Experiences of persons with multiple sclerosis with the Covid-19 vaccination: A cross-sectional study of the Swiss Multiple Sclerosis Registry.

BACKGROUND: Despite strong recommendations for coronavirus disease 2019 (Covid-19) vaccination by multiple sclerosis (MS) organizations, some persons with MS (pwMS) remain vaccine hesitant. The Swiss MS Registry conducted a survey to explore Covid-19 vaccine hesitancy, self-reported side effects and changes in MS symptoms following vaccination in adult pwMS. METHODS: Self-reported data were analyzed cross-sectionally. Multivariable logistic regression was used to explore participant characteristics associated with Covid-19 vaccine hesitancy. RESULTS: Of 849 respondents, 73 (8.6%) were unvaccinated. Hesitation to vaccinate was most often a personal preference (N = 42, 57.53%). Factors negatively associated with vaccine hesitancy included older age (OR = 0.97 per year, 95% CI [0.94, 0.99]) and regularly seeing healthcare professionals (OR = 0.25, 95% CI [0.07, 0.85]). A history of confirmed Covid-19 infection (OR = 3.38, 95% CI [1.69, 6.77]) and being underweight (OR = 4.50, 95% CI [1.52, 13.36]) were positively associated with vaccine hesitancy. Of 768 participants who provided information, 320 (41.2%) and 351 (45.2%) reported vaccination side effects after the first and second vaccinations, respectively. Changes in MS symptoms were reported by 49 (6.3%) participants after the first and 67 (9.0%) participants after the second vaccination, and were most often described as increased or new-onset fatigue (N = 17/49 (34.7%) after the first and N = 21/67 (31.3%) after the second dose). CONCLUSIONS: Covid-19 vaccine hesitancy was low among surveyed pwMS. The risk of vaccine hesitancy was higher among younger pwMS, those with a history of Covid-19 infection, and those without regular contact with healthcare professionals.

The Real-World Experiences of Persons With Multiple Sclerosis During the First COVID-19 Lockdown: Application of Natural Language Processing.

BACKGROUND: The increasing availability of "real-world" data in the form of written text holds promise for deepening our understanding of societal and health-related challenges. Textual data constitute a rich source of information, allowing the capture of lived experiences through a broad range of different sources of information (eg, content and emotional tone). Interviews are the "gold standard" for gaining qualitative insights into individual experiences and perspectives. However, conducting interviews on a large scale is not always feasible, and standardized quantitative assessment suitable for large-scale application may miss important information. Surveys that include open-text assessments can combine the advantages of both methods and are well suited for the application of natural language processing (NLP) methods. While innovations in NLP have made large-scale text analysis more accessible, the analysis of real-world textual data is still complex and requires several consecutive steps. OBJECTIVE: We developed and subsequently examined the utility and scientific value of an NLP pipeline for extracting real-world experiences from textual data to provide guidance for applied researchers. METHODS: We applied the NLP pipeline to large-scale textual data collected by the Swiss Multiple Sclerosis (MS) registry. Such textual data constitute an ideal use case for the study of real-world text data. Specifically, we examined 639 text reports on the experienced impact of the first COVID-19 lockdown from the perspectives of persons with MS. The pipeline has been implemented in Python and complemented by analyses of the "Linguistic Inquiry and Word Count" software. It consists of the following 5 interconnected analysis steps: (1) text preprocessing; (2) sentiment analysis; (3) descriptive text analysis; (4) unsupervised learning-topic modeling; and (5) results interpretation and validation. RESULTS: A topic modeling analysis identified the following 4 distinct groups based on the topics participants were mainly concerned with: "contacts/communication;" "social environment;" "work;" and "errands/daily routines." Notably, the sentiment analysis revealed that the "contacts/communication" group was characterized by a pronounced negative emotional tone underlying the text reports. This observed heterogeneity in emotional tonality underlying the reported experiences of the first COVID-19-related lockdown is likely to reflect differences in emotional burden, individual circumstances, and ways of coping with the pandemic, which is in line with previous research on this matter. CONCLUSIONS: This study illustrates the timely and efficient applicability of an NLP pipeline and thereby serves as a precedent for applied researchers. Our study thereby contributes to both the dissemination of NLP techniques in applied health sciences and the identification of previously unknown experiences and burdens of persons with MS during the pandemic, which may be relevant for future treatment.

Specific Aspects of Immunotherapy for Multiple Sclerosis in Switzerland - A Structured Commentary, Update 2022

Multiple sclerosis (MS), particularly relapsing MS (RMS), has become a treatable disease in recent decades, and immunotherapies are now able to influence long-term disease course. A wide range of disease-modifying drugs are available, which makes the choice of therapy in individual cases considerably more complex. Due to specific regulatory aspects (partly diverging approvals by Swissmedic compared to the European Medicines Agency (EMA), and an independent evaluation process for the Federal Office of Public Health (FOPH) specialities list (SL)), we issued a consensus recommendation regarding specific aspects of immunotherapy for MS in Switzerland in 2019. Here, we present revised recommendations with an update on newly approved drugs and new safety aspects, also in reference to the risk of COVID-19 infection and vaccination.

Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results.

BACKGROUND: The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting. METHODS: An interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months. RESULTS: In total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication. CONCLUSIONS: Overall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced. TRIAL REGISTRATION: BASEC ID 2018-02,375 in the Register of All Projects in Switzerland (RAPS).

A CLEIA Antigen Assay in Diagnosis and Follow-Up of SARS-CoV-2-Positive Subjects.

