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Purpose: The Comprehensive assessment of Acceptance and Commitment Therapy (CompACT) is a 23-item questionnaire measuring psychological flexibility, a quality of life protective factor. An 18-item version was recently produced. We assessed validity and reliability of CompACT, and equivalence of paper and electronic (eCompACT) versions in people with multiple sclerosis (PwMS) in Italy, Germany and Spain. Methods: We used confirmatory factor analysis and assessed CompACT-23 and CompACT-18 measurement invariance between the three language versions. We assessed construct validity (Spearman's correlations) and internal consistency (Cronbach's alpha). Test–retest reliability (intraclass correlation coefficient, ICC) and equivalence of paper and eCompACT (ICC and linear regression model for repeated measures) were assessed in subsamples of PwMS. Results: A total of 725 PwMS completed the study. The three-factor structure of the CompACT-23 showed poor fit (RMSEA 0.07; CFI 0.82; SRMR 0.08), while the fit of the CompACT-18 was good (RMSEA 0.05; CFI 0.93; SRMR 0.05). Configural and partial metric invariance were confirmed, as well as partial scalar invariance (reached when five items were allowed to vary freely). The CompACT-18 showed good internal consistency (all alpha ≥ 0.78); and test–retest reliability (all ICCs ≥ 0.86). Equivalence between paper and eCompACT was excellent (all ICCs ≥ 0.86), with no mode, order, or interaction effects. Conclusion: Results support using the refined CompACT-18 as a three-factor measure of psychological flexibility in PwMS. Paper and eCompACT-18 versions are equivalent. CompACT-18 can be used cross-culturally, but sub-optimal scalar invariance suggests that direct comparison between the three language versions should be interpreted with caution. [ABSTRACT FROM AUTHOR]

Introduction: Spasticity is a common symptom in multiple sclerosis (MS) and it is often associated with other symptoms such as spasms/cramps and pain. The concept of Spasticity-Plus syndrome takes into account that spasticity is accompanied by one or more symptoms (spasms/cramps, pain, bladder dysfunction, sleep disorders, fatigue and/or tremor). As these symptoms share a common cannabinoid control, therapy acting on cannabinoid receptors may be useful. The main study objectives were to determine the number of MS patients who met Spasticity-Plus syndrome criteria and to identify the most common symptoms. Methods: Clinical records of MS patients treated with nabiximols in a tertiary hospital from 2002 to 2022 were reviewed retrospectively. Results: Of the 73 patients included in the study, 53.4% were women, and most had secondary progressive MS (64.4%). All patients met the criteria for Spasticity-Plus syndrome: 100% had spasticity and at least another symptom. Pain was the second most common symptom (91.8%), followed by spasms/cramps (79.4%), and fatigue (76.7%). Sleep disturbances (p< 0.0001) and tremor (p< 0.027) were more frequent in patients with relapsing-remitting MS than in patients with progressive MS. No statistically significant differences were found for spasticity, pain, spasms/cramps, and fatigue between MS phenotypes. Regarding symptoms clusters, 94.4% of the patients had three or more symptoms. Spasticity was more frequently associated with pain (91.8%) and spasms/cramps (79.4%). Conclusion: Spasticity-Plus syndrome was present in all the study population of patients with different MS phenotypes, and treated with nabiximols. [ABSTRACT FROM AUTHOR]

Background: Alemtuzumab is a high-efficacy treatment approved for relapsing-remitting multiple sclerosis (RRMS). Although clinical trials and observational studies are consistent in showing its efficacy and manageable safety profile, further studies under clinical practice conditions are needed to further support its clinical use. Objective: The aim of this observational retrospective study was to evaluate the effectiveness and safety of alemtuzumab to add to the current real-world evidence on the drug. Methods: A cohort of 115 adult patients with RRMS treated with alemtuzumab between 2014 and 2020 was retrospectively followed up in five centers in Spain. Analysis included annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW), 6-month confirmed disability improvement (CDI), radiological activity, no evidence of disease activity (NEDA-3), and safety signals. Given the different follow-up periods among participants, ARR was calculated using the person-years method. CDI was defined as a ≥ 1.0-point decrease in Expanded Disability Status Scale (EDSS) score assessed in patients with a baseline EDSS score ≥ 2.0 confirmed 6 months apart. CDW was defined as a ≥ 1.0-point increase in EDSS score assessed in patients with a baseline EDSS score ≥ 1.0 (≥ 1.5 if baseline EDSS = 0), confirmed 6 months apart. Results: ARR decreased from 1.9 (95% confidence interval 1.60–2.33) in the year prior to alemtuzumab initiation to 0.28 (0.17–0.37) after 1 year of treatment (87% reduction), and to 0.22 (0.13–0.35) after the second year. Over the entire follow-up period, ARR was 0.24 (0.18–0.30). At year 1, 75% of patients showed no signs of magnetic resonance imaging (MRI) activity and 70% at year 5. One percent of patients experienced 6-month CDW at year 1, 2.6% at year 2, 7.4% at year 3, and no patients over years 4 and 5. A total of 7.7% of patients achieved 6-month CDI in year 1, 3.6% in year 2, and maintained it at years 3 and 4. Most patients achieved annual NEDA-3: year 1, 72%; year 2, 79%; year 3, 80%; year 4, 89%; year 5, 75%. Infusion-related reactions were observed in 95% of patients and infections in 74%. Thyroid disorders occurred in 30% of patients, and only three patients developed immune thrombocytopenia. No cases of progressive multifocal leukoencephalopathy were reported. Conclusions: This study shows that alemtuzumab reduced the relapse rate and disability worsening in real-world clinical practice, with many patients achieving and sustaining NEDA-3 over time. The safety profile of alemtuzumab was consistent with previous findings, and no new or unexpected safety signals were observed. As this was an observational and retrospective study, the main limitation of not having all variables comprehensively available for all patients should be considered when interpreting results. [ABSTRACT FROM AUTHOR]

