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1.
Mult Scler Relat Disord ; 75: 104741, 2023 Jul.
Article in English | MEDLINE | ID: covidwho-20242964

ABSTRACT

BACKGROUND: Vaccination in patients with neuromyelitis optica spectrum disorders (NMOSD) is challenging because there is a concern that vaccines can lead to clinical attacks. However, little is known about the risk and the characteristics of attacks occurring after vaccination. METHODS: We performed a systematic review and meta-analysis using PubMed and Embase databases to estimate a summary frequency of attacks occurring after vaccination and describe the clinical features of theses attacks. We defined attacks occurring after vaccination as typical NMOSD attacks that occurred up to 30 days after vaccine administration.  For the frequency of attacks occurring after vaccination, we selected observational studies that reported the number of attacks and total number of patients that received vaccines; for the clinical description of the attacks, case reports and case series were also included. RESULTS: We included 377 participants from 5 studies to estimate the frequency of NMOSD attacks occurring after vaccination. We found a summary frequency of of 2% (95% CI 1-4%, I2 = 0%). We evaluated 17 studies to identify that 13 different vaccines were associated with NMOSD attacks. A higher-than-expected proportion of males, simultaneous optic neuritis and transverse myelitis attacks, and anti-aquaporin 4 antibody negative cases were identified in vaccine-associated attacks from 24 participants from 17 studies. Nearly two-thirds of attacks occurring after vaccination were an initial event of NMOSD. CONCLUSION: The frequency of NMOSD attacks occurring after vaccination is low and non-specific to different vaccine technologies. Our work reinforces the safety of vaccine recommendations in patients with NMOSD.


Subject(s)
Myelitis, Transverse , Neuromyelitis Optica , Optic Neuritis , Vaccines , Male , Humans , Neuromyelitis Optica/complications , Myelitis, Transverse/complications , Optic Neuritis/complications , Vaccination/adverse effects , Vaccines/adverse effects , Autoantibodies
2.
Ther Adv Neurol Disord ; 16: 17562864221150314, 2023.
Article in English | MEDLINE | ID: covidwho-20236686

ABSTRACT

Background: Neuromyelitis optica spectrum disorder (NMOSD) is a rare relapsing autoimmune disease of the central nervous system, affecting mainly optic nerves and spinal cord. NMOSD pathophysiology is associated with anti-aquaporin-4 (AQP4) immunoglobulin G (IgG) autoantibodies. Rapid extracorporeal elimination of autoantibodies with apheresis techniques, such as immunoadsorption (IA), was proven to be an effective treatment of NMOSD attacks. Data on the long-term use of IA to prevent attacks or progression of NMOSD are lacking. Objectives: The aim of this study was to evaluate efficacy and safety of maintenance IA for preventing recurrence of NMOSD attacks in patients refractory to other immunotherapies. Design: Case study. Methods: Retrospective analysis of two female patients with severe NMOSD refractory to conventional immunotherapies was performed. Both patients had responded to tryptophan IA (Tr-IA) as attack therapy and subsequently were treated with biweekly maintenance Tr-IA. Results: Patient 1 (AQP4-IgG seropositive, age 42 years) had 1.38 attacks of optic neuritis per year within 10.1 years before commencing regular Tr-IA. With maintenance Tr-IA for 3.1 years, one mild attack occurred, which was responsive to steroid pulse therapy. Expanded Disability Status Scale (EDSS) was stable at 5.0. Visual function score of the last eye improved from 3 to 1. Patient 2 (AQP4-IgG seronegative, age 43 years) experienced 1.7 attacks per year, mainly acute myelitis and optic neuritis, during the period of 10.0 years before the start of Tr-IA. During regular Tr-IA treatment, no further NMOSD attack occurred. The patient was clinically stable without any additional immunosuppressive treatment for 5.3 years. EDSS improved from 6.0 to 5.0, and the ambulation score from 7 to 1. Tolerability of Tr-IA was good in both patients. No serious adverse events occurred during long-term clinical trajectories. Conclusion: Tr-IA was well tolerated as maintenance treatment and resulted in clinical stabilization of two patients with highly active NMOSD, who were refractory to standard drug therapy.

