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1,064 results on '"Hauser, Stephen"'

1. A Precision Medicine Tool for Patients With Multiple Sclerosis (the Open MS BioScreen): Human-Centered Design and Development

Author

Schleimer, Erica, Pearce, Jennifer, Barnecut, Andrew, Rowles, William, Lizee, Antoine, Klein, Arno, Block, Valerie J, Santaniello, Adam, Renschen, Adam, Gomez, Refujia, Keshavan, Anisha, Gelfand, Jeffrey M, Henry, Roland G, Hauser, Stephen L, and Bove, Riley

Subjects
Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
Abstract

BackgroundPatients with multiple sclerosis (MS) face several challenges in accessing clinical tools to help them monitor, understand, and make meaningful decisions about their disease course. The University of California San Francisco MS BioScreen is a web-based precision medicine tool initially designed to be clinician facing. We aimed to design a second, openly available tool, Open MS BioScreen, that would be accessible, understandable, and actionable by people with MS. ObjectiveThis study aimed to describe the human-centered design and development approach (inspiration, ideation, and implementation) for creating the Open MS BioScreen platform. MethodsWe planned an iterative and cyclical development process that included stakeholder engagement and iterative feedback from users. Stakeholders included patients with MS along with their caregivers and family members, MS experts, generalist clinicians, industry representatives, and advocacy experts. Users consisted of anyone who wants to track MS measurements over time and access openly available tools for people with MS. Phase I (inspiration) consisted of empathizing with users and defining the problem. We sought to understand the main challenges faced by patients and clinicians and what they would want to see in a web-based app. In phase II (ideation), our multidisciplinary team discussed approaches to capture, display, and make sense of user data. Then, we prototyped a series of mock-ups to solicit feedback from clinicians and people with MS. In phase III (implementation), we incorporated all concepts to test and iterate a minimally viable product. We then gathered feedback through an agile development process. The design and development were cyclical—many times throughout the process, we went back to the drawing board. ResultsThis human-centered approach generated an openly available, web-based app through which patients with MS, their clinicians, and their caregivers can access the site and create an account. Users can enter information about their MS (basic level as well as more advanced concepts), visualize their data longitudinally, access a series of algorithms designed to empower them to make decisions about their treatments, and enter data from wearable devices to encourage realistic goal setting about their ambulatory activity. Agile development will allow us to continue to incorporate precision medicine tools, as these are validated in the clinical research arena. ConclusionsAfter engaging intended users into the iterative human-centered design of the Open MS BioScreen, we will now monitor the adaptation and dissemination of the tool as we expand its functionality and reach. The insights generated from this approach can be applied to the development of a number of self-tracking, self-management, and user engagement tools for patients with chronic conditions.

Published
2020
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2. Correction: Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study

Author

Midaglia, Luciana, Mulero, Patricia, Montalban, Xavier, Graves, Jennifer, Hauser, Stephen L, Julian, Laura, Baker, Michael, Schadrack, Jan, Gossens, Christian, Scotland, Alf, Lipsmeier, Florian, van Beek, Johan, Bernasconi, Corrado, Belachew, Shibeshih, and Lindemann, Michael

Subjects
Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
Published
2019
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3. An autoantibody signature predictive for multiple sclerosis

Author

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

Published
2024
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4. Inflammatory and neurodegenerative serum protein biomarkers increase sensitivity to detect clinical and radiographic disease activity in multiple sclerosis

Author

Chitnis, Tanuja, Qureshi, Ferhan, Gehman, Victor M., Becich, Michael, Bove, Riley, Cree, Bruce A. C., Gomez, Refujia, Hauser, Stephen L., Henry, Roland G., Katrib, Amal, Lokhande, Hrishikesh, Paul, Anu, Caillier, Stacy J., Santaniello, Adam, Sattarnezhad, Neda, Saxena, Shrishti, Weiner, Howard, Yano, Hajime, and Baranzini, Sergio E.

