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1.
Multiple Sclerosis Journal ; 28(3 Supplement):653-654, 2022.
Article in English | EMBASE | ID: covidwho-2138851

ABSTRACT

Background: Vaccination during immunosuppression can result in impaired vaccine responses. In highly active patients requiring a rapid treatment initiation, vaccination can delay treatment onset. Natalizumab (NTZ) is a high-efficacy agent with potential low interference in vaccination responses, and could be a bridge therapy to achieve an adequate immunisation before starting another treatment. Objective(s): To assess the safety and immunogenicity of inactivated vaccines administered during NTZ treatment. Method(s): Self-controlled study based on an ongoing prospective cohort that included adult MS patients with complete immunisation schedules for hepatitis B vaccine (HBV), hepatitis A vaccine (HAV) and/or COVID-19 vaccine during NTZ treatment, between September 2016 and February 2022. Seroprotection rates were calculated for each vaccine. Demographic, clinical and radiological characteristics were collected the year before (pre-exposure period) and after vaccination (post-exposure period). Differences in annual relapse rate (ARR), contrast-enhancing lesions (CELs), new T2 lesions (NewT2) and changes in Expanded Disability Status Scale (EDSS) during pre and post exposure period were evaluated. Patients were also categorised according to time on NTZ exposure before vaccination (long-term exposure >1 year and short-exposure <=1 year) and according to JCV status. Result(s): From 248 patients treated with NTZ, 60 were vaccinated during NTZ exposure: 44 (73%) women, mean age 45 years, mean disease duration 17 (SD 8.7) years. Thirty (50%) patients bridged to anti-CD20 after immunisation, because of high titers of JC virus. Between the pre and post-exposure period, we observed a decrease in both the AAR (0.28 vs 0.01;p=0.004) and newT2 (0.8 vs 0.02;p=0.1) and no changes in disability accumulation (EDSS 3.5 vs 3.5 p=0.6). The global seroprotection rate was 93% (91.6% (IC95% 73-99) for HAV (n=24), 92.6% (IC95% 76- 99) for HBV (n=27), 100% (IC95% 84-100) for Covid-19 (n=23)). No differences were seen between short and long term NTZ exposure or between JCV positive or negative patients, in terms of safety and immunogenicity. Conclusion(s): Immunisation with inactivated vaccines during NTZ treatment is safe and effective, both for short and long term NTZ exposure. In highly active PwMS who need immunisation, NTZ could be a valuable strategy to avoid delays in the onset of high-efficacy DMD, even in JC virus positive in which it could be used as a bridge therapy strategy.

2.
Multiple Sclerosis Journal ; 27(3 SUPPL):17, 2021.
Article in English | EMBASE | ID: covidwho-1582622

ABSTRACT

Background: Since the Covid-19 pandemic started, it has been necessary to adapt our clinical practice to limit physical contact. We have established a virtual/presential rehabilitation program (VPR) in patients with EDSS ≤6.5. Methods: Our aim was to compare the effectiveness of the VPR with the previous face-to-face rehabilitation program (PR). Retrospective data were obtained from all patients with an EDSS≤6.5 who were admitted between September and December of 2019 and 2020. All patients were attended 3 times per week for 4 months. In the 2019 group the sessions were PR based, whereas in the 2020 group patients received a VPR, with one face-to-face session plus 2 virtual sessions. Outcomes (obtained pre and post rehabilitation programs) compared between VPR and PR groups were: 10MWT, Tinnetti Test (TT) and Berg Balance Scale (BBS). A minimally clinical significant difference was established for each test: 20% for 10MWT, 3 points for BBS and 1 point for TT. Results: One hundred and forty people were included in the groups VPR (n=80) / PR (N=60). For VPR and PR groups, mean age was 51.45y (SD10.71) / 54.65y (SD11.19) and mean EDSS 4.62 (SD1.45) / 4.64 (SD1.46). All clinical outcomes demonstrated statistically significant improvements pre-post intervention in both groups. Comparing VPR vs PR scores, test didn't show differences using a U of Mann-Whitney for independent samples: BBS 54.2%/44.1% (p =0.27);10MWT 36.7%/22.0% (p =0.13) and TT 40.7%/37.3% (p =0.72). Conclusions: No differences were observed in the effectiveness of VPR versus PR in any of the tests. The VPR program could be a useful tool for patients with an EDSS≤6.5, as the VPR provides a series of subjective benefits (ease of occupational and family life, reduction of fatigue caused by long journeys) while maintaining effectiveness. Further studies with improved designs are warranted to confirm these findings.