3.
Neuroimmunology Reports ; 3 (no pagination), 2023.
Article in English | EMBASE | ID: covidwho-2315103

ABSTRACT

Background: With the COVID-19 vaccine now available, there have been occasional reports of post-vaccination neurological complications. Case presentation: In this report, we present a case of neuromyelitis optica spectrum disorder (NMOSD) that developed one month after the patient received the second dose of BIBP COVID-19 vaccine (SARS-CoV-2-Vaccine [Vero Cell] Inactivated). The patient presented with itching, numbness in the hand and right side of the face, as well as nausea, vomiting, and hiccups. Brain MRI revelead lesions in the area postrema, medulla, and bilateral hypothalamus, which are typical of NMOSD. Serum antibodies to anti-AQP4 and anti-MOG were negative. Conclusion(s): The pathogenesis of NMOSD development after vaccination is still unknown. NMOSD is generally aggressive and disabling, it is important for the neurologist to be attentive to the highly variable clinical presentation after COVID-19 vaccination for early diagnosis and effective treatment.Copyright © 2023

4.
Transcriptomics in Health and Disease, Second Edition ; : 249-275, 2022.
Article in English | Scopus | ID: covidwho-2293585

ABSTRACT

Autoimmune diseases are a group of different inflammatory disorders characterized by systemic or localized inflammation, affecting approximately 0.1–1% of the general population. Several studies suggest that genetic risk loci are shared between different autoimmune diseases and pathogenic mechanisms may also be shared. The strategy of performing differential gene expression profiles in autoimmune disorders has unveiled new transcripts that may be shared among these disorders. Microarray technology and bioinformatics offer the most comprehensive molecular evaluations and it is widely used to understand the changes in gene expression in specific organs or in peripheral blood cells. The major goal of transcriptome studies is the identification of specific biomarkers for different diseases. It is believed that such knowledge will contribute to the development of new drugs, new strategies for early diagnosis, avoiding tissue autoimmune destruction, or even preventing the development of autoimmune disease. In this review, we primarily focused on the transcription profiles of three typical autoimmune disorders, including type 1 diabetes mellitus (destruction of pancreatic islet beta cells), systemic lupus erythematosus (immune complex systemic disorder affecting several organs and tissues), and multiple sclerosis (inflammatory and demyelinating disease of the nervous system). © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2014, 2022.

5.
Mult Scler Relat Disord ; 73: 104627, 2023 May.
Article in English | MEDLINE | ID: covidwho-2305543

ABSTRACT

BACKGROUND: Neuromyelitis optica spectrum disorders (NMOSD) is considered a complex multifactorial disorder. Most cases are sporadic, and familial NMOSD is assumed as a rare occurrence. However, few studies reported familial aggregation of the disorder. OBJECTIVES: To report familial NMOSD cases in Thailand and conduct a systematic review of familial NMOSD. METHODS: A retrospective chart review of familial NMOSD patients at the university hospital was performed. Articles related to "genetic" and "NMOSD" were systematically searched and reviewed. We included NMOSD patients whose one or more relatives were diagnosed with the same disease or multiple sclerosis (MS). Data regarding demographics, clinical features, disease outcomes, and genetic testing were collected and analyzed using descriptive statistics. RESULTS: We identified 6 familial cases from 165 NMOSD cases (3.6%) at our hospital and gathered 77 cases from a systematic review, totaling 83 cases from 40 families. The mean (SD) age at onset was 37.2 (18.0) years. Familial NMOSD involved 1-2 generations with mainly 2 affected individuals. The most common kinship pattern was siblingship in 21 families (52.5%). Initial syndromes were mostly optic neuritis and transverse myelitis. Serum aquaporin-4 IgG was positive in 79.7% of cases. Median number of relapses was 3 (range 1-26). Median expanded disability status scale in the last visit was 2 (range 0-8). Reported human leukocyte antigens (HLA) alleles shared between familial cases were HLA-A*01 and HLA-DRB1*03. CONCLUSION: Familial clustering of NMOSD is more common than would be expected in the general population. The demographic, clinical, and outcome profiles of familial cases were not different from sporadic cases. Certain specific HLA haplotypes were shared among familial cases. Our systematic review highlighted complex genetic predisposition to NMOSD.


