Long‐term safety and efficacy of eculizumab in generalized myasthenia gravis

ABSTRACT Introduction: Eculizumab is effective and well tolerated in patients with antiacetylcholine receptor antibody‐positive refractory generalized myasthenia gravis (gMG; REGAIN; NCT01997229). We report an interim analysis of an open‐label extension of REGAIN, evaluating eculizumab's long‐t...

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Veröffentlicht in:	Muscle & nerve 2019-07, Vol.60 (1), p.14-24
Hauptverfasser:	Illa, Isabel, Wang, Jing Jing, Garcia, Alejandra Dalila, de Koning, Kathy, Stevens, Olivier, Pozo, Marina, Souza Duca, Luciana, Guerreiro, Alexandre, Carrara, Fernanda, Siddiqi, Zaeem, Kurkova, Barbora, Pitha, Jiri, Wolfova, Marcela, Pedersen, Jane, Oksaranta, Olli, Jakab, Gedeonne, Antonini, Giovanni, Di Pasquale, Antonella, Costabile, Teresa, Marsili, Angela, Bonanno, Silvia, Camera, Giorgia, Pasanisi, Maria, Gabriele, Maria, Uzawa, Akiyuki, Matsushita, Takuya, Kikutake, Keiko, Nakamura, Yumiko, Samukawa, Makoto, Mitazaki, Teiichiro, Yoshimura, Shunsuke, Tsurumaru, Masako, Makamori, Masayuki, Takahashi, Masanori, Hasuike, Tomoya, Kobayashi, Hisako, Osakada, Kaori, Imai, Tomihiro, Tsuda, Emiko, Murahara, Takashi, Suzuki, Shuichiro, Uwasa, Kaori, Min, Ju-Hong, Koh, Da Yoon, Kwon, JuYoung, Hwang, Ji Ye, Kim, Miri, Jung, JinWoo, Shin, Ha Young, Shin, Miju, Lazaro, Ana, Diez Tejedor, Exuperio, Salvado, Maria, Mazuela, Gonzalo, Diaz-Manera, Jordi, Piehl, Fredrik, Hietala, Albert, Sengun, Ihsan, Bekircan‐Kurt, Can Ebru, Orsel, Gulsah, Semiz, Cansu, Veske, Adife, Gollogly, Jakit, Sokratous, Giannis, Sohail, Faisal, Arndt, Heike, Amato, Anthony, Salajegheh, Mohammed, Patrick, Kara, Bravver, Elena, Cunningham, Scott, Schommer, Clara, Carnes, Donna, Bodkin, Cynthia, Carter, Cynthia, Jeffery, Dennis, Chelnick, Sharon, Marburger, Tessa, Gilchrist, James, Andoin, Angela, Seelback, Jenna, Bhavaraju-Sanka, Ratna, Alsharabati, Mohammad, Lu, Liang, Rosenfeld, Jeffrey, Pulley, Michael, Shah, Jaimin, Gutmann, Ludwig, Pasnoor, Mamatha, Jenci, Nicole, Locheke, Jerry, Fondaw, Alex, Sharma, Khema, Steele, Julie, Chopra, Manisha, Katzin, Lara, Beydoun, Said, Waheed, Waqar, Distad, Jane, Robeson, Kimberly
Format:	Artikel
Sprache:	eng
Schlagworte:	Activities of Daily Living Adult Angioedema - chemically induced Angioedema - epidemiology Antibodies Antibodies, Monoclonal, Humanized - therapeutic use Aspergillosis - epidemiology Aspergillosis - etiology Clinical Clinical s Complement Inactivating Agents - therapeutic use Disease Progression eculizumab Effectiveness Female Heart Diseases - chemically induced Heart Diseases - epidemiology Humans Injection Site Reaction - epidemiology Injection Site Reaction - etiology Longitudinal Studies Male Meningococcal Infections - epidemiology Meningococcal Infections - etiology Meningococcal Infections - prevention & control Meningococcal Vaccines - therapeutic use MGC MG‐ADL MG‐QOL15 Middle Aged Monoclonal antibodies Muscle Strength Myasthenia Myasthenia gravis Myasthenia Gravis - drug therapy Myasthenia Gravis - physiopathology Neuromuscular junctions Pharmacology QMG Quality of Life Remission Safety Treatment Outcome
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Zusammenfassung:	ABSTRACT Introduction: Eculizumab is effective and well tolerated in patients with antiacetylcholine receptor antibody‐positive refractory generalized myasthenia gravis (gMG; REGAIN; NCT01997229). We report an interim analysis of an open‐label extension of REGAIN, evaluating eculizumab's long‐term safety and efficacy. Methods: Eculizumab (1,200 mg every 2 weeks for 22.7 months [median]) was administered to 117 patients. Results: The safety profile of eculizumab was consistent with REGAIN; no cases of meningococcal infection were reported during the interim analysis period. Myasthenia gravis exacerbation rate was reduced by 75% from the year before REGAIN (P
ISSN:	0148-639X 1097-4598
DOI:	10.1002/mus.26447