Eculizumab in refractory generalized myasthenia gravis previously treated with rituximab: subgroup analysis of REGAIN and its extension studyopen access
- Authors
- Siddiqi, Zaeem A.; Nowak, Richard J.; Mozaffar, Tahseen; O'Brien, Fanny; Yountz, Marcus; Patti, Francesco; 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; de Siqueira Carvalho, Alzira Alves; Brockhausen, Igor Dias; Feder, David; Ambrosio, Daniel; César, Pamela; Melo, Ana Paula; Ribeiro, Renata Martins; Rocha, Rosana; Rosa, Bruno Bezerra; Veiga, Thabata; da Silva, Luiz Augusto; Engel, Murilo Santos; Geraldo, Jordana Gonçalves; da Penha Ananias Morita, Maria; Coelho, Erica Nogueira; Paiva, Gabriel; Pozo, Marina; Prando, Natalia; Torres, Debora Dada Martineli; Butinhao, Cristiani Fernanda; Duran, Gustavo; Fialho, Tomás Augusto Suriane; da Silva, Tamires Cristina Gomes; Gonçalves, Luiz Otavio Maia; Pazetto, Lucas Eduardo; Volpe, Luciana Renata Cubas; Duca, Luciana Souza; Friedrich, Maurício André Gheller; Guerreiro, Alexandre; Mohr, Henrique; Martins, Maurer Pereira; da Cruz Pacheco, Daiane; Ferreira, Luciana; Macagnan, Ana Paula; Pinto, Graziela; de Cassia Santos, Aline; Oliveira, Acary Souza Bulle; de Andrade, Ana Carolina Amaral; Annes, Marcelo; Silva, Liene Duarte; Lino, Valeria Cavalcante; Pinto, Wladimir; Assis, Natália; Carrara, Fernanda; Miranda, Carolina; Souza, Iandra; Fernandes, Patrícia; 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; Autzen, Anne Mette Ostergaard; Pedersen, Jane; Erälinna, Juha-Pekka; Laaksonen, Mikko; Oksaranta, Olli; Harrison, Tuula; Eriksson, Jaana; Rozsa, Csilla; Horvath, Melinda; Lovas, Gabor; Matolcsi, Judit; Szabo, Gyorgyi; Jakab, Gedeonne; Szabadosne, Brigitta; Vecsei, Laszlo; Dezsi, Livia; Varga, Edina; Konyane, Monika; Antonini, Giovanni; Di Pasquale, Antonella; Garibaldi, Matteo; Morino, Stefania; Troili, Fernanda; Fionda, Laura; Saccà, Francesco; Filla, Alessandro; Costabile, Teresa; Marano, Enrico; Fasanaro, Angiola; Marsili, Angela; Puorro, Giorgia; Mantegazza, Renato; Antozzi, Carlo; Bonanno, Silvia; Camera, Giorgia; Locatelli, Alberta; Maggi, Lorenzo; Pasanisi, Maria; Campanella, Angela; Evoli, Amelia; Alboini, Paolo Emilio; D'Amato, Valentina; Iorio, Raffaele; Inghilleri, Maurizio; Frasca, Vittorio; Giacomelli, Elena; Gori, Maria; Lopergolo, Diego; Onesti, Emanuela; Gabriele, Maria; 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; Shiraishi, Hirokazu; Miyazaki, Teiichiro; Motomura, Masakatsu; Mukaino, Akihiro; Yoshimura, Shunsuke; Asada, Shizuka; Yoshida, Seiko; Amamoto, Shoko; Kobashikawa, Tomomi; Koga, Megumi; Maeda, Yasuko; Takada, Kazumi; Takada, Mihoko; Tsurumaru, Masako; Yamashita, Yumi; Yoshida, Seiko; Suzuki, Yasushi; Akiyama, Tetsuya; Narikawa, Koichi; Tano, Ohito; Tsukita, Kenichi; Kurihara, Rikako; Meguro, Fumie; Fukuda, Yusuke; Sato, Miwako; Okumura, Meinoshin; Funaka, Soichiro; Kawamura, Tomohiro; Nakamori, Masayuki; Takahashi, Masanori; Taichi, Namie; Hasuike, Tomoya; Higuchi, Eriko; Kobayashi, Hisako; Osakada, Kaori; 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; Kim, Byung-Jo; Lee, Chang Nyoung; Koo, Yong Seo; Seok, Hung Youl; Kang, Hoo Nam; Ra, Hye Jin; Kim, Byoung Joon; Cho, Eun Bin; Choi, Mi Song; Lee, Hye Lim; Min, Ju-Hong; Seok, Jinmyoung; Lee, Ji Eun; Koh, Da Yoon; Kwon, Ju Young; Park, Sang Ae; 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, Jin Woo; Kim, Yool-hee; Lee, Hyung Seok; Shin, Ha Young; Hwang, Eun Bi; Shin, Miju; van der Kooi, Anneke; de Visser, Marianne; Gibson, Tamar; Casasnovas, Carlos; Aguilo, Maria