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101. Retinal Changes After Acute and Late Optic Neuritis in Aquaporin-4 Antibody Seropositive NMOSD

Author

Oertel, Frederike C., primary, Zimmermann, Hanna G., additional, Motamedi, Seyedamirhosein, additional, Bereuter, Charlotte, additional, Asseyer, Eva Susanna, additional, Chien, Claudia, additional, Marignier, Romain, additional, Cobo-Calvo, Alvaro, additional, Leocani, Letizia, additional, Pisa, Marco, additional, Radaelli, Marta, additional, Villoslada, Pablo, additional, Sanchez-Dalmau, Bernardo, additional, Martinez-Lapiscina, Elena H., additional, Lana-Peixoto, Marco Aurélio, additional, Fontenelle, Mariana Andrade, additional, Aktas, Orhan, additional, Ringelstein, Marius, additional, Albrecht, Philipp, additional, Green, Ari J., additional, Yeaman, Michael R., additional, Smith, Terry J., additional, Cook, Lawrence, additional, Paul, Friedemann, additional, and Brandt, Alexander U., additional

Published
2023
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102. Transcobalamin Receptor Autoantibodies in Central Vitamin B12 Deficiency

Author

Pluvinage, John V, primary, Ngo, Thomas, additional, Bartley, Christopher M, additional, Bodansky, Aaron, additional, Alvarenga, Bonny D, additional, Zorn, Kelsey C, additional, Fouassier, Camille, additional, Zamecnik, Colin, additional, McCann, Adrian, additional, Huynh, Trung, additional, Browne, Weston, additional, Tubati, Asritha, additional, Kondapavulur, Sravani, additional, Anderson, Mark S, additional, Green, Ari J, additional, Green, Ralph, additional, Douglas, Vanja, additional, Louine, Martineau, additional, Cree, Bruce, additional, Hauser, Stephen, additional, Seeley, William, additional, Holmes, Brandon B, additional, Wells, James A, additional, Spudich, Serena, additional, Farhadian, Shelli, additional, Ramachandran, Prashanth, additional, Gillum, Leslie, additional, Hales, Chadwick M, additional, Smith, Bryan, additional, Nath, Avindra, additional, Suh, Gina A, additional, Flanagan, Eoin P, additional, Gelfand, Jeffrey M, additional, DeRisi, Joseph L, additional, Pleasure, Samuel J, additional, and Wilson, Michael R, additional

Published
2023
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103. Adaptive Optics Scanning Laser Ophthalmoscopy Images in a Family with the Mitochondrial DNA T8993C Mutation

Author

Yoon, Michael K, Roorda, Austin, Zhang, Yuhua, Nakanishi, Chiaki, Wong, Lee-Jun C, Zhang, Qing, Gillum, Leslie, Green, Ari, and Duncan, Jacque L

Subjects
Biomedical and Clinical Sciences, Ophthalmology and Optometry, Neurodegenerative, Eye Disease and Disorders of Vision, Clinical Research, Rare Diseases, Genetics, Neurosciences, 2.1 Biological and endogenous factors, Aetiology, Eye, Adolescent, Adult, Age of Onset, Ataxia, DNA Mutational Analysis, DNA, Mitochondrial, Female, Humans, Lasers, Male, Middle Aged, Muscle Weakness, Ophthalmoscopy, Pedigree, Point Mutation, Polymerase Chain Reaction, Retinal Cone Photoreceptor Cells, Retinitis Pigmentosa, Syndrome, Tomography, Optical Coherence, Biological Sciences, Medical and Health Sciences, Ophthalmology & Optometry, Ophthalmology and optometry
Abstract

PurposeThis study was designed to assess the effect of mitochondrial DNA (mtDNA) mutation T8993C on cone structure in a family expressing neurogenic muscle weakness, ataxia, and retinitis pigmentosa (NARP) syndrome.MethodsFive family members were studied, using clinical examination, nerve conduction studies, perimetry, optical coherence tomography (OCT) measures of central retinal thickness, and electroretinography. High-resolution images of cone structure using adaptive optics scanning laser ophthalmoscopy (AOSLO) were obtained in four subjects with stable fixation. Cone spacing was compared to 18 age-similar normal subjects and converted to z-scores at each location where unambiguous cones were identified. Tissue levels of T8993C mutant heteroplasmy in blood and hair follicles were quantified using real-time allele-refractory mutations system (ARMS) quantitative polymerase chain reaction (qPCR).ResultsSubjects expressing the T8993C mutation showed varying levels of disease severity. The subject with the lowest mutant load (42%-54%) showed no neurologic or retinal abnormalities. The remaining four subjects with over 77% mutant load all expressed severe neurologic and/or retinal abnormalities. AOSLO images revealed three patterns of cone spacing: pattern 1, normal; pattern 2, increased cone spacing within a contiguous cone mosaic; and pattern 3, patchy cone loss with increased cone spacing. Visual function was most severely affected in pattern 3.ConclusionsHigh levels of T8993C mutant load were associated with severe neurologic or visual dysfunction, while lower levels caused no detectable abnormalities. Visual function was better in patients with a contiguous and regular cone mosaic. Patients expressing high levels of the mtDNA T8993C mutation show abnormal cone structure, suggesting normal mitochondrial DNA is necessary for normal waveguiding by cones.

Published
2009

106. A Predictive Autoantibody Signature in Multiple Sclerosis

Author

Zamecnik, Colin R., primary, Sowa, Gavin M., additional, Abdelhak, Ahmed, additional, Dandekar, Ravi, additional, Bair, Rebecca D., additional, Wade, Kristen J., additional, Bartley, Christopher M., additional, Tubati, Asritha, additional, Gomez, Refujia, additional, Fouassier, Camille, additional, Gerungan, Chloe, additional, Alexander, Jessica, additional, Wapniarski, Anne E., additional, Loudermilk, Rita P., additional, Eggers, Erica L., additional, Zorn, Kelsey C., additional, Ananth, Kirtana, additional, Jabassini, Nora, additional, Mann, Sabrina A., additional, Ragan, Nicholas R., additional, Santaniello, Adam, additional, Henry, Roland G., additional, Baranzini, Sergio E., additional, Zamvil, Scott S., additional, Bove, Riley M., additional, Guo, Chu-Yueh, additional, Gelfand, Jeffrey M., additional, Cuneo, Richard, additional, von Büdingen, H.-Christian, additional, Oksenberg, Jorge R., additional, Cree, Bruce AC, additional, Hollenbach, Jill A., additional, Green, Ari J., additional, Hauser, Stephen L., additional, Wallin, Mitchell T., additional, DeRisi, Joseph L., additional, and Wilson, Michael R., additional

Published
2023
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109. Multiple sclerosis progression: time for a new mechanism-driven framework