3.
Heliyon ; 7(11): e08443, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1525794

ABSTRACT

This article analyzes the personal leadership resources utilized by a sample of school principals in Catalonia (Spain) during the confinement and post-confinement periods due to the COVID-19 crisis. A questionnaire was designed, validated, and provided to the principals from Primary Education schools to carry out the study. The questionnaire analyzed personal leadership resources used by the principals during the confinement and post-confinement periods, compared to a former ¨normal situation¨. The data analysis results confirmed that the role of the principals was crucial in redirecting the situation and completing the academic course satisfactorily. The principals scored their leadership resources remarkably high in the former normality and maintained proactivity at a similar level during the crisis. However, other resources scored lower during the same period. As a direct result, there was a high degree of adaptation to this situation from the principals. The results indicate that principals do not lead in the same manner in times of crisis as in normal times. Age, experience, and type of school influence the results only in former normal situations but not in times of crisis.

4.
Multiple Sclerosis Journal ; 27(2 SUPPL):758-759, 2021.
Article in English | EMBASE | ID: covidwho-1496076

ABSTRACT

Introduction: Information about how SARS-CoV-2 specific humoral and cellular response is modified by disease-modifying therapies (DMTs) is scarce. Objective: To investigate humoral and cellular responses to SARS-CoV-2 and factors for presenting them in a Barcelona cohort of pwMS. Methods: Retrospective cohort study of adult unvaccinated PwMS with confirmed COVID-19 with at least one SARS-CoV-2 antibody (Ab) determination included from February 2020 to May 2021 and followed until May 2021. Demographic, clinical and laboratory data were obtained. Humoral SARS-CoV-2 response was measured with commercial chemiluminescence immunoassays targeting specific Ab against spike (IgG-S) and nucleocapsid proteins (Ig-N), as per clinical practice. SARS-CoV-2 specific T-cell response was studied in 42 selected pwMS according to DMT by a whole blood Interferon-Gamma (IFN-y) Release Immunoassay. Humoral and cellular response was assesed using a logistic regression model corrected for age, sex, comorbidities, MS form, expanded disability status scale, DMT, COVID-19 severity and PCR result. Results: 145 pwMS were enrolled (mean age 46.8 years;64.1% female;18.6% progressive forms, 20.7% untreated, 22.8% on anti-CD20s therapies and 56.6% on other DMTs). Humoral and cellular tests were performed from 0.3 to 13.1 months after COVID-19. 121(83.5%) presented positive Ab (57.6% anti-CD20 therapy, 90.2% other DMTs, 93.3% untreated). Untreated patients presented higher Ig-N titres (34.3[128.8]) compared to those with anti-CD20s (0.08[0.13], p<0.01), and other DMTs (19.55[42.92], p<0.01). Humoral response persisted over 6 months in 12/12 untreated, 9/22 with anti-CD20s and 22/28 with other DMTs (p=0.068). 31/42(73.8%) presented cellular response (81.0% anti- CD20, 62.5% other DMTs, 80.0% untreated), with similar levels of IFN-y levels among DMTs. 5/12(41.7%) anti-CD20-treated PwMS with negative Ab presented cellular response. In the multivariate analysis, humoral response decreased in anti-CD20 therapy (OR 0.08[95% CI,0.01-0.55]) and was associated with male sex (OR 3.59[1.02-12.68]). Cellular response was associated with seropositivity (OR13.0[1.29-130.4]), but can be present even in the absence of Ab. Conclusions: Humoral response is altered by DMTs, specially in anti-CD20-treated PwMS. Cellular response is associated with seropositivity but can be present in anti-CD20-treated PwMS even in the absence of Ab. Both can be detected up to 13.1 months after COVID-19.