Subject(s)
Neuromyelitis Optica , Humans , Adult , Neuromyelitis Optica/epidemiology , Neuromyelitis Optica/genetics , Retrospective Studies , Autoantibodies , Neoplasm Recurrence, Local , Aquaporin 4
6.
eNeurologicalSci ; 31: 100464, 2023 Jun.
Article in English | MEDLINE | ID: covidwho-2305214

ABSTRACT

Optical coherence tomography (OCT) is a non-invasive tool to measure thickness of various layers of retina. Recently, retinal nerve fibre layer (RNFL) and ganglion cell and inner plexiform layer (GCIP) thinning has been observed in OCT in patients with multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD), This study compared OCT profile, along with visual acuity (VA), color vision (CV), contrast saturation (CS) and visual evoked potentials (VEP) in two main cohorts of MS and NMOSD and with controls, during acute episode of optic neuritis (ON), at 3 and 6 months. We found that changes of ON were present in 75% of MS eyes and in 45% of NMOSD patients. Of these, subclinical involvement was present in 56.25% of MS eyes and only in 5% of NMOSD eyes suggesting frequent subclinical involvement in the former. Mean RNFL was 95.23 ± 15.53 in MS and 66.14 ± 43.73 in NMOSD after 6 months of ON episode. Thinning of NQ and IQ was observed in NMOSD eyes in the immediate period after ON attack. At 6 months relative sparing of RNFL in TQ was observed in NMOSD ON eyes and MS ON showed predilection for involvement of TQ.

7.
Mult Scler ; : 13524585221113272, 2022 Jul 28.
Article in English | MEDLINE | ID: covidwho-2292936

ABSTRACT

Neuromyelitis optica spectrum disorder (NMOSD) is a devastating antibody-mediated condition of the central nervous system. As in other autoimmune diseases, there is considerable evidence to suggest that NMOSD arises from complex interactions between genetic susceptibility and environmental factors. However, whether factors like aquaporin-4-Antibody production initiate NMOSD attacks, currently remains unclear, and requires further investigation. Infectious diseases have also been proposed as possible environmental factors associated with NMOSD onset or relapses, some of which are more common in Asia and Latin America than in Europe and North America, in parallel with the higher incidence of NMOSD in these geographic locations. In this review, we examine current evidence on specific infections and vaccines associated with NMOSD onset and/or attacks, as well as the most recent data on gut microbiome composition and SARS-CoV-2 infection in NMOSD patients.

8.
Role of Microorganisms in Pathogenesis and Management of Autoimmune Diseases: Volume II: Kidney, Central Nervous System, Eye, Blood, Blood Vessels and Bowel ; 2:195-210, 2023.
Article in English | Scopus | ID: covidwho-2272465

ABSTRACT

Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune inflammatory disease of the central nervous system with astrocytopathy characteristics. Antibodies against aquaporin-4 water channels which are mainly located in astrocyte podocytes play an important role in NMOSD pathogenesis. Like other autoimmune disorders, it seems that both genetic and environmental factors are involved in NMOSD risk, but the role of environmental risk factors is more significant. Infections are known to be an effective factor not only in the incidence but also in the exacerbation of autoimmune diseases. In this chapter, the roles of microorganisms in two categories of viruses and bacteria in the pathogenesis and management of NMOSD patients are discussed. In this regard the relation between infection with tuberculosis, Helicobacter pylori, Epstein-Barr virus, SARS-CoV-2, varicella-zoster virus, dengue virus, cytomegalovirus, herpes simplex virus 2 and Zika virus, as well as gut microbiome and NMOSD occurrence are mentioned. On the other hand, susceptibility of NMOSD patients for developing infectious diseases due to receiving immunosuppressive drugs and the role of infection in NMOSD attack and disease exacerbation are outlined. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2022.