Author

Kuhlmann, Tanja, primary, Moccia, Marcello, additional, Coetzee, Timothy, additional, Cohen, Jeffrey A, additional, Correale, Jorge, additional, Graves, Jennifer, additional, Marrie, Ruth Ann, additional, Montalban, Xavier, additional, Yong, V Wee, additional, Thompson, Alan J, additional, Reich, Daniel S, additional, Amato, Maria Pia, additional, Banwell, Brenda, additional, Barkhof, Frederik, additional, Chataway, Jeremy, additional, Chitnis, Tanuja, additional, Comi, Giancarlo, additional, Derfuss, Tobias, additional, Finlayson, Marcia, additional, Goldman, Myla, additional, Green, Ari, additional, Hellwig, Kerstin, additional, Kos, Daphne, additional, Miller, Aaron, additional, Mowry, Ellen, additional, Oh, Jiwon, additional, Salter, Amber, additional, Sormani,, Maria Pia, additional, Tintore, Mar, additional, Tremlett,, Helen, additional, Trojano, Maria, additional, van der Walt, Anneke, additional, Vukusic, Sandra, additional, and Waubant, Emmaunelle, additional

Published
2023
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111. sj-docx-1-msj-10.1177_13524585231172145 – Supplemental material for Attack adjudication in neuromyelitis optica spectrum disorder: Substantiation of criteria by magnetic resonance imaging and biomarkers in N-MOmentum

Author

Weinshenker, Brian G, Wingerchuk, Dean M, Green, Ari J, Bennett, Jeffrey L, Kim, Ho Jin, Pittock, Sean J, Fujihara, Kazuo, Paul, Friedemann, Cutter, Gary, Marignier, Romain, Aktas, Orhan, Hartung, Hans-Peter, She, Dewei, Smith, Michael, Rees, William, Patterson, Kristina, Cimbora, Daniel, Katz, Eliezer, and Cree, Bruce AC

Subjects
FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material, sj-docx-1-msj-10.1177_13524585231172145 for Attack adjudication in neuromyelitis optica spectrum disorder: Substantiation of criteria by magnetic resonance imaging and biomarkers in N-MOmentum by Brian G Weinshenker, Dean M Wingerchuk, Ari J Green, Jeffrey L Bennett, Ho Jin Kim, Sean J Pittock, Kazuo Fujihara, Friedemann Paul, Gary Cutter, Romain Marignier, Orhan Aktas, Hans-Peter Hartung, Dewei She, Michael Smith, William Rees, Kristina Patterson, Daniel Cimbora, Eliezer Katz and Bruce AC Cree in Multiple Sclerosis Journal

Published
2023
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113. Author Correction: Transcriptional profiling and therapeutic targeting of oxidative stress in neuroinflammation

Author

Mendiola, Andrew S., Ryu, Jae Kyu, Bardehle, Sophia, Meyer-Franke, Anke, Ang, Kenny Kean-Hooi, Wilson, Chris, Baeten, Kim M., Hanspers, Kristina, Merlini, Mario, Thomas, Sean, Petersen, Mark A., Williams, Alexander, Thomas, Reuben, Rafalski, Victoria A., Meza-Acevedo, Rosa, Tognatta, Reshmi, Yan, Zhaoqi, Pfaff, Samuel J., Machado, Michael R., Bedard, Catherine, Coronado, Pamela E. Rios, Jiang, Xiqian, Wang, Jin, Pleiss, Michael A., Green, Ari J., Zamvil, Scott S., Pico, Alexander R., Bruneau, Benoit G., Arkin, Michelle R., and Akassoglou, Katerina

Published
2020
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115. Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: An exploratory analysis from N-MOmentum, a double-blind, randomised, placebo-controlled, multicentre phase 2/3 trial

Author

Bennett, Jeffrey L., primary, Aktas, Orhan, additional, Rees, William A., additional, Smith, Michael A., additional, Gunsior, Michele, additional, Yan, Li, additional, She, Dewei, additional, Cimbora, Daniel, additional, Pittock, Sean J., additional, Weinshenker, Brian G., additional, Paul, Friedemann, additional, Marignier, Romain, additional, Wingerchuk, Dean, additional, Cutter, Gary, additional, Green, Ari, additional, Hartung, Hans-Peter, additional, Kim, Ho Jin, additional, Fujihara, Kazuo, additional, Levy, Michael, additional, Katz, Eliezer, additional, and Cree, Bruce A.C., additional

Published
2022
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120. Neurofilament Light Chain Elevation and Disability Progression in Multiple Sclerosis

Author

Abdelhak, Ahmed, Benkert, Pascal, Schaedelin, Sabine, Boscardin, W. John, Cordano, Christian, Oechtering, Johanna, Ananth, Kirtana, Granziera, Cristina, Melie-Garcia, Lester, Montes, Shivany Condor, Beaudry-Richard, Alexandra, Achtnichts, Lutz, Oertel, Frederike C., Lalive, Patrice H., Leppert, David, Müller, Stefanie, Henry, Roland G., Pot, Caroline, Matthias, Amandine, Salmen, Anke, Oksenberg, Jorge R., Disanto, Giulio, Zecca, Chiara, D’Souza, Marcus, Du Pasquier, Renaud, Bridel, Claire, Gobbi, Claudio, Kappos, Ludwig, Hauser, Stephen L., Cree, Bruce A. C., Kuhle, Jens, and Green, Ari J.

