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2. Taste disorders and alopecia in myasthenia gravis

Author

Uzawa, Akiyuki, Suzuki, Shigeaki, Kuwabara, Satoshi, Akamine, Hiroyuki, Onishi, Yosuke, Yasuda, Manato, Ozawa, Yukiko, Kawaguchi, Naoki, Kubota, Tomoya, Takahashi, Masanori P., Suzuki, Yasushi, Watanabe, Genya, Kimura, Takashi, Sugimoto, Takamichi, Samukawa, Makoto, Minami, Naoya, Masuda, Masayuki, Konno, Shingo, Nagane, Yuriko, and Utsugisawa, Kimiaki

Published
2024
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3. Worsening of myasthenic symptoms associated with statins

Author

Sugimoto, Takamichi, Suzuki, Shigeaki, Uzawa, Akiyuki, Yamawaki, Takemori, Masuda, Masayuki, Minami, Naoya, Kawaguchi, Naoki, Kubota, Tomoya, Takahashi, Masanori P., Suzuki, Yasushi, Watanabe, Genya, Konno, Shingo, Kimura, Takashi, Samukawa, Makoto, Ishizuchi, Kei, Akamine, Hiroyuki, Onishi, Yosuke, Yasuda, Manato, Nagane, Yuriko, Maruyama, Hirofumi, Murai, Hiroyuki, and Utsugisawa, Kimiaki

Published
2024
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5. Impact of Early Treatment with Intravenous High-Dose Methylprednisolone for Ocular Myasthenia Gravis

Author

Uzawa, Akiyuki, Suzuki, Shigeaki, Kuwabara, Satoshi, Akamine, Hiroyuki, Onishi, Yosuke, Yasuda, Manato, Ozawa, Yukiko, Kawaguchi, Naoki, Kubota, Tomoya, Takahashi, Masanori P., Suzuki, Yasushi, Watanabe, Genya, Kimura, Takashi, Sugimoto, Takamichi, Samukawa, Makoto, Minami, Naoya, Masuda, Masayuki, Konno, Shingo, Nagane, Yuriko, and Utsugisawa, Kimiaki

Published
2023
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6. Clinical features and outcomes of patients with muscle-specific kinase antibody-positive myasthenia gravis in Japan

Author

Yasuda, Manato, Uzawa, Akiyuki, Kuwabara, Satoshi, Suzuki, Shigeaki, Akamine, Hiroyuki, Onishi, Yosuke, Ozawa, Yukiko, Kawaguchi, Naoki, Kubota, Tomoya, Takahashi, Masanori P., Suzuki, Yasushi, Watanabe, Genya, Kimura, Takashi, Sugimoto, Takamichi, Samukawa, Makoto, Minami, Naoya, Masuda, Masayuki, Konno, Shingo, Nagane, Yuriko, and Utsugisawa, Kimiaki

Published
2023
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7. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study

