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Background: Whether vaccines play a role triggering or reactivating inflammation in Multiple Sclerosis (MS) has been long debated. There are few reports suggesting that Sars-Cov2 vaccines, as well as COVID-19 infection, may exacerbate relapses in MS. Studies on large cohorts are needed to establish the safety of Sars-Cov2 vaccines in the MS population. Aim(s): To assess the risk of clinical and radiological reactivation following Sars-Cov2 vaccines in patients with MS. Method(s): Patients with MS with known date of SarsCov2 vaccination were identified among those followed up at the Multiple Sclerosis Center of the Tor Vergata University Hospital. Data on clinical relapses and radiological activity (Gadolinium enhancing and new T2 lesions) in the 12 months before and after vaccination were extracted from clinical charts. Result(s): We enrolled 751 patients (64,7% female, mean age 45.9 +/- 11.63 years, 89.9% relapsing-remitting, 5.5% secondary progressive and 4.7% primary progressive, disease duration 11.2 +/- 8.11 years, median EDSS 2.0 [1.0 - 4.0], 12.1% untreated, 41.1% treated with first line immunomodulators and 46.7% with second line high efficacy treatments). Among them, 96.7% received mRNABNT162b2 (Pfizer), 2% mRNA-1273 (Moderna) and 1.3% other COVID-19 vaccines. In the whole cohort we did not find a significant increase of the rate of patients with relapse in the 12 months after vaccines (2.3%) compared to the 12 months before (2,9%, McNemar test, p=0.5), as well as of the rate of patients with radiological activity (both 11.5%, McNemar test, p=0.13). Similar findings were obtained separately analysing untreated patients, patients treated with first line and treated with second line drugs at the time of vaccination. Conclusion(s): Our preliminary results in a large monocentric cohort of MS patients suggest that vaccination with Sars-Cov2 vaccines does not induce disease reactivation. Further analyses are needed to confirm these findings.
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Introduction: In the general population, maternal SARS-CoV-2 infection during pregnancy is associated with an increased risk of several adverse maternal and fetal outcomes. In patients with Multiple Sclerosis (PwMS) an increased risk of severe COVID- 19 was reported after treatment with antiCD20 or corticosteroid close to COVID-19 onset. However, no data are currently available about maternal and fetal outcomes in pregnant women with MS who contracted COVID-19 during gestation. Objective(s): To evaluate maternal and fetal outcomes and their predictors in a population of pregnant women with MS with COVID-19 diagnosis selected from two large national registries and compared with matched control pregnancies extracted from a historical Italian MS cohort. Method(s): We recruited pregnant pwMS who contracted SARSCoV- 2 infection after conception and were prospectively followed- up in Italian and Turkish MS Centres, in the period 2020-2022. All the patients were administered a structured interview which gathered detailed information on pregnancy course and outcomes, as well as on possible confounders, including disease modifying treatments. A historical matched control group was extracted from a previous Italian multicenter cohort. Data on pregnancy outcomes were compared using logistic and linear multivariable regression analyses, when appropriate. Result(s): So far clinical characteristics and data on COVID-19 outcomes are available for 85 pregnant MS women (mean age 35.2+/-6.4 years, 83 relapsing remitting (RR), mean disease duration 8.3+/-6.86 years, median Expanded Disability Status Scale (EDSS) 1.0 (IQR 1.0-2.5), body mass index 24.5+5.8, current smokers 10.6%, occasional or regular alcohol consumption 28.3%). As for COVID-19 course, 8 women (9.4%) were hospitalized;no one required transfer to intensive care. The historical control group consists of 232 women with RRMS (mean age 34.6+/-3.1 years, mean disease duration 8.8+/-4.8 years, median EDSS 1.5 (IQR 1.0-2.0). The collection of information on maternal and fetal outcomes is ongoing: eclampsia, maternal mortality and admission to intensive care unit, spontaneous abortion, stillbirths, congenital abnormalities, preterm delivery, child weight and length at birth, admission to neonatal intensive care unit. Conclusion(s): Our preliminary data show no increased risk of severe COVID-19 in MS patients who contracted the infection during pregnancy. The analysis on pregnancy-related maternal and fetal outcomes is ongoing.