Abstract

IMPORTANCE: Mechanisms contributing to disability accumulation in multiple sclerosis (MS) are poorly understood. Blood neurofilament light chain (NfL) level, a marker of neuroaxonal injury, correlates robustly with disease activity in people with MS (MS); however, data on the association between NfL level and disability accumulation have been conflicting. OBJECTIVE: To determine whether and when NfL levels are elevated in the context of confirmed disability worsening (CDW). DESIGN, SETTING, AND PARTICIPANTS: This study included 2 observational cohorts: results from the Expression, Proteomics, Imaging, Clinical (EPIC) study at the University of California San Francisco (since 2004) were confirmed in the Swiss Multiple Sclerosis Cohort (SMSC), a multicenter study in 8 centers since 2012. Data were extracted from EPIC in April 2022 (sampling July 1, 2004, to December 20, 2016) and SMSC in December 2022 (sampling June 6, 2012, to September 2, 2021). The study included 2 observational cohorts in tertiary MS centers. All participants of both cohorts with available NfL results were included in the study, and no eligible participants were excluded or declined to participate. EXPOSURE: Association between NfL z scores and CDW. MAIN OUTCOME MEASURES: CDW was defined as Expanded Disability Status Scale (EDSS) worsening that was confirmed after 6 or more months and classified into CDW associated with clinical relapses (CDW-R) or independent of clinical relapses (CDW-NR). Visits were classified in relation to the disability worsening events into CDW(−2) for 2 visits preceding event, CDW(−1) for directly preceding event, CDW(event) for first diagnosis of EDSS increase, and the confirmation visit. Mixed linear and Cox regression models were used to evaluate NfL dynamics and to assess the association of NfL with future CDW, respectively. RESULTS: A total of 3906 EPIC visits (609 participants; median [IQR] age, 42.0 [35.0-50.0] years; 424 female [69.6%]) and 8901 SMSC visits (1290 participants; median [IQR] age, 41.2 [32.5-49.9] years; 850 female [65.9%]) were included. In CDW-R (EPIC, 36 events; SMSC, 93 events), NfL z scores were 0.71 (95% CI, 0.35-1.07; P < .001) units higher at CDW-R(−1) in EPIC and 0.32 (95% CI, 0.14-0.49; P < .001) in SMSC compared with stable MS samples. NfL elevation could be detected preceding CDW-NR (EPIC, 191 events; SMSC, 342 events) at CDW-NR(−2) (EPIC: 0.23; 95% CI, 0.01-0.45; P = .04; SMSC: 0.28; 95% CI, 0.18-0.37; P < .001) and at CDW-NR(−1) (EPIC: 0.27; 95% CI, 0.11-0.44; P < .001; SMSC: 0.09; 95% CI, 0-0.18; P = .06). Those findings were replicated in the subgroup with relapsing-remitting MS. Time-to-event analysis confirmed the association between NfL levels and future CDW-R within approximately 1 year and CDW-NR (in approximately 1-2 years). CONCLUSIONS AND RELEVANCE: This cohort study documents the occurrence of NfL elevation in advance of clinical worsening and may hint to a potential window of ongoing dynamic central nervous system pathology that precedes the diagnosis of CDW.

Published
2023
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122. Differences in Age-related Retinal and Cortical Atrophy Rates in Multiple Sclerosis

Author

Cordano, Christian, primary, Nourbakhsh, Bardia, additional, Yiu, Hao H., additional, Papinutto, Nico, additional, Caverzasi, Eduardo, additional, Abdelhak, Ahmed, additional, Oertel, Frederike C., additional, Beaudry-Richard, Alexandra, additional, Santaniello, Adam, additional, Sacco, Simone, additional, Bennett, Daniel J., additional, Gomez, Apraham, additional, Sigurdson, Christina J., additional, Hauser, Stephen L., additional, Magliozzi, Roberta, additional, Cree, Bruce A.C., additional, Henry, Roland G., additional, and Green, Ari J., additional

Published
2022
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123. The Pediatric Optic Neuritis Prospective Outcomes Study

Author

Pineles, Stacy L., primary, Henderson, Robert J., additional, Repka, Michael X., additional, Heidary, Gena, additional, Liu, Grant T., additional, Waldman, Amy T., additional, Borchert, Mark S., additional, Khanna, Sangeeta, additional, Graves, Jennifer S., additional, Collinge, Janine E., additional, Conley, Julie A., additional, Davis, Patricia L., additional, Kraker, Raymond T., additional, Cotter, Susan A., additional, Holmes, Jonathan M., additional, Chang, Melinda Y., additional, Contractor, Dilshad, additional, Zolfaghari, Emily J., additional, Vyas, Aarti, additional, Yuen, Tiffany, additional, Shah, Veeral S., additional, Paysse, Evelyn A., additional, Romany, Gihan, additional, Peragallo, Jason H., additional, Brower, Judy L., additional, Raghuram, Aparna, additional, Al Wattar, Bilal, additional, Chinn, Ryan, additional, Kothari, Srishti, additional, Siatkowski, R. Michael, additional, Lim, Maria E., additional, Brewer, Alisha N., additional, Doughty, Annette M., additional, Icks, Sonny W., additional, Almeida, Shannon, additional, de Alba Campomanes, Alejandra, additional, Banwait, Premilla, additional, Hajkazemshirazi, Leila, additional, Bastea-Forte, Yizhuo, additional, Arjona, Jennifer K., additional, Chen, Jeremy, additional, Cooper, Karen, additional, Ghadban, Rafif, additional, Chung, Sophia M., additional, Cruz, Oscar A., additional, Christenson, Traci A., additional, Breeding, Lisa L., additional, Govreau, Dawn M., additional, Wallis, Beth A., additional, Geddie, Brooke E., additional, Wolinski, Elisabeth T., additional, Rudaitis, Indre M., additional, Twite, Jacqueline, additional, Bloomquist, Carrie S., additional, Laboy, Sarah R., additional, Twite, Jackie M., additional, Pineles, Stacy L., additional, Doan, Michelle V., additional, Bernardo, Marianne J., additional, Brodsky, Michael C., additional, Chen, John J., additional, Wernimont, Suzanne M., additional, Czaplewski, Lindsay L., additional, Eastman, Stacy L., additional, Keehn, Moriah A., additional, Priebe, Debbie M., additional, Bremer, Don L., additional, Golden, Richard P., additional, Jordan, Catherine O., additional, McGregor, Mary Lou, additional, Reem, Rachel E., additional, Rogers, David L., additional, Schreckengost, Amanda N., additional, Maletic, Sara A., additional, Dairi, Mays A., additional, Enyedi, Laura B., additional, Jones, Sarah K., additional, Barman, Navajyoti R., additional, House, Robert J., additional, Nasrazadani, David A., additional, Gratton, Sean M., additional, Marsh, Justin D., additional, Dent, Rebecca J., additional, Bond, Lezlie L., additional, Soske, Lori L., additional, Sudhakar, Padmaja, additional, Willen, Christi M., additional, Taylor, Deborah, additional, Moliterno, Nathaniel Q., additional, Nsoesie, Michael, additional, Vally, Shaista, additional, Phillips, Paul H., additional, Lowery, Robert S., additional, Colon, Beth, additional, Stotts, Nancy L., additional, To, Kelly D., additional, McClelland, Collin M., additional, Areaux, Raymond G., additional, Holleschau, Ann M., additional, Merrill, Kim S., additional, Ospina, Luis H., additional, Superstein, Rosanne, additional, Thibeault, Maryse, additional, Gagnon, Helene, additional, Donahue, Sean P., additional, Ruark, Scott T., additional, Fraine, Lisa A., additional, Sprouse, Petrice A., additional, Biernacki, Ronald J., additional, Avery, Robert A., additional, Forbes, Brian J., additional, Jivraj, Imran, additional, Kohli, Anita A., additional, Richter, Meg M., additional, Baumritter, Agnieshka, additional, Mitchell, Ellen B., additional, Nischal, Ken K., additional, Runkel, Lauren M., additional, Blaha, Bianca, additional, Churchfield, Whitney, additional, Fulwylie, Christina, additional, Ko, Melissa W., additional, Mejico, Luis J., additional, Iqbal, Muhammad, additional, Attanasio, Catherine E., additional, Deb, Lena F., additional, Goodrich, Courtney B., additional, Hartwell, Alisha M., additional, Moore, Jennifer A., additional, Bohra, Lisa, additional, Apkarian, Alexandra O., additional, Gianfermi, Elena M., additional, Roarty, John D., additional, Rotberg, Leemor B., additional, Perzyk, Susan N., additional, Beck, Roy W., additional, Austin, Darrell S., additional, Boyle, Nicole M., additional, Chandler, Danielle L., additional, Connelly, Patricia L., additional, Conner, Courtney L., additional, Dean, Trevano W., additional, Donahue, Quayleen, additional, Fimbel, Brooke P., additional, Hercinovic, Amra, additional, Hoepner, James E., additional, Kaplon, Joseph D., additional, Li, Zhuokai, additional, Ortiz, Gillaine, additional, Robinson, Julianne L., additional, Stutz, Kathleen M., additional, Toro, David O., additional, Woodard, Victoria C., additional, Wu, Rui, additional, Balcer, Laura, additional, Kupersmith, Mark, additional, Lazar, Elizabeth L., additional, Waldman, Amy, additional, Wallace, David K., additional, Birch, Eileen E., additional, Chen, Angela M., additional, Christiansen, Stephen P., additional, Erzurum, S. Ayse, additional, Everett, Donald F., additional, Freedman, Sharon F., additional, Good, William V., additional, Lee, Katherine A., additional, London, Richard, additional, Manh, Vivian M., additional, Manny, Ruth E., additional, Morrison, David G., additional, Schweinler, Bonita R., additional, Silver, Jayne L., additional, Verderber, Lisa C., additional, Weise, Katherine K., additional, Green, Ari, additional, Diener-West, Marie, additional, Baker, John D., additional, Davis, Barry, additional, Phelps, Dale L., additional, Poff, Stephen W., additional, Saunders, Richard A., additional, and Tychsen, Lawrence, additional

