A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)

The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.

开始日期2022-04-07

申办/合作机构

上海医药集团股份有限公司

NCT05540262 / RecruitingN/AIIT

Edaravone in the Treatment of Aquaporin-4 Antibody-positive Optic Neuritis

Edaravone has demonstrated a beneficial effect in promoting remyelination and protecting axons in animals with NMOSD. The researchers posit that edaravone may enhance visual outcomes in patients with aquaporin-4 antibody-positive optic neuritis.

开始日期2022-01-15

申办/合作机构

广西医科大学第一附属医院

NCT03586557 / Unknown statusN/AIIT

Effectiveness of Plasma Exchange in Treating With Severe Acute AQP4-Ab Positive Optic Neuritis

Patients aged between 18 and 70 with acute aquaporin-4 immunoglobulin G antibodies (AQP4-IgG) positive optic neuritis, irrespective of prior using of corticosteroids in this episode of disease, are chosen by the physician. Patients will then be randomized to receive high dose of intravenous corticosteroids combined with plasma exchange (PE), or merely high dose of intravenous corticosteroids followed subsequent taper. The main outcome of visual acuity and OCT parameters will be compared at baseline, one, three and six months after treatments, and other assessments will also be recorded and compared. This will allow for determination on whether additional PE plays a role in better prognosis in acute AQP4-IgG positive optic neuritis.

开始日期2018-09-01

申办/合作机构

中国人民解放军总医院

100 项与水通道蛋白4抗体阳性视神经炎相关的临床结果

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100 项与水通道蛋白4抗体阳性视神经炎相关的转化医学

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0 项与水通道蛋白4抗体阳性视神经炎相关的专利（医药）

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136

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2025-01-01·Neurology Neuroimmunology & Neuroinflammation

A Retrospective Single-Center Study of Myelitis Associated With Rheumatologic Disease

Article

作者: Krett, Jonathan D. ; Barreras, Paula ; Filippatou, Angeliki G. ; Sotirchos, Elias S. ; Gelber, Allan C. ; Pardo, Carlos A.

BACKGROUND AND OBJECTIVESPrevious reports of patients with myelitis associated with rheumatologic disease may have had unrecognized aquaporin-4 (AQP4)-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated disease (MOGAD). We clinicoradiologically and serologically characterized patients with myelitis associated with rheumatologic disease evaluated in the era of availability of MOG-IgG and more sensitive AQP4-IgG cell-based assays.METHODSA retrospective cohort (2018-2023) at Johns Hopkins Medicine with diagnoses of myelopathy and rheumatologic comorbidity was identified by electronic medical record (EMR) query. All patients with myelitis unrelated to typical multiple sclerosis (MS) were included and analyzed by chart review.RESULTSOf 238 patients identified by EMR query, 197 were excluded (148 not meeting prespecified inclusion criteria, 49 had typical MS), resulting in 41 patients for review. The mean age at myelitis onset was 44 ± 15 years; 39 (95%) were female. Rheumatologic diagnoses included 17 (41.5%) with systemic lupus erythematosus (SLE), 10 (24.3%) Sjögren syndrome (SS), 6 (15%) undifferentiated connective tissue disease (UCTD), 5 (12%) combinations of SLE/SS/UCTD with antiphospholipid antibody syndrome, 1 (2.4%) rheumatoid arthritis, 1 (2.4%) psoriatic arthritis, and 1 (2.4%) Behçet disease. 20 patients (49%) were diagnosed with AQP4-IgG seropositive NMOSD, 3 (7%) with MOGAD, and 18 (44%) had "double-seronegative" myelitis. Of these 18, 3 were diagnosed with AQP4-IgG seronegative NMOSD, 1 neuro-Behçet disease, and 14 other (unclassifiable) myelitis. Excluding 1 patient with neuro-Behçet disease, 18 (90%) of 20 AQP4-IgG seropositive patients had longitudinally extensive cord lesions compared with 5 (29%; p < 0.001) of 17 "double-seronegative" patients and 2 (67%) of 3 with MOGAD. "Double-seronegative" patients more commonly had CSF-restricted oligoclonal bands. Functional outcomes did not differ by diagnosis, and most patients received acute immunotherapy at the time of initial myelitis diagnosis with at least partial recovery over a median follow-up of 38 (interquartile range: 9-74) months.DISCUSSIONApproximately half of our rheumatologic disease cohort with myelitis unrelated to MS had AQP4-IgG seropositive NMOSD while MOGAD accounted for a small but clinically relevant proportion of patients. Further research is needed to characterize myelitis etiology in patients who are seronegative for both AQP4-IgG and MOG-IgG.