Author

Genge, Angela, Massie, Rami, Berube, Maxime, Bril, Vera, Daniyal, Lubna, Mannan, Shabber, Ng, Eduardo, Raman, Ritesh Rohan Raghu, Sarpong, Evelyn, Alcantara, Monica, Dionne, Annie, Siddiqi, Zaeem, Blackmore, Derrick, Hussain, Faraz, Matte, Genevieve, Botez, Stephan, Tyblova, Michaela, Jakubikova, Michala, Junkerova, Jana, Vissing, John, Witting, Nanna, Holm-Yildiz, Sonja, Stemmerik, Mads, Andersen, Henning, Obál, Izabella, Solé, Guilhem, Mathis, Stéphane, Violleau, Marie-Hélène, Tranchant, Christine, Messai, Sihame, Chanson, Jean-Baptiste, Nadaj-Pakleza, Aleksandra, Verloes, Arnaud, Zaidi, Leila, Sacconi, Sabrina, Gambella, Manuela, Cavalli, Michele, Stojkovic, Tanya, Demeret, Sophie, Le Guennec, Loic, Querin, Giorgia, Weiss, Nicolas, Masingue, Marion, Magy, Laurent, Ghorab, Karima, Rukhadze, Ia, Tsiskaridze, Alexander, Janelidze, Marina, Margania, Temur, Then Bergh, Florian, Hänsel, Eike, Kalb, Andrea, Meilick, Bianca, Reuschel, Mandy, Teußer, Lars-Malte, Unterlauft, Astrid, Goedel, Clemens, Hagenacker, Tim, Totzeck, Andreas, Stolte, Benjamin, Blaes, Franz, Bindler, Christine, Tsoutsikas, Vasilios, Roediger, Annekathrin, Geis, Christian, Schmidt, Jens, Zschüntzsch, Jana, Schwarz, Margret, Meyer, Stefanie, Kummer, Karsten, Glaubitz, Stefanie, Zeng, Rachel, Wiendl, Heinz, Klotz, Luisa, Lammerskitten, Anna, Lünemann, Jan, Diószeghy, Péter, Mantegazza, Renato, Maggi, Lorenzo, Rinaldi, Elena, Gastaldi, Matteo, Mazzacane, Federico, Businaro, Pietro, Iorio, Raffaele, Antonini, Giovanni, Fionda, Laura, Rinaldi, Rita, Rossi, Simone, Habetswallner, Francesco, Tuccillo, Francesco, Umehara, Haruna, Uenaka, Eiko, Takahashi, Masanori, Higashi, Keiko, Kinoshita, Makoto, Yoneda, Emika, Nakamura, Noriko, Fujita, Saeka, Kubota, Tomoya, Ono, Masami, Yamamoto, Sana, Hatano, Taku, Oikoshi, Kazuki, Yokoyama, Kazumasa, Oji, Yutaka, Tomizawa, Yuji, Uzawa, Akiyuki, Yasuda, Manato, Akita, Sachiko, Ozawa, Yukiko, Onishi, Yosuke, Takaki, Miki, Yamada, Hiromi, Minemoto, Kanako, Sanko, Miki, Izawa, Nanae, Nakayama, Mayumi, Masuda, Masayuki, Tsuji, Rune, Ido, Nobuhiro, Hyodo, Yumi, Okubo, Yoshihiko, Minohara, Akiko, Haraguchi, Nana, Naito, Makiko, Yoshida, Seiko, Fukushige, Yuri, Tsujino, Akira, Nagaoka, Atsushi, Miyazaki, Teiichiro, Yoshimura, Shunsuke, Hirayama, Takuro, Shima, Tomoaki, Okamoto, Naoko, Matsumoto, Riki, Sekiguchi, Kenji, Ueda, Takehiro, Chihara, Norio, Kirimura, Mari, Sunagawa, Emi, Suzuki, Ayaka, Suzuki, Shigeaki, Wada, Aozora, Ishizuchi, Kei, Suzuki, Yasushi, Yata, Mitsuo, Komatsu, Yuka, Tsukita, Kenichi, Watanabe, Genya, Sato, Kazuki, Kawasaki, Emiko, Yamamoto, Naoki, Ono, Hirohiko, Tsuda, Tomoko, Ohashi, Shigeki, Utsugisawa, Kimiaki, Fujisawa, Yuka, Yokota, Yumiko, Nagane, Yuriko, Ayumi, Kameda, Takematsu, Yuka, Naito, Hiroyuki, Sugimoto, Takamichi, Kuwada, Kumiko, Rejdak, Konrad, Szklener, Sebastian, Kitowska, Monika, Derkacz, Kandyda, Druzdz, Artur, Berkowicz, Tomasz, Budzinska, Paulina, Halas, Marek, Zaslavskiy, Leonid, Skornyakova, Evgeniya, Kotov, Sergey, Novikova, Ekaterina, Sidorova, Olga, Goldobin, Vitalii, Alekseeva, Tatiana, Isabekova, Patimat, Malkova, Nadezhda, Korobko, Denis, Djordjevic, Gordana, Stojanov, Aleksandar, Peric, Stojan, Lavrnic, Dragana, Bozovic, Ivo, Palibrk, Aleksa, Casasnovas, Carlos, Nedkova-Hristova, Velina, Vidal Fernández, Nuria, Cortés Vicente, Elena, Querol Gutiérrez, Luis, Salvadó Figueras, Maria, Canovas Segura, Anna, Juntas Morales, Raúl, Sanchez Tejerina, Daniel, Saiz, Albert, Blanco Morgado, Yolanda, Llufriú Durán, Sara, Sepúlveda Gázquez, María, Martínez Hernández, Eugenia María, Gutiérrez Gutiérrez, Gerardo, Iniesta, Paqui, Meca Lallana, José, Guo, Yuh-Cherng, Chiu, Hou-Chang, Yeh, Jiann-Horng, Chen, Ya Hui, Lee, Mei Fen, Lee, Yi-Chung, Lai, Kuan Lin, Beydoun, Said, Akhter, Salma, Vu, Tuan, Lam, Lucy, Thomas, Alisha, Rivner, Michael, Quarles, Brandy, Lange, Dale, Holzberg, Shara, Pavlakis, Pantelis, Goutham, Ashwathy, Kaminski, Henry, Aly, Radwa, Ashworth, Lisa, Bender, Kathryn, Bond, Karie, Buckner, Joanne, Byerly, Sara, Caress, James, Clemons, Jessyca, Farmer, Asha, Franklin, Catherine, Harris, Summer, Hiatt, Meredith, Gandhi Mehta, Rachana, Miller, Gina, Smith, Lynn, Smith, Rose, Strittmatter, Brian, Mozaffar, Tahseen, Habib, Ali A, Hernandez, Isela, Moulton, Kelsey, Karam, Chafic, Ravikumar, Pranali, Lomen-Hoerth, Catherine, Rosow, Laura, George, Hannah, Irodenko, Viktoriya, Kang, Min, Denny, Carol, Hanson, Bart, Klein, Sara, Martinez-Thompson, Jennifer, Naddaf, Elie, Padgett, Denny, Sorenson, Eric, L Sultze, Jane, Weis, Delena, Rezania, Kourosh, Thonhoff, Jason, Shroff, Sheetal, Pascuzzi, Robert, Micheels, Angela, Bodkin, Cynthia, Comer, Adam, Baras, Gelasio, Wagner, Renee, Mahuwala, Zabeen, Ryan, Stephen, Su, Kai, Sharma, Khema, Brown, Andrew, Liow, Kore, Drużdż, Artur, Grosskreutz, Julian, Boehnlein, Marion, Bozorg, Ali, Gayfieva, Maryam, Greve, Bernhard, Woltering, Franz, and Kaminski, Henry J