Published
2022
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124. Characterizing Fixational Eye Motion Variance Over Time as Recorded by the Tracking Scanning Laser Ophthalmoscope.

Author

Condor Montes, Shivany Y, Condor Montes, Shivany Y, Bennett, Daniel, Bensinger, Ethan, Rani, Lakshmisahithi, Sherkat, Younes, Zhao, Chao, Helft, Zachary, Roorda, Austin, Green, Ari J, Sheehy, Christy K, Condor Montes, Shivany Y, Condor Montes, Shivany Y, Bennett, Daniel, Bensinger, Ethan, Rani, Lakshmisahithi, Sherkat, Younes, Zhao, Chao, Helft, Zachary, Roorda, Austin, Green, Ari J, and Sheehy, Christy K

Abstract

PurposeThe purpose of this study was to characterize the benign biological variance of fixational microsaccades in a control population using a tracking scanning laser ophthalmoscope (TSLO), accounting for machine accuracy and precision, to determine ideal testing conditions to detect pathologic change in fixational eye motion (FEM).MethodsWe quantified the accuracy and precision of the TSLO, analyzing measurements made by three operators on a model eye. Repeated, 10-second retinal motion traces were then recorded in 17 controls, 3 times a day (morning, afternoon, and evening), on 3 separate days. Microsaccade metrics (MMs) of frequency, average amplitude, peak velocity, and peak acceleration were extracted. Trace to trace, interday, and intraday variability were calculated across all subjects.ResultsIntra-operator and machine variation contributed minimally to total variation, with only 0.007% and 0.14% contribution for frequency and amplitude respectively. Bias was detected, with lower accuracy for higher amplitudes. Participants had an average (SD) microsaccade frequency of 0.84 Hz (0.52 Hz), amplitude of 0.32 degrees (0.11 degrees), peak velocity of 43.68 degrees/s (14.02 degrees/s), and peak acceleration of 13,920.04 degrees/s2 (4,186.84 degrees/s2). The first trace recorded within a session significantly differed from the second two in both microsaccade acceleration and velocity (P < 0.05), and frequency was 0.098 Hz higher in the evenings (P < 0.05). There was no MM difference between days and no evidence of a session-level learning effect (P > 0.05).ConclusionsThe TSLO is both accurate and precise. However, biological inter- and intra-individual variance is present. Trace to trace variability and time of day should be accounted for to optimize detection of pathologic change.

Published
2022

125. Transitioning From S1P Receptor Modulators to B Cell-Depleting Therapies in Multiple Sclerosis: Clinical, Radiographic, and Laboratory Data.

Author

Rowles, William M, Rowles, William M, Hsu, Wan-Yu, McPolin, Kira, Li, Alyssa, Merrill, Steven, Guo, Chu-Yueh, Green, Ari J, Gelfand, Jeffrey Marc, Bove, Riley M, Rowles, William M, Rowles, William M, Hsu, Wan-Yu, McPolin, Kira, Li, Alyssa, Merrill, Steven, Guo, Chu-Yueh, Green, Ari J, Gelfand, Jeffrey Marc, and Bove, Riley M

Abstract

Background and objectivesPatients with multiple sclerosis (MS) transition from oral sphingosine-1-receptor (S1P) modulators to anti-CD20 therapies for several circumstances. Optimal timing of this transition is uncertain, given competing concerns of rebound disease activity and ensuring immune reconstitution. The objective of this study was to evaluate the relationship between inflammatory activity and the transition period from fingolimod to anti-CD20 therapies in a real-world MS cohort.MethodsMedical records were reviewed for all patients at our center transitioning from fingolimod to rituximab or ocrelizumab between 2010 and October 2020. Time periods reviewed were the following: before fingolimod discontinuation, interval between fingolimod and anti-CD20 treatments, and after the first anti-CD20 infusion. The primary outcome was clinical relapses; MRI activity, time to absolute lymphocyte count (ALC) recovery, and infections were secondary. Clinical and demographic factors significant in univariable analyses were included in multivariable analyses.ResultsTransition data were available for 108 patients (68.5% women, 68.5% relapsing-remitting MS, mean age 44.6 years). The median (interquartile range) interval between fingolimod and anti-CD20 therapy was 28 (1-115.2) days. Six of 51 patients (11.8%) with intervals >1 month and 0/57 patients with shorter intervals experienced a relapse (MRI confirmed) within 6 months of fingolimod discontinuation. In the year following anti-CD20 initiation, 4/108 patients (3.7%) experienced a relapse (median 214.5 days after infusion). An additional 7% of those undergoing contrast-enhanced MRIs developed Gd+ lesions. ALC normalized following treatment switch in 89/92; the interval between treatments was unrelated to ALC recovery or infection.DiscussionDelaying anti-CD20 start to monitor ALC after S1P modulator discontinuation may not be necessary and could increase rebound risk. ALC monitoring could instead occur after a rapid sw