Published
2024
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8. Patient-reported outcome parameters and disability worsening in progressive multiple sclerosis

Author

Abdelhak, Ahmed, Antweiler, Kai, Kowarik, Markus C., Senel, Makbule, Havla, Joachim, Zettl, Uwe K., Kleiter, Ingo, Hoshi, Muna-Miriam, Skripuletz, Thomas, Haarmann, Axel, Stahmann, Alexander, Huss, Andre, Gingele, Stefan, Krumbholz, Markus, Selge, Charlotte, Friede, Tim, Ludolph, Albert C., Overell, James, Koendgen, Harold, Clinch, Susanne, Wang, Qing, Ziemann, Ulf, Hauser, Stephen L., Kümpfel, Tania, Green, Ari J, and Tumani, Hayrettin

Published
2024
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10. Blood neurofilament light levels predict non-relapsing progression following anti-CD20 therapy in relapsing and primary progressive multiple sclerosis: findings from the ocrelizumab randomised, double-blind phase 3 clinical trials

Author

Bar-Or, Amit, Thanei, Gian-Andrea, Harp, Christopher, Bernasconi, Corrado, Bonati, Ulrike, Cross, Anne H., Fischer, Saloumeh, Gaetano, Laura, Hauser, Stephen L., Hendricks, Robert, Kappos, Ludwig, Kuhle, Jens, Leppert, David, Model, Fabian, Sauter, Annette, Koendgen, Harold, Jia, Xiaoming, and Herman, Ann E.

Published
2023
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13. A pathogenic and clonally expanded B cell transcriptome in active multiple sclerosis

Author

University of California, San Francisco MS-EPIC Team, Ramesh, Akshaya, Schubert, Ryan D., Greenfield, Ariele L., Dandekar, Ravi, Loudermilk, Rita, Sabatino, Joseph J., Koelzer, Matthew T., Tran, Edwina B., Koshal, Kanishka, Kim, Kicheol, Pröbstel, Anne-Katrin, Banerji, Debarko, Guo, Chu-Yueh, Green, Ari J., Bove, Riley M., DeRisi, Joseph L., Gelfand, Jeffrey M., Cree, Bruce A. C., Zamvil, Scott S., Baranzini, Sergio E., Hauser, Stephen L., and Wilson, Michael R.

Published
2020

15. Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial

Author

Wolinsky, Jerry S, Arnold, Douglas L, Brochet, Bruno, Hartung, Hans-Peter, Montalban, Xavier, Naismith, Robert T, Manfrini, Marianna, Overell, James, Koendgen, Harold, Sauter, Annette, Bennett, Iain, Hubeaux, Stanislas, Kappos, Ludwig, and Hauser, Stephen L

Published
2020
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17. A specific amino acid motif of HLA-DRB1 mediates risk and interacts with smoking history in Parkinson’s disease

Author

Hollenbach, Jill A., Norman, Paul J., Creary, Lisa E., Damotte, Vincent, Montero-Martin, Gonzalo, Caillier, Stacy, Anderson, Kirsten M., Misra, Maneesh K., Nemat-Gorgani, Neda, Osoegawa, Kazutoyo, Santaniello, Adam, Renschen, Adam, Marin, Wesley M., Dandekar, Ravi, Parham, Peter, Tanner, Caroline M., Hauser, Stephen L., Fernandez-Viña, Marcelo, and Oksenberg, Jorge R.