Published
2023
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8. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study

Author

Sembinelli, Dylan, Teitelbaum, Jeanne, Nicolle, Michael, Bernard, Emilien, Svahn, Juliette, Spinazzi, Marco, Stojkovic, Tanya, Demeret, Sophie, Weiss, Nicolas, Le Guennec, Loïc, Messai, Sihame, Tranchant, Christine, Nadaj-Pakleza, Aleksandra, Chanson, Jean-Baptiste, Suliman, Muhtadi, Zaidi, Leila, Tard, Celine, Lecointe, Peggy, Zschüntzsch, Jana, Schmidt, Jens, Glaubitz, Stefanie, Zeng, Rachel, Scholl, Matthias, Kowarik, Markus, Ziemann, Ulf, Krumbholz, Markus, Martin, Pascal, Ruschil, Christoph, Dünschede, Jutta, Kemmner, Roswitha, Rumpel, Natalie, Berger, Benjamin, Totzeck, Andreas, Hagenacker, Tim, Stolte, Benjamin, Iorio, Raffaele, Evoli, Amelia, Falso, Silvia, Antozzi, Carlo, Frangiamore, Rita, Vanoli, Fiammetta, Rinaldi, Elena, Deguchi, Kazushi, Minami, Naoya, Nagane, Yuriko, Suzuki, Yasushi, Ishida, Sayaka, Suzuki, Shigeaki, Nakahara, Jin, Nagaoka, Astushi, Yoshimura, Shunsuke, Konno, Shingo, Tsuya, Youko, Uzawa, Akiyuki, Kubota, Tomoya, Takahashi, Masanori, Okuno, Tatsusada, Murai, Hiroyuki, Gilhus, Nils Erik, Boldingh, Marion, Rønning, Tone Hakvåg, Chyrchel-Paszkiewicz, Urszula, Kumor, Klaudiusz, Zielinski, Tomasz, Banaszkiewicz, Krzysztof, Błaż, Michał, Kłósek, Agata, Świderek-Matysiak, Mariola, Szczudlik, Andrzej, Paśko, Aneta, Szczechowski, Lech, Banach, Marta, Ilkowski, Jan, Kapetanovic Garcia, Solange, Ortiz Bagan, Patricia, Belén Cánovas Segura, Ana, Turon Sans, Joana, Vidal Fernandez, Nuria, Cortes Vicente, Elena, Rodrigo Armenteros, Patricia, Ashraghi, Mohammad, Cavey, Ana, Haslam, Liam, Emery, Anna, Liow, Kore, Yegiaian, Sharon, Barboi, Alexandru, Vazquez, Rosa Maria, Lennon, Joshua, Pascuzzi, Robert M, Bodkin, Cynthia, Guingrich, Sandra, Comer, Adam, Bromberg, Mark, Janecki, Teresa, Saba, Sami, Tellez, Marco, Elsheikh, Bakri, Freimer, Miriam, Heintzman, Sarah, Govindarajan, Raghav, Guptill, Jeffrey, Massey, Janice M, Juel, Vern, Gonzalez, Natalia, Habib, Ali A, Mozaffar, Tahseen, Korb, Manisha, Goyal, Namita, Machemehl, Hannah, Manousakis, Georgios, Allen, Jeffrey, Harper, Emily, Farmakidis, Constantine, Saavedra, Lilli, Dimachkie, Mazen, Pasnoor, Mamatha, Akhter, Salma, Beydoun, Said, McIlduff, Courtney, Nye, Joan, Roy, Bhaskar, Munro Sheldon, Bailey, Nowak, Richard, Barnes, Benjamin, Rivner, Michael, Suresh, Niraja, Shaw, Jessica, Harvey, Brittany, Lam, Lucy, Thomas, Nikki, Chopra, Manisha, Traub, Rebecca E, Jones, Sarah, Wagoner, Mary, Smajic, Sejla, Aly, Radwa, Katz, Jonathan, Chen, Henry, Miller, Robert G, Jenkins, Liberty, Khan, Shaida, Khatri, Bhupendra, Sershon, Lisa, Pavlakis, Pantelis, Holzberg, Shara, Li, Yuebing, Caristo, Irys B, Marquardt, Robert, Hastings, Debbie, Rube, Jacob, Lisak, Robert P, Choudhury, Aparna, Ruzhansky, Katherine, Sachdev, Amit, Shin, Susan, Bratton, Joan, Fetter, Mary, McKinnon, Naya, McKinnon, Jonathan, Sissons-Ross, Laura, Sahu, Amos, Distad, B Jane, Howard, James F, Jr, Bresch, Saskia, Genge, Angela, Hewamadduma, Channa, Hinton, John, Hussain, Yessar, Juntas-Morales, Raul, Kaminski, Henry J, Maniaol, Angelina, Mantegazza, Renato, Masuda, Masayuki, Sivakumar, Kumaraswamy, Śmiłowski, Marek, Utsugisawa, Kimiaki, Vu, Tuan, Weiss, Michael D, Zajda, Małgorzata, Boroojerdi, Babak, Brock, Melissa, de la Borderie, Guillemette, Duda, Petra W, Lowcock, Romana, Vanderkelen, Mark, and Leite, M Isabel