Published
2022

126. Cell-based therapeutic strategies for multiple sclerosis

Author

Scolding, Neil J, Pasquini, Marcelo, Reingold, Stephen C, Cohen, Jeffrey A, Atkins, Harold, Banwell, Brenda, Bar-Or, Amit, Bebo, Bruce, Bowen, James, Burt, Richard, Calabresi, Peter, Cohen, Jeffrey, Comi, Giancarlo, Connick, Peter, Cross, Anne, Cutter, Gary, Derfuss, Tobias, Ffrench-Constant, Charles, Freedman, Mark, Galipeau, Jacques, Goldman, Myla, Goldman, Steven, Goodman, Andrew, Green, Ari, Griffith, Linda, Hartung, Hans-Peter, Hemmer, Bernhard, Hyun, Insoo, Iacobaeus, Ellen, Inglese, Matilde, Jubelt, Burk, Karussis, Dimitrios, Küry, Patrick, Landsman, Douglas, Laule, Cornelia, Liblau, Roland, Mancardi, Giovanni, Ann Marrie, Ruth, Miller, Aaron, Miller, Robert, Miller, David, Mowry, Ellen, Muraro, Paolo, Nash, Richard, Ontaneda, Daniel, Pasquini, Marcelo, Pelletier, Daniel, Peruzzotti-Jametti, Luca, Pluchino, Stefano, Racke, Michael, Reingold, Stephen, Rice, Claire, Ringdén, Olle, Rovira, Alex, Saccardi, Riccardo, Sadiq, Saud, Sarantopoulos, Stefanie, Savitz, Sean, Scolding, Neil, Soelberg Sorensen, Per, Pia Sormani, Maria, Stuve, Olaf, Tesar, Paul, Thompson, Alan, Trojano, Maria, Uccelli, Antonio, Uitdehaag, Bernard, Utz, Ursula, Vukusic, Sandra, Waubant, Emmanuelle, and Wilkins, Alastair

Published
2017
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127. Plasma neurofilament light chain levels suggest neuroaxonal stability following therapeutic remyelination in people with multiple sclerosis

Author

Abdelhak, Ahmed, primary, Cordano, Christian, additional, Boscardin, W John, additional, Caverzasi, Eduardo, additional, Kuhle, Jens, additional, Chan, Brandon, additional, Gelfand, Jeffrey M, additional, Yiu, Hao H, additional, Oertel, Frederike C, additional, Beaudry-Richard, Alexandra, additional, Condor Montes, Shivany, additional, Oksenberg, Jorge R, additional, Lario Lago, Argentina, additional, Boxer, Adam, additional, Rojas-Martinez, Julio C, additional, Elahi, Fanny M, additional, Chan, Jonah R, additional, and Green, Ari J, additional

Published
2022
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131. A hormonal therapy for menopausal women with MS: A phase Ib/IIa randomized controlled trial

Author

Bove, Riley, primary, Anderson, Annika, additional, Rowles, William, additional, Rankin, Kelsey A., additional, Hills, Nancy K., additional, Carleton, Mia, additional, Cooper, Joanna, additional, Cree, Bruce A.C., additional, Gelfand, Jeffrey M., additional, Graves, Jennifer S., additional, Henry, Roland G., additional, Krysko, Kristen M, additional, Rush, Gillian, additional, Zamvil, Scott S., additional, Joffe, Hadine, additional, Chan, Jonah R., additional, and Green, Ari J., additional

Published
2022
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133. Astrocytic outer retinal layer thinning is not a feature in AQP4-IgG seropositive neuromyelitis optica spectrum disorders

Author

Lu, Angelo, Zimmermann, Hanna G, Specovius, Svenja, Motamedi, Seyedamirhosein, Chien, Claudia, Bereuter, Charlotte, Lana-Peixoto, Marco A, Fontenelle, Mariana Andrade, Ashtari, Fereshteh, Kafieh, Rahele, Dehghani, Alireza, Pourazizi, Mohsen, Pandit, Lekha, D'Cunha, Anitha, Kim, Ho Jin, Hyun, Jae-Won, Jung, Su-Kyung, Leocani, Letizia, Pisa, Marco, Radaelli, Marta, Siritho, Sasitorn, May, Eugene F, Tongco, Caryl, De Sèze, Jérôme, Senger, Thomas, Palace, Jacqueline, Roca-Fernández, Adriana, Leite, Maria Isabel, Sharma, Srilakshmi M, Stiebel-Kalish, Hadas, Asgari, Nasrin, Soelberg, Kerstin Kathrine, Martinez-Lapiscina, Elena H, Havla, Joachim, Mao-Draayer, Yang, Rimler, Zoe, Reid, Allyson, Marignier, Romain, Cobo-Calvo, Alvaro, Altintas, Ayse, Tanriverdi, Uygur, Yildirim, Rengin, Aktas, Orhan, Ringelstein, Marius, Albrecht, Philipp, Tavares, Ivan Maynart, Bichuetti, Denis Bernardi, Jacob, Anu, Huda, Saif, Soto de Castillo, Ibis, Petzold, Axel, Green, Ari J, Yeaman, Michael R, Smith, Terry J, Cook, Lawrence, Paul, Friedemann, Brandt, Alexander U, Oertel, Frederike Cosima, and GJCF International Clinical Consortium for NMOSD

Subjects
Adult, Male, Aquaporin 4, vision, Neurology & Neurosurgery, GJCF International Clinical Consortium for NMOSD, Neuromyelitis Optica, Psychology and Cognitive Sciences, Neurosciences, Middle Aged, Neurodegenerative, Medical and Health Sciences, Retina, Brain Disorders, ophthalmology, Cross-Sectional Studies, Optical Coherence, Astrocytes, Humans, Female, clinical neurology, Tomography, Eye Disease and Disorders of Vision, Autoantibodies
Abstract

BackgroundPatients with anti-aquaporin-4 antibody seropositive (AQP4-IgG+) neuromyelitis optica spectrum disorders (NMOSDs) frequently suffer from optic neuritis (ON) leading to severe retinal neuroaxonal damage. Further, the relationship of this retinal damage to a primary astrocytopathy in NMOSD is uncertain. Primary astrocytopathy has been suggested to cause ON-independent retinal damage and contribute to changes particularly in the outer plexiform layer (OPL) and outer nuclear layer (ONL), as reported in some earlier studies. However, these were limited in their sample size and contradictory as to the localisation. This study assesses outer retinal layer changes using optical coherence tomography (OCT) in a multicentre cross-sectional cohort.Method197 patients who were AQP4-IgG+ and 32 myelin-oligodendrocyte-glycoprotein antibody seropositive (MOG-IgG+) patients were enrolled in this study along with 75 healthy controls. Participants underwent neurological examination and OCT with central postprocessing conducted at a single site.ResultsNo significant thinning of OPL (25.02±2.03 µm) or ONL (61.63±7.04 µm) were observed in patients who were AQP4-IgG+ compared with patients who were MOG-IgG+ with comparable neuroaxonal damage (OPL: 25.10±2.00 µm; ONL: 64.71±7.87 µm) or healthy controls (OPL: 24.58±1.64 µm; ONL: 63.59±5.78 µm). Eyes of patients who were AQP4-IgG+ (19.84±5.09 µm, p=0.027) and MOG-IgG+ (19.82±4.78 µm, p=0.004) with a history of ON showed parafoveal OPL thinning compared with healthy controls (20.99±5.14 µm); this was not observed elsewhere.ConclusionThe results suggest that outer retinal layer loss is not a consistent component of retinal astrocytic damage in AQP4-IgG+ NMOSD. Longitudinal studies are necessary to determine if OPL and ONL are damaged in late disease due to retrograde trans-synaptic axonal degeneration and whether outer retinal dysfunction occurs despite any measurable structural correlates.