9.
Neuroimmunology Reports ; 1 (no pagination), 2021.
Article in English | EMBASE | ID: covidwho-2261045

ABSTRACT

Background: Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune disease, targeting the central nervous system, rarely associated with vaccination. Case report: We report a case of a 47 year-old healthy woman who presented, ten days after the first dose of SARS-CoV-2 Vaccine AstraZeneca (Vaxzevria), with back pain, tetraplegia, urinary retention, dysarthria and dysphagia. The patient was diagnosed NMOSD. She underwent intravenous-corticosteroids, vein-Immunoglobulin and plasma-exchange without significant improvement . Conclusion(s): The absence of any possible related conditions, the temporal relation with anti-SARS-CoV-2 vaccination, suggest that, in our case, NMOSD may be due to the cross reaction from Vaxzevria.Copyright © 2021 The Author(s)

10.
Clin Pract ; 11(4): 919-932, 2021 Dec 02.
Article in English | MEDLINE | ID: covidwho-2284023

ABSTRACT

Coordination of care for patients with neuro-ophthalmic disorders can be very challenging in the community emergency department (ED) setting. Unlike university- or tertiary hospital-based EDs, the general ophthalmologist is often not as familiar with neuro-ophthalmology and the examination of neuro-ophthalmology patients in the acute ED setting. Embracing image capturing of the fundus, using a non-mydriatic camera, may be a game-changer for communication between ED physicians, ophthalmologists, and tele-neurologists. Patient care decisions can now be made with photographic documentation that is then conveyed through HIPAA-compliant messaging with accurate and useful information with both ease and convenience. Likewise, external photos of the anterior segment and motility are also helpful. Finally, establishing clinical and imaging guidelines for common neuro-ophthalmic disorders can help facilitate complete and appropriate evaluation and treatment.

11.
Neurol Res Pract ; 3(1): 18, 2021 Mar 15.
Article in English | MEDLINE | ID: covidwho-2266453

ABSTRACT

Since the outbreak of coronavirus disease 2019 (COVID-19), a growing number of cases of acute transverse myelitis associated with COVID-19 have been reported. Here, we present the case of a patient who developed sensory ataxia after COVID-19 with MR lesions suggestive for longitudinal myelitis and in the splenium of the corpus callosum. The patient was successfully treated with immunoadsorption.

12.
Front Neurol ; 14: 1142640, 2023.
Article in English | MEDLINE | ID: covidwho-2271238

ABSTRACT

Neuromyelitis optica spectrum disorder (NMOSD) is a rare and disabling neurological disorder, marked by recurrent attacks of the central nervous system. NMO has a high female predominance and disproportionately affects racial and ethnic groups who are under- and unemployed in the USA. Three focus groups, involving 20 working age adults with NMOSD in the USA, were convened via Zoom online, to discuss the topic of employment in NMOSD. Consolidated Criteria for Reporting Qualitative research (COREQ) were followed. Discussions were coded for major themes using an inductive approach. The following themes emerged: (1) Barriers due to NMOSD on employment including (i) visible and invisible symptoms, (ii) the burden of treatment, and (iii) time to diagnosis; (2) Mitigating factors when NMOSD affects employment; (3) Impact of COVID-19; (4) Impact on income; (5) Impact on new and future employment and higher education opportunities; and (6) Unmet needs that are pragmatically addressable, outside of major policy or scientific changes.

13.
Mult Scler ; 29(4-5): 576-584, 2023 04.
Article in English | MEDLINE | ID: covidwho-2280229

ABSTRACT

BACKGROUND: Pediatric patients with multiple sclerosis (POMS) and related disorders, clinically isolated syndrome (CIS), myelin oligodendrocyte glycoprotein antibody disorder (MOGAD), and neuromyelitis optica spectrum disorder (NMOSD), are commonly treated with immunosuppressants. Understanding the impact of SARS-CoV-2 infection in patients may inform treatment decisions. OBJECTIVE: Characterize SARS-CoV-2 infection prevalence and severity among a cohort of patients with POMS and related disorders, as well as the impact of disease-modifying therapies (DMTs). METHODS: POMS and related disorders patients enrolled in a large, prospective registry were screened for COVID-19 during standard-of-care neurology visits. If confirmed positive of having infection, further analysis was undertaken. RESULTS: Six hundred and sixty-nine patients were surveyed between March 2020 and August 2021. There were 73 confirmed COVID-19 infections. Eight of nine hospitalized patients (89%), and all patients admitted to the ICU were treated with B cell depleting therapy. The unadjusted odds ratio of hospitalization among those who tested positive of having had COVID-19 was 15.27 among those on B-cell-depleting therapy (p = 0.016). CONCLUSIONS: B-cell-depleting treatment was associated with a higher risk of COVID-19, higher rates of hospitalization, and ICU admission, suggesting this therapy carries a higher risk of severe infection in POMS and related disorders.