Published
2023
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12. Real‐world experience with eculizumab and switching to ravulizumab for generalized myasthenia gravis.

Author

Tokuyasu, Daiki, Suzuki, Shigeaki, Uzawa, Akiyuki, Nagane, Yuriko, Masuda, Masayuki, Konno, Shingo, Kubota, Tomoya, Samukawa, Makoto, Sugimoto, Takamichi, Ishizuchi, Kei, Oyama, Munenori, Yasuda, Manato, Akamine, Hiroyuki, Onishi, Yosuke, Suzuki, Yasushi, Kawaguchi, Naoki, Minami, Naoya, Kimura, Takashi, Takahashi, Masanori P., and Murai, Hiroyuki

Subjects
*MYASTHENIA gravis, *ECULIZUMAB, *CLINICAL trials, *PATIENTS' attitudes
Abstract

Objective: Eculizumab and ravulizumab are complement protein C5 inhibitors, showing efficacy and tolerability for patients with anti‐acetylcholine receptor‐positive (AChR+) generalized myasthenia gravis (gMG) in phase 3 clinical trials and subsequent analyses. The purpose of the present study was to evaluate the clinical significance of eculizumab and switching to ravulizumab for refractory AChR+ gMG patients in the real‐world experience. Methods: Among the database of Japan MG registry survey 2021, we studied AChR+ gMG patients who received eculizumab. We also evaluated these patients who switched from eculizumab to ravulizumab. Responder was defined as an improvement of at least 3 points in MG‐ADL. We performed a questionnaire of preference between eculizumab and ravulizumab. Results: Among 1,106 patients with AChR+ gMG, 36 patients (3%) received eculizumab (female 78%, mean age 56.0 years). Eculizumab was preferentially used in severe and refractory MG patients. The duration of eculizumab treatment was 35 months on average. MG‐ADL improved from 9.4 ± 4.9 to 5.9 ± 5.1, and 25 (70%) of the 36 gMG patients were responders. Postintervention status was markedly improved after the eculizumab treatment. Of 13 patients who did not continue eculizumab, 6 showed insufficiencies. Early onset MG was most effective. However, 15 patients switching from eculizumab to ravulizumab kept favorable response and tolerability. Questionnaire surveys showed preference for ravulizumab over eculizumab. Interpretation: Eculizumab and switching to ravulizumab showed to be effective for refractory AChR+ gMG patients in clinical settings. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Efficacy of ravulizumab in patients with generalized myasthenia gravis by time from diagnosis: A post hoc subgroup analysis of the CHAMPION MG study.

Author

Howard, James F., Vu, Tuan, Mantegazza, Renato, Kushlaf, Hani, Suzuki, Shigeaki, Wiendl, Heinz, Beasley, Kathleen N., Liao, Serena, and Meisel, Andreas

Abstract

Introduction/Aims: The CHAMPION MG study demonstrated that ravulizumab significantly improved Myasthenia Gravis‐Activities of Daily Living (MG‐ADL) and Quantitative Myasthenia Gravis (QMG) total scores versus placebo in adults with acetylcholine receptor antibody‐positive generalized myasthenia gravis (AChR+ gMG). This post hoc analysis aimed to assess these outcomes by time from MG diagnosis. Methods: Changes from baseline to week 26 in MG‐ADL and QMG total scores were analyzed by time from MG diagnosis to study entry (≤2 vs. >2 years). Within each subgroup, least‐squares (LS) mean changes for ravulizumab and placebo were compared using mixed models for repeated measures. Results: In ravulizumab‐treated patients, differences in LS mean (standard error of the mean) changes from baseline to week 26 were not statistically significant in the ≤2‐years subgroup versus the >2‐years subgroup for MG‐ADL (−4.3 [0.70] vs. −2.9 [0.37]; p =.0511) or QMG (−4.3 [0.94] vs. −2.5 [0.50]; p =.0822) scores. No clear trends were observed in the placebo group. LS mean changes from baseline were significantly greater for ravulizumab versus placebo in both the ≤2 and >2 years from diagnosis subgroups for MG‐ADL and QMG scores (all p <.05). The difference in treatment effect between the ≤2‐years and >2‐years subgroups was not statistically significant. No clinically meaningful between‐subgroup differences in treatment‐emergent adverse events were observed in ravulizumab‐treated patients. Discussion: Ravulizumab treatment improved clinical outcomes for patients with AChR+ gMG regardless of time from diagnosis. A numerical trend was observed favoring greater treatment effect with earlier versus later treatment after diagnosis. Further studies are required for confirmation. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Efficacy and safety of zilucoplan in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the phase III randomized RAISE study.

