Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 15 de 15
Filter
1.
Multiple Sclerosis Journal ; 28(3 Supplement):690-691, 2022.
Article in English | EMBASE | ID: covidwho-2138911

ABSTRACT

Introduction: Balance impairments are common in multiple sclerosis (MS). Pilates is a popular alternative method for balance performance maintenance and improvement that may reduce the rapid symptoms worsening frequently associated with physical inactivity. An Italian network of fifteen experts in MS rehabilitation developed through a User-Centered Design approach the MS-FIT exergame, a Kinect-based tool, to autonomously train balance through Pilates exercises. The MS-FIT user executes the exercises shown by a teacher's avatar and improves the performances through the feedbacks on the execution correctness. Aim(s): This study (Clinical.Trials.gov, NCT04011579) aims at evaluating the feasibility of an at-home intervention with MS-FIT. Method(s): Feasibility was investigated in terms of adherence (sessions number), usability (usability items of Tele-healthcare Satisfaction Questionnaire, u-TSQ, satisfaction (Client Satisfaction Questionnaire, CSQ-8), safety (adverse events), and physical effectiveness (Timed UP-&-GO, TUG;Timed 25-Foot Walk, T25FW;2-Minutes Walking Test, 2MWT). Result(s): Forty-five people with MS (PwMS) were enrolled and randomized into the experimental (EXP, n=23) and control (CTRL, n=22) groups. During the 6 weeks of the study, only the usual physical activities were admitted (rehabilitation excluded) and, in addition, EXP had to practice MS-FIT at least three times a week. Due to organizational consequences of COVID pandemic, 8 subjects dropped-out (EXP, n=17;CTRL, n=20). The sample analysed showed the following characteristics: gender (EXP: 6M;CTRL: 7M), age (EXP: 41.9+/-9.6y;CTRL: 43.3+/-10.5y), course (EXP: 94.4% and CTRL: 95.0% relapsing-remitting), disease duration (EXP: 9.9+/-7.2y;CTRL: 12.5+/-9.8y) and EDSS (EXP: 2.6+/-0.8;CTRL: 2.6+/-0.8). EXP highly adhered to the MS-FIT training (23.6+/-6.1 sessions);the tool was usable (u-TSQ: 3.01/4);satisfaction was medium-tohigh (CSQ-8: 25.1/32);the training with MS-FIT was safe (no adverse events). The groups did not differ in TUG, T25FW and 2MWT. An analysis separate for each group showed a significant improvement only in EXP (TUG: pre 7.5+/-1.2s, post 7.0+/-1.2s, p<0.05;T25FW: pre 6.1+/-1.5s, post 5.0+/-1.2s, p<0.01;2MWT: pre 175.4+/-51.0m, post 194.1+/-56.9m, p<0.01). Conclusion(s): MS-FIT is well-accepted and effective and could be a complement of traditional MS interventions. Based on the results and participants' feedbacks MS-FIT has been refined and is used in an ongoing randomized controlled trial.

2.
Multiple Sclerosis Journal ; 28(3 Supplement):623-624, 2022.
Article in English | EMBASE | ID: covidwho-2138875

ABSTRACT

Introduction: Anti-SARS-CoV2 vaccination induces specific Tand B-cell responses in healthy subjects (HS). In MS patients treated with anti-CD20 drugs, the antibody response is reduced or absent, whereas specific T-cell responses are maintained. It is not known whether and how vaccination affects innate responses mediated by natural killer (NK) cells in HS and in MS patients treated with anti-CD20 drugs. Objective(s): To evaluate whether and how NK cells contribute to the immune response following anti-SARS-CoV2 vaccination in HS and in ocrelizumab-treated MS patients Aims: The aims of this work were: 1) to evaluate the effects of anti-SARS CoV2 vaccination on the phenotype of NK cells from HS and from ocrelizumab-treated MS patients and 2) to evaluate how peptides from the SARS-CoV2 spike protein affect NK cell responses before and after anti-SARS-CoV2 vaccination. Method(s): We enrolled 21 MS patients treated with ocrelizumab and 20 HS. Peripheral blood mononuclear cells (PBMCs) were isolated from peripheral blood and stored under liquid nitrogen. Thawed PBMCs were cultured overnight in presence/absence of SARS-CoV2 peptides or peptides from the cytomegalovirus (CMV), with/without activating cytokines. Phenotype of NK cells through a 13-marker flow cytometry panel and intracellular production of IFN-gamma were evaluated after culture. Result(s): Findings: 1) Vaccination increased the proportion of CD56dim NK cells in HS and MS patients. CD56posCD16neg NK cells, more abundant in MS patients before vaccination, decreased thereafter. Lower pre-vaccination activation capability of NK cells from MS patients compared to HS in response to stimulus with cytokines was reverted by vaccination. 2) Before vaccination, peptides from the SARS-CoV2 protein downregulated the production of IFN- gamma from NK cells of HS, but not ocrelizumabtreated MS patients, who had significantly lower baseline IFN-gamma NK cells 3) After vaccination, peptides from the SARS-CoV2 protein did not affect the production of IFN- gamma from NK cells of HS. Conclusion(s): The results of this work demonstrate anti-SARSCoV2 vaccination increases the proportion of effector CD56dim NK cells in HS and ocrelizumab-treated patients. Spike peptides inhibit the function of NK cells from HS before, but not after vaccination. Such phenomenon may contribute to the pathogenicity of SARS-CoV2 in unvaccinated subjects.