Subject(s)
COVID-19 , Multiple Sclerosis , Neuromyelitis Optica , Humans , SARS-CoV-2 , COVID-19/epidemiology , Multiple Sclerosis/epidemiology , B-Lymphocytes , Myelin-Oligodendrocyte Glycoprotein , Autoantibodies , Aquaporin 4
14.
J Neuroimmunol ; 370: 577928, 2022 09 15.
Article in English | MEDLINE | ID: covidwho-2265938

ABSTRACT

BACKGROUND: Various vaccines, tumor-necrosis-factor-alpha inhibitors (TNFAIs), immune-checkpoint inhibitors (ICIs), and other immunomodulators have been linked to inflammatory CNS events. The prevalence of iatrogenic events in the neuroimmunology clinic is unknown. OBJECTIVE: To evaluate the prevalence and clinical characteristics of iatrogenic CNS inflammation in a tertiary neuroimmunology clinic. METHODS: We analyzed 422 consecutive patients seen over five years at a tertiary neuroimmunology clinic who were systematically screened for exposure to vaccines, TNFAIs, ICIs, or other immunomodulators. In patients with suspected iatrogenic events, the Naranjo Adverse Drug Reaction Probability Scale was used to score the probability of iatrogenicity. RESULTS: In total, 27 potential iatrogenic events were observed, accounting for 6.4% of all new referrals. The average Naranjo score was 5.78 +/- 1.65 with 74% of the cases scored as probable and 26% scored as possible. The clinical phenotypes included MS relapses (37%); autoimmune encephalitis (30%); NMOSD attacks (15%); transverse myelitis (11%); optic neuritis (4%); and MOGAD attacks (4%). A monophasic course was observed in 44% of cases while 41% had a relapsing course. All patients stopped or interrupted treatment with the offending agent. In addition, 41% of the iatrogenic events were fully responsive to corticosteroids; 22% were partially responsive; and 15% resolved spontaneously. The most common potential triggers were vaccines (37%) followed by TNFAIs (33%) then ICIs (26%). A significantly higher number of probable iatrogenic events were observed among the ICI and vaccine groups compared to a higher number of possible events among the TNFAI group. The latter group also had a significantly longer interval since exposure. The ICI group was more likely to present with monophasic autoimmune encephalitis. CONCLUSION: Iatrogenic CNS inflammation is rare and typically involves steroid-responsive monophasic events. A subset of iatrogenic events can unmask or worsen relapsing disorders. The probability of iatrogenicity was higher in vaccine and ICI-related events compared to TNFAI-related events.


Subject(s)
Encephalitis , Neuromyelitis Optica , Autoantibodies/therapeutic use , Encephalitis/chemically induced , Encephalitis/epidemiology , Hashimoto Disease , Humans , Iatrogenic Disease/epidemiology , Immunologic Factors/therapeutic use , Inflammation/epidemiology , Prevalence
15.
Front Neurol ; 13: 925216, 2022.
Article in English | MEDLINE | ID: covidwho-2246682
16.
Neurol Ther ; 2022 Nov 18.
Article in English | MEDLINE | ID: covidwho-2238857