Author

Utsugisawa, Kimiaki, Deguchi, Kazushi, Konno, Shingo, Masuda, Masayuki, Minami, Naoya, Murai, Hiroyuki, Suzuki, Shigeaki, Suzuki, Yasushi, Tsujino, Akira, Uzawa, Akiyuki, Boroojerdi, Babak, de la Borderie, Guillemette, Brock, Melissa, Duda, Petra W., Vanderkelen, Mark, and Howard, James F.

Subjects
MYASTHENIA gravis, JAPANESE people, CHOLINERGIC receptors, THYMECTOMY, SUBGROUP analysis (Experimental design), ACTIVITIES of daily living
Abstract

Objectives: RAISE (NCT04115293) was a randomized, multicenter, double‐blind, placebo‐controlled phase III study of zilucoplan, a macrocyclic peptide and complement component 5 inhibitor with a dual mechanism of action, in patients with acetylcholine receptor autoantibody‐positive generalized myasthenia gravis (MG). RAISE showed clinically meaningful and statistically significant improvements in MG‐specific outcomes in the overall population. Here, we assess efficacy and safety of zilucoplan in patients with generalized myasthenia gravis in the Japanese patients enrolled in RAISE. Methods: Adults with acetylcholine receptor autoantibody‐positive generalized MG (MGFA disease class II–IV) were randomized 1:1 to daily self‐administered subcutaneous zilucoplan 0.3 mg/kg or placebo injections for 12 weeks. The primary efficacy endpoint was change from baseline to week 12 in the MG Activities of Daily Living score. Safety was assessed by the incidence of treatment‐emergent adverse events. Efficacy and safety outcomes of a Japanese subgroup were prespecified. Results: Overall, 16 Japanese patients were randomized to zilucoplan 0.3 mg/kg (n = 7) or placebo (n = 9). There was a clinically meaningful improvement in the MG Activities of Daily Living score at week 12 for zilucoplan versus placebo in the Japanese population, with least squares mean difference of −4.26 (95% confidence interval −7.40, −1.12), which was comparable with the overall population. The incidence of treatment‐emergent adverse events was similar in both treatment arms, with 57.1% and 55.6% of patients in the zilucoplan and placebo groups, respectively, experiencing treatment‐emergent adverse events. Conclusions: In a subgroup of Japanese patients, zilucoplan showed clinically meaningful improvement in MG‐specific outcomes with a favorable safety profile, consistent with the overall RAISE population. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial

Author

Misawa, S, Kuwabara, S, Sato, Y, Yamaguchi, N, Nagashima, K, Katayama, K, Sekiguchi, Y, Iwai, Y, Amino, H, Suichi, T, Yokota, T, Nishida, Y, Kanouchi, T, Kohara, N, Kawamoto, M, Ishii, J, Kuwahara, M, Suzuki, H, Hirata, K, Kokubun, N, Masuda, R, Kaneko, J, Yabe, I, Sasaki, H, Kaida, K, Takazaki, H, Suzuki, N, Suzuki, S, Nodera, H, Matsui, N, Tsuji, S, Koike, H, Yamasaki, R, Kusunoki, S, Nagashima, T, Shimizu, T, Hirotani, M, Kadoya, M, Nakahara, J, Shimizu, J, Tanaka, M, Sobue, G, Katsuno, M, Yamaguchi, H, Ogata, H, Misawa, Sonoko, Kuwabara, Satoshi, Sato, Yasunori, Yamaguchi, Nobuko, Nagashima, Kengo, Katayama, Kanako, Sekiguchi, Yukari, Iwai, Yuta, Amino, Hiroshi, Suichi, Tomoki, Yokota, Takanori, Nishida, Yoichiro, Kanouchi, Tadashi, Kohara, Nobuo, Kawamoto, Michi, Ishii, Junko, Kuwahara, Motoi, Suzuki, Hidekazu, Hirata, Koichi, Kokubun, Norito, Masuda, Ray, Kaneko, Juntaro, Yabe, Ichiro, Sasaki, Hidenao, Kaida, Ken-ichi, Takazaki, Hiroshi, Suzuki, Norihiro, Suzuki, Shigeaki, Nodera, Hiroyuki, Matsui, Naoko, Tsuji, Shoji, Koike, Haruki, Yamasaki, Ryo, and Kusunoki, Susumu

Published
2018
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30. A clinical predictive score for postoperative myasthenic crisis

