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2. 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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7. Long-term safety, efficacy & self-injection satisfaction with zilucoplan in myasthenia gravis: RAISE-XT interim analysis

Author

Genge, Angela, primary, Leite, M. Isabel, additional, Bresch, Saskia, additional, Freimer, Miriam, additional, Hewamadduma, Channa, additional, Hussain, Yessar, additional, Maniaol, Angelina, additional, Mantegazza, Renato, additional, Smilowski, Marek, additional, Utsugisawa, Kimiaki, additional, Vu, Tuan, additional, Duda, Petra W., additional, Boroojerdi, Babak, additional, Vanderkelen, Mark, additional, De La Borderie, Guillemette, additional, Bloemers, Jos, additional, and Howard, James F., additional

Published
2023
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9. Long-term safety and efficacy of zilucoplan in patients with generalized myasthenia gravis: interim analysis of the RAISE-XT open-label extension study.

Author

Howard Jr, James F., Bresch, Saskia, Farmakidis, Constantine, Freimer, Miriam, Genge, Angela, Hewamadduma, Channa, Hinton, John, Hussain, Yessar, Juntas-Morales, Raul, Kaminski, Henry J., Maniaol, Angelina, Mantegazza, Renato, Masuda, Masayuki, Nowak, Richard J., Sivakumar, Kumaraswamy, Śmiłowski, Marek, Utsugisawa, Kimiaki, Vu, Tuan, Weiss, Michael D., and Zajda, Małgorzata

Subjects
MYASTHENIA gravis, DRUG efficacy, CHOLINERGIC receptors, CLINICAL trials, AUTOANTIBODIES
Abstract

Background: Generalized myasthenia gravis (gMG) is a chronic, unpredictable disease associated with high treatment and disease burdens, with a need for more effective and well-tolerated treatments. Objectives: To evaluate the long-term safety, tolerability, and efficacy of zilucoplan in a mild-to-severe, acetylcholine receptor autoantibody-positive (AChR+) gMG population. Design: Ongoing, multicenter, phase III open-label extension (OLE) study. Methods: Eligible patients had completed a qualifying randomized, placebo-controlled phase II or phase III zilucoplan study and received daily, self-administered subcutaneous 0.3 mg/kg zilucoplan. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Secondary efficacy endpoints included change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Results: In total, 200 patients enrolled. At the cut-off date (8 September 2022), median (range) exposure to zilucoplan in RAISE-XT was 1.2 (0.11–4.45) years. Mean age at OLE baseline was 53.3 years. A total of 188 (94%) patients experienced a TEAE, with the most common being MG worsening (n = 52, 26%) and COVID-19 (n = 49, 25%). In patients who received zilucoplan 0.3 mg/kg in the parent study, further improvements in MG-ADL score continued through to Week 24 (least squares mean change [95% confidence interval] from double-blind baseline −6.06 [−7.09, −5.03]) and were sustained through to Week 60 (−6.04 [−7.21, −4.87]). In patients who switched from placebo in the parent study, rapid improvements in MG-ADL score were observed at the first week after switching to zilucoplan; further improvements were observed at Week 24, 12 weeks after switching (−6.46 [−8.19, −4.72]), and were sustained through to Week 60 (−6.51 [−8.37, −4.65]). Consistent results were observed in other efficacy endpoints. Conclusion: Zilucoplan demonstrated a favorable long-term safety profile, good tolerability, and sustained efficacy through to Week 60 with consistent benefits in a broad AChR+ gMG population. Additional long-term data will be available in future analyses. Trial registration: ClinicalTrials.gov identifier: NCT04225871 (https://clinicaltrials.gov/ct2/show/NCT04225871) [ABSTRACT FROM AUTHOR]

Published
2024
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12. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study

Author

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

Published
2023
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14. Subgroup outcomes from RAISE: A randomized, Phase 3 trial of zilucoplan in generalized myasthenia gravis (P1-5.006)

Author

Weiss, Michael D., primary, Bresch, Saskia, additional, Freimer, Miriam, additional, Hewamadduma, Channa, additional, Juntas-Morales, Raul, additional, Leite, M. Isabel, additional, Maniaol, Angelina, additional, Masuda, Masayuki, additional, Sivakumar, Kumaraswamy, additional, Zajda, Malgorzata, additional, Boroojerdi, Babak, additional, Duda, Petra W., additional, De La Borderie, Guillemette, additional, and Howard, James F., additional

Published
2023
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15. The radiologically isolated syndrome: revised diagnostic criteria