Introduction: The risk of SARS-CoV-2 infection or severe coronavirus disease 2019 (COVID-19) has been shown to increase in patients with multiple sclerosis (MS). Vaccination is recommended in this patient population, and the effect of disease-modifying treatments (DMTs) on response to vaccination should be considered. Methods: This prospective, observational, cross-sectional study investigated humoral response after COVID-19 vaccination as well as possible predictors for response in patients with MS and other neuroinflammatory diseases who received DMTs in routine clinical practice in Spain. Responses were compared versus those seen in healthy controls. Results: After vaccination against COVID-19, most patients with MS developed an immune response comparable to that of healthy individuals. However, approximately half of patients receiving a sphingosine-1-phosphate modulator (SP1-M, fingolimod or siponimod) or a B-cell-depleting agent (aCD20, ocrelizumab or rituximab) did not develop protective antibodies, although patients receiving other DMTs had humoral immune responses comparable to healthy controls. Lymphocyte count was not associated with reduced humoral response in patients receiving an SP1-M or aCD20, whereas, in patients receiving an aCD20 or SP1-M, older age was associated with lower anti-SARS-CoV-2 spike protein immunoglobulin G antibody levels. Conclusions: Treatment with aCD20 or SP1-M therapies appears to be associated with a lower humoral response to vaccines against SARS-CoV-2. Vaccination prior to initiation of these DMTs should be recommended whenever possible. [ABSTRACT FROM AUTHOR]

Our objective was to know the COVID-19 vaccination coverage in multiple sclerosis (MS) patients and its factors associated. A retrospective cohort study was carried out. Patients seen at the MS unit of the University Clinical Hospital of Zaragoza between 2017 and 2021 were included. Variables were obtained by reviewing the specialized and primary care records. Associations between receiving COVID-19 full primo-vaccination, as well as one booster dose since autumn 2022, and the other variables were analyzed using bivariate analysis and multiple logistic regression models. Of the 359 included patients, 90.3% received the COVID-19 full primo-vaccination. Having been born in Spain (aOR = 3.40) and having received the 2020–2021 influenza vaccine (aOR = 6.77) were associated with receiving the COVID-19 full primo-vaccination. Vaccination with a COVID-19 booster dose was detected in 141 patients (39.3%). Sex (man) (aOR = 2.36), age (60 years or over) (aOR = 6.82), type of MS (Primary Progressive/Secondary Progressive) (aOR = 3.94), and having received the 2022–2023 influenza vaccine (aOR = 27.54) were associated with receiving such a booster dose. The COVID-19 booster dose was administered at the same time as the 2022–2023 influenza vaccine in 57.8% (67/116) of the patients vaccinated with both vaccines. The COVID-19 full primo-vaccination coverage is higher than in other countries. However, the decrease in vaccination coverage with the booster dose makes it necessary to develop strategies to improve it that are not limited to administering the flu vaccine together with the COVID-19 booster dose. Such strategies should be in focus, especially for women under 60 years of age. [ABSTRACT FROM AUTHOR]

Context: Treatment with Alemtuzumab (ALZ) in patients with Relapsing–Remitting Multiple Sclerosis (RRMS) is associated with the development of ALZ-induced Graves' disease (GD-ALZ). Some cases may develop associated Graves´ Orbitopathy (GO-ALZ), with possible visual compromise. Aim: The aim of this study was to describe the main clinical and biochemical characteristics of GD-ALZ, as well as the clinical course of a case series of GO-ALZ Methods: This study is a retrospective observational study, carried out in a reference hospital for the care of patients with RRMS in Spain. Cases treated with ALZ in the period 2014–2022 were included. GO-ALZ cases were identified among those with clinical symptoms compatible with thyroid eye disease after initiating ALZ treatment. Results: A total of 135 cases, with a mean follow-up of 69.6 months after the first ALZ cycle, were included. The incidence of GD-ALZ was 32.6% (44/135), with a predominance of women (77.3%) and mean age of 41.9 years. The presence of first-degree relatives with hypothyroidism was identified as risk factor for the development of GD-ALZ (adjusted P-value: 0.02). GO-ALZ was diagnosed in 6 cases (incidence: 13.6%), of which 3 had severe clinical forms of GO, requiring anti-IL-6 treatment. A favorable response was reported in all of them, with a significant decrease in disease activity and improvement in proptosis. Conclusions: We report one of the largest cohorts of GD-ALZ and GO-ALZ cases. The diagnosis of these entities should be taken into account in patients treated with Alemtuzumab, given the risk of developing severe clinical forms. In moderate-severe forms of GO-ALZ, drugs with anti-IL-6 activity are a safe and effective option. [ABSTRACT FROM AUTHOR]

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Introduction: Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing–remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. Methods: This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. Results: A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14–0.21) from the baseline of 0.42 (95% CI 0.38–0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12–24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. Conclusion: Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression. [ABSTRACT FROM AUTHOR]

Background: Severe cases of lymphopenia have been reported during siponimod clinical trials, which may negatively impact its benefit/risk profile. Objective: We aimed to evaluate the incidence of lymphopenia following the initiation of siponimod treatment in clinical practice. The secondary objectives included the analysis of factors predisposing to and the clinical relevance of lymphopenia events. Methods: In this multicenter retrospective cohort study, information collected from the medical records of 129 patients with MS from 15 tertiary hospitals in Spain who initiated treatment with Siponimod were followed-up for at least 3 months, including at least one lymphocyte count evaluation per patient. Results: Of the 129 patients, 121 (93.6%) reported lymphopenia events, including 110 (85.3%) with grade ≤ 3 and 11 (8.5%) with grade 4 lymphopenia, higher than those reported in the pivotal clinical trial (73.3% and 3.3% for grade ≤ 3 and grade 4 lymphopenia, respectively). The study included an unexpectedly high proportion of male subjects (72.9%), which might have led to an underestimation of the actual magnitude of the risk. Conclusions: In this study, the incidence and severity of lymphopenia after starting siponimod treatment were higher than those reported in previous clinical trials. Therefore, our results reinforce the need for the closer monitoring of novel MS drugs in clinical practice, as well as larger and longer follow-up studies to properly characterize this risk. [ABSTRACT FROM AUTHOR]

