ABSTRACT
Introduction: Neurologic complications of Coronavirus Infectious Disease 2019 (COVID-19) are well recognized and may affect both the central and peripheral nervous system.Cases of acute myelitis in close temporal relationship withCOVID-19 are increasingly reported in the literature but may underly a reporting bias. Aim(s): This study aimed to provide insights into acute myelitis associated with COVID-19 by analyzing cases treated at four tertiary care neurology centers. Patients and Methods: The retrospective observational study was conducted at the University Hospital Centre Zagreb in Croatia, University Medical Centre Ljubljana in Slovenia, University Clinical Centre of Serbia in Serbia, and Landesklinikum Mistelbach- Ganserndorf in Austria.We searched foracute myelitis cases that occurred during or after COVID-19. Demographic data, clinical course, magnetic resonance imaging (MRI) findings, cerebrospinal fluid (CSF) analysis, treatment, and outcome were analyzed. Result(s): We identified ten patients (70% male). The mean age was 49.2 years (standard deviation 17.9). In five patients COVID- 19 presented with upper respiratory symptoms. Five patients suffered from COVID-19 pneumonia, but none required mechanical ventilation. Neurological disturbances caused by acute myelitis occurred after a median of 13 days (range 5 to 76 days following the onset of systemic or respiratory COVID-19 symptoms. Spinal cord lesions were identified in eight patients on MRI. CSF examination was performed in eight patients and oligoclonal bands were detected in one patient. Anti-myelin oligodendrocyte glycoprotein (MOG) antibodies were present in one patient. Eight patients were treated with corticosteroids, and three of them received intravenous immunoglobulins. One patient received mycophenolate mofetil. The outcome was good, with partial or complete recovery in nine patients and only one patient experiencing no significant improvement. Conclusion(s): Our study raises awareness for this potential neurological complication of COVID-19. While the time lag of COVID-19 and clinical signs of myelitis point at either post- or parainfectious mechanisms, causality needs to be corroborated. Moreover, further studies need to define the diagnostic approach and clarify the optimal standards of care.
ABSTRACT
Background: The aim of this study was to determine the pooled prevalence of COVID-19 vaccination among people with multiple sclerosis (pwMS) compared to the general population in Croatia. Method(s): Data from all pwMS entered in the MS Base register until24.03.2022 were extracted including age, sex, MS phenotype, disease-modifying therapy (DMT), COVID-19 vaccine, and date of vaccination (1st, 2ndand/or 3rddose). Data on the general population of Croatia were obtained from the vaccination register of the Croatian Institute of Public Health. Result(s): 464 pwMS (317 females, with a median age of 38.1 years, disease duration of 6.1 years, EDSS 1.5) were included in the analysis. 386 (83.2%) pwMS had relapsing-remitting, 26 (5.6%) primary progressive, 19 (4.1%) secondary progressive phenotypes, and 16 (3.4%) clinically isolated syndrome. Fifty-six (12.1%) pwMS were treatment naive, 21 (4.5%) were not on DMT at the moment of the last visit, 134 (28.9%) were on injectable DMTs, 84 (18.1%) on 1stline oral DMTs, and 169 (36.4%) were on high efficacy DMTs. 295 (63.6%) pwMS were fully COVID-19 vaccinated compared to 59.7% of the general population (p=0.089). However, in the age groups, 20-24 and 35-39 significantly more pwMS received 2 doses compared to the general population (p=0.001 and p=0.03, respectively). Vaccinated pwMS were older (40.5 vs 37.6 years, p=0.01), had higher EDSS (2.0 vs 1.0, p=0.025), and longer disease duration (6.39 vs 5.35 years, p=0.02), were more likely to have progressive disease course (p=0.049) and on high efficacy DMTs (p=0.045) compared to unvaccinated pwMS.In a multivariable logistic regression model, there were no predictors for COVID-19 vaccination in pwMS. Conclusion(s): There was a similar prevalence of vaccinated individuals in pwMS and the general population. However, in younger age groups significantly more pwMS were vaccinated when compared to the general population.