5.
Multiple Sclerosis Journal ; 27(2 SUPPL):769-770, 2021.
Article in English | EMBASE | ID: covidwho-1496075

ABSTRACT

Background: Information about humoral and cellular responses to SARS-CoV-2 vaccination in patients with Multiple Sclerosis (PwMS) and other autoimmune diseases (AID) is scarce. Objective: To determine humoral and cellular responses after SARS-CoV-2 vaccination in PwMS and anti-CD20-treated patients with other AID. Methods: Ongoing prospective study performed in two Catalan MS centres from February 2021. Unvaccinated adult pwMS and other anti-CD20-treated AID were recruited. Demographic, clinical and laboratory data were obtained. Whole blood samples were obtained before and 30-90 days after vaccination. The humoral response to SARS-CoV-2 was qualitatively and quantitatively measured before and after vaccination with commercial chemiluminescence immunoassays targeting SARS-CoV-2 antibodies against spike (TrimericS, IgG anti-S) and nucleocasid proteins (Elecsys, Ig anti-N). In 150 selected patients according to diseasemodifying therapy (DMT), the SARS-CoV-2 specific T-cell response was assessed after vaccination by a whole blood Interferon-Gamma Release immuno Assay (IGRA) that uses two Qiagen proprietary mixes of SARS-CoV-2 S protein (Ag.1 and Ag.2) selected to activate both CD4 and CD8 T cells. Results: 457 patients have been enrolled in the study (anti-CD20 therapy n=164, S1P DMTs n=37, natalizumab n=32, cladribine n=29, alemtuzumab n=31, other DMTs n=129, no DMT n=35). Participants characteristics are: mean age 48.1 years (SD 12.0), 69% female, 422 pwMS (29.4% progressive forms) and 35 with other AID, disease duration 13.9 years (IQR 14.1), median EDSS 3.0 (IQR 3.0). 450 have been fully vaccinated (94.2% mRNA vaccine). Pre-vaccination samples were collected 0.33 days (SD 0.5) before the first vaccine dose of which 12 (3.35%) had positive anti S/N immunoglobulin (Ig). As of June 30th, 42 post-vaccination samples have been obtained (1.3 months [SD 0.42] after the 2nd vaccination dose). Positive IgG rates were 44.8% (n=13/29) for CD20s, 100% (8/8) for other DMTs and 100% (4/4) for no DMT. No anti-N Ig were detected. Media titres of anti-S IgG were lower in anti-CD20-treated patients (7.8 [IQR 50.1]) compared to untreated patients (800 [0], p<0.01) or other DMTs (755 [228], p<0.01). Conclusions: Initial results of the study suggest blunted anti-S/N Ig response under anti-CD20 therapy. Knowledge of the cellular response in these patients will be crucial. Data from the cellular study and the completed humoral study will be presented at the meeting.

6.
Multiple Sclerosis Journal ; 27(2 SUPPL):562-563, 2021.
Article in English | EMBASE | ID: covidwho-1495938

ABSTRACT

Background: Data on the effects of multiple sclerosis (MS) disease modifying therapies (DMTs) on SARS-CoV-2 vaccine response are needed. Initial studies suggest CD20 cell depleting therapies and fingolimod attenuate IgG response to SARS-CoV-2 vaccination in MS patients (pts), consistent with previous studies of vaccine responses in pts treated with those DMTs. Methods: Participants with MS enrolled in the MS PATHS network in the US, Germany, and Spain were asked to provide blood serum samples up to 30 days pre-SARS-CoV-2 vaccination and 28-90 days post final vaccine dose. The goal is to obtain & ge;45 post-vaccination samples per approved DMT and among pts not currently treated with a DMT. Semi-quantitative measures of SARS-CoV-2 IgG response to spike protein (Siemens SARSCoV- 2 IgG assay) and nucleocapsid protein (Abbott SARS-CoV-2 IgG assay) will be used to distinguish humoral responses to vaccination vs prior infection. The impact of demographic factors, MS disease subtype and duration, disability level, DMT type, vaccine type, and time since last DMT dose, and vaccine dose on IgG response will be evaluated. Results: As of May 17, 2021, 379 unique pts provided a serum sample: CD20 DMTs (n=139), S1P DMTs (n=31), natalizumab (n=39), other DMTs (n=117), and no DMT (n=53);183 pts have a pre-vaccination sample awaiting a post-vaccination sample, 186 have only a post-vaccination sample, and 10 have both. Prevaccination samples were collected at a mean (SD) of 4.5 (7.5) days prior to the first vaccine dose, and post-vaccination samples were collected 46.6 (15.2) days after the last dose, 91.8% following an mRNA vaccine. Pt (n=379) characteristics were: age 50.3 (12.5) yrs, 67% female, disease duration 16.6 (9.6) yrs, 27.7% progressive MS, and Patient Determined Disease Steps 2.0 (2.3). Reactive IgG rates (IgG index & gt;1) from initial post-vaccination testing were CD20 DMTs 21/41 (51%), S1P DMTs 4/8 (50%), and 100% for all other groups, including natalizumab (n=9), fumarates (n=8), interferons (n=8), glatiramer acetate (n=8), teriflunomide (n=2), alemtuzumab (n=1) and no DMT (n=17). Conclusions: Preliminary results, based on a limited sample size, suggest CD20 and S1P DMTs may reduce IgG response to SARS-CoV-2 vaccination. Quantifying post-vaccination IgG response across DMTs is crucial to optimize MS management. Data from ongoing sample collection will be presented at the meeting.

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