Aims and Objectives: We aimed to identify correlates of cannabinoid‐based products (CBP) use in patients with multiple sclerosis (MS) in France and Spain. Background: MS is responsible for a wide range of symptoms, including pain. Access to CBP differs according to local legislation. The French context is more restrictive than the Spanish one, and no data regarding cannabis use among MS patients has yet been published. Characterizing MS patients who use CBP constitutes a first step toward identifying persons most likely to benefit from them. Design: An online cross‐sectional survey was submitted to MS patients who were members of a social network for people living with chronic diseases and were living in France or Spain. Methods: Two study outcomes measured therapeutic CBP use and daily therapeutic CBP use. Seemingly unrelated bivariate probit regression models were used to test for associations between the outcomes and patients' characteristics while accounting for country‐related differences. STROBE guidelines were followed in reporting this study. Results: Among 641 study participants (70% from France), the prevalence of CBP use was similar in both countries (23.3% in France vs. 20.1% in Spain). MS‐related disability was associated with both outcomes, with a gradient observed between different degrees of disability. MS‐related pain level was associated with CBP use only. Conclusions: CBP use is common in MS patients from both countries. The more severe the MS, the more participants turned to CBP to alleviate their symptoms. Easier access to CBP should be ensured for MS patients in need of relief, especially from pain. Relevance to clinical practice: This study highlights the characteristics of MS patients using CBP. Such practices should be discussed by healthcare professional with MS patients. [ABSTRACT FROM AUTHOR]

This single-center study included 68 multiple sclerosis (MS) patients who received the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination from one of several approved vaccine preparations in Spain. Blood samples were collected one to three months after the second dose of the vaccine had been administered. Cellular immune responses to the vaccine were assessed using QuantiFERON analysis, and peripheral blood mononuclear cell subsets were assayed using flow cytometry. Response associated with higher percentages of total lymphocytes, naïve CD4+ T-cells (p = 0.028), CD8+ T-cells (p = 0.013), and, mostly, naïve CD8+ T-cells (p = 0.0003). These results were confirmed by analyzing absolute numbers (p = 0.019; p = 0.002, and p = 0.0003, respectively). Naïve CD8 T-cell numbers higher than 17 cells/μL were closely associated with an optimal cellular response to SARS-CoV-2 vaccination (odds ratio: 24.0, confidence interval: 4.8–460.3; p = 0.0001). This finding clearly shows that independent of the treatment received, higher numbers of naïve CD8+ T-cells yield a strong cellular response to SARS-CoV-2 vaccines in MS patients. If this finding is validated with other viruses/vaccines, it could provide a good tool for identifying MS patients undergoing treatment who will develop strong cellular responses to anti-virus vaccines. [ABSTRACT FROM AUTHOR]

Background: Spasticity is a frequent symptom of multiple sclerosis (MS), which may negatively influence daily living activities (ADL). Objectives: To (1) explore the feasibility to conduct a structured interview by specialist nurses about limitations in ADL; (2) determine the percentage of people with MS (PwMS) with limitations in ADL related to spasticity; (3) to assess the knowledge about spasticity and describe its clinical features. Design: Observational, cross‐sectional, multicentre study in 16 MS units of Catalonia (Spain). Participants were recruited from the outpatient facility and day‐care hospital between July 2018 and June 2019 and met the following criteria: (1) age 18 or older, (2) diagnosis of MS according to McDonald criteria 2010 and (3) no clinical relapse in previous 30 days. Methods: Specialist nurses conducted a structured interview divided in two parts: the assessment of (1) limitations in the ADL and (2) the presence of spasticity and associated symptoms. The usefulness of this intervention was requested. This study met the STROBE reporting guidelines checklist for observational studies. Results: Three hundred sixty eight pwMS (244 women) with a mean age of 46 years and a median Expanded Disability Status Scale score of 2.5 (range, 0–8.5) were included. 262 (71%) pwMS had limitations in the ADL, and spasticity was reported as the most limiting symptom in 59 (23%). As a result of the interview, spasticity was observed in 199 (76%) participants; 47 (24%) of them were unaware that they had spasticity and 102 (51%) would not have reported it spontaneously. The level of the interview satisfaction was high (90%). Conclusions: Spasticity is a complex and limiting symptom in MS. The structured interview conducted by specialist nurses is feasible and has good acceptance. Patient contribution Specialist nurses can be proactive in MS clinical assessment, which may help to detect symptoms with negative impact on quality of life. [ABSTRACT FROM AUTHOR]

Multiple sclerosis (MS) symptoms and unpredictability can damage patient well-being. This study is aimed to investigate the relation between sociodemographic and clinical characteristics and the use of coping strategies as well as social support on health-related quality of life (HRQOL). We evaluated 314 MS outpatients of Virgen Macarena University Hospital in Sevilla/Spain (mean age 45 years, 67.8% women) twice over an 18-months period by Brief COPE Questionnaire (COPE-28), Multidimensional Scale of Perceived Social Support (MSPSS) and 12-Item Short Form Health Survey (SF-12). Female gender was significantly related to religion (r= 0.175, p< 0.001), self-distraction (r= 0.160, p< 0.001) and self-blame (r= 0.131, p< 0.05). Age correlated positively with religion (r= 0.240, p< 0.001), and self-blame (r= 0.123, p< 0.05). Progressive MS as well as functional impairment (EDSS) showed a positive relation with denial (r= 0.125, p< 0.05; r= 0.150, p< 0.001). Longer duration since diagnosis was related to lower perceived support from family (r= −0.123, p< 0.05). EDSS (β= −0.452, p< 0.001) was the strongest negative predictor of physical HRQOL followed by age (β= −0.123, p< 0.001), whereas family support was a protective factor (β= 0.096, p< 0.001). Denial (β= −0.132, p< 0.05), self-blame (β= −0.156, p< 0.05), female gender (β= −0.115, p< 0.05) and EDSS (β= −0.108, p< 0.05) negatively impacted on mental HRQOL 18 months later, whereas positive reframing (β= 0.142, p< 0.05) was a protective factor. Our study could identify sociodemographic and clinical variables associated with dysfunctional coping strategies, such as self-blame and denial, which specifically predict worse mental HRQOL as opposed to positive reframing. Diminishing dysfunctional coping and supporting cognitive reframing may contribute to improve HRQOL in MS. [ABSTRACT FROM AUTHOR]