ABSTRACT
Introduction: Per WHO, >190 million people worldwide have been affected by COVID-19 as of 20-Jul-2021. Although people with MS are not at a higher risk of SARS-CoV-2 infection, factors such as age, comorbidity, MS severity and treatment with DMTs may affect COVID-19 severity and outcomes. Understanding the risks, severity and outcomes of COVID-19 in people with MS receiving DMTs, including anti-CD20 DMTs, is important to healthcare practitioners (HCPs) managing MS. Objectives: To report the characteristics and outcomes of COVID- 19 adverse events (AEs) in relapsing MS (RMS) patients taking ofatumumab enrolled in the ongoing, open-label, long-term extension Phase 3b ALITHIOS study and from post-marketing surveillance of people receiving ofatumumab 20 mg subcutaneously. Methods: Patient demographics, baseline characteristics, incidence of COVID-19 AEs, seriousness category (including hospitalization), severity, outcomes, ofatumumab exposure before the start of infection, and action taken with ofatumumab were assessed. Results: As of 29-Jan-2021, 139/1703 (8.2%) patients enrolled in ALITHIOS (mean±SD age at baseline: 37.7±8.7 years;female, 64%) treated with ofatumumab reported COVID-19 AEs (confirmed: 115 [82.7%];suspected: 24 [17.3%]). Of these, 10 (7.2%) experienced COVID-19 serious AEs and all 10 (7.2%) were hospitalized. Most AEs reported were mild (Grade [G] 1;69 [49.6%]) or moderate (G2;62 [44.6%]) in severity. Severe (G3) and life threatening (G4) AEs were reported in 6 (4.3%) and 2 (1.4%) patients, respectively. One (0.7%) patient (48-year-old at COVID- 19 onset;BMI 28.3 kg/m2;recent MS relapse) with confirmed COVID-19 and pneumonia had a fatal outcome. At data cut-off, most patients (128 [92.1%]) had recovered from COVID-19 AEs;2 (1.4%) were recovering, 4 (2.9%) had recovered with sequelae and 4 (2.9%) had not recovered. COVID-19 AEs led to temporary interruption of ofatumumab in 22 (15.8%) patients. As of 31-Jan- 2021, an additional 28 RMS patients with COVID-19 AEs were identified in the Novartis safety database. Further details to be presented. Conclusions: In ALITHIOS, 139 RMS patients on ofatumumab reported COVID-19 AEs (as of 31-Jan-2021). Most (94%) COVID-19 cases were mild or moderate in severity. There were few hospitalizations but one fatal outcome. At data cut-off, most (92%) patients had recovered/resolved from COVID-19. ALITHIOS data extends the understanding of the long-term safety profile of ofatumumab in people living with MS.
ABSTRACT
Objective: Report characteristics of COVID-19 infections in people with multiple sclerosis (pwMS) receiving subcutaneous 20mg of atumumab, a human anti-CD20 monoclonal antibody, every 4 weeks. Background: A global pandemic of COVID-19 has resulted in over 40 million cases as of 19 October 2020. Risks of COVID-19 in pwMS receiving disease-modifying therapies are of increased interest, but still under investigation. Design/Methods: Demographics, COVID-19 seriousness category, of atumumab treatment duration and action taken with of atumumab, interventions and COVID-19 outcomes were recorded for pwMS in the open-label extension study ALITHIOS or in the post-marketing setting. Results: As of 28 September 2020, 12/1623 pwMS (5/12 females;9/12 white) in the ALITHIOS study were reported to have laboratory-confirmed SARS-CoV-2 infection. Mean age was 37.8 years (median 44 years, range 25-51 years), disease duration 3 to 23 years, and EDSS score 0-5.5. Ofatumumab exposure range was 8.5-13.8 months (n=6 who received of atumumab only in ALITHIOS) and 17.4-44.2 months (n=6 who continued of atumumab from prior trials). One of 12 had COVID-19 seriousness grade 3-A 39 year old white male with bilateral pneumonia requiring hospitalization who recovered with normal follow-up chest X-ray. The remaining 11 cases were non-serious grades 1 or 2: Seven reported as completely recovered, one recovering, two as ongoing and one asymptomatic with SARS-CoV-2 IgM and IgG positive. Six patients were treated with anti-infectives (three received both antivirals and antibacterials and three received antibacterials). Ofatumumab treatment was unchanged in seven and interrupted in four (resumed in three;information not available for one) patients;action unknown in one. To date, no post-marketing COVID-19 cases have been reported. Conclusions: We report 12 cases (11 non-serious;one serious hospitalized for bilateral pneumonia) of laboratory-confirmed SARS-CoV-2 infection in pwMS treated with of atumumab. More surveillance data are needed to determine the risks associated with COVID19 in pwMS treated with of atumumab.
ABSTRACT
Multiple disease-modifying therapies (DMTs) have been approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). There are two approaches to treating MS. One approach is the continuous application of therapy (maintenance therapy), which can then be optimized depending on the course of the disease. Maintenance therapy includes interferon beta, glatiramer acetate, teriflunomide, dimethyl fumarate, natalizumab, S1P receptor modulators (fingolimod), and ocrelizumab. Another recent approach in the treatment of MS is immune reconstitution therapy. Immune reconstitution therapy includes alemtuzumab and cladribine. In general, with the exception of beta-interferon and glatiramer acetate, all other DMTs are associated with varying degrees of risk of infection. It is this increased risk of infection in MS with various DMTs that has become very relevant in the COVID-19 pandemic. It should be emphasized that we do not currently know whether people with MS are at increased risk of catching COVID-19 or developing severe COVID-19 disease. There is also no scientific evidence that the DMTs we use to treat MS affect the possibility of infection or the course of COVID-19 infection. Clearly, any decision to initiate DMTs during the COVID-19 pandemic must be made carefully and will depend on the state of the pandemic, not only in a specific country but also in a specific area where a person lives and receives therapy. In doing so, care should be taken to take a proactive approach to MS treatment and focus on the patient at all stages of the disease, in order to minimize its aftereffects and maximize the quality of life. © 2020, PLIVA d.d.. All rights reserved.