3.
Multiple Sclerosis Journal ; 28(3 Supplement):444-446, 2022.
Article in English | EMBASE | ID: covidwho-2138857

ABSTRACT

Background: An earlier follow-up study from the CogEx rehabilitation trial showed little change in symptoms of depression, anxiety and psychological distress during the first COVID-19 lockdown compared to pre-pandemic measurements. Objective(s): Here we provide a second follow-up set of behavioral data on the CogEx sample. Method(s): Data were obtained from the CogEx study, a randomized controlled trial of exercise and cognitive rehabilitation in people with progressive MS involving 11 centres in North America and Europe. Participants completed the same COVID Impact Survey and self-report measures of depression, anxiety and MS symptoms that had been obtained during the first pandemic lockdown period. Result(s): The average time between measurements was 11.4 (SD=5.56) months. Sample size declined from 131 to 72 largely because pandemic restrictions prevented data collection from sites in Denmark and England. There were no significant differences in age, sex, EDSS, disease course and duration between those who participated in the current follow-up study (n=74) and the group that could not (n=57). One participant caught Covid in the time between assessments. Participants now took a more negative view of their mental/psychological wellbeing (p=.0001), physical wellbeing (p=.0009) and disease course (p=.005) compared to their last assessment. Depression scores increased on the HADS-depression scale (p = .01) and now exceeded the clinically significant threshold of >= 8.0 for the first time. Anxiety scores on the HADS remained unchanged. Poorer mental wellbeing was predicted by HADS depression scores (p=.012) and a secondary-progressive disease course (p=.0004). Conclusions and Relevance: A longer follow-up period revealed the later onset of clinically significant depressive symptoms on the HADS and a decline in self-perceptions of mental and physical wellbeing associated with the COVID-19 pandemic.

5.
Multiple Sclerosis Journal ; 27(2 SUPPL):743-744, 2021.
Article in English | EMBASE | ID: covidwho-1496079

ABSTRACT

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.

6.
Multiple Sclerosis Journal ; 27(2 SUPPL):754-755, 2021.
Article in English | EMBASE | ID: covidwho-1496059

ABSTRACT

Introduction: The SARS-CoV-2 pandemic has raised, among others, a particular concern for people taking immune-suppressants. The Italian MS Foundation (FISM), Neuroimmunology Association (AINI), Neurological Society (SIN), and MS Registry have constituted an Alliance to tackle these issues. In the field of multiple sclerosis, several reports have suggested a higher risk of infection and an increased severity of the disease in persons treated with anti-CD20 monoclonal antibody. Serological investigations, showing a blunted production of anti-SARS-CoV-2 antibodies, questioned the usefulness of vaccination in these subjects, without, however, considering T cell responses. Objectives and Aims: To investigate antiviral T cell responses after infection with SARS-CoV-2 in persons with MS (pwMS) treated with Ocrevus.Control groups include pwMS treated with Ocrevus without SARS-CoV-2 infection, persons without MS with SARS-CoV-2 infection, and healthy individuals vaccinated or not with BNT16b2. Methods: Blood samples were collected and processed to isolate PBMCs, that were then stored frozen. PBMCs were stimulated with SARS-CoV-2 peptide pools and T cell reactivity was assessed by ELISPOT for IFNg detection, and by multiparametric FACS analyses for assessment and characterization of T cell activation. Results: ELISPOT assay against the spike and the N protein of SARS-CoV-2 displayed specific T cell reactivity in 80% pwMS treated with Ocrevus and infected by SARS-CoV-2, similar to infected persons without MS. FACS analysis following stimulation with SARS-CoV-2 peptide pools, showed the presence of activation-induced markers (AIM) in both CD4 and CD8 T cell subsets in 96% and 92% of these individuals, respectively. CD4 AIM+ cells were mostly central and effector memory cells, while CD8 cells were largely CD45RA+ terminally differentiated effectors (TEMRA) and poised for cytotoxicity, with a significant fraction of naïve cells. Within naïve AIM+ CD4 and CD8 cells we detected memory stem cells, suggesting the acquisition of long-term memory and protection from reinfection. COVID-19- recovered pwMS treated with Ocrevus had T cell responses comparable to healthy individuals vaccinated with BNT162b2, particularly concerning the ability to produce cytokines. Conclusions: B-cell depletion using Ocrevus does not impair the development of anti-SARS-CoV-2 T cell responses. Multistakeholder initiatives are mandatory to rapidly obtain unbiased clinically crucial information.