Background. The Multiple Sclerosis Intimacy and Sexuality Questionnaire-15 (MSISQ-15) is a valid and reliable tool to assess the sexuality of people with multiple sclerosis. The objectives of this study were: 1) to cross-culturally adapt and examine the psychometric properties of the MSISQ-15 in the Spanish context and 2) to examine the association between sexual dysfunction and other related factors. Methods. We conducted a instrumental study. People diagnosed with multiple sclerosis and members of multiple sclerosis associations in Spain were included. The linguistic adaptation of the questionnaire was performed through a translation-back translation procedure. For the psychometric validation, the confirmatory factor analysis was used while the internal consistency was examined by the ordinal alpha test. The construct validity was examined by correlating the results with the Male Sexual Function (FSH), Female Sexual Function-2 (FSM-2), Dyadic Adjustment Scale-13 (EAD-13) and Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) questionnaires. Results. A total of 208 participants were included. Both the fit of the Spanish version of the MSISQ-15 to the original scale and the internal consistency were adequate (α = 0:89). The construct validity showed correlations with the FSH, FSM-2, and MusiQoL but not with the EAD-13. Conclusions. The Spanish version of the MSISQ-15 is a valid and reliable tool to assess the sexuality of people with multiple sclerosis in the Spanish context. [ABSTRACT FROM AUTHOR]

Background: Alemtuzumab (ALZ) is a humanized monoclonal antibody approved for the treatment of patients with highly active relapsing-remitting multiple sclerosis (RRMS) administered in two annual courses. The objective of this study was to describe the effectiveness and safety data of ALZ and to report the health resource utilization in patients receiving this treatment. Methods: In this retrospective, non-interventional study, information was retrieved from patients' medical charts at one center in Spain. Included patients were =18 years old, and ALZ treatment was initiated between 1 March 2015 and 31 March 2019, according to routine clinical practice and local labeling. Results: Of 123 patients, 78% were women. Themean (standard deviation, SD) age of patients at diagnosis was 40.3 (9.1) years, and themean time since diagnosis was 13.8 (7.3) years. Patients were previously treated with amedian (interquartile range; IQR) number of two (2.0-3.0) disease-modifying treatments (DMTs). Patients were treated with ALZ for a mean (SD) of 29.7 (13.8) months. ALZ reduced the annualized relapse rate (ARR) (1.5 before vs. 0.05 after; p < 0.001) and improved themedian EDSS (4.63 before vs. 4.00 after; p < 0.001). Most (90.2%) patients were relapse-free while receiving ALZ. The mean number of gadolinium-enhancing [Gd+] T1 lesions was reduced (1.7 before vs. 0.1 after; p < 0.001), and the mean number of T2 hyperintense lesions was maintained (35.7 before vs. 35.4 after; p = 0.392). A total of 27 (21.9%) patients reported 29 autoimmune diseases: hyperthyroidism (12), hypothyroidism (11), idiopathic thrombocytopenic purpura (ITP) (3), alopecia areata (1), chronic urticaria (1), and vitiligo (1). Themean number of health resources (outpatient visits, emergency room visits, hospital admissions, and tests performed in the hospital) used while patients were treated with ALZ progressively decreased from year 1 to year 4, except for a slight increase at year 2 of outpatient visits. Conclusion: The ReaLMS study provides real-world evidence that ALZ can promote clinical and magnetic resonance imaging disease remission, as well as disability improvement in patients with MS, despite several prior DMT failures. The ALZ safety profile was consistent with data available from clinical trials and other real-world studies. Healthcare resource use was reduced throughout the treatment period. [ABSTRACT FROM AUTHOR]

Purpose: Adherence to disease-modifying therapies (DMTs) in multiple sclerosis (MS) is a complex and multidimensional phenomenon. Identifying the predictors of therapeutic adherence in MS will guide the design of interventions to improve health outcomes. Our aim was to assess the degree of adherence to pharmacological treatments, assess the relationship between patient-related factors and pharmacological adherence and to identify predictors of adherence to pharmacological treatments in patients with MS in Spain. Patients and Methods: A cross-sectional nationwide study was carried out in Spain between December 2020 and September 2021. The web-based evaluation protocol consisted of a self-questionnaire survey designed ad hoc and the application of validated questionnaires to assess adherence, as well as beliefs about medication and quality of life. Predictor variables of adherence to MS treatment were assessed using multivariate analysis. Results: A total of 152 patients with MS participated (mean age: 44 years; 64% were female; and 78% had relapsing-remitting MS). Seventy-three percent of the patients reported being adherent to their pharmacological treatment for MS. Forgetfulness was the most common cause of non-adherence. Necessity beliefs and concerns beliefs were not statistically associated with adherence. The adherent group shows statistically significant better levels of quality of life in the cognitive function subscale than the non-adherent participants (p=0.040). Role limitations-emotional, emotional well-being and overall quality of life were not significantly associated with adherence. Predictors with a statistical association with adherence to treatment were years of education (OR=0.79; 95% CI: 0.65– 0.96; p=0.020) and intravenous treatment (OR=3.17; 95% CI: 1.07– 9.45; p=0.038). Conclusion: We found an adequate adherence to pharmacological treatment. Low education and intravenous treatment were significant predictors of adherence to DMTs. [ABSTRACT FROM AUTHOR]