Published
2019

18. Pan-viral serology implicates enteroviruses in acute flaccid myelitis

Author

Schubert, Ryan D., Hawes, Isobel A., Ramachandran, Prashanth S., Ramesh, Akshaya, Crawford, Emily D., Pak, John E., Wu, Wesley, Cheung, Carly K., O’Donovan, Brian D., Tato, Cristina M., Lyden, Amy, Tan, Michelle, Sit, Rene, Sowa, Gavin M., Sample, Hannah A., Zorn, Kelsey C., Banerji, Debarko, Khan, Lillian M., Bove, Riley, Hauser, Stephen L., Gelfand, Amy A., Johnson-Kerner, Bethany L., Nash, Kendall, Krishnamoorthy, Kalpathy S., Chitnis, Tanuja, Ding, Joy Z., McMillan, Hugh J., Chiu, Charles Y., Briggs, Benjamin, Glaser, Carol A., Yen, Cynthia, Chu, Victoria, Wadford, Debra A., Dominguez, Samuel R., Ng, Terry Fei Fan, Marine, Rachel L., Lopez, Adriana S., Nix, W. Allan, Soldatos, Ariane, Gorman, Mark P., Benson, Leslie, Messacar, Kevin, Konopka-Anstadt, Jennifer L., Oberste, M. Steven, DeRisi, Joseph L., and Wilson, Michael R.

Published
2019
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22. Synaptic injury in the inner plexiform layer of the retina is associated with progression in multiple sclerosis

Author

Oksenberg, Jorge, Henry, Roland, Baranzini, Sergio, Wilson, Michael, Bove, Riley, Cuneo, Richard, Gupta, Sasha, Sabatino, Joseph, Guo, Joanne, Sacco, Simone, Papinutto, Nico, Hollenbach, Jill, Gelfand, Jeff, Pleasure, Sam, Zamvil, Scott, Goodin, Douglas, Waubant, Emmanuelle, Gomez, Refujia, Cerono, Gabriel, Cordano, Christian, Werneburg, Sebastian, Abdelhak, Ahmed, Bennett, Daniel J., Beaudry-Richard, Alexandra, Duncan, Greg J., Oertel, Frederike C., Boscardin, W. John, Yiu, Hao H., Jabassini, Nora, Merritt, Lauren, Nocera, Sonia, Sin, Jung H., Samana, Isaac P., Condor Montes, Shivany Y., Ananth, Kirtana, Bischof, Antje, Nourbakhsh, Bardia, Hauser, Stephen L., Cree, Bruce A.C., Emery, Ben, Schafer, Dorothy P., Chan, Jonah R., and Green, Ari J.

Published
2024
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24. The Development of Ofatumumab, a Fully Human Anti-CD20 Monoclonal Antibody for Practical Use in Relapsing Multiple Sclerosis Treatment

Author

Hauser, Stephen L, Kappos, Ludwig, Bar-Or, Amit, Wiendl, Heinz, Paling, David, Williams, Mitzi, Gold, Ralf, Chan, Andrew, Milo, Ron, Das Gupta, Ayan, Karlsson, Goeril, Sullivan, Roseanne, Graham, Gordon, Merschhemke, Martin, Häring, Dieter A, and Vermersch, Patrick