Author

Lebrun-Frénay, Christine, Okuda, Darin, Siva, Aksel, Landes-Chateau, Cassandre, Azevedo, Christina, Mondot, Lydiane, Carra-Dallière, Clarisse, Zephir, Helene, Louapre, Celine, Durand-Dubief, Françoise, Le Page, Emmanuelle, Bensa, Caroline, Ruet, Aurélie, Ciron, Jonathan, Laplaud, David, Casez, Olivier, Mathey, Guillaume, de Seze, Jerome, Zeydan, Burcu, Makhani, Naila, Tutuncu, Melih, Levraut, Michael, Cohen, Mikael, Thouvenot, Eric, Pelletier, Daniel, Kantarci, Orhun, Sehaki, Sabrina, Devys-Meyer, Nathalie, Bereau, Mathieu, Cappe, Chrystelle, Brochet, Bruno, Ouallet, Jean-Christophe, Kounkou, Katy-Kim, Defer, Gilles, Branger, Pierre, Taithe, Frédéric, Dumont, Emilie, Lescieux, Edwige, Fromont, Agnès, Protin, Alexia, Kane, Maty Diop, Hautecoeur, Patrick, Outteryck, Olivier, Vermersch, Patrick, Boucher, Julie, Petit, Julie, Kasonde, Irène Tabellah, de Vilmarrest, Aymeric, Magy, Laurent, Nicol, Marie, Malbezin, Muriel, Olaiz, Javier, Rigaud-Bully, Claire, Debard, Nadine, Cotton, Sandra Vukusic François, Ionescu, Iuliana, Abdelalli, Amalle, Pelletier, Jean, Audoin, Bertrand, Maarouf, Adil, Di Lelio, Bernadette, Ayrignac, Xavier, Labauge, Pierre, Pinna, Frédéric, Guillemin, Francis, Debouverie, Marc, Ziegler, Amandine, Wiertlevski, Sandrine, Bresch, Saskia, Callier, Céline, David, Elodie, Castelnovo, Giovanni, Papeix, Caroline, Maillart, Elisabeth, Lubetzki, Catherine, Zehrouni, Karima, Fontaine, Bertrand, Giannesini, Claire, Hodel, Jérôme, Wahab, Abir, Zedet, Mickaël, Fagniez, Ombeline, Laage, Clémence, Pottier, Corinne, Slesari, Iuliana, Sampaio, Mathilde, Rabois, Emilie, Castex, Cédric, Hebant, Benjamin, Guillaume, Maxime, Vimont, Christine, Gout, Olivier, Guegen, Antoine, Michel, Laure, Muraz, Romain, Le Port, Damien, Leray, Emmanuelle, Henry, Carole, de Broucker, Thomas, Collongues, Nicolas, Berthe, Carole, Biotti, Damien, Freitas, Noellie, Visneux, Vincent, Forestier, Mélanie, Beltran, Stéphane, Meunier, Géraldine, Servan, Jérôme, Pico, Fernando, Chatagner, Virginie, Radji, Fatai, Morel, Nathalie, Grosset-Jeannin, Deborah, Ungureanu, Aurelian, Boyer, Latine, Suchet, Laurent, Lebrun-Frenay, Christine, Centre Hospitalier Universitaire de Nice (CHU Nice), Université Côte d'Azur (UCA), Unité de Recherche Clinique de la Côte d’Azur (URRIS UR2CA), Centre Hospitalier Universitaire de Nice (CHU Nice)-Université Côte d'Azur (UCA), University of Texas Southwestern Medical Center [Dallas], Cerrahpasa Faculty of Medicine, Istanbul University, University of Southern California (USC), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Lille, Lille Neurosciences & Cognition - U 1172 (LilNCog), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), Hôpital neurologique et neurochirurgical Pierre Wertheimer [CHU - HCL], Hospices Civils de Lyon (HCL), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Fondation Ophtalmologique Adolphe de Rothschild [Paris], Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale (U1215 Inserm - UB), Université de Bordeaux (UB)-Institut François Magendie-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Institut Toulousain des Maladies Infectieuses et Inflammatoires (Infinity), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CIC Plurithématique de Nantes, Institut National de la Santé et de la Recherche Médicale (INSERM)-Ministère des Affaires sociales et de la Santé-Direction générale de l'offre de soins (DGOS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche en Transplantation et Immunologie - Center for Research in Transplantation and Translational Immunology (U1064 Inserm - CR2TI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Translational Research in Autoimmunity and Inflammation Group (TIMC-T-RAIG), Translational Innovation in Medicine and Complexity / Recherche Translationnelle et Innovation en Médecine et Complexité - UMR 5525 (TIMC ), VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), Université Grenoble Alpes (UGA)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), Université Grenoble Alpes (UGA), Centre Hospitalier Universitaire [Grenoble] (CHU), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Adaptation, mesure et évaluation en santé. Approches interdisciplinaires (APEMAC), Université de Lorraine (UL), CHU Strasbourg, CIC Strasbourg (Centre d’Investigation Clinique Plurithématique (CIC - P) ), Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nouvel Hôpital Civil de Strasbourg-Hôpital de Hautepierre [Strasbourg], Mayo Clinic [Rochester], Yale School of Medicine [New Haven, Connecticut] (YSM), Service de Neurologie [CHU Nimes] (Pôle NIRR), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), and None