To evaluate the impact of early (at first-line) vs delayed (3-year delay) ofatumumab initiation and long-term clinical, societal, and economic outcomes of ofatumumab vs teriflunomide in relapsing multiple sclerosis (RMS) patients from a Spanish societal perspective. A cost-consequence analysis was conducted using an Expanded Disability Status Scale (EDSS)-based Markov model. Inputs were sourced from ASCLEPIOS I and II trials and published literature. At the end of 10 years, compared with first-line teriflunomide treatment, early first-line ofatumumab initiation was projected to result in 35.6% fewer patients progressing to EDSS ≥ 7 and 27.8% fewer relapses. The ofatumumab cohort required 7.3% reduced informal care time and had 19% fewer disability-adjusted life years (DALYs) than the teriflunomide cohort. A 3-year delay in ofatumumab treatment (3-year teriflunomide + 7-year ofatumumab) was projected to result in 32.2% more patients progressing to EDSS ≥ 7, 20.2% more relapses, 5.4% increased informal care time, and 16.6% more DALYs compared with early ofatumumab initiation. Early ofatumumab initiation was associated with total annual cost savings (excluding disease-modifying-therapies' acquisition costs) of €35,328 ($34,549; conversion factor 1€= $1.02255) and €24,373 ($23,836) per patient vs teriflunomide and 3-year delayed ofatumumab initiation, respectively. This study highlights the benefits of early initiation of high-efficacy therapy such as ofatumumab vs its delayed initiation for improving the outcomes in RMS patients (having characteristics similar to those of patients included in the ASCLEPIOS trials). Ofatumumab treatment was projected to provide improved long-term clinical, societal, and economic outcomes vs teriflunomide treatment in RMS patients from a Spanish societal perspective. The therapeutic benefits of ofatumumab in relapsing multiple sclerosis (RMS) patients have been reported in the ASCLEPIOS I and II trials. Using an Expanded Disability Status Scale-based Markov model, this study aimed to assess the impact of early (i.e. at first-line, as the first treatment after diagnosis) vs delayed (i.e. 3-year delay) ofatumumab initiation in RMS patients from a Spanish societal perspective. In addition, the long-term clinical, societal, and economic outcomes of ofatumumab vs teriflunomide treatment were assessed. Evidence from this study suggests that early initiation of a high-efficacy therapy such as ofatumumab, compared with its delayed initiation, is an effective and cost-saving strategy for improving outcomes in RMS patients. Furthermore, patients receiving ofatumumab for 10 years are projected to experience comparatively better outcomes (clinical, societal, and economic) than those receiving teriflunomide. [ABSTRACT FROM AUTHOR]

Cladribine is a disease-modifying selective immune reconstitution oral therapy for adult patients with highly active relapsing multiple sclerosis (RMS). It was approved in the USA in 2019 and in Europe in 2017, thus there are still gaps in existing guidelines for using cladribine tablets in clinical practice. Nine experts with extensive experience in managing patients with multiple sclerosis in Spain identified some of the unanswered questions related to the real-life use of cladribine tablets. They reviewed the available clinical trial data and real-world evidence, including their own experiences of using cladribine, over the course of three virtual meetings held between November 2020 and January 2021. This article gathers their practical recommendations to aid treatment decision-making and optimise the use of cladribine tablets in patients with RMS. The consensus recommendations cover the following areas: candidate patient profiles, switching strategies (to and from cladribine), managing response to cladribine and safety considerations. [ABSTRACT FROM AUTHOR]

In the context of the COVID-19 pandemic, the co-circulation of influenza and SARS-CoV-2 viruses may have severe complications for vulnerable populations. For this reason, the World Health Organization pointed to the 2020–2021 anti-influenza campaign as being of special relevance. Our aim was to assess the 2020–2021 influenza vaccination coverage, and its associated factors, among patients in a Spanish multiple sclerosis (MS) unit. A cross–sectional study was conducted. People attending the MS unit of the Clinical Hospital of Zaragoza during 2020 were included. Variables were obtained by reviewing records. Associations with 2020–2021 influenza vaccination were analyzed using bivariate analysis and a multiple logistic regression model. A total of 302 patients were studied; 62.6% were women, whose mean age (standard deviation) was 47.3 (11.5) years. The 2020–2021 influenza vaccination coverage was 55.3% (59.8% in women and 47.8% in men). A total of 89.7% had at least one other indication for vaccination (e.g., immunosuppressive treatment in 225 patients). The variables associated with getting vaccinated were being female (adjusted odds ratio (95% confidence interval) (aOR (95%CI) = 2.12 (1.12–3.99)), having received the 2019–2020 influenza vaccine (aOR (95%CI) = 31.82 (14.71–68.86)) and being born in Spain (aOR (95%CI) = 12.91 (1.07–156.28)). Coverage is moderate compared to other countries. It is necessary to develop strategies to improve it, especially in men and those born outside Spain. [ABSTRACT FROM AUTHOR]

To examine the acute and chronic effects of 10-weeks of progressive resistance training on sleep quality and sleeping heart rate variability in persons with Multiple Sclerosis (pwMS). Eighteen pwMS (age = 44.8 ± 10.6 years; EDSS = 3.1 ± 1.7) completed a 10-week of resistance training, with three training sessions per week. Each session consisted of 4 lower body exercises, performing 2–4 sets of each exercise, with 8–15 repetitions each set, at an intensity ranging from 60 to 75% of 1-repetition maximum. Subjective and actigraphic sleep quality and sleeping heart rate variability were carried out at 4 different times: (1) Before the starting of the intervention on a rest day; (2) the night after training week 1 (3) the night after training week 10 and 4) after completing the resistance training program on a rest day. Regarding subjective sleep quality, significant main effects were observed on the variables of sleep quality, sleep comfort, easy of falling sleep, easy of waking up and felling of rest. Sleep quality, sleep comfort and easy of falling sleep were greater in rest night in week 1 vs. rest night in week 10. Actigraphic sleep quality also improved after the training program (rest night in week 1 vs. rest night in week 10). In the pair-wise comparison showed an acute effect in the session after the training program (rest night in week 10< training night in week 10) on HF, pNN50 and RMMSD. Resistance training is a non-pharmacological treatment that has the capacity to improve the regulation of autonomic system and, consequently, the sleep quality in pwMS. 10 Weeks of resistance training improves the sleep quality of persons with multiple sclerosis. Resistance training can modulate autonomic cardiac control in this population. Improving the sleep quality is essential for persons with MS because of its close relationship to other variables, such as symptomatic fatigue. [ABSTRACT FROM AUTHOR]