7.
Multiple Sclerosis Journal ; 27(2 SUPPL):630-631, 2021.
Article in English | EMBASE | ID: covidwho-1496038

ABSTRACT

Introduction: Onco-hematological patients, specifically those treated with hematopoietic stem cell transplantation (HSCT) [2], are particularly at risk of severe acute respiratory syndrome due to Coronavirus-2 (SARS-CoV-2). Conversely, evidences regarding Coronavirus Disease 2019 (COVID-19) in aggressive multiple sclerosis (MS) treated with autologous HSCT (aHSCT) are not available. At pandemic start, and in the absence of data, European Society for Blood and Marrow transplantation/Autoimmune Disease Working Party (EBMT/ADWP) suggested delaying not life-sparing HSCT. Aim: To describe cases of COVID-19 in a population of aggressive MS treated with aHSCT. Materials and Methods: Data were collected from 4 centers (march-2020 to april-2021). Patients' health-status was periodically monitored by phonecall. Patients transplanted within a 12-month period were asked to maintain a strict home-isolation. Those transplanted from longer than 12 months were asked to keep safe behaviour, as recommended by EBMT/ADWP. Results: We recorded 5 cases out of 70 patients. At COVID-19 time, mean (standard deviation) disease duration (dd) was 12.0 (±4.9) years and median expanded disability status scale (EDSS) was 4.5 (range 3.0-7.5). Mean time from aHSCT was 24.7 (±9.8) months (range 12.9-37.0). All patients presented normal lymphocyte values besides one with grade-two lymphopenia (617.0 cc/ mm

8.
Neurology ; 96(15 SUPPL 1), 2021.
Article in English | EMBASE | ID: covidwho-1407870

ABSTRACT

Objective: To evaluate efficacy and Safety of multiple sclerosis (MS) patients (pts) who switched to ocrelizumab (OCR) due to persistence of disease activity after two courses of alemtuzumab (ALM) Background: The management of MS pts who show disease activity after 2 ALM courses represents an unsolved issue Design/Methods: MS patients who switched from ALM to OCR from March 2019 to March 2020 were retro-A nd prospectively recruited from different Italian MS Centers. Clinical, immunological and neuroradiological data about ALM treatment period, ALM-OCR interval and OCR treatment period were collected Results: 23 MS pts [mean age: 35.7(6.8);female, 40.1%;Relapsing Remitting, (RR): 75.8%, active Secondary progressive, (aSP): 24.2%;mean time interval (days) from II ALM course 87.4(108);cumulative number of relapses: 21;mean number of new T2 and Gd+ lesions: 4.1(4.5) and 1.6(3.1);median EDSS:3(range 1-7)]. The mean follow-up (FU) from OCR start: 7.9±7.4 months. 4 (17.4%) pts had a relapse after OCR start (1 during the interval between first and the second OCR infusion and 3 pts after 3, 11 and 15 months from OCR start. 4 (17.4%) pts showed only radiological activity at 3 (n=2), 4 (n=1) and 9 months (n=1). Infusion Associated Reactions occurrence was lower than ALM courses (p<0.05) ;mild upper airways (n=1), urinary infections (n=1), appendicectomy (n=1) and fever due to probable Sars-Cov2 infection (n=1). No pts showed T CD4+ cell count <200 cell/mm3 at 3, 6-months and 1-year FU;B CD19+ cell depletion (<5 cell/mm3) was confirmed at 3, 6-months and 1-year FU with the exception of 1 pt (B CD19+ count 12 cells/mm3 at 6 month FU (n=12 pts)). 10 (43.4%) pts developed hypogammaglobulinemia without infectious events. No ALM-related new complications occurred. Conclusions: Short-term FU suggests that the switch to OCR in MS after 2 ALM courses is characterized by a good safety and efficacy profile.

