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Journal: Neurology Neuroimmunology & Neuroinflammation; May 31, 2023
Author(s): Friedemann Paul, Romain Marignier, Jacqueline Palace, Georgina Arrambide, Nasrin Asgari, Jeffrey L. Bennett, Bruce Anthony Campbell Cree, Jérôme De Sèze, Kazuo Fujihara, Ho Jin Kim, Rebecca Hornby, Saif Huda, Najib Kissani, Ingo Kleiter, Satoshi Kuwabara, Marco Lana-Peixoto, Lisa Law, M. Isabel Leite, Lekha Pandit, Sean J. Pittock, Chao Quan, Sudarshini Ramanathan, Dalia Rotstein, Albert Saiz, Douglas Kazutoshi Sato, Adi Vaknin-Dembinsky
Recommendations for management of NMOSD with eculizumab, inebilizumab, and satralizumab: Consensus among international experts
This study aimed to get consensus from an international panel of 24 NMOSD experts on management of the disease and recommendations for the three recently approved therapies: eculizumab, inebilizumab, and satralizumab. The 24 clinical experts were asked to complete a questionnaire on NMOSD management, using free-text responses based on available research evidence and their own clinical experience. Responses were used to generate draft statements on NMOSD-related themes, and panelists anonymously indicated their level of agreement with each statement. Twenty-five statements were agreed in total: 11 on starting with or switching between eculizumab, inebilizumab, and satralizumab; 3 on monotherapy (treatment with one of these drugs alone) and/or combination therapy; 7 on safety and patient population considerations; 3 on biomarkers (blood levels and other measures) and/or patient-reported outcomes; and 1 on research gaps. This consensus paper can serve as a useful guide to clinicians and patients for shared decision-making in NMOSD management.
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Journal: Nature Reviews Neurology; October 28, 2021
Author(s): Sean J. Pittock, Anastasia Zekeridou, Brian G. Weinshenker
New research and approved therapies bringing hope to NMOSD patients
Until recently, no regulator-approved therapies were available for NMOSD. Traditional immunosuppressant therapies, including mycophenolate mofetil, azathioprine, and rituximab, were widely used, but their benefits have not been assessed in controlled studies. Recent research has led to an improved understanding of the underlying disease mechanism of NMOSD and has enabled the development of more targeted new therapies. In recent clinical trials, eculizumab, inebilizumab, satralizumab, and rituximab all reduced the risk of relapse, and the former three therapies have now been approved specifically for NMOSD. Because of differences in the study designs, it is difficult to conclude which treatment is preferable. Previous experience with therapy, efficacy, safety, accessibility, cost, and convenience are all factors to be considered in treatment selection. The accessibility and affordability of the newly approved treatments will vary between countries and regions and will influence decisions to start patients on or switch to these drugs. While the rituximab clinical trial included too few patients to quantify its effects in reducing the risk of relapse, the extensive clinical experience with rituximab and its relatively low cost mean that it will remain an important treatment option.
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Journal: Annals of Neurology; February 14, 2021
Author(s): Dean M Wingerchuk, Kazuo Fujihara, Jacqueline Palace, Achim Berthele, Michael Levy, Ho Jin Kim, Ichiro Nakashima, Celia Oreja-Guevara, Kai-Chen Wang, Larisa Miller, Shulian Shang, Guido Sabatella, Marcus Yountz, Sean J Pittock; PREVENT Study Group
Long-term safety and efficacy of eculizumab in NMOSD patients testing positive for aquaporin-4 antibodies
The PREVENT clinical trial was conducted for the medicine eculizumab, a recently approved therapy for NMOSD. This study was conducted as an interim analysis of eculizumab’s safety and efficacy during the open-label extension (the phase of a trial where participants are aware what drug they are being administered) of the PREVENT study. Across the PREVENT study and the open-label extension, 137 patients received eculizumab and were monitored for a median duration of 133 weeks (duration ranging from 5.1-276.9 weeks). At 192 weeks (3.7 years), 94.4% of patients remained relapse-free. During the open-label extension, 44 of 119 patients stopped or decreased the use of the background immunosuppressants they were on. The results of this study showed that eculizumab has a similar long-term safety profile in NMOSD as it is known to have for other conditions where it is approved. The results also showed that long-term eculizumab treatment had a sustained effect in reducing the relapse risk in patients with AQP4-antibody-positive NMOSD.