Subjects
[SCCO.NEUR]Cognitive science/Neuroscience, diagnostic criteria, radiologically isolated syndrome, Neurology (clinical), prognosis, multiple sclerosis, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, MRI
Abstract

The radiologically isolated syndrome (RIS) was defined in 2009 as the presence of asymptomatic, incidentally identified demyelinating-appearing white matter lesions in the CNS within individuals lacking symptoms typical of multiple sclerosis (MS). The RIS criteria have been validated and predict the transition to symptomatic MS reliably. The performance of RIS criteria that require fewer MRI lesions is unknown. 2009-RIS subjects, by definition, fulfil three to four of four criteria for 2005 dissemination in space (DIS) and subjects fulfilling only one or two lesions in at least one 2017 DIS location were identified within 37 prospective databases. Univariate and multivariate Cox regression models were used to identify predictors of a first clinical event. Performances of different groups were calculated. Seven hundred and forty-seven subjects (72.2% female, mean age 37.7 ± 12.3 years at the index MRI) were included. The mean clinical follow-up time was 46.8 ± 45.4 months. All subjects had focal T2 hyperintensities suggestive of inflammatory demyelination on MRI; 251 (33.6%) fulfilled one or two 2017 DIS criteria (designated as Groups 1 and 2, respectively), and 496 (66.4%) fulfilled three or four 2005 DIS criteria representing 2009-RIS subjects. Group 1 and 2 subjects were younger than the 2009-RIS group and were more likely to develop new T2 lesions over time (P < 0.001). Groups 1 and 2 were similar regarding survival distribution and risk factors for transition to MS. At 5 years, the cumulative probability for a clinical event was 29.0% for Groups 1 and 2 compared to 38.7% for 2009-RIS (P = 0.0241). The presence of spinal cord lesions on the index scan and CSF-restricted oligoclonal bands in Groups 1–2 increased the risk of symptomatic MS evolution at 5 years to 38%, comparable to the risk of development in the 2009-RIS group. The presence of new T2 or gadolinium-enhancing lesions on follow-up scans independently increased the risk of presenting with a clinical event (P < 0.001). The 2009-RIS subjects or Groups 1 and 2 with at least two of the risk factors for a clinical event demonstrated better sensitivity (86.0%), negative predictive value (73.1%), accuracy (59.8%) and area under the curve (60.7%) compared to other criteria studied. This large prospective cohort brings Class I evidence that subjects with fewer lesions than required in the 2009 RIS criteria evolve directly to a first clinical event at a similar rate when additional risk factors are present. Our results provide a rationale for revisions to existing RIS diagnostic criteria.

Published
2023

17. Kappa Free Light Chains Intrathecal Synthesis Biomarkers are Efficient Tools for the Diagnosis of Multiple Sclerosis: a Large Multicenter Cohort Study (S19.003)

Author

Levraut, Michael, primary, Ayrignac, Xavier, additional, Bigaut, Kevin, additional, Chabalier, Sabine, additional, Rival, Manon, additional, Agherbi, Hanane, additional, Squalli, Sanae, additional, Zephir, Helene, additional, Alberto, Tifanie, additional, Pekar, Jean David, additional, Ciron, Jonathan, additional, Freitas, Noellie, additional, Biotti, Damien, additional, Camdessanche, Jean-Phillippe, additional, Tholance, Yannick, additional, Visneux, Vincent, additional, Casez, Olivier, additional, Toussaint, Bertrand, additional, Marion, Jeanne, additional, Le Gouellec, Audrey, additional, Moreau, Thibault, additional, Lakomy, Daniela, additional, Thomasset, Audrey, additional, Maillart, Elisabeth, additional, Sterlin, Delphine, additional, Maurousset, Aude, additional, Rocher, Auriane, additional, Cohen, Mikael, additional, Delourme, Adrien, additional, Bresch, Saskia, additional, Laplaud, David, additional, Bigot-Corbel, Edith, additional, Pelletier, Jean, additional, Boucraut, Jose, additional, Labauge, Pierre, additional, Huby, Sophie, additional, Vincent, Thierry, additional, De Seze, Jerome, additional, Jahn, Isabelle, additional, Seitz-Polski, Barbara, additional, Thouvenot, Eric, additional, and Lebrun-Frenay, Christine, additional

Published
2022
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33. HNPP et/ou polyradiculonévrite ?