This study includes 259 consecutive nasopharyngeal swabs which tested positive for a molecular SARS-CoV-2 test and 77 subjects who were followed longitudinally, with nasopharyngeal swabs performed weekly until clinical recovery and a negative result for the molecular test were reached. All swabs were also tested with a Lumipulse SARS-CoV-2 chemiluminescence enzyme immunoassay (CLEIA) antigen assay. The antigen test was positive in 169 (65.3%) out of the 259 subjects, while no antigen was detected in 90 subjects (34.7%). In the antigen-positive subjects, clinical status moved slightly toward a more frequent presence of symptoms. Longitudinal follow-up shows how the time of negativization has a faster kinetic in the antigenic test than in the molecular test. Antigenic test result values, considered as a time-dependent covariate and log-transformed, were highly associated with the time to negative swab, with good prediction ability. Receiver operating characteristic (ROC) curve analysis showed a very good discrimination ability of antigenic tests in classifying negative swabs. The optimal cutoff which jointly maximized sensitivity and specificity was 1.55, resulting in an overall accuracy of 0.75, a sensitivity of 0.73, and a specificity of 0.83. After dichotomizing the antigenic test according to the previously determined cutoff value of 1.55, the time-dependent covariate Cox model again suggests a highly significant association of antigenic test values with the time to negative swab molecular: a subject with an antigenic test value lower than 1.55 had almost a 13-fold higher probability to also result negative in the molecular test compared to a subject with an antigenic test value higher than 1.55. IMPORTANCE Our work explores the possibility of using a sensible and reliable antigenic test in a wider range of SARS-CoV-2 diagnostic and clinical applications. Furthermore, this tool seems particularly promising in follow-up with infected subjects, because while the molecular test frequently yields the persistence of low positivities, raising yet unanswered questions, this antigenic test shows more uniform and faster negativization during the evolution of the infection, somehow paralleling the dynamics of infectivity. Although more data will be required to definitely prove it, we believe these findings might be of great interest.

Longitudinal Postvaccine SARS-CoV-2 Immunoglobulin G Titers, Memory B-Cell Responses, and Risk of COVID-19 in Multiple Sclerosis Over 1 Year.

BACKGROUND AND OBJECTIVES: Some disease-modifying treatments impair response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in multiple sclerosis (MS), potentially increasing the risk of breakthrough infections. We aimed to investigate longitudinal SARS-CoV-2 antibody dynamics and memory B cells after 2 and 3 messenger RNA (mRNA) vaccine doses and their association with the risk of COVID-19 in patients with MS on different treatments over 1 year. METHODS: Prospective observational cohort study in patients with MS undergoing SARS-CoV-2 mRNA vaccinations. Antispike (anti-S) immunoglobulin G (IgG) titers were measured by chemiluminescence microparticle immunoassay. Frequencies of spike-specific memory B cells were measured on polyclonal stimulation of peripheral blood mononuclear cells and screening of secreted antibodies by ELISA. RESULTS: We recruited 120 patients with MS (58 on anti-CD20 antibodies, 9 on sphingosine 1-phosphate (S1P) receptor modulators, 15 on cladribine, 24 on teriflunomide (TFL), and 14 untreated) and collected 392 samples up to 10.8 months after 2 vaccine doses. When compared with untreated patients, anti-CD20 antibodies (ß = -2.07, p < 0.001) and S1P modulators (ß = -2.02, p < 0.001) were associated with lower anti-S IgG, while TFL and cladribine were not. Anti-S IgG decreased with months since vaccine (ß = -0.14, p < 0.001), independently of treatments. Within anti-CD20 patients, anti-S IgG remained higher in those with greater baseline B-cell counts and were not influenced by postvaccine anti-CD20 infusions. Anti-S IgG increase after a 3rd vaccine was mild on anti-CD20 and S1P modulators. Spike-specific memory B-cell responses were weaker on S1P modulators and anti-CD20 than on TFL and influenced by postvaccine anti-CD20 infusions. The frequency of breakthrough infections was comparable between DMTs, but the risk of COVID-19 was predicted by the last measured anti-S IgG titer before infection (OR = 0.56, 95% CI = 0.37-0.86, p = 0.008). DISCUSSION: Postvaccine anti-S IgG titers decrease over time regardless of MS treatment and are associated with breakthrough COVID-19. Both humoral and specific memory B-cell responses are diminished on S1P modulators. Within anti-CD20-treated patients, B-cell count at first vaccine determines anti-S IgG production, whereas postvaccine anti-CD20 infusions negatively affect spike-specific memory B cells.

Feelings of loneliness, COVID-19-specific-health anxiety and depressive symptoms during the first COVID-19 wave in Swiss persons with multiple sclerosis.

The aim of our study was to investigate whether self-reported feeling of loneliness (FoL) and COVID-19-specific health anxiety were associated with the presence of depressive symptoms during the first coronavirus disease 2019 (COVID-19) wave. Questionnaires of 603 persons of the Swiss Multiple Sclerosis Registry (SMSR) were cross-sectionally analyzed using descriptive and multivariable regression methods. The survey response rate was 63.9%. Depressive symptoms were assessed by the Beck Depression Inventory-Fast Screen (BDI-FS). COVID-19-specific health anxiety and FoL were measured using two 5-item Likert scaled pertinent questions. High scoring FoL (2.52, 95% confidence interval (CI) (2.06-2.98)) and/or COVID-19 specific health anxiety (1.36, 95% CI (0.87-1.85)) were significantly associated with depressive symptoms. Further stratification analysis showed that the impact of FoL on depressive symptoms affected all age groups. However, it was more pronounced in younger PwMS, whereas an impact of COVID-19 specific health anxiety on depressive symptoms was particularly observed in middle-aged PwMS. FoL and COVID-19-specific health anxiety were age-dependently associated with depressive symptoms during the first COVID-19 wave in Switzerland. Our findings could guide physicians, health authorities, and self-help groups to better accompany PwMS in times of public health crises.