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Journal: The Lancet; September 5, 2019
Author(s): Bruce A C Cree, Jeffrey L Bennett, Ho Jin Kim, Brian G Weinshenker, Sean J Pittock, Dean M Wingerchuk, Kazuo Fujihara, Friedemann Paul, Gary R Cutter, Romain Marignier, Ari J Green, Orhan Aktas, Hans-Peter Hartung, Fred D Lublin, Jorn Drappa, Gerard Barron, Soraya Madani, John N Ratchford, Dewei She, Daniel Cimbora, Eliezer Katz; N-MOmentum study investigators
Clinical trial paper of Inebilizumab for the treatment of NMOSD
This study was conducted prior to approval of inebilizumab, a recently approved disease-modifying therapy for NMOSD. This clinical trial study (called the N-Momentum study) assessed the efficacy and safety of inebilizumab in reducing the risk of attacks and disability in NMOSD. Between Jan 6, 2015, and Sept 24, 2018, 230 participants were recruited to the trial and randomly assigned to receive inebilizumab or placebo. The random assignment to groups was stopped before all participants were recruited because a clear efficacy benefit of inebilizumab over placebo was seen; 174 participants received inebilizumab and 56 received placebo. 21 (12%) of 174 participants receiving inebilizumab had an attack versus 22 (39%) of 56 participants receiving placebo. Adverse events occurred in 125 (72%) of 174 participants receiving inebilizumab and 41 (73%) of 56 participants receiving placebo. Serious adverse events occurred in eight (5%) of 174 participants receiving inebilizumab and five (9%) of 56 participants receiving placebo. Compared with placebo, inebilizumab reduced the risk of an NMOSD attack.
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Journal: Journal of Investigative Medicine; March 13, 2023
Author(s): Jacqueline F Rosenthal, Benjamin M Hoffman, William R Tyor
A review of MS, NMOSD, and MOGAD
Although multiple sclerosis is the most common central nervous system (CNS) inflammatory demyelinating disorder, NMOSD and MOGAD share some clinical characteristics of multiple sclerosis, such as optic neuritis and myelitis, which can make a specific diagnosis challenging. However, it is important to distinguish these diseases because they can have distinct clinical features and prognosis and require different treatments. Careful review of the patients’ history, neurological exam, imaging, and/or spinal fluid results are essential to making an accurate diagnosis. This review examines the clinical presentation, diagnosis, and natural history of these inflammatory CNS disorders.
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Journal: Multiple Sclerosis Journal – Experimental, Translational and Clinical; June 25, 2021
Author(s): Friederike Held, Sudhakar Reddy Kalluri, Achim Berthele, Ana-Katharina Klein 1, Markus Reindl 2, Bernhard Hemmer
How often do general neurologic patients test positive for MOG antibodies?
This study assessed how many general patients admitted to a neurology department tested positive for MOG antibodies. Blood samples of 2,107 consecutive adult neurologic patients admitted between 2016 and 2017 were tested for Mog antibodies. The results showed that MOG antibodies may be detected at some level in a wide range of neurological disease. High levels of MOG antibody titers were associated with patients who showed clinical features of NMOSD and MOGAD, whereas low titers were presented in several other diseases. Thus, low levels of MOG antibodies are not a strong diagnostic indicator of the underlying condition.
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Journal: Journal of Neuroinflammation; November 1, 2016
Author(s): Florence Pache, Hanna Zimmermann, Janine Mikolajczak, Sophie Schumacher, Anna Lacheta, Frederike C. Oertel, Judith Bellmann-Strobl, Sven Jarius, Brigitte Wildemann, Markus Reindl, Amy Waldman, Kerstin Soelberg, Nasrin Asgari, Marius Ringelstein, Orhan Aktas, Nikolai Gross, Mathias Buttmann, Thomas Ach, Klemens Ruprecht, Friedemann Paul, Alexander U. Brandt & in cooperation with the Neuromyelitis Optica Study Group (NEMOS)
Mog antibodies in patients with NMO and related disorders: Damage to the visual system after optic neuritis
This study compared the long-term damage to the visual system after optic neuritis in MOG-IgG-positive (MOGAD) patients versus AQP4-positive (NMOSD) patients. No differences were seen in the extent of visual damage between the two groups —— visual impairment and damage to the visual nerve system are as severe in MOGAD as in NMOSD. In MOGAD patients, the cumulative damage may be driven by higher relapse rates, whereas in NMOSD patients, there may be fewer but more severe episodes of ON.