Author

Puma, Angela, primary, Soriani, Marie-Hélène, additional, Bresch, Saskia, additional, Launay, Maël, additional, Desnuelle, Claude, additional, and Sacconi, Sabrina, additional

Published
2015
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35. CO.18

Author

Bresch, Saskia and Colamarino, Rénato

Abstract

Pourquoi parler de sexualité avec nos patients neurologiques ?

Published
2023
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36. Traitement précoce du syndrome de Susac par rituximab

Author

Mazloum, Myriam Perla, Cohen, Mikael, Bresch, Saskia, Mondot, Lydiane, and Lebrun-Frenay, Christine

Abstract

Le syndrome de Susac (SS) est une microvascularite rare et potentiellement grave des vaisseaux cérébraux, rétiniens et cochléaires. Le recours à des immunosuppresseurs est suggéré mais sans recommandations établies à ce jour.

Published
2023
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37. Cerebral Amyloid Angiopathy-Related Inflammation and Biopsy-Positive Primary Angiitis of the CNS: A Comparative Study.

Author

Grangeon L, Boulouis G, Capron J, Bala F, Renard D, Raposo N, Ozkul-Wermester O, Triquenot-Bagan A, Ayrignac X, Wallon D, Gerardin E, Kerschen P, Sablot D, Formaglio M, Pico F, Turc G, Verny M, Humbertjean L, Gaudron M, Vannier S, Dequatre N, Guillon B, Isabel C, Arquizan C, Detante O, Godard S, Casolla B, Levraut M, Gollion C, Gerfaud-Valentin M, Kremer L, Daelman L, Lambert N, Lanthier S, Poppe A, Régent A, Weisenburger-Lile D, Verdure P, Quesney G, Vautier M, Wacongne A, Thouvenot E, Pariente J, Coulette S, Labauge PM, Olivier N, Allou T, Zephir H, Néel A, Bresch S, Terrier B, Martinaud O, Schneckenburger R, Papo T, Comarmond-Ortoli C, Jouvent E, Subréville M, Poncet-Megemont L, Khatib MA, Lun F, Henry C, Magnin E, Thomas Q, Graber M, Boukriche Y, Blanchet-Fourcade G, Ratiu D, Pagnoux C, Touzé E, de Boysson H, Alamowitch S, and Nehme A

Subjects
Humans, Female, Male, Aged, Middle Aged, Retrospective Studies, Biopsy, Magnetic Resonance Imaging, Aged, 80 and over, Brain pathology, Brain diagnostic imaging, Adult, Recurrence, Cerebral Amyloid Angiopathy diagnostic imaging, Cerebral Amyloid Angiopathy pathology, Cerebral Amyloid Angiopathy complications, Vasculitis, Central Nervous System diagnostic imaging, Vasculitis, Central Nervous System pathology
Abstract