Author

Kanai, Tetsuya, Uzawa, Akiyuki, Sato, Yasunori, Suzuki, Shigeaki, Kawaguchi, Naoki, Himuro, Keiichi, Oda, Fumiko, Ozawa, Yukiko, Nakahara, Jin, Suzuki, Norihiro, Takahashi, Yuko K., Ishibashi, Satoru, Yokota, Takanori, Ogawa, Takashi, Yokoyama, Kazumasa, Hattori, Nobutaka, Izaki, Shoko, Oji, Satoru, Nomura, Kyoichi, Kaneko, Juntaro, Nishiyama, Kazutoshi, Yoshino, Ichiro, and Kuwabara, Satoshi

Published
2017
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31. Muscle pathology of antisynthetase syndrome according to antibody subtypes.

Author

Tanboon, Jantima, Inoue, Michio, Hirakawa, Shinya, Tachimori, Hisateru, Hayashi, Shinichiro, Noguchi, Satoru, Okiyama, Naoko, Fujimoto, Manabu, Suzuki, Shigeaki, and Nishino, Ichizo

Subjects
DERMATOMYOSITIS, INCLUSION body myositis, IMMUNOGLOBULINS, HLA-DR antigens, PATHOLOGY
Abstract

Identification of antisynthetase syndrome (ASS) could be challenging due to inaccessibility and technical difficulty of the serology test for the less common non‐Jo‐1 antibodies. This study aimed to describe ASS antibody‐specific myopathology and evaluate the diagnostic utility of myofiber HLA‐DR expression. We reviewed 212 ASS muscle biopsies and compared myopathologic features among subtypes. Additionally, we compared their HLA‐DR staining pattern with 602 non‐ASS myositis and 140 genetically confirmed myopathies known to have an inflammatory component. We used t‐test and Fisher's exact for comparisons and used sensitivity, specificity, positive and negative predictive values to assess the utility of HLA‐DR expression for ASS diagnosis. RNAseq performed from a subset of myositis cases and histologically normal muscle biopsies was used to evaluate interferon (IFN)‐signaling pathway‐related genes. Anti‐OJ ASS showed prominent myopathology with higher scores in muscle fiber (4.6 ± 2.0 vs. 2.8 ± 1.8, p = 0.001) and inflammatory domains (6.8 ± 3.2 vs. 4.5 ± 2.9, p = 0.006) than non‐OJ ASS. HLA‐DR expression and IFN‐γ‐related genes upregulation were prominent in ASS and inclusion body myositis (IBM). When dermatomyositis and IBM were excluded, HLA‐DR expression was 95.4% specific and 61.2% sensitive for ASS with a positive predictive value of 85.9% and a negative predictive value of 84.2%; perifascicular HLA‐DR pattern is common in anti‐Jo‐1 ASS than non‐Jo‐1 ASS (63.1% vs. 5.1%, p < 0.0001). In the appropriate clinicopathological context, myofiber HLA‐DR expression help support ASS diagnosis. The presence of HLA‐DR expression suggests involvement of IFN‐γ in the pathogenesis of ASS, though the detailed mechanisms have yet to be elucidated. [ABSTRACT FROM AUTHOR]

Published
2023
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32. Association of immune‐mediated necrotizing myopathy with HLA polymorphisms.

Author

Ohnuki, Yuko, Suzuki, Shigeaki, Uruha, Akinori, Oyama, Munenori, Suzuki, Shingo, Kulski, Jerzy K., Nishino, Ichizo, and Shiina, Takashi

Subjects
*AUTOANTIBODIES, *MUSCLE diseases, *MUSCLE weakness, *ALLELES, *CREATINE kinase, *COLLAGEN diseases, *MYOSITIS
Abstract

Immune‐mediated necrotizing myopathy (IMNM) is a type of autoimmune myositis typically characterized clinically by proximal muscle weakness with elevated creatine kinase levels, pathologically by myofiber necrosis and regeneration with paucity of lymphocytic cell infiltration, and serologically by the presence of either of two myositis‐specific autoantibodies, anti‐SRP, and anti‐HMGCR antibodies. However, the HLA loci and alleles associated with IMNM are still not fully understood at least partly because IMNM was a relatively recently established condition. In this study, we genotyped the six HLA loci (HLA‐A, ‐B, ‐C, ‐DRB1, ‐DQB1 and ‐DPB1) in 250 patients (237 patients over age 18 years and 13 juvenile patients) diagnosed with IMNM based on clinicopathological features and autoantibody information and performed a case control study with Japanese healthy subjects. In the adult patients, specific HLA alleles associated with IMNM were identified at all HLA loci, with DRB1*08:03 showing the strongest association (OR = 2.5; p = 0.00000017). Furthermore, subgroup analysis with various clinical information showed that C*03:04 (OR = 3.7; p = 0.00012) was a higher risk allele for collagen disease in adult patients, and B*13:01 (OR = 23.2; p = 0.021) and C*03:04 (OR = 5.8; p = 0.0074) were higher risk for juvenile patients with anti‐HMGCR antibody‐positive IMNM. These findings will help to better understand the HLA genetic background and features of IMNM in designing future studies. [ABSTRACT FROM AUTHOR]