ABSTRACT

BACKGROUND AND OBJECTIVES: Acute COVID-19 infection has been associated with neurological involvement. We report a case series of newly diagnosed patients with multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) developed in a short period of time after acute COVID-19 infection. METHODS: New MS patients developing initial symptoms shortly after an acute COVID-19 infection were diagnosed based on the 2017 McDonald Criteria [Garcia-Ramos et al. in Cells, 2021]. The patients diagnosed with NMOSD met the 2015 International Panel criteria for the diagnosis of NMOSD (IPDN) [Thompson et al. in Lancet Neurol 17:162-173, 2018]. RESULTS FROM THE MS PATIENT GROUP: Ten patients were included who had developed initial MS symptoms after COVID-19 infection. Gender distribution was equal (50% male). The mean age was 28 (range 17-39) years. Average time to neurological presentation was between 2 and 6 weeks following acute COVID-19 infection. Partial transverse myelitis was the initial presentation in 40% of the cases, and 60% of patients had spinal cord lesions present at the moment of diagnosis. All patients showed enhancing lesions on brain magnetic resonance imaging (MRI). The presence of cerebrospinal fluid (CSF) oligoclonal bands was found in all six tested cases. The majority of patients (80%) were unvaccinated for COVID-19. The two vaccinated patients had received two doses of the monovalent COVID-19 messenger ribonucleic acid (mRNA) (Pfizer Biotech) vaccine and no booster, a year prior to contracting COVID-19. RESULTS FROM THE NMOSD GROUP: Two patients with NMOSD were included. Positive aquoporin-4 protein antibody (AQP-4 Ab) was detected in serum in both cases [one Enzyme Linked immunosorbent assay (ELISA) and one cell based]. Both patients had mild COVID-19 infection prior to presentation, initial neurologic symptoms presented between 3 and 6 weeks after COVID-19 infection. Neither patients were vaccinated. Both responded partially to steroids, one developed a relapse 40 days after diagnosis. CONCLUSION: COVID-19 infection has been linked to several neurological and immune-driven conditions. This study suggests that in susceptible individuals, acute COVID-19 infection may act as a trigger for developing MS and NMOSD.

17.
Neurol Sci ; 2022 Oct 27.
Article in English | MEDLINE | ID: covidwho-2236492

ABSTRACT

BNT162b2 is one of the effective COVID-19 vaccines. However, some researchers have also reported some neurological adverse events after the vaccination. Here, we present a case of a 52-year-old female who developed aquaporin (AQP) 4-IgG-positive neuromyelitis optica spectrum disorder (NMOSD) 14 days after the first dose of BNT162b2. She experienced the neck pain, weakness of the left arm and leg, numbness of the left hand, and impaired temperature sensation of the right leg. MRI showed T2WI hyperintense lesions in the area postrema and cervical spinal cord ranging from C1 to C6 level and Gd-enhanced lesions from C3 to C5 level; especially left lateral column was predominantly enhanced. Cell-based assays showed anti-AQP4 antibody (AQP4Ab) was positive. We diagnosed AQP4-IgG-positive NMOSD. After high-dose glucocorticoid therapy, she is showing improved symptoms. The present case was characterized by the findings that a Gd-enhanced lesion in the cervical cord localized dominantly at the left lateral column, consistent with the side of the shoulder where the vaccine was injected. Many studies suggested that AQP4-IgG-positive NMOSD development has multistep mechanisms following the blood-brain barrier (BBB) breakdown. We suspected that immune responses following vaccination lead to BBB disruptions. Through the limitedly damaged BBB, the plasma cells producing AQP4Abs might be recruited to CNS, and AQP4Abs might bind to the cervical cord and the area postrema. A population-based study revealed that neurological events following COVID-19 vaccination were less likely to be observed than COVID-19 infectious symptoms. Considering rare adverse events, clinicians need to observe any changes in patient condition.

18.
Mult Scler Relat Disord ; 58: 103394, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-2228485

ABSTRACT

Neuromyelitis optica spectrum disorders (NMOSDs) are uncommon antibody-mediated autoimmune diseases of the central nervous system (CNS), mainly occurring in optic nerves and spinal cord, which can cause visual impairment, paralysis, and occasionally bulbar dysfunction. Such neurological deficits can adversely affect pulmonary functions and increase complicated infection risk. Besides, most NMOSD patients undergo immunosuppressive therapy. All these factors make NMOSD patients the potential high-risk group under the current pandemic of coronavirus disease 2019 (COVID-19). Meanwhile, COVID-19 infection has already been demonstrated as a risk factor for NMOSD relapses. This review discusses the basic immunology of vaccination and common problems, including immunogenicity, safety, and efficacy of vaccination on NMOSD patients. Additionally, we offered vaccination recommendations, health care and treatment advice for NMOSD patients under the background of COVID-19.