Antonia Alberti; Homedes-Pedret, Christian; Palacios, Natalia Julia; Porras, Laura Diez; Santamaria, Valentina Velez; Lazaro, Ana; Tejedor, Exuperio Diez; Salcedo, Pilar Gomez; Fernandez-Fournier, Mireya; Ruiz, Pedro Lopez; de Rivera, Francisco Javier Rodriguez; Sastre, Maria; Carbonell, Josep Gamez; Sune, Pilar; Figueras, Maria Salvado; Gili, Gisela; Mazuela, Gonzalo; Illa, Isabel; Vicente, Elena Cortes; Diaz-Manera, Jordi; Gutiérrez, Luis Antonio Querol; Garcia, Ricardo Rojas; Vidal, Nuria; Arribas-Ibar, Elisabet; 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; Wolfe, Gil; 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; Sanjak, Mohammad; 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; Muppidi, Srikanth; 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; 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; Howard, James; 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; Dicapua, Daniel; Keung, Benison; Kumar, Aditya; Patwa, Huned; Robeson, Kimberly; Yang, Irene; Nye, Joan; Vu, Hong
- Issue Date
- Dec-2021
- Publisher
- John Wiley & Sons Inc.
- Keywords
- acetylcholine receptor; eculizumab; myasthenia gravis; refractory; rituximab
- Citation
- Muscle and Nerve, v.64, no.6, pp 662 - 669
- Pages
- 8
- Indexed
- SCIE
SCOPUS
- Journal Title
- Muscle and Nerve
- Volume
- 64
- Number
- 6
- Start Page
- 662
- End Page
- 669
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/65286
- DOI
- 10.1002/mus.27422
- ISSN
- 0148-639X
1097-4598
- Abstract
- Introduction/Aims: Individuals with refractory generalized myasthenia gravis (gMG) who have a history of rituximab use and experience persistent symptoms represent a population with unmet treatment needs. The aim of this analysis was to evaluate the efficacy and safety of eculizumab in patients with refractory anti-acetylcholine receptor antibody-positive (AChR+) gMG previously treated with rituximab. Methods: This post hoc subgroup analysis of the phase 3 REGAIN study (NCT01997229) and its open-label extension (OLE; NCT02301624) compared baseline characteristics, safety, and response to eculizumab in participants who had previously received rituximab with those who had not. Rituximab use was not permitted within the 6 months before screening or during REGAIN/OLE. Results: Of 125 REGAIN participants, 14 had received rituximab previously (7 received placebo and 7 received eculizumab). In the previous-rituximab group, 57% had used at least four other immunosuppressants compared with 16% in the no-previous-rituximab group. Myasthenia Gravis Activities of Daily Living total scores from eculizumab baseline to week 130 of eculizumab treatment improved in both the previous-rituximab and no-previous-rituximab groups (least-squares mean −4.4, standard error of the mean [SEM] 1.0 [n = 9] and least-squares mean −4.6, SEM 0.3 [n = 67], respectively; difference = 0.2, 95% confidence interval −1.88 to 2.22). In addition, in both groups, most patients who were treated with eculizumab for 130 weeks achieved a Myasthenia Gravis Foundation of America post-intervention status of minimal manifestations (66.7% and 65.0%, respectively). The eculizumab safety profile was similar between groups and consistent with its established profile. Discussion: Eculizumab is an effective therapy for patients with refractory AChR+ gMG, irrespective of whether they had received rituximab treatment previously. © 2021 Wiley Periodicals LLC.
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