Published
2022

134. Spinal Cord Atrophy Predicts Progressive Disease in Relapsing Multiple Sclerosis

Author

Bischof, Antje, Papinutto, Nico, Keshavan, Anisha, Rajesh, Anand, Kirkish, Gina, Zhang, Xinheng, Mallott, Jacob M, Asteggiano, Carlo, Sacco, Simone, Gundel, Tristan J, Zhao, Chao, Stern, William A, Caverzasi, Eduardo, Zhou, Yifan, Gomez, Refujia, Ragan, Nicholas R, Santaniello, Adam, Zhu, Alyssa H, Juwono, Jeremy, Bevan, Carolyn J, Bove, Riley M, Crabtree, Elizabeth, Gelfand, Jeffrey M, Goodin, Douglas S, Graves, Jennifer S, Green, Ari J, Oksenberg, Jorge R, Waubant, Emmanuelle, Wilson, Michael R, Zamvil, Scott S, University of California, San Francisco MS-EPIC Team, Cree, Bruce AC, Hauser, Stephen L, and Henry, Roland G

Subjects
Adult, Male, Multiple Sclerosis, Clinical Sciences, San Francisco MS-EPIC Team, Relapsing-Remitting, Neurodegenerative, Autoimmune Disease, University of California, Predictive Value of Tests, Humans, 2.1 Biological and endogenous factors, Foramen Magnum, Prospective Studies, Aetiology, Neurology & Neurosurgery, Neurosciences, Brain, Middle Aged, Prognosis, Magnetic Resonance Imaging, Brain Disorders, Spinal Cord, Neurological, Disease Progression, Female, Atrophy
Abstract

ObjectiveA major challenge in multiple sclerosis (MS) research is the understanding of silent progression and Progressive MS. Using a novel method to accurately capture upper cervical cord area from legacy brain MRI scans we aimed to study the role of spinal cord and brain atrophy for silent progression and conversion to secondary progressive disease (SPMS).MethodsFrom a single-center observational study, all RRMS (n=360) and SPMS (n=47) patients and 80 matched controls were evaluated. RRMS patient subsets who converted to SPMS (n=54) or silently progressed (n=159), respectively, during the 12-year observation period were compared to clinically matched RRMS patients remaining RRMS (n=54) or stable (n=147), respectively. From brain MRI, we assessed the value of brain and spinal cord measures to predict silent progression and SPMS conversion.ResultsPatients who developed SPMS showed faster cord atrophy rates (-2.19%/yr) at least 4 years before conversion compared to their RRMS matches (-0.88%/yr, p

Published
2022

136. AQP4-IgG-seronegative patient outcomes in the N-MOmentum trial of inebilizumab in neuromyelitis optica spectrum disorder

Author

Marignier, Romain, primary, Pittock, Sean J., additional, Paul, Friedemann, additional, Kim, Ho Jin, additional, Bennett, Jeffrey L., additional, Weinshenker, Brian G., additional, Wingerchuk, Dean M., additional, Green, Ari J., additional, Fujihara, Kazuo, additional, Cutter, Gary, additional, Aktas, Orhan, additional, Hartung, Hans-Peter, additional, Drappa, Jorn, additional, Ratchford, John N., additional, She, Dewei, additional, Smith, Michael, additional, Rees, William, additional, Cimbora, Daniel, additional, Katz, Eliezer, additional, and Cree, Bruce A.C., additional

Published
2022
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137. Retinal arteriolar parameters as a surrogate marker of intracranial vascular pathology

Author

Abdelhak, Ahmed, primary, Solomon, Isaac, additional, Montes, Shivany Condor, additional, Saias, Alexandra, additional, Cordano, Christian, additional, Asken, Breton, additional, Fonseca, Corrina, additional, Oertel, Frederike Cosima, additional, Arfanakis, Konstantinos, additional, Staffaroni, Adam M., additional, Kramer, Joel H., additional, Geschwind, Michael, additional, Miller, Bruce L., additional, Elahi, Fanny M., additional, and Green, Ari J., additional

Published
2022
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138. Optical coherence tomography in multiple sclerosis: A 3-year prospective multicenter study

Author

Paul, Friedemann, Calabresi, Peter, Barkhof, Frederik, Kardon, Randy, Sastre-Garriga, Jaume, Schippling, Sven, Vermersch, Patrick, Saidha, Shiv, Gerendas, Bianca, Schmidt-Erfurth, Ursula, Agoropoulou, Catherine, Zhang, Ying, Seifer, Gustavo, Petzold, Axel, and Green, Ari

Subjects
sense organs
Abstract

OBJECTIVE: To evaluate changes over 3 years in the thickness of inner retinal layers including the peripapillary retinal nerve fiber layer (pRNFL), and combined macular ganglion cell and inner plexiform layers (mGCIPL), in individuals with relapsing-remitting multiple sclerosis (RRMS) versus healthy controls; to determine whether optical coherence tomography (OCT) is sufficiently sensitive and reproducible to detect small degrees of neuroaxonal loss over time that correlate with changes in brain volume and disability progression as measured by the Expanded Disability Status Scale (EDSS). METHODS: Individuals with RRMS from 28 centers (n = 333) were matched with 64 healthy participants. OCT scans were performed on Heidelberg Spectralis machines (at baseline; 1 month; 6 months; 6-monthly thereafter). RESULTS: OCT measurements were highly reproducible between baseline and 1 month (intraclass correlation coefficient >0.98). Significant inner retinal layer thinning was observed in individuals with multiple sclerosis (MS) compared with controls regardless of previous MS-associated optic neuritis--group differences (95% CI) over 3 years: pRNFL: -1.86 (-2.54, -1.17) µm; mGCIPL: -2.03 (-2.78, -1.28) µm (both p 5 years (pRNFL: p

Published
2021

139. Micropillar arrays as a high-throughput screening platform for therapeutics in multiple sclerosis

Author

Mei, Feng, Fancy, Stephen P.J., Shen, Yun-An A., Niu, Jianqin, Zhao, Chao, Presley, Bryan, Miao, Edna, Lee, Seonok, Mayoral, Sonia R., Redmond, Stephanie A., Etxeberria, Ainhoa, Xiao, Lan, Franklin, Robin J.M., Green, Ari, Hauser, Stephen L., and Chan, Jonah R.