Subjects
610 Medicine & health
Abstract

The importance of B cells in multiple sclerosis (MS) has been demonstrated through the advent of B-cell-depleting anti-CD20 antibody therapies. Ofatumumab is the first fully human anti-CD20 monoclonal antibody (mAb) developed and tested for subcutaneous (SC) self-administration at monthly doses of 20 mg, and has been approved in the US, UK, EU, and other regions and countries worldwide for the treatment of relapsing MS. The development goal of ofatumumab was to obtain a highly efficacious anti-CD20 therapy, with a safety and tolerability profile that allows for self-administration by MS patients at home and a positive benefit-risk balance for use in the broad relapsing MS population. This development goal was enabled by the unique binding site, higher affinity to B cells, and higher potency of ofatumumab compared to previous anti-CD20 mAbs; these properties of ofatumumab facilitate rapid B-cell depletion and maintenance with a low dose at a low injection volume (20 mg/0.4 ml). The high potency in turn enables the selective targeting of B cells that reside in the lymphatic system via subcutaneous (SC) administration. Through a comprehensive dose-finding program in two phase 2 studies (one intravenous and one SC) and model simulations, it was found that safety and tolerability can be further improved, and the risk of systemic injection-related reactions (IRRs) minimized, by avoiding doses ≥ 30 mg, and by reaching initial and rapid B-cell depletion via stepwise weekly administration of ofatumumab at Weeks 0, 1, and 2 (instead of a single high dose). Once near-complete B-cell depletion is reached, it can be maintained by monthly doses of 20 mg/0.4 ml. Indeed, in phase 3 trials (ASCLEPIOS I/II), rapid and sustained near-complete B-cell depletion (largely independent of body weight, race and other factors) was observed with this dosing regimen, which resulted in superior efficacy of ofatumumab versus teriflunomide on relapse rates, disability worsening, neuronal injury (serum neurofilament light chain), and imaging outcomes. Likely due to its fully human nature, ofatumumab has a low immunogenic risk profile-only 2 of 914 patients receiving ofatumumab in ASCLEPIOS I/II developed anti-drug antibodies-and this may also underlie the infrequent IRRs (20% with ofatumumab vs. 15% with the placebo injection in the teriflunomide arm) that were mostly (99.8%) mild to moderate in severity. The overall rates of infections and serious infections in patients treated with ofatumumab were similar to those in patients treated with teriflunomide (51.6% vs. 52.7% and 2.5% vs. 1.8%, respectively). The benefit-risk profile of ofatumumab was favorable compared to teriflunomide in the broad RMS population, and also in the predefined subgroups of both recently diagnosed and/or treatment-naïve patients, as well as previously disease-modifying therapy-treated patients. Interim data from the ongoing extension study (ALITHIOS) have shown that long-term treatment with ofatumumab up to 4 years is well-tolerated in RMS patients, with no new safety risks identified. In parallel to the phase 3 trials in which SC administration was carried out with a pre-filled syringe, an autoinjector pen for more convenient self-administration of the ofatumumab 20 mg dose was developed and is available for use in clinical practice.

Published
2023

28. In depth comparison of an individual's DNA and its lymphoblastoid cell line using whole genome sequencing

Author

Nickles, Dorothee, Madireddy, Lohith, Yang, Shan, Khankhanian, Pouya, Lincoln, Steve, Hauser, Stephen L, Oksenberg, Jorge R, and Baranzini, Sergio E

Abstract

Abstract Background A detailed analysis of whole genomes can be now achieved with next generation sequencing. Epstein Barr Virus (EBV) transformation is a widely used strategy in clinical research to obtain an unlimited source of a subject’s DNA. Although the mechanism of transformation and immortalization by EBV is relatively well known at the transcriptional and proteomic level, the genetic consequences of EBV transformation are less well understood. A detailed analysis of the genetic alterations introduced by EBV transformation is highly relevant, as it will inform on the usefulness and limitations of this approach. Results We used whole genome sequencing to assess the genomic signature of a low-passage lymphoblastoid cell line (LCL). Specifically, we sequenced the full genome (40X) of an individual using DNA purified from fresh whole blood as well as DNA from his LCL. A total of 217.33 Gb of sequence were generated from the cell line and 238.95 Gb from the normal genomic DNA. We determined with high confidence that 99.2% of the genomes were identical, with no reproducible changes in structural variation (chromosomal rearrangements and copy number variations) or insertion/deletion polymorphisms (indels). Conclusions Our results suggest that, at this level of resolution, the LCL is genetically indistinguishable from its genomic counterpart and therefore their use in clinical research is not likely to introduce a significant bias.