Introduction: Greater understanding of the prevalence and incidence of multiple sclerosis in Spain and their temporal trends is necessary to improve the allocation of healthcare resources and to study aetiological factors., Methods: We performed a systematic search of the MedLine database and reviewed the reference lists of the articles gathered. We collected studies reporting prevalence or incidence rates of multiple sclerosis in any geographical location in Spain, with no time limits. In 70% of cases, data were extracted by 2 researchers (FGL and EAC); any discrepancies were resolved by consensus., Results: We identified 51 prevalence and 33 incidence studies published between 1968 and 2018. In the adjusted analysis, the number of prevalent cases per 100 000 population increased by 26.6 (95% confidence interval [CI], 21.5-31.8) every 10 years. After adjusting for year and latitude, the number of incident cases per 100 000 population increased by 1.34 (95% CI, 0.98-1.69) every 10 years. We observed a trend toward higher prevalence and incidence rates at higher latitudes., Conclusions: The prevalence of multiple sclerosis in Spain has increased in recent decades, although case ascertainment appears to be incomplete in many studies. Incidence rates have also increased, but this may be due to recent improvements in the detection of new cases., (Copyright © 2022 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Women have a higher risk of developing multiple sclerosis (MS) than men. The natural reproductive period from menarche to menopause corresponds to the period of active inflammatory disease in MS. Mothers and pregnant women with MS need information about how their disease may affect pregnancy and breastfeeding., Aim: The aim was to explore the reproductive factors in an MS-diagnosed population and to identify ways to support patients and their decision-making process., Methods: We conducted a cross-sectional, Web-based survey of women living with MS in Asturias (Spain) using a community-based participatory approach., Findings: Early menarche may predict the onset of MS. Pregnancy improves the general health of patients and reduces the number of relapses. Breastfeeding is often not practised and may cause concern in women. MS does not affect the age of menopause, but it can worsen symptoms. However, menopause does not increase the number of MS relapses., Conclusions: MS is increasingly diagnosed at an earlier age, which increases the number of women who become pregnant after being diagnosed with MS. The decrease in MS relapses during pregnancy and the increase during the postpartum period are consistent with previous reports. Women who choose to breastfeed are in the minority due to treatment incompatibility, although some currently used treatments are compatible with breastfeeding. However, there is a lack of information on this which should be investigated., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: To evaluate the safety of COVID-19 vaccines in patients with multiple sclerosis (MS) by assessing their impact on serum neurofilament light chain (sNfL) levels as a marker of neuroaxonal damage., Methods: Single-center observational longitudinal study including patients with MS who consecutively received their initial vaccination against SARS-CoV-2 at Hospital Universitario Ramón y Cajal, following the first national immunization program in Spain. Serum samples were collected at baseline and after receiving the second dose of the vaccine. sNfL levels were quantified using the single molecule array (SIMOA) technique. Adverse events, including clinical or radiological reactivation of the disease, were recorded., Results: Fifty-two patients were included (median age, 39.7 years [range, 22.5-63.3]; 71.2% female). After SARS-CoV-2 vaccination, no increased inflammatory activity, either determined by the presence of relapses and/or new MRI lesions and/or high sNfL levels, was detected. Accordingly, there was no difference between median sNfL levels before and after vaccination (5.39 vs. 5.76 pg/ml, p=0.6). Despite this, when looking at baseline patient characteristics before vaccination, younger age associated with disease activity after vaccination (OR 0.87, 95% CI: 0.77-0.98, p=0.022). Larger studies are needed to validate these results., Conclusion: COVID-19 vaccines did not cause reactivation of disease at a clinical, radiological or molecular level, thus suggesting that they are safe in MS patients., Competing Interests: SS received research grants, travel support or honoraria for speaking engagements from Almirall, Biogen, Bristol Myers Squibb, Janssen, Merck, Novartis, Roche, Sanofi-Genzyme, and Teva. EM received research grants, travel support or honoraria for speaking engagements from Almirall, Biogen, Janssen, Merck, Novartis, Roche, and Sanofi-Genzyme. JC-G has received honorary for speaking engagements or consulting services from Biogen, Bayer, Bial, Bristol-Myers, Johnson&Johnson and Sanofi-Genzyme. FR-J has received honorary for speaking engagements or consulting services from Bial, Biogen, Johnson&Johnson and Sanofi-Genzyme. RS-A has received honorary for speaking engagements from Johnson&Johnson. LC-F received speaker fees, travel support, and/or served on advisory boards by Almirall, Bayer, Biogen, Biopas, Bristol Myers Squibb, Celgene, Ipsen, Janssen, Merck, Novartis, Roche, Sanofi and Teva. LV received research grants, travel support or honoraria for speaking engagements from Biogen, Bristol Myers Squibb, Merck, Novartis, Roche and Sanofi-Genzyme. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Sainz de la Maza, Rodero-Romero, Monreal, Chico-García, Villarrubia, Rodríguez-Jorge, Fernández-Velasco, Sainz-Amo, Costa-Frossard, Masjuan and Villar.)