9.
European Journal of Neurology ; 28(SUPPL 1):909, 2021.
Article in English | EMBASE | ID: covidwho-1307820

ABSTRACT

Background and aims: Severe acute respiratory syndrome due to Coronavirus 2 (SARS-CoV-2) pandemic forced deferrals on most of autologous hematopoietic stem-cell transplantation (aHSCT), specifically for autoimmune diseases, in line with European Society for Blood and Marrow transplantation/Autoimmune Disease Working Party indications. Though concerns on the possible repercussions of the infection in transplanted autoimmune patients required higher monitoring, the impending activity that characterizes some forms of Multiple Sclerosis (MS) demanded a special evaluation on the benefit-risk balance. We aim to describe our experience in treating MS-patients with aHSCT along SARS-CoV-2-pandemic. Methods: Patients candidated to aHSCT were collegially discussed with our haematological and infectious-diseases expertise. two consecutive SARS-CoV-2 negative swabs, a two-weeks-long home-isolation and a five-days intradepartment observation were required for treatment start. Patients recently transplanted were all asked to keep safe behaviour and periodically monitored for possible Coronavirus Disease 2019 (COVID-19) symptoms;in particular, those treated in the previous 12-month were asked to maintain a strict home-isolation. Results: None of the three patients transplanted during pandemic (July, November and December 2020) developed COVID-19. Of the six transplanted in 2019 and that reached one-year from procedure within the outbreak, One developed pauci-symptomatic COVID-19 at the 13th month, confirmed by SARS-CoV-2 swab;white-bloodcells, lymphocyte (totals, CD4+, CD8+ and CD19+) and gamma-globulins levels were normal. two of the remaining 17 patients transplanted from 2015 developed slight COVID-19 symptoms at 30th and 57th month respectively. Conclusion: Three patients with highly-active MS were treated with aHSCT during pandemic without complications;three minor cases of COVID-19 were recorded in our cohort.

10.
J Neurol Sci ; 427: 117501, 2021 08 15.
Article in English | MEDLINE | ID: covidwho-1240454

ABSTRACT

During SARS-CoV-2 pandemic, we adopted a personalized delayed protocol for ocrelizumab infusions in Relapsing Remitting Multiple Sclerosis (RRMS) patients according to the national recommendations. Out of the 83 RRMS patients whose infusion was scheduled between March and December 2020, 56 patients experienced a delay in treatment based on MS severity and SARS-CoV2 infection risk profile. In most cases, the immunophenotype was performed monthly to guide re-infusions. Specifically, B CD19 + cells repopulation rate was monitored. Mean infusion delay was 103,1 [SD 40,6] days, and none of the patients presented relapses or active disease at MRI at the end of the observation period. Treatment naïve status and the interval between immunophenotyping and the last ocrelizumab infusion were predictors of earlier B CD19 + cells repopulation. Two patients contracted SARS-CoV2 with complete recovery. Definitive data about Sars-Cov2 vaccine efficacy in patients treated with ocrelizumab are still lacking. Our findings suggest that a personalized treatment with a delayed infusion schedule does not compromise ocrelizumab short-term efficacy and may help to lengthen the therapeutic window for an effective response to SARS-CoV2 vaccine.


Subject(s)
COVID-19 , Multiple Sclerosis, Relapsing-Remitting , Multiple Sclerosis , Antibodies, Monoclonal, Humanized , Humans , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Multiple Sclerosis, Relapsing-Remitting/epidemiology , Pandemics , RNA, Viral , SARS-CoV-2
11.
Multiple Sclerosis Journal ; 26(3 SUPPL):316, 2020.
Article in English | EMBASE | ID: covidwho-1067125