Published
2012

29. Evidence of novel fine-scale structural variation at autism spectrum disorder candidate loci

Author

Hedges, Dale J, Hamilton-Nelson, Kara L, Sacharow, Stephanie J, Nations, Laura, Beecham, Gary W, Kozhekbaeva, Zhanna M, Butler, Brittany L, Cukier, Holly N, Whitehead, Patrice L, Ma, Deqiong, Jaworski, James M, Nathanson, Lubov, Lee, Joycelyn M, Hauser, Stephen L, Oksenberg, Jorge R, Cuccaro, Michael L, Haines, Jonathan L, Gilbert, John R, and Pericak-Vance, Margaret A

Abstract

Abstract Background Autism spectrum disorders (ASD) represent a group of neurodevelopmental disorders characterized by a core set of social-communicative and behavioral impairments. Gamma-aminobutyric acid (GABA) is the major inhibitory neurotransmitter in the brain, acting primarily via the GABA receptors (GABR). Multiple lines of evidence, including altered GABA and GABA receptor expression in autistic patients, indicate that the GABAergic system may be involved in the etiology of autism. Methods As copy number variations (CNVs), particularly rare and de novo CNVs, have now been implicated in ASD risk, we examined the GABA receptors and genes in related pathways for structural variation that may be associated with autism. We further extended our candidate gene set to include 19 genes and regions that had either been directly implicated in the autism literature or were directly related (via function or ancestry) to these primary candidates. For the high resolution CNV screen we employed custom-designed 244 k comparative genomic hybridization (CGH) arrays. Collectively, our probes spanned a total of 11 Mb of GABA-related and additional candidate regions with a density of approximately one probe every 200 nucleotides, allowing a theoretical resolution for detection of CNVs of approximately 1 kb or greater on average. One hundred and sixty-eight autism cases and 149 control individuals were screened for structural variants. Prioritized CNV events were confirmed using quantitative PCR, and confirmed loci were evaluated on an additional set of 170 cases and 170 control individuals that were not included in the original discovery set. Loci that remained interesting were subsequently screened via quantitative PCR on an additional set of 755 cases and 1,809 unaffected family members. Results Results include rare deletions in autistic individuals at JAKMIP1, NRXN1, Neuroligin4Y, OXTR, and ABAT. Common insertion/deletion polymorphisms were detected at several loci, including GABBR2 and NRXN3. Overall, statistically significant enrichment in affected vs. unaffected individuals was observed for NRXN1 deletions. Conclusions These results provide additional support for the role of rare structural variation in ASD.

Published
2012

32. Modeling the Cumulative Genetic Risk for Multiple Sclerosis from Genome Wide Association Data

Author

Wang, Joanne H, Pappas, Derek, De Jager, Philip L, Pelletier, Daniel, de Bakker, Paul IW, Kappos, Ludwig, Polman, Chris H, james.wiley@florey.edu.au, Chibnik, Lori B, Hafler, David A, Matthews, Paul M, Hauser, Stephen L, Baranzini, Sergio E, and Oksenberg, Jorge R

Abstract

Abstract Background Multiple sclerosis (MS) is the most common cause of chronic neurologic disability beginning in early to middle adult life. Results from recent genome-wide association studies (GWAS) have substantially lengthened the list of disease loci and provide convincing evidence supporting a multifactorial and polygenic model of inheritance. Nevertheless, the knowledge of MS genetics remains incomplete, with many risk alleles still to be revealed. Methods We used a discovery GWAS dataset (8,844 samples, 2,124 cases and 6,720 controls) and a multi-step logistic regression protocol to identify novel genetic associations. The emerging genetic profile included 350 independent markers and was used to calculate and estimate the cumulative genetic risk in an independent validation dataset (3,606 samples). Analysis of covariance (ANCOVA) was implemented to compare clinical characteristics of individuals with various degrees of genetic risk. Gene ontology and pathway enrichment analysis was done using the DAVID functional annotation tool, the GO Tree Machine, and the Pathway-Express profiling tool. Results In the discovery dataset, the median cumulative genetic risk (P-Hat) was 0.903 and 0.007 in the case and control groups, respectively, together with 79.9% classification sensitivity and 95.8% specificity. The identified profile shows a significant enrichment of genes involved in the immune response, cell adhesion, cell communication/signaling, nervous system development, and neuronal signaling, including ionotropic glutamate receptors, which have been implicated in the pathological mechanism driving neurodegeneration. In the validation dataset, the median cumulative genetic risk was 0.59 and 0.32 in the case and control groups, respectively, with classification sensitivity 62.3% and specificity 75.9%. No differences in disease progression or T2-lesion volumes were observed among four levels of predicted genetic risk groups (high, medium, low, misclassified). On the other hand, a significant difference (F = 2.75, P = 0.04) was detected for age of disease onset between the affected misclassified as controls (mean = 36 years) and the other three groups (high, 33.5 years; medium, 33.4 years; low, 33.1 years). Conclusions The results are consistent with the polygenic model of inheritance. The cumulative genetic risk established using currently available genome-wide association data provides important insights into disease heterogeneity and completeness of current knowledge in MS genetics.