Published
2023
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37. Pediatric necrotizing myopathy associated with anti-3-hydroxy-3-methylglutaryl-coenzyme A reductase antibodies

Author

Liang, Wen-Chen, Uruha, Akinori, Suzuki, Shigeaki, Murakami, Nobuyuki, Takeshita, Eri, Chen, Wan-Zi, Jong, Yuh-Jyh, Endo, Yukari, Komaki, Hirofumi, Fujii, Tatsuya, Kawano, Yutaka, Mori-Yoshimura, Madoka, Oya, Yasushi, Xi, Jianying, Zhu, Wenhua, Zhao, Chongbo, Watanabe, Yurika, Ikemoto, Keisuke, Nishikawa, Atsuko, Hamanaka, Kohei, Mitsuhashi, Satomi, Suzuki, Norihiro, and Nishino, Ichizo

Published
2017
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39. Japan MG registry: Chronological surveys over 10 years.

Author

Suzuki, Shigeaki, Masuda, Masayuki, Uzawa, Akiyuki, Nagane, Yuriko, Konno, Shingo, Suzuki, Yasushi, Kubota, Tomoya, Sugimoto, Takamichi, Samukawa, Makoto, Watanabe, Genya, Ishizuchi, Kei, Akamine, Hiroyuki, Onishi, Yosuke, Yoshizumi, Kazuki, Uchi, Takafumi, Amino, Itaru, Ueta, Yuki, Minami, Naoya, Kawaguchi, Naoki, and Kimura, Takashi

Subjects
*MEDICAL care, *MYASTHENIA gravis, *PREDNISOLONE, *STEROID drugs
Abstract

The primary purpose of the Japanese myasthenia gravis registry (JAMG‐R) has been to research and promote high‐quality medical care for MG patients in Japan. We reviewed the findings of surveys performed by JAMG‐R over an ~10‐y period. The first goal for favorable quality of life (QOL) is a status of minimal manifestations (MM) or better with an oral prednisolone (PSL) dose of 5 mg/d or less (MM‐5 mg). Early and aggressive use of nonoral fast‐acting treatment together with low‐dose oral PSL (the "EFT strategy") is recommended to reduce disease severity with minimal oral steroid use so that the MM‐5 mg target can be met as soon as possible. We conducted the fourth largest multicenter survey ever in 2021, obtaining detailed clinical information from 1710 consecutive MG patients all over Japan, and compared the 2021 surveys with those from 2012 and 2015. The frequency of patients treated with EFT strategies showed a gradual increase, reaching 39% of the total MG patients in the 2021 survey. The current and maximum dose of PSL and the number of days at high‐dose (>20 mg/d) PSL showed decreases. Survey results indicate that as EFT strategies have spread, the percentage of patients on MM‐5 mg has increased. We again confirmed that MM‐5 mg was associated with favorable QOL in the 2021 survey. Recent data regarding COVID‐19 suggests that it did not seriously impact the MG population in Japan; unfortunately, refractory MG, observed in 21% of patients, is still an unresolved problem. [ABSTRACT FROM AUTHOR]

Published
2023
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40. The Japanese clinical guidelines 2022 for myasthenia gravis and Lambert–Eaton myasthenic syndrome.

Author

Murai, Hiroyuki, Utsugisawa, Kimiaki, Motomura, Masakatsu, Imai, Tomihiro, Uzawa, Akiyuki, and Suzuki, Shigeaki

Subjects
MYASTHENIA gravis, SYNDROMES
Abstract

The revised Japanese clinical guidelines for myasthenia gravis (MG) and Lambert–Eaton myasthenic syndrome (LEMS) were published in 2022. The notable points in these guidelines (GLs) are as follows: (i) these are the first Japanese GLs to include a description of LEMS; (ii) diagnostic criteria of MG are revised to lessen the incidence of false negative patients; (iii) MG is divided into six clinical subtypes; (iv) a high‐dose oral steroid regimen with escalation and de‐escalation schedule is not recommended by the GLs; (v) the GLs promote the early fast‐acting treatment strategy initially proposed in the previous GLs; (vi) refractory MG is defined; (vii) the use of molecular targeted drugs is included; (viii) diagnostic criteria of LEMS are proposed; and (ix) treatment algorithms for both MG and LEMS are presented. These new GLs are expected to improve the patients' quality of life and will serve to bridge the present era with the molecular targeted treatment eras. [ABSTRACT FROM AUTHOR]

Published
2023
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41. Statin Intolerance Clinical Guide 2018

Author

Kajinami, Kouji, Tsukamoto, Kazuhisa, Koba, Shinji, Inoue, Ikuo, Yamakawa, Masashi, Suzuki, Shigeaki, Hamano, Tadanori, Saito, Hidetsugu, Saito, Yoshiro, Masuda, Satohiro, Nakayama, Takeo, Okamura, Tomonori, Yamashita, Shizuya, Kagawa, Tatehiro, Kaneyama, Junji, Kuriyama, Akira, Tanaka, Rumi, Hirata, Aya, Statin Intolerance Clinical Guide Working Group, and The Japan Society of Hepatology, Japanese Society of Neurology, Japan Atherosclerosis Society, The Japanese Society for the Study of Xenobiotics

Subjects
Statin intolerance, Myopathy, Renal dysfunction, Liver injury, Rhabdomyolysis
Published
2020

45. Efgartigimod for generalized myasthenia gravis with or without anti-acetylcholine receptor antibodies: a worldwide and Japanese perspective.