Background and Objectives: Cerebral amyloid angiopathy-related inflammation (CAA-RI) and biopsy-positive primary angiitis of the CNS (BP-PACNS) have overlapping clinicoradiologic presentations. It is unknown whether clinical and radiologic features can differentiate CAA-RI from BP-PACNS and whether both diseases have different relapse rates. The objectives of this study were to compare clinicoradiologic presentations and relapse rates in patients with CAA-RI vs BP-PACNS., Methods: Patients with CAA-RI and BP-PACNS were enrolled from 2 retrospective multicenter cohorts. Patients with CAA-RI were biopsy-positive or met probable clinicoradiologic criteria. Patients with BP-PACNS had histopathologic confirmation of CNS angiitis, with no secondary etiology. A neuroradiologist read brain MRIs, blinded to the diagnosis of CAA-RI or BP-PACNS. Clinicoradiologic features were compared using univariable logistic regression models. Relapse rates were compared using a univariable Fine-Gray subdistribution hazard model, with death as a competing risk., Results: This study enrolled 104 patients with CAA-RI (mean age 73 years, 48% female sex) and 52 patients with BP-PACNS (mean age 45 years, 48% female sex). Patients with CAA-RI more often had white matter hyperintense lesions meeting the probable CAA-RI criteria (93% vs 51%, p < 0.001), acute subarachnoid hemorrhage (15% vs 2%, p = 0.02), cortical superficial siderosis (27% vs 4%, p < 0.001), ≥1 lobar microbleed (94% vs 26%, p < 0.001), past intracerebral hemorrhage (17% vs 4%, p = 0.04), ≥21 visible centrum semiovale perivascular spaces (34% vs 4%, p < 0.01), and leptomeningeal enhancement (70% vs 27%, p < 0.001). Patients with BP-PACNS more often had headaches (56% vs 31%, p < 0.01), motor deficits (56% vs 36%, p = 0.02), and nonischemic parenchymal gadolinium enhancement (82% vs 16%, p < 0.001). The prevalence of acute ischemic lesions was 18% in CAA-RI and 22% in BP-PACNS ( p = 0.57). The features with the highest specificity for CAA-RI were acute subarachnoid hemorrhage (98%), cortical superficial siderosis (96%), past intracerebral hemorrhage (96%), and ≥21 visible centrum semiovale perivascular spaces (96%). The probable CAA-RI criteria had a 71% sensitivity (95% CI 44%-90%) and 91% specificity (95% CI 79%-98%) in differentiating biopsy-positive CAA-RI from BP-PACNS. The rate of relapse in the first 2 years after remission was lower in CAA-RI than in BP-PACNS (hazard ratio 0.46, 95% CI 0.22-0.96, p = 0.04)., Conclusion: Clinicoradiologic features differed between patients with CAA-RI and those with BP-PACNS. Specific markers for CAA-RI were hemorrhagic signs of subarachnoid involvement, past intracerebral hemorrhage, ≥21 visible centrum semiovale perivascular spaces, and the probable CAA-RI criteria. A biopsy remains necessary for diagnosis in some cases of CAA-RI. The rate of relapse in the first 2 years after disease remission was lower in CAA-RI than in BP-PACNS.

Published
2024
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38. Kappa Free Light Chain Index Predicts Disease Course in Clinically and Radiologically Isolated Syndromes.

Author

Levraut M, Gavoille A, Landes-Chateau C, Cohen M, Bresch S, Seitz-Polski B, Mondot L, and Lebrun-Frenay C

Subjects
Female, Humans, Adult, Male, Syndrome, Immunoglobulin kappa-Chains, Disease Progression, Demyelinating Diseases diagnostic imaging, Autoimmune Diseases of the Nervous System, Multiple Sclerosis diagnostic imaging
Abstract

Background and Objectives: To evaluate whether the kappa free light chain index (K-index) can predict the occurrence of new T2-weighted MRI lesions (T2L) and clinical events in clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS)., Methods: All consecutive patients presenting for the diagnostic workup, including CSF analysis, of clinical and/or MRI suspicion of multiple sclerosis (MS) since May 1, 2018, were evaluated. All patients diagnosed with CIS and RIS with at least 1-year follow-up were included. Clinical events and new T2L were collected during follow-up. The K-index performances in predicting new T2L and a clinical event were evaluated using time-dependent ROC analyses. The time to clinical event or new T2L was estimated using survival analysis according to the binarized K-index using an independent cutoff of 8.9, and the ability of each variable to predict outcomes was compared using the Harrell c-index., Results: One hundred and eighty two patients (146 CIS and 36 RIS, median age 39 [30; 48] y-o, 70% females) were included with a median follow-up of 21 [13, 33] months. One hundred five (58%) patients (85 CIS and 20 RIS) experienced new T2L, and 28 (15%; 21 CIS and 7 RIS) experienced a clinical event. The K-index could predict new T2L over time in CIS (area under the curve [AUC] ranging from 0.86 to 0.96) and in RIS (AUC ranging from 0.84 to 0.54) but also a clinical event in CIS (AUC ranging from 0.75 to 0.87). Compared with oligoclonal bands (OCBs), the K-index had a better sensitivity and a slight lower specificity in predicting new T2L and clinical events in both populations. In the predictive model, the K-index was the variable that best predict new T2L in both CIS and RIS but also clinical events in CIS (c-index ranging from 0.70 to 0.77), better than the other variables, including OCB., Discussion: This study provides evidence that the K-index predicts new T2L in CIS and RIS but also clinical attack in patients with CIS. We suggest adding the K-index in the further MS diagnosis criteria revisions as a dissemination-in-time biomarker., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.)

Published
2023
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