Published
2011

33. Author Correction: Pan-viral serology implicates enteroviruses in acute flaccid myelitis

Author

Schubert, Ryan D., Hawes, Isobel A., Ramachandran, Prashanth S., Ramesh, Akshaya, Crawford, Emily D., Pak, John E., Wu, Wesley, Cheung, Carly K., O’Donovan, Brian D., Tato, Cristina M., Lyden, Amy, Tan, Michelle, Sit, Rene, Sowa, Gavin M., Sample, Hannah A., Zorn, Kelsey C., Banerji, Debarko, Khan, Lillian M., Bove, Riley, Hauser, Stephen L., Gelfand, Amy A., Johnson-Kerner, Bethany L., Nash, Kendall, Krishnamoorthy, Kalpathy S., Chitnis, Tanuja, Ding, Joy Z., McMillan, Hugh J., Chiu, Charles Y., Briggs, Benjamin, Glaser, Carol A., Yen, Cynthia, Chu, Victoria, Wadford, Debra A., Dominguez, Samuel R., Ng, Terry Fei Fan, Marine, Rachel L., Lopez, Adriana S., Nix, W. Allan, Soldatos, Ariane, Gorman, Mark P., Benson, Leslie, Messacar, Kevin, Konopka-Anstadt, Jennifer L., Oberste, M. Steven, DeRisi, Joseph L., and Wilson, Michael R.

Published
2021
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34. Genetic variation in the odorant receptors family 13 and the MHC loci influence mate selection in a Multiple Sclerosis dataset

Author

Khankhanian, Pouya, Gourraud, Pierre-Antoine, Caillier, Stacy J, Santaniello, Adam, Hauser, Stephen L, Baranzini, Sergio E, and Oksenberg, Jorge R

Abstract

Abstract Background When selecting mates, many vertebrate species seek partners with major histocompatibility complex (MHC) genes different from their own, presumably in response to selective pressure against inbreeding and towards MHC diversity. Attempts at replication of these genetic results in human studies, however, have reached conflicting conclusions. Results Using a multi-analytical strategy, we report validated genome-wide relationships between genetic identity and human mate choice in 930 couples of European ancestry. We found significant similarity between spouses in the MHC at class I region in chromosome 6p21, and at the odorant receptor family 13 locus in chromosome 9. Conversely, there was significant dissimilarity in the MHC class II region, near the HLA-DQA1 and -DQB1 genes. We also found that genomic regions with significant similarity between spouses show excessive homozygosity in the general population (assessed in the HapMap CEU dataset). Conversely, loci that were significantly dissimilar among spouses were more likely to show excessive heterozygosity in the general population. Conclusions This study highlights complex patterns of genomic identity among partners in unrelated couples, consistent with a multi-faceted role for genetic factors in mate choice behavior in human populations.

Published
2010

36. Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension.