Author

Suzuki, Shigeaki, Uzawa, Akiyuki, and Murai, Hiroyuki

Subjects
MYASTHENIA gravis, RECEPTOR antibodies, FC receptors, MENTAL health, QUALITY of life
Abstract

The management of myasthenia gravis (MG) has been improved due to immunotherapy advances, but 20% of individuals with MG are refractory to the conventional therapy, and the need for novel biological drugs remains. The Japanese clinical guidelines for MG published in May 2022 include the concept that treatment is often lifelong and should aim to maintain a sufficient quality of life and mental health. We provide an overview of the therapeutic strategy for generalized MG in Japan, in comparison with the international consensus. We summarize the clinical efficacy, safety, and tolerability of efgartigimod, the first approved anti-neonatal Fc receptor inhibitor for MG. A phase III study showed that efgartigimod was well-tolerated and efficacious in patients with generalized MG. Efgartigimod is a promising biological drug for patients with moderate to severe generalized MG with or without anti-acetylcholine receptor antibodies in Japan. [ABSTRACT FROM AUTHOR]

Published
2022
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46. Safety and effectiveness of eculizumab in Japanese patients with generalized myasthenia gravis: Analysis of 1‐year postmarketing surveillance.

Author

Murai, Hiroyuki, Suzuki, Shigeaki, Fukamizu, Yuji, Osawa, Takehiko, Kikui, Hidekazu, and Utsugisawa, Kimiaki

Subjects
*JAPANESE people, *MYASTHENIA gravis, *DRUG side effects, *ECULIZUMAB, *SEROTHERAPY, *INTRAVENOUS therapy
Abstract

Introduction: Eculizumab, a terminal complement protein C5 inhibitor, is approved in Japan for the treatment of patients with anti‐acetylcholine receptor antibody‐positive (AChR Ab+) generalized myasthenia gravis (gMG) that is difficult to control with plasmapheresis or high‐dose intravenous immunoglobulin therapy. Methods: This analysis of mandatory postmarketing surveillance in Japan assessed the safety and effectiveness of eculizumab in patients with AChR Ab+ gMG who had completed case‐report forms at 26 wk after eculizumab initiation up to the cutoff date of April 2021. Changes from baseline were assessed for Myasthenia Gravis‐Activities of Daily Living (MG‐ADL) and Quantitative Myasthenia Gravis (QMG) total scores overall, and MG‐ADL scores in patient subgroups according to sex, age at diagnosis and baseline, and baseline disease severity. The change in concomitant corticosteroid use was also evaluated. Results: Data were available for 134 adults (67.2% female; mean age 51.9 y); the effectiveness‐analysis set comprised 126 patients. After 26 wk, 78% of patients were continuing eculizumab treatment. Adverse drug reactions were reported by 49 patients (37%) (most frequently headache [n = 10]). Improvements in MG‐ADL scores were seen regardless of sex; age at diagnosis (<50/≥50 y); baseline age (18 to <40/≥40 to <65/≥65 y); Myasthenia Gravis Foundation of America disease classification (IIa/IIb/IIIa/IIIb/IVa/IVb/V); or baseline MG‐ADL score (<6/≥6). Of patients receiving corticosteroids, the proportion receiving low doses (average ≤5 mg/d) increased from 7.0% before eculizumab initiation to 26.4% by Week 52. Conclusion: Eculizumab was well tolerated and effective in treating AChR Ab+ gMG across a broad spectrum of adult Japanese patients with difficult‐to‐control gMG. [ABSTRACT FROM AUTHOR]

Published
2022
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49. Necklace cytoplasmic bodies in hereditary myopathy with early respiratory failure

Author

Uruha, Akinori, Hayashi, Yukiko K, Oya, Yasushi, Mori-Yoshimura, Madoka, Kanai, Masahiro, Murata, Miho, Kawamura, Mayumi, Ogata, Katsuhisa, Matsumura, Tsuyoshi, Suzuki, Shigeaki, Takahashi, Yukako, Kondo, Takayuki, Kawarabayashi, Takeshi, Ishii, Yuko, Kokubun, Norito, Yokoi, Satoshi, Yasuda, Rei, Kira, Jun-ichi, Mitsuhashi, Satomi, Noguchi, Satoru, Nonaka, Ikuya, and Nishino, Ichizo

Published
2015
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