekah; Echevarria, Laura; Garcia, Sonia; Pulley, Michael; Aranke, Shachie; Berger, Alan Ross; Shah, Jaimin; Shabbir, Yasmeen; Smith, Lisa; Varghese, Mary; Gutmann, Laurie; Gutmann, Ludwig; Jerath, Nivedita; Nance, Christopher; Swenson, Andrea; Olalde, Heena; Kressin, Nicole; Sieren, Jeri; Barohn, Richard; Dimachkie, Mazen; Glenn, Melanie; McVey, April; Pasnoor, Mamatha; Statland, Jeffery; Wang, Yunxia; Liu, Tina; Emmons, Kelley; Jenci, Nicole; Locheke, Jerry; Fondaw, Alex; Johns, Kathryn; Rico, Gabrielle; Walsh, Maureen; Herbelin, Laura; Hafer-Macko, Charlene; Kwan, Justin; Zilliox, Lindsay; Callison, Karen; Young, Valerie; Disanzo, Beth; Naunton, Kerry; Benatar, Michael; Bilsker, Martin; Sharma, Khema; Cooley, Anne; Reyes, Eliana; Michon, Sara-Claude; Sheldon, Danielle; Steele, Julie; Traub, Rebecca; Chopra, Manisha; Vu, Tuan; Katzin, Lara; McClain, Terry; Harvey, Brittany; Hart, Adam; Huynh, Kristin; Beydoun, Said; Chilingaryan, Amaiak; Doan, Victor; Droker, Brian; Gong, Hui; Karimi, Sanaz; Lin, Frank; Polaka, Krishna; Shah, Akshay; Tran, Anh; Akhter, Salma; Malekniazi, Ali; Tandan, Rup; Hehir, Michael; Waheed, Waqar; Lucy, Shannon; Weiss, Michael; Distad, Jane; Strom, Susan; Downing, Sharon; Kim, Bryan; Bertorini, Tulio; Arnold, Thomas; Henderson, Kendrick; Pillai, Rekha; Liu, Ye; Wheeler, Lauren; Hewlett, Jasmine; Vanderhook, Mollie; Nowak, Richard; Dicapua, Daniel; Keung, Benison; Kumar, Aditya; Patwa, Huned; Robeson, Kimberly; Yang, Irene; Nye, Joan; Vu, Hong
- 발행일
- 2021-01
- 유형
- Article
- 저널명
- Neurology
- 권
- 96
- 호
- 4
- 페이지
- E610 ~ E618
- 언어
- ENG
- 출판사
- Lippincott Williams & Wilkins Ltd.
- 발행국가
- 미국
- ISSN
- E 1526-632X
P 0028-3878