Author

Hauser, Stephen L, Zielman, Ronald, Das Gupta, Ayan, Xi, Jing, Stoneman, Dee, Karlsson, Goeril, Robertson, Derrick, Cohen, Jeffrey A, and Kappos, Ludwig

Subjects
*MULTIPLE sclerosis, *CONTINUOUS groups, *PATIENT safety, *CONFIDENCE intervals, *CYTOPLASMIC filaments, *MONOCLONAL gammopathies
Abstract

Background: Ofatumumab has demonstrated superior efficacy and favorable safety for up to 2.5 years versus teriflunomide in relapsing multiple sclerosis (RMS). Objective: Further characterize efficacy and safety of ofatumumab in RMS. Methods: Efficacy set: patients randomized to ofatumumab/teriflunomide in ASCLEPIOS I/II (core). Safety set: patients who received ⩾ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS (all core), or ALITHIOS (umbrella open-label extension). Patients received continuous ofatumumab or were newly switched from teriflunomide. Data cut-off: 25 September 2021. Results: In the efficacy set (n = 1882), the continuous ofatumumab group had a low annualized relapse rate (ARR 0.05 (95% confidence interval: 0.04–0.07)), low numbers of gadolinium-enhancing (Gd+) T1 lesions (0.01 lesions/scan) and fewer new/enlarging T2 lesions (annualized rate 0.08). Overall, 78.8% met three-parameter "no evidence of disease activity" criteria through 4 years. Switching from teriflunomide led to reduced ARR, risk of confirmed disability worsening (CDW), new/enlarging T2 lesions, Gd+ T1 lesions, and serum neurofilament light chain. In the continuous and newly switched ofatumumab groups, cumulative 3- and 6-month CDW rates remained low. In the safety set (n = 1969), the most frequently reported adverse events were infections and infestations (58.35%). No new safety signals were identified. Conclusion: Ofatumumab has a favorable longer-term benefit–risk profile in RMS. Trial registry: ALITHIOS (NCT03650114): https://clinicaltrials.gov/ct2/show/NCT03650114 [ABSTRACT FROM AUTHOR]

Published
2023
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37. Progressive multifocal leukoencephalopathy in a patient with relapsing multiple sclerosis treated with ocrelizumab: A case report.

Author

Puig‐Casadevall, Marc, Álvarez‐Bravo, Gary, Varela, Ana Quiroga, Robles‐Cedeño, René, Sànchez Cirera, Laura, Miguela, Albert, Laguillo, Gemma, Montalban, Xavier, Hauser, Stephen L., and Ramió‐Torrentà, Lluis

Subjects
PROGRESSIVE multifocal leukoencephalopathy, JOHN Cunningham virus, MULTIPLE sclerosis, DISEASE relapse, SYMPTOMS, IMMUNOSUPPRESSIVE agents
Abstract

Introduction: Progressive multifocal leukoencephalopathy is a rare but often fatal complication of some multiple sclerosis treatments. Although it has mainly been associated with natalizumab treatment, its appearance with other immunosuppressive therapies has also been reported. Aims: The aim of this case report is to describe the development of progressive multifocal encephalopathy in a patient with relapsing–remitting multiple sclerosis treated with ocrelizumab without previous use of natalizumab. Conclusions: A summary of the presentation and disease course is provided, presented in the context of the current literature and likely pathophysiology. [ABSTRACT FROM AUTHOR]

Published
2023
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38. Serum antibodies to phosphatidylcholine in MS

Author

Sádaba, Maria Cruz, Rothhammer, Veit, Muñoz, Úrsula, Sebal, Cristina, Escudero, Esther, Kivisäkk, Pia, Garcia Sanchez, Maria Isabel, Izquierdo, Guillermo, Hauser, Stephen L., Baranzini, Sergio E., Oksenberg, Jorge R., Álvarez-Lafuente, Roberto, Bakshi, Rohit, Weiner, Howard L., and Quintana, Francisco J.

Published
2020
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