ABSTRACT

Background: Sars-Cov2 pandemic led neurologists to modify the therapeutic approach in Multiple Sclerosis (MS) care setting, especially with regard to immunodepleting treatments. Objectives: to describe management and outcome of MS patients (pts) treated with ocrelizumab (OCR) during Sars-Cov2 pandemic in the MS Center of University of Genoa. Methods: we collected data about pts scheduled to undergo OCR infusion from 1st March to 30th June 2020. Pts that previously underwent the first OCR infusion completed the induction cycle. No further OCR cycles during March and April 2020 were performed. Starting from May, we adopted an infusion scheme based on B-cell repopulation, differently applied for Relapsing Remitting (RR) and Progressive (P) pts. RRMS pts performed immunophenotype (IF) and received OCR infusion when B CD19+ cell count overcame the cut-off of 1%. Conversely, for PMS pts OCR infusions were delayed for 3 months. Then, PMS pts underwent OCR infusion based on B CD19+ cell monitoring. For pts with evidence of B CD19+ cells repopulation brain 3T MRI was planned before OCR re-infusion. Results: 77 MS pts were included [45 (58%) RRMS, 32 (41%) PMS;mean age 44.7 (SD: 11.1) years, mean disease duration 21.7 (22.3) years, mean number of previous DMT before OCR: 1.6 (1.6), mean number of previous OCR infusions 3.9 (SD 2.3). 11 (13.1%, 9 RR, 2 PP) of the 49 pts that performed a first IF presented B CD19+ cell repopulation and received OCR re-infusion, with a mean delay from scheduled infusion of 70 (48.9) days. The mean number of previous OCR infusions was 3.0 (1.2) and 3.1 (1.6) for pts with and without evidence of B-cell repopulation respectively. No effect of previous OCR infusions number on the probability to develop B CD19+ cell repopulation at the first IF was detected by ANCOVA analysis, correcting for the delay between the date of scheduled infusion and the date in which the first IF has been performed. Considering the global cohort, 1 pt presented a dubious sensory relapse with no evidence of radiological activity. None of the pts who performed brain MRI before OCR re-infusion showed new T2 or Gd+ enhancing lesions. 3 pts were infected by Sars- Cov2;2 of them needed hospitalization but recovered completely. Conclusions: the management of patients treated with OCR during Sars-Cov2 pandemic with a personalized infusion protocol based on B CD19+ cells repopulation was associated with good results in terms of efficacy and safety outcome.

12.
Multiple Sclerosis Journal ; 26(3 SUPPL):195-196, 2020.
Article in English | EMBASE | ID: covidwho-1067117

ABSTRACT

Background: the management of MS patients (pts) who show disease activity after 2 alemtuzumab (ALM) courses represents an unsolved issue. No real-life data about the switch to ocrelizumab (OCR) have been reported yet. Objectives: To describe efficacy and safety outcome of OCR patients switching from ALM due to persistence of disease activity after ALM Methods: MS pts who switched from ALM to OCR from March 2019 to March 2020 were retro- and prospectively recruited from different Italian MS Centers. Clinical, immunological and neuroradiological data about ALM treatment period, ALM-OCR interval and OCR treatment period were collected. Results: we recruited 23 MS pts [mean age: 35.7(SD±6.8);female, 40.1%;Relapsing Remitting, (RR): 75.8%, active Secondary progressive, (aSP): 24.2%;mean time interval (days) from II ALM course: 87.4(SD±108);cumulative number of relapses: 21;mean number of new T2 and Gd+ lesions: 4.1(SD±4.5) and 1.6(SD±3.1);median EDSS:3(range 1-7)]. The mean follow-up (FU) from OCR start was 7.9±7.4 months. Efficacy: 4 (17.4%) pts had a relapse after OCR start (1 pt relapsed between the first and the second OCR infusion and 3 pts after 3, 11 and 15 months from OCR start respectively), with complete recovery after steroid treatment. 4 (17.4%) pts showed radiological activity with no clinical correlates at 3 months (n=2), 4 months (n=1) and 9 months (n=1). EDSS was stable except for 1 aSP patient who showed 1-year disability progression. Safety: I) Infusion Associated Reactions (IARs) occurrence was significantly lower with respect to alemtuzumab courses (p<0.05);(ii) infections: mild upper airways (n=1), urinary infections (n=1), appendicectomy (n=1) and fever due to probable Sars-Cov2 infection (n=1). For 12 pts, data about immunophenotype were available. Of them, no pts showed T CD4+ cell count decrease <200 cell/mm3 at 3, 6-months and 1-year FU;complete B CD19+ cell depletion (<5 cell/mm3) was confirmed at 3, 6-months and 1-year FU. 10 (43.4%) pts developed hypogammaglobulinemia without developing associated infectious events. C) Autoimmunity: no alemtuzumab-related new complications occurred. Conclusions: short-term FU seems to suggest that the switch to OCR in MS patients who showed disease activity after 2 ALM courses is characterized by a good safety and efficacy profile, although clinical and neuroradiological activity can be detected both in an early and in a later phase of treatment. Longer followup is warranted and recruitment is still ongoing.

13.
Multiple Sclerosis Journal ; 26(3_SUPPL):62-63, 2020.
Article in English | Web of Science | ID: covidwho-1008501
SELECTION OF CITATIONS
SEARCH DETAIL