Subjects
United States. Food and Drug Administration, Multiple sclerosis -- Diagnosis -- Care and treatment, High-throughput screening (Biochemical assaying) -- Analysis, Biological sciences, Health
Abstract

Functional screening for compounds that promote remyelination represents a major hurdle in the development of rational therapeutics for multiple sclerosis. Screening for remyelination is problematic, as myelination requires the presence of axons. Standard methods do not resolve cell-autonomous effects and are not suited for high-throughput formats. Here we describe a binary indicant for myelination using micropillar arrays (BIMA). Engineered with conical dimensions, micropillars permit resolution of the extent and length of membrane wrapping from a single two-dimensional image. Confocal imaging acquired from the base to the tip of the pillars allows for detection of concentric wrapping observed as 'rings' of myelin. The platform is formatted in 96-well plates, amenable to semiautomated random acquisition and automated detection and quantification. Upon screening 1,000 bioactive molecules, we identified a cluster of antimuscarinic compounds that enhance oligodendrocyte differentiation and remyelination. Our findings demonstrate a new high-throughput screening platform for potential regenerative therapeutics in multiple sclerosis., Loss of myelin in diseases such as multiple sclerosis results in the disruption of the nerve signal, damage to the axon and, finally, neuro- degeneration. In order to effectively treat [...]

Published
2014
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142. Changes in wall thickness of retinal arterioles as a surrogate marker of intracranial vascular pathology

Author

Abdelhak, Ahmed, primary, Solomon, Isaac, additional, Saias, Alexandra, additional, Montes, Shivany Condor, additional, Cordano, Christian, additional, Asken, Breton, additional, Fonseca, Corrina, additional, Oertel, Frederike Cosima, additional, Arfanakis, Konstantinos, additional, Staffaroni, Adam M., additional, Geschwind, Michael, additional, Elahi, Fanny M., additional, and Green, Ari J., additional

Published
2021
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143. Retinal biomarkers predict future cognitive performance in progranulin‐haploinsufficient frontotemporal dementia

Author

Oertel, Frederike Cosima, primary, Younes, Kyan, additional, Cobigo, Yann, additional, Keihani, Azeen, additional, Fonseca, Corrina, additional, Bennett, Daniel J, additional, Abdelhak, Ahmed, additional, Saias, Alexandra, additional, Montes, Shivany Condor, additional, Chen, Robert Y, additional, Cordano, Christian, additional, Green, Ari J, additional, and Elahi, Fanny M, additional

Published
2021
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144. Optical coherence tomography in multiple sclerosis: A 3‐year prospective multicenter study

Author

Paul, Friedemann, primary, Calabresi, Peter A., additional, Barkhof, Frederik, additional, Green, Ari J., additional, Kardon, Randy, additional, Sastre‐Garriga, Jaume, additional, Schippling, Sven, additional, Vermersch, Patrick, additional, Saidha, Shiv, additional, Gerendas, Bianca S., additional, Schmidt‐Erfurth, Ursula, additional, Agoropoulou, Catherine, additional, Zhang, Ying, additional, Seifer, Gustavo, additional, and Petzold, Axel, additional

Published
2021
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145. Astrocytic outer retinal layer thinning is not a feature in AQP4-IgG seropositive neuromyelitis optica spectrum disorders

Author

Lu, Angelo, primary, Zimmermann, Hanna G, additional, Specovius, Svenja, additional, Motamedi, Seyedamirhosein, additional, Chien, Claudia, additional, Bereuter, Charlotte, additional, Lana-Peixoto, Marco A, additional, Fontenelle, Mariana Andrade, additional, Ashtari, Fereshteh, additional, Kafieh, Rahele, additional, Dehghani, Alireza, additional, Pourazizi, Mohsen, additional, Pandit, Lekha, additional, D'Cunha, Anitha, additional, Kim, Ho Jin, additional, Hyun, Jae-Won, additional, Jung, Su-Kyung, additional, Leocani, Letizia, additional, Pisa, Marco, additional, Radaelli, Marta, additional, Siritho, Sasitorn, additional, May, Eugene F, additional, Tongco, Caryl, additional, De Sèze, Jérôme, additional, Senger, Thomas, additional, Palace, Jacqueline, additional, Roca-Fernández, Adriana, additional, Leite, Maria Isabel, additional, Sharma, Srilakshmi M, additional, Stiebel-Kalish, Hadas, additional, Asgari, Nasrin, additional, Soelberg, Kerstin Kathrine, additional, Martinez-Lapiscina, Elena H, additional, Havla, Joachim, additional, Mao-Draayer, Yang, additional, Rimler, Zoe, additional, Reid, Allyson, additional, Marignier, Romain, additional, Cobo-Calvo, Alvaro, additional, Altintas, Ayse, additional, Tanriverdi, Uygur, additional, Yildirim, Rengin, additional, Aktas, Orhan, additional, Ringelstein, Marius, additional, Albrecht, Philipp, additional, Tavares, Ivan Maynart, additional, Bichuetti, Denis Bernardi, additional, Jacob, Anu, additional, Huda, Saif, additional, Soto de Castillo, Ibis, additional, Petzold, Axel, additional, Green, Ari J, additional, Yeaman, Michael R, additional, Smith, Terry J, additional, Cook, Lawrence, additional, Paul, Friedemann, additional, Brandt, Alexander U, additional, and Oertel, Frederike Cosima, additional

Published
2021
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147. Validating visual evoked potentials as a preclinical, quantitative biomarker for remyelination efficacy.

Author

Cordano, Christian, Sin, Jung H, Timmons, Garrett, Yiu, Hao H, Stebbins, Karin, Guglielmetti, Caroline, Cruz-Herranz, Andres, Xin, Wendy, Lorrain, Daniel, Chan, Jonah R, and Green, Ari J

Subjects
MYELIN sheath diseases, VISUAL evoked potentials, DEMYELINATION, OPTIC nerve, CHEMICAL models, NEUROLOGICAL disorders, TRANSGENIC animals
Abstract