Subject(s)
COVID-19 , Neuromyelitis Optica , COVID-19/prevention & control , Humans , Neuromyelitis Optica/complications , SARS-CoV-2 , Spinal Cord , Vaccination/adverse effects
19.
Mult Scler Relat Disord ; 66: 104025, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-2181739

ABSTRACT

BACKGROUND: This analysis evaluated long-term safety findings from the SAkuraSky and SAkuraStar studies with satralizumab in patients with neuromyelitis optica spectrum disorder (NMOSD). METHODS: SAkuraSky (satralizumab in combination with baseline immunosuppressive therapy; IST) and SAkuraStar (satralizumab monotherapy) are international, multicenter, randomized, placebo-controlled, phase 3 studies consisting of a double-blind (DB) period followed by an open-label extension (OLE). The overall satralizumab treatment (OST) period safety population comprised patients receiving ≥1 dose of satralizumab in the DB and/or OLE periods (cut-off date: 22 February 2021). Safety was evaluated in the DB and OST periods. RESULTS: In the SAkuraSky DB period, patients received satralizumab (n = 41) or placebo (n = 42) in addition to stable baseline IST; 75 patients were included in the OST population. In the SAkuraStar DB period, 63 patients received satralizumab monotherapy and 32 received placebo; 91 patients were included in the OST population. Median treatment exposure in the OST period was 4.4 years (range 0.1-7.0) in SAkuraSky and 4.0 years (range 0.1-6.1) in SAkuraStar. Rates of adverse events (AEs per 100 patient-years) and serious AEs in the OST period were comparable with satralizumab and placebo in the DB periods of both studies. Similarly, overall rates of infections and serious infections were consistent between the OST and DB periods with satralizumab, with no increase in rates of infections or serious infections over time. In the OST periods, longer exposure to satralizumab was not associated with a higher risk of severe (grade ≥3) laboratory changes versus the DB periods. No deaths or anaphylactic reactions to treatment with satralizumab were reported during the OST periods of both studies. CONCLUSION: The safety profile of satralizumab as a monotherapy or in combination with IST was maintained in the OLE, and no new safety concerns versus the DB period were observed. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT02028884 (SAkuraSky) and NCT02073279 (SAkuraStar).


Subject(s)
Antibodies, Monoclonal, Humanized , Neuromyelitis Optica , Humans , Double-Blind Method , Neuromyelitis Optica/drug therapy , Antibodies, Monoclonal, Humanized/adverse effects
20.
Vaccine ; 41(5): 1003-1008, 2023 01 27.
Article in English | MEDLINE | ID: covidwho-2165938

ABSTRACT

BACKGROUND: Several reports have been documented in possible association with the administration of different severe acute respiratory coronavirus 2 (SARS-CoV-2) vaccines and central nervous system (CNS)demyelinating disorders, specifically post mRNA vaccines. We report twelve cases of developing Multiple sclerosis (MS) or Neuromyelitis Optica spectrum disorders (NMOSD) following neither the first nor second dose of inactivated or viral vector COVID-19 vaccine. METHODS: We retrospectively compiled twelve patients' medical information with a new onset of MS or NMOSD in their first six weeks following a COVID-19 vaccine. RESULTS: We report twelve cases of MS (n = 9), clinically isolated syndrome (CIS)(n = 1), and NMOSD (n = 2) following COVID-19 inactivated vaccines (n = 11) or viral vector vaccines (n = 1), within some days following either the first (n = 3), second dose (n = 8), or third dose (n = 1). Their median age was 33.3 years, ranging from 19 to 53 years. Ten were women (83 %). All patients fully (n = 5) or partially (n = 2) recovered after receiving 3 doses of Corticosteroids. Common medications were Natalizumab, Teriflunomide, Dimethyl fumarate, and Rituximab. Also, Interferon beta 1-a was administered to one patient with severe symptoms of numbness. CONCLUSION: Our case series identifies the Sinopharm BBIBP-CorV and the AstraZeneca AZD1222 vaccines as potential triggers for CNS demyelinating diseases. Vaccine administration routines are not affected by these rare and coincidental events. However, these manifestations are not deniable and require serious attention. Further investigations are needed to clarify the actual mechanisms and real associations.


Subject(s)
COVID-19 Vaccines , COVID-19 , Demyelinating Diseases , Multiple Sclerosis , Adult , Female , Humans , Male , ChAdOx1 nCoV-19 , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Retrospective Studies , SARS-CoV-2 , Vaccines, Inactivated/adverse effects
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