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INTRODUCTION: The use of telemedicine increased during the COVID-19 pandemic. However, the impact on patient satisfaction in the Neuro-oncology population is unknown. This quality improvement project compares outpatient satisfaction before and during the COVID-19 pandemic as well as in-person versus telemedicine platforms during the pandemic. METHODS: We performed an IRB-exempt retrospective analysis of aggregate de-identified outpatient satisfaction scores among Neurooncology patients seen at The Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke University. The Clinician & Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) is a survey developed and distributed by Press Ganey Associates, and is the most widely used outpatient satisfaction survey in the United States. We compared pre- COVID-19 CG-CAHPS scores from patients who received in-person care at the PRBTC between April 2019 and March 2020 to COVID-19 pandemic CG-CAHPS scores (i.e. those who received either telemedicine or in-person care at the PRTBTC) from April 2020 to March 2021. RESULTS: Approximately 1448 surveys were completed for both in-person and telemedicine visits. During the pandemic, 48.6% of surveys represented telemedicine, with monthly variations from 84.6% (April 2020) to 21.4% (March 2021). Patient satisfaction scores pre-COVID-19 were similar to those during the pandemic: overall provider rating from 0-10 (9.28 v 9.36), knowledge of medical history (96.9% v 95.4%), listens carefully (96.6% v 96.9%), shows respect (97.2% v 98.1%), and time spent (93.2% v 95.5%). During the COVID-19 pandemic, in-person and telemedicine demonstrate similar levels of satisfaction: overall provider rating from 0-10 (9.29 v 9.48), knowledge of medical history (94.9% v 96.1%), listens carefully (95.4% v 99.0%), shows respect (97.5% v 99.0%), and time spent (94.7% v 96.7%). CONCLUSION: Outpatient satisfaction prior to and during the COVID-19 pandemic was similar. Patients reported similar satisfaction between in-person and telemedicine platforms. We support the ongoing use of telemedicine for outpatient Neuro-oncology.
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Introduction: In patients with Multiple Sclerosis (pwMS) disease- modifying therapies (DMTs) are known to affect immune response to antigens and possibly to SARS-CoV2 vaccine. Therefore, post-vaccination serological assessments are needed to evaluate the effect of the vaccine on SARS-CoV-2 antibody response. Objectives and aims: We designed a prospective multicenter cohort study enrolling pwMS who were scheduled for SARSCov- 2 vaccination with mRNA vaccines (BNT162b2, Pfizer/ BioNTech, Inc or mRNA-1273, Moderna Tx, Inc) to evaluate their effect on SARS-CoV-2 antibody response. Methods: A blood collection for the measure of SARS-CoV-2 antibody before the first vaccine dose and 4 weeks after the second dose was planned, with a centralized and blinded serological assessment (electrochemiluminescence immunoassay, ECLIA, Roche Diagnostics). Results: Preliminary data were collected on 780 pwMS (76% BNT162b2 and 24% mRNA-1273) who had pre- and 4-week post-vaccination blood assessments. 87 (11.2%) were untreated, 154 (19.7%) on ocrelizumab, 25 (3.2%) on rituximab, 85 (10.9%) on fingolimod, 25 (3.2%) on cladribine and 404 (51.7%) on other DMTs. 677 patients (86.8%) had detectable post-vaccination SARS-CoV-2 antibodies. At multivariate analysis, the antibody levels of patients on ocrelizumab (178-fold decrease, p<0.001), fingolimod (26-fold decrease, p<0.001) and rituximab (17-fold decrease, p<0.001) were significantly reduced as compared to untreated patients. Vaccination with mRNA-1273 resulted in a systematically 3.5-fold higher antibody level than with the BNT162b2 vaccine (p<0.001). Interpretation: In pwMS, anti-CD20 treatment and fingolimod led to a reduced humoral response to mRNA-based SARS-CoV-2 vaccines. As mRNA-1273 elicits 3.5-higher antibody levels than BNT162b2, this vaccine may be preferentially considered for patients under anti-CD20 treatment or fingolimod. Combining our data with those that will be produced by studying the cellular immune response to vaccines, and including clinical follow-up, will contribute to better define the most appropriate SARS-CoV-2 vaccine strategies in the context of DMTs and MS. At the time of the ECTRIMS presentation data on the full sample (about 2000 subjects) will be presented.
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Introduction: Extending natalizumab (NTZ) dosing in patients with Multiple Sclerosis (MS) may increase the risk of disease reactivation. Nevertheless, evidence is lacking on the safety of reinfusion during active Sars-Cov-2 infection in patients needing retreatment. Aims and Objective: To describe the clinical outcome of patients with MS (PwMS) receiving NTZ redosing during active Sars- Cov-2 infection. Methods: 14 NTZ treated PwMS (mean age 39 years, females 11, median number of NTZ infusions 47) from 6 Italian MS centers with diagnosis of Sars-Cov2 infection confirmed by positive RT-PCR nasopharyngeal swab were retrospectively included.The main variables analyzed were baseline characteristics, outcome of infection after reinfusion, hospitalization, time to negative swab and occurrence of neurological complications. Results: All patients had symptomatic COVID-19 (13 mild, 1 moderate). None required respiratory support or hospitalization. At the time of NTZ reinfusion (median interval 52 days from the previous infusion), 14/14 had a positive molecular test performed within a median time of 3 days (0-11) and 4/14 were symptomatic. After infusion, none complained of worsening of COVID-19 symptoms or reported neurological complications. Median time to negative swab was 14,5 days (2-36) from infusion and 34,5 days (12-62) from first positive swab. Conclusions: In response to primary concerns about potential worsening of COVID-19 symptoms, due to the neuro and gastrointestinal tropism of Sars-Cov-2, our data support the safety of NTZ redosing in patients with active infection;therefore, in this condition, NTZ should not be interrupted/delayed, in order to minimize the risk of relapses.