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Journal: Journal of Neuroinflammation; November 1, 2016
Author(s): Sven Jarius, Ingo Kleiter, Klemens Ruprecht, Nasrin Asgari, Kalliopi Pitarokoili, Nadja Borisow, Martin W Hümmert, Corinna Trebst, Florence Pache, Alexander Winkelmann, Lena-Alexandra Beume, Marius Ringelstein, Oliver Stich, Orhan Aktas, Mirjam Korporal-Kuhnke, Alexander Schwarz, Carsten Lukas, Jürgen Haas, Kai Fechner, Mathias Buttmann, Judith Bellmann-Strobl, Hanna Zimmermann, Alexander U Brandt, Diego Franciotta, Kathrin Schanda, Friedemann Paul, Markus Reindl, Brigitte Wildemann; in cooperation with the Neuromyelitis Optica Study Group (NEMOS)
Mog antibodies in patients with NMO and related disorders: How often is the brainstem involved? What are the clinical features and outcomes in this case?
In this study, 15 of 50 (one-third of) patients with optic neuritis and/or myelitis who tested positive for MOG antibodies showed brainstem inflammation, accompanied by a range of symptoms. In cases with brainstem inflammation, the disease course was generally more aggressive than usual. As brainstem inflammation may take a serious or even fatal course in patients testing positive for MOG antibodies, physicians should pay particular attention to signs or symptoms of additional brainstem involvement in these patients.
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Journal: Journal of Neuroinflammation; October 28, 2016
Author(s): Sven Jarius, Klemens Ruprecht, Ingo Kleiter, Nadja Borisow, Nasrin Asgari, Kalliopi Pitarokoili, Florence Pache, Oliver Stich, Lena-Alexandra Beume, Martin W. Hümmert, Marius Ringelstein, Corinna Trebst, Alexander Winkelmann, Alexander Schwarz, Mathias Buttmann, Hanna Zimmermann, Joseph Kuchling, Diego Franciotta, Marco Capobianco, Eberhard Siebert, Carsten Lukas, Mirjam Korporal-Kuhnke, Jürgen Haas, Kai Fechner, in cooperation with the Neuromyelitis Optica Study Group (NEMOS)
Mog antibodies in patients with NMO and related disorders: What populations are affected and how commonly? How do they manifest clinically and in imaging studies? What are the treatment responses and long-term outcomes?
MOG antibodies might be present and play a role in a subset of patients with neuromyelitis optica and related disorders. This study evaluated the populations demographics, clinical and radiological features, and findings of cerebrospinal fluid (CSF) and other tests. Among other findings, the results showed that the disease often followed a relapsing course and resulted in severe and/or persisting disability in a substantial number of cases. MOG antibodies need to be considered in both children as well as elderly patients; women are more frequently affected than men; attacks may occur during pregnancy and post-partum; and it is rare for patients to have other co-existing autoimmune conditions.
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Journal: Journal of Neuroinflammation; October 27, 2016
Author(s): Sven Jarius, Klemens Ruprecht, Ingo Kleiter, Nadja Borisow, Nasrin Asgari, Kalliopi Pitarokoili, Florence Pache, Oliver Stich, Lena-Alexandra Beume, Martin W. Hümmert, Corinna Trebst, Marius Ringelstein, Orhan Aktas, Alexander Winkelmann, Mathias Buttmann, Alexander Schwarz, Hanna Zimmermann, Alexander U. Brandt, Diego Franciotta, Marco Capobianco, Joseph Kuchling, Jürgen Haas, Mirjam Korporal-Kuhnke, Soeren Thue Lillevang, in cooperation with the Neuromyelitis Optica Study Group (NEMOS)
Mog antibodies in patients with NMO and related disorders: How frequently are they detected? Are they associated with AQP4? When are they detected and how long do they stay in the blood?
MOG antibodies might be present and play a role in a subset of patients with neuromyelitis optica and related disorders. This study tested (i) the frequency of MOG-IgG in a large (mainly Caucasian) group of patients with optic neuritis (ON) and/or myelitis; (ii) the frequency of MOG-IgG among patients testing positive for AQP4 and vice versa; (iii) the origin and frequency of MOG-IgG in the cerebrospinal fluid (CSF); (iv) the presence of MOG-IgG at the first appearance of disease; and (v) the influence of disease activity and treatment status on MOG-IgG titers. The results showed that MOG-IgG is present in a substantial subset of patients with ON and/or myelitis, but not in classical MS. It is very rare that patients test positive for both MOG-IgG and AQP4-IgG. Serum MOG-IgG can be detected at the first appearance of the disease and remains detectable in the long-term disease course. Serum titers depend on disease activity and treatment status.
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