2024-11-01·Multiple Sclerosis and Related Disorders

Preliminary findings of a ‘test bundle’ to accelerate the diagnosis of MS and NMOSD following optic neuritis

Article

作者: Lundgren, Karen B ; Anderson-Benge, Ellen ; McLouth, Christopher ; Das, Saurav ; Lundgren, Karen B. ; Khawla, Abusamra ; Anderson-benge, Ellen ; Avasarala, Jagannadha ; Wilkerson, Paul

No study has investigated the length of time it takes to diagnose multiple sclerosis (MS) or neuromyelitis optic spectrum disorder (NMOSD, aquaporin 4 antibody disease or myelin oligodendrocyte glycoprotein antibody disease, MOGAD) following the onset of de novo optic neuritis (ON). Minimizing the time between ON and downstream diagnoses needs urgency since early diagnosis equals early treatment. The time elapsed from ON to a subsequent diagnosis of MS/NMOSD was estimated through analysis of retrospective data collected from the Axon Registry (AR) of the American Academy of Neurology (AAN) and from the University of Kentucky (UK), Lexington. The time to diagnose MS/NMOSD was arbitrarily set as occurring < 6 months (early) or > 6 months (delayed) following ON. Data was collected between 2007 and 2021 (AR) and 2012 to 2022, for UK, respectively. Of the 4015 ON patients from the AR dataset, 1069 (26.6 %) were diagnosed with MS, with 857 (80.2 %) diagnosed < 6 months (early) and 212 (19.8 %) diagnosed after > 6 months (delayed). Secondly, 420/4015 (10.4 %) were diagnosed with NMOSD (either MOGAD or AQP4 antibody disease), of which 340/420 (80.9 %) were diagnosed < 6 months (early) and 80/420 (19 %) diagnosed > 6 months (delayed). In the UK dataset, a total of 90/1464 individuals (6.14 %) were diagnosed with MS; of these, 69 patients (76.7 %) were diagnosed at < 6 months (early) and included a sub-group of 25 (27.8 %) diagnosed < 4 weeks; 21 (23.3 %) were diagnosed > 6 months (delayed) following ON. In either dataset (AR or UK, between 20 % - 23 % of MS diagnoses occurred > 6 months (delayed) after a diagnosis of ON. An accelerated diagnosis (4 weeks or less) of MS/NMOSD following ON in the UK data suggests that it is possible to minimize the time to a downstream diagnosis if a 'test bundle' of MRI of orbits, brain, C-spine, cerebrospinal fluid (CSF) analysis, and serum testing for NMOSD is used. Additional studies using prospective, larger datasets are required to confirm our findings.

2024-10-01·Journal Français d'Ophtalmologie

Optic neuritis following COVID-19 vaccination: Case series and review of the literature

Review

作者: Mardi, R ; Nouri, H ; Panahi Seifabad, M ; Abtahi, S-H ; Jannesari, A ; Bathaei, R ; Salari, M ; Etemadifar, M ; Dehghani, A

OBJECTIVETo review cases of optic neuritis after COVID-19 vaccination and add similar cases to the literature.METHODSThorough PubMed and Scopus searches were conducted, and data from studies describing optic neuritis after COVID-19 vaccination were extracted, tabulated, pooled, and reviewed.RESULTSWe present 6 cases of optic neuritis following COVID-19 vaccination. Our literature search yielded 48 similar cases. All 54 cases were divided into 3 groups with respect to their serostatus: (1) double-seronegative or unknown serostatus optic neuritis cases, (2) myelin oligodendrocyte glycoprotein (MOG)-associated optic neuritis cases, and (3) aquaporin-4-associated optic neuritis cases. Data from each group were separately pooled and reviewed. While the most frequent vaccine among the anti-AQP4+ subgroup was BNT162b2 (Pfizer-BioNTech) (2/3), recombinant vaccines, e.g., AZD122 and Ad26.Cov2.s were mostly injected in the other subgroups (23/51). No significant gender inclination was seen among different subgroups. The mean interval from vaccination to symptom onset was less than one month in all subgroups; symptom manifestations mainly occurred after the first dose (28/54). Almost all cases showed improvement after steroid therapy±plasma exchange (52/54).CONCLUSIONDespite having rare side effects such as optic neuritis, vaccination remains our most helpful protection against SARS-CoV-2. Nevertheless, larger studies are needed to ascertain the pathophysiology of such adverse effects. Likewise, the association between COVID-19 vaccination and optic neuritis warrants further investigation.