Patients with multiple sclerosis (MS) with respiratory muscle weakness could have physical function impairments, given the functional/biomechanical link of the trunk stabilising system. Thus, clinicians could employ new treatment strategies targeting respiratory muscles to improve their physical function. This study pretends to evaluate the relationship between respiratory muscle strength, pulmonary function and pelvic floor function, and also to correlate these variables with physical function (gait function, disability and quality of life) in patients with MS. 41 patients participated in this descriptive cross-sectional study. Respiratory muscle strength [maximal respiratory pressures (MIP/MEP)], pulmonary function (forced spirometry), pelvic floor function [urinary incontinence (UI)], physical function [Timed Up & Go (TUG) test, Barthel index and health status questionnaire (SF-12)] were evaluated. Respiratory muscle strength and pulmonary function were moderately related to UI (MIP: rho = −0.312; MEP: rho = −0.559). MEP was moderately related to physical function (TUG: rho = −0.508; Barthel index: rho = 0.418). Patients with and without expiratory muscle weakness showed differences in UI, pulmonary and physical function. Patients with MS with greater deterioration in pulmonary function and respiratory muscle strength, especially expiratory muscles, showed greater deterioration in UI and physical function. Expiratory muscle weakness had a negative impact on urinary, physical and pulmonary function. Pulmonary function is associated with urinary incontinence and gait functionality in patients with multiple sclerosis (MS). Expiratory muscle weakness is associated with impaired urinary and physical function in patients with MS. The inclusion of respiratory muscle training to the rehabilitation programs of patients with MS could improve their pelvic floor disorders and physical function. [ABSTRACT FROM AUTHOR]

Our objective was to determine the influenza vaccination rate in a Spanish cohort of multiple sclerosis (MS) patients. A retrospective cohort study was carried out. Patients who attended the MS unit of the Lozano Blesa Hospital of Zaragoza between January 2015 and 2020 were included. The variables were obtained by reviewing the specialized and primary care records. Associations between receiving the vaccine in each flu season and the other variables were analyzed using bivariate analysis and multiple logistic regression models. A total of 260 patients were studied, with a median age of 31 years at the time of diagnosis. A total of 62.3% (162/260) were women. Vaccination coverage ranged from 20.4% in the 2015–2016 and 2016–2017 seasons to 41.5% in the 2019–2020 season (p = 0.000). Having been vaccinated in the previous season (ORa: 16.47–390.22; p = 0.000) and receiving a vaccination recommendation from the hospital vaccination unit (ORa: 2.44–3.96; p < 0.009) were associated with being vaccinated. The coverage is in an intermediate position compared to other countries. It is necessary to improve the referral system of these patients to the hospital vaccination unit because the information obtained by this service contributed to higher vaccination rates. [ABSTRACT FROM AUTHOR]

Compulsory home confinement due to COVID-19 pandemic has had an influence on the physical and emotional health. Nevertheless, it has been more prevalent in women and in people with chronic illness such as multiple sclerosis, so the aim of this study was to know the experience of women with multiple sclerosis during the home confinement period in Spain. Seven women aged over 18 years, with a definitive diagnosis of multiple sclerosis and who belonged to multiple sclerosis associations completed semi-structured interviews. Two main themes and multiple subthemes were identified. The first them was "living with multiple sclerosis during home confinement" which included the physical and emotional impact, confinement coping ability and time for reflection. The second theme was "the environment during confinement" and it included solidarity and support, family cooperation, importance of peer contact and adjustments in the health environment during the pandemic. The period of compulsory home confinement in Spain did not worsen the physical and emotional symptoms of these women. This might be related to the increased support they had received as well as the continuity of their rehabilitation activities at home. Regarding changes in health system, the participants referred the necessity to return to face-to-face visits. [ABSTRACT FROM AUTHOR]

Background and purpose: Limited information is available on incidence and outcomes of COVID‐19 in patients with multiple sclerosis (MS). This study investigated the risks of SARS‐CoV‐2 infection and COVID‐19‐related outcomes in patients with MS, and compared these with the general population. Methods: A regional registry was created to collect data on incidence, hospitalization rates, intensive care unit admission, and death in patients with MS and COVID‐19. National government outcomes and seroprevalence data were used for comparison. The study was conducted at 14 specialist MS treatment centers in Madrid, Spain, between February and May 2020. Results: Two‐hundred nineteen patients were included in the registry, 51 of whom were hospitalized with COVID‐19. The mean age ± standard deviation was 45.3 ± 12.4 years, and the mean duration of MS was 11.9 ± 8.9 years. The infection incidence rate was lower in patients with MS than the general population (adjusted incidence rate ratio = 0.78, 95% confidence interval [CI] = 0.70–0.80), but hospitalization rates were higher (relative risk = 5.03, 95% CI = 3.76–6.62). Disease severity was generally low, with only one admission to an intensive care unit and five deaths. Males with MS had higher incidence rates and risk of hospitalization than females. No association was found between the use of any disease‐modifying treatment and hospitalization risk. Conclusions: Patients with MS do not appear to have greater risks of SARS‐CoV‐2 infection or severe COVID‐19 outcomes compared with the general population. The decision to start or continue disease‐modifying treatment should be based on a careful risk–benefit assessment. [ABSTRACT FROM AUTHOR]

Introduction: LEMVIDA is a real-world prospective study of 3-year follow-up on quality of life of patients with multiple sclerosis (MS) receiving alemtuzumab in Spain., Methods: This is an interim analysis evaluating the baseline characteristics of patients who started alemtuzumab between October 2016-September 2018. For 3 additional subanalysis patients were categorised by baseline EDSS score; time of alemtuzumab initiation during the recruitment period (cohort 1: October 2016-March 2017, cohort 2: April-September 2017, cohort 3: October 2017-March 2018 and cohort 4: April-September 2018); and the presence of highly active MS criteria., Results: 161 patients were analysed: 67.1% female, age 38.7 ± 9.4 years, MS duration 8.5 ± 6.0 years, EDSS 3.3 ± 1.7 and number of relapses in the previous 2 years 1.8 ± 1.3. 48.3% of patients presented gadolinium-enhanced (Gd+) lesions (mean: 5.2 ± 6.9) and 63.1% had received prior treatment with fingolimod or natalizumab. Baseline EDSS scores and number of Gd+ lesions were higher in cohort 1 than in cohort 4 (4.1 ± 1.8 vs 3.2 ± 1.7; P = .040 and 10.9 ± 11.9 vs 4.5 ± 5.7; P = .020). The frequency of prior treatment with fingolimod and natalizumab was lower in cohort 4 (60.6%) than in cohort 1 (70.6%) (comparison between groups not analysed)., Conclusions: Unlike phase 3 studies of alemtuzumab, the patients included in LEMVIDA are older, have a longer duration of MS, higher disability and have received previous immunosuppressants. However, throughout the recruitment period, there is a tendency towards an early beginning of treatment with alemtuzumab, probably due to the evidence of higher effectiveness in the early stages of MS., (Copyright © 2023. Published by Elsevier España, S.L.U.)