Many biomarkers in clinical neuroscience lack pathological certification. This issue is potentially a significant contributor to the limited success of neuroprotective and neurorestorative therapies for human neurological disease-and is evident even in areas with therapeutic promise such as myelin repair. Despite the identification of promising remyelinating candidates, biologically validated methods to demonstrate therapeutic efficacy or provide robust preclinical evidence of remyelination in the CNS are lacking. Therapies with potential to remyelinate the CNS constitute one of the most promising and highly anticipated therapeutic developments in the pipeline to treat multiple sclerosis and other demyelinating diseases. The optic nerve has been proposed as an informative pathway to monitor remyelination in animals and human subjects. Recent clinical trials using visual evoked potential have had promising results, but without unequivocal evidence about the cellular and molecular basis for signal changes on visual evoked potential, the interpretation of these trials is constrained. The visual evoked potential was originally developed and used in the clinic as a diagnostic tool but its use as a quantitative method for assessing therapeutic response requires certification of its biological specificity. Here, using the tools of experimental pathology we demonstrate that quantitative measurements of myelination using both histopathological measures of nodal structure and ultrastructural assessments correspond to visual evoked potential latency in both inflammatory and chemical models of demyelination. Visual evoked potential latency improves after treatment with a tool remyelinating compound (clemastine), mirroring both quantitative and qualitative myelin assessment. Furthermore, clemastine does not improve visual evoked potential latency following demyelinating injury when administered to a transgenic animal incapable of forming new myelin. Therefore, using the capacity for therapeutic enhancement and biological loss of function we demonstrate conclusively that visual evoked potential measures myelin status and is thereby a validated tool for preclinical verification of remyelination. [ABSTRACT FROM AUTHOR]

Published
2022
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148. Retinal Optical Coherence Tomography in Neuromyelitis Optica

Author

Oertel, Frederike Cosima, primary, Specovius, Svenja, additional, Zimmermann, Hanna G., additional, Chien, Claudia, additional, Motamedi, Seyedamirhosein, additional, Bereuter, Charlotte, additional, Cook, Lawrence, additional, Lana Peixoto, Marco Aurélio, additional, Fontanelle, Mariana Andrade, additional, Kim, Ho Jin, additional, Hyun, Jae-Won, additional, Palace, Jacqueline, additional, Roca-Fernandez, Adriana, additional, Leite, Maria Isabel, additional, Sharma, Srilakshmi, additional, Ashtari, Fereshteh, additional, Kafieh, Rahele, additional, Dehghani, Alireza, additional, Pourazizi, Mohsen, additional, Pandit, Lekha, additional, D'Cunha, Anitha, additional, Aktas, Orhan, additional, Ringelstein, Marius, additional, Albrecht, Philipp, additional, May, Eugene, additional, Tongco, Caryl, additional, Leocani, Letizia, additional, Pisa, Marco, additional, Radaelli, Marta, additional, Martinez-Lapiscina, Elena H., additional, Stiebel-Kalish, Hadas, additional, Siritho, Sasitorn, additional, de Seze, Jérome, additional, Senger, Thomas, additional, Havla, Joachim, additional, Marignier, Romain, additional, Calvo, Alvaro Cobo, additional, Bichuetti, Denis, additional, Tavares, Ivan Maynart, additional, Asgari, Nasrin, additional, Soelberg, Kerstin, additional, Altintas, Ayse, additional, Yildirim, Rengin, additional, Tanriverdi, Uygur, additional, Jacob, Anu, additional, Huda, Saif, additional, Rimler, Zoe, additional, Reid, Allyson, additional, Mao-Draayer, Yang, additional, Soto de Castillo, Ibis, additional, Petzold, Axel, additional, Green, Ari J., additional, Yeaman, Michael R., additional, Smith, Terry, additional, Brandt, Alexander U., additional, and Paul, Friedemann, additional

Published
2021
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149. sj-pdf-1-msj-10.1177_1352458521988926 – Supplemental material for Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD

Author

Cree, Bruce AC, Bennett, Jeffrey L, Kim, Ho Jin, Weinshenker, Brian G, Pittock, Sean J, Wingerchuk, Dean, Fujihara, Kazuo, Paul, Friedemann, Cutter, Gary R, Marignier, Romain, Green, Ari J, Aktas, Orhan, Hans-Peter Hartung, Williams, Ian M, Drappa, Jorn, Dewei She, Cimbora, Daniel, Rees, William, Ratchford, John N, and Katz, Eliezer

Subjects
FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material, sj-pdf-1-msj-10.1177_1352458521988926 for Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD by Bruce AC Cree, Jeffrey L Bennett, Ho Jin Kim, Brian G Weinshenker, Sean J Pittock, Dean Wingerchuk, Kazuo Fujihara, Friedemann Paul, Gary R Cutter, Romain Marignier, Ari J Green, Orhan Aktas, Hans-Peter Hartung, Ian M Williams, Jorn Drappa, Dewei She, Daniel Cimbora, William Rees, John N Ratchford and Eliezer Katz in Multiple Sclerosis Journal

Published
2021
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150. Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD.

Author

Cree, Bruce Ac, Cree, Bruce Ac, Bennett, Jeffrey L, Kim, Ho Jin, Weinshenker, Brian G, Pittock, Sean J, Wingerchuk, Dean, Fujihara, Kazuo, Paul, Friedemann, Cutter, Gary R, Marignier, Romain, Green, Ari J, Aktas, Orhan, Hartung, Hans-Peter, Williams, Ian M, Drappa, Jorn, She, Dewei, Cimbora, Daniel, Rees, William, Ratchford, John N, Katz, Eliezer, Cree, Bruce Ac, Cree, Bruce Ac, Bennett, Jeffrey L, Kim, Ho Jin, Weinshenker, Brian G, Pittock, Sean J, Wingerchuk, Dean, Fujihara, Kazuo, Paul, Friedemann, Cutter, Gary R, Marignier, Romain, Green, Ari J, Aktas, Orhan, Hartung, Hans-Peter, Williams, Ian M, Drappa, Jorn, She, Dewei, Cimbora, Daniel, Rees, William, Ratchford, John N, and Katz, Eliezer

Abstract

BackgroundIn the N-MOmentum trial, the risk of an adjudicated neuromyelitis optica spectrum disorder (NMOSD) attack was significantly reduced with inebilizumab compared with placebo.ObjectiveTo demonstrate the robustness of this finding, using pre-specified sensitivity and subgroup analyses.MethodsN-MOmentum is a prospective, randomized, placebo-controlled, double-masked trial of inebilizumab, an anti-CD19 monoclonal B-cell-depleting antibody, in patients with NMOSD. Pre-planned and post hoc analyses were performed to evaluate the primary endpoint across a range of attack definitions and demographic groups, as well as key secondary endpoints.ResultsIn the N-MOmentum trial (ClinicalTrials.gov: NCT02200770), 174 participants received inebilizumab and 56 received placebo. Attack risk for inebilizumab versus placebo was consistently and significantly reduced, regardless of attack definition, type of attack, baseline disability, ethnicity, treatment history, or disease course (all with hazard ratios < 0.4 favoring inebilizumab, p < 0.05). Analyses of secondary endpoints showed similar trends.ConclusionN-MOmentum demonstrated that inebilizumab provides a robust reduction in the risk of NMOSD attacks regardless of attack evaluation method, attack type, patient demographics, or previous therapy.The N-MOmentum study is registered at ClinicalTrials.gov: NCT2200770.

Published
2021

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