Introduction: We have different treatment alternatives for relapsing-remitting multiple sclerosis–RRMS–within the so-called platform drugs. It would be desirable to know the ideal drug for each patient. Real clinical practice studies provide us with data on drug efficacy in the medium and long term, safety beyond clinical trials, and can help us to know the patient profile appropriate for each therapy. Material and Methods: An observational multicenter study of real clinical practice in patients with RRMS who were treated with teriflunomide in the Valencian Community, since teriflunomide was authorized in Spain. The database created for this study collects retrospectively patients followed prospectively in the MS clinics. Objectives: To analyze the efficacy and safety of teriflunomide treatment in patients with RRMS under the conditions of real clinical practice, and to identify a patient profile responding to the treatment. Results: We obtained data from 340 patients who received at least one dose of 14 mg teriflunomide. The patients were 69.4% female to 30.6% male, had a mean age of 46.4 years, and a mean time of progression of MS of 11.5 years. The mean pre-teriflunomide relapse rate was 0.4 years, the mean EDSS scorewas 1.98, IgG Oligoclonal bands were present in the CSF of 66.2% of the patients, IgM Oligoclonal bands were present in 46.9%, and the mean number of gadolinium-enhancing lesions was 1.07 lesions per patient at the beginning of treatment. The average number of treatments previously received was 1.04, and 28.53% were naïve. After a follow-up of up to 4 years, a reduction in the annualized and cumulative annualized relapse rate was observed in the first year, in the second year, and in the third year, compared to the pre-treatment year. The EDSS scores were stabilized throughout the follow-up. Likewise, there was a reduction in gadolinium-enhancing lesions in the 1st and 2nd years compared to the pre-treatment period. Applying different generalized multiple linear regression models, we identified a profile of a responding patient to teriflunomide as a male without IgM oligoclonal bands in the CSF, a previous EDSS score of <3, and more than 5 years duration of MS. [ABSTRACT FROM AUTHOR]

Background. People with multiple sclerosis (MS) suffer from symptoms related to neural control, such as reduced central activation, lower muscle activity, and accentuated spasticity. A forced 9-week home confinement related to COVID-19 in Spain may have worsened these symptoms. However, no study has demonstrated the impact of home confinement on neuromuscular mechanisms in the MS population. This study was aimed at analyzing the effects of a 9-week home confinement on central activation, muscle activity, contractile function, and spasticity in MS patients. Methods. Eighteen participants were enrolled in the study. Left and right knee extensor maximum voluntary isometric contraction (MVIC), maximal neural drive via peak surface electromyography (EMG) of the vastus lateralis, central activation ratio (CAR), and muscle contractile function via electrical stimulation of the knee extensor muscles, as well as spasticity using the pendulum test, were measured immediately before and after home confinement. Results. Seventeen participants completed the study. CAR significantly decreased after lockdown (ES = 1.271 , p < 0.001). Regarding spasticity, there was a trend to decrease in the number of oscillations (ES = 0.511 , p = 0.059) and a significant decrease in the duration of oscillations (ES = 0.568 , p = 0.038). Furthermore, in the left leg, there was a significant decrease in the first swing excursion (ES = 0.612 , p = 0.027) and in the relaxation index (ES = 0.992 , p = 0.001). Muscle contractile properties, MVIC, and EMG variables were not modified after confinement. Conclusions. The results suggest that a home confinement period of 9 weeks may lead to an increase in lower limb spasticity and a greater deficit in voluntary activation of the knee extensors. [ABSTRACT FROM AUTHOR]

Objective: To describe the profile of patients with multiple sclerosis (MS) treated with fingolimod in Spain and to assess the effectiveness and safety of fingolimod after 4 years of inclusion in the Spanish Gilenya Registry. Methods: An observational, retrospective/prospective, multicenter case registry, including all patients with relapsing-remitting MS (RRMS) starting treatment with fingolimod in 43 centers in Spain. Analyses were performed in the overall population and in subgroups according to prior disease-modifying therapy (DMT): glatiramer acetate/interferon beta-1 (BRACE), natalizumab, other treatment, or naïve. Results: Six hundred and sixty-six evaluable patients were included (91.1% previously treated with at least one DMT). The mean annualized relapse rate (ARR) prior to fingolimod was 1.12, and the mean EDSS at fingolimod initiation was 3.03. Fingolimod reduced the ARR by 71.4%, 75%, 75.5%, and 80.3%, after 1, 2, 3 and 4 years, respectively (p<0.001). This significant reduction in the ARR continued to be observed in all subgroups. After 4 years, the EDSS showed a minimal deterioration, with the EDSS scores from year 1 to year 4 remaining mostly stable. The percentage of patients without T1 Gd+ lesions progressively increased from 45.6% during the year prior to fingolimod initiation to 88.2% at year 4. The proportion of patients free from new/enlarged T2 lesions after 4 years of fingolimod treatment was 80.3%. This trend in both radiological measures was also observed in the subgroups. Adverse events (AEs) were experienced by up to 41.6% of patients (most commonly: lymphopenia [12.5%] and urinary tract infection [3.7%]). Most AEs were mild in severity, 3.6% of patients had serious AEs. Conclusions: The patient profile was similar to other observational studies. The results obtained from the long-term use of fingolimod showed that it was effective, regardless of prior DMT, and it had adequate safety results, with a positive benefit-risk balance. [ABSTRACT FROM AUTHOR]

Background. Multiple sclerosis is a disorder which causes a loss of functionality, affecting the person's ability to perform activities of daily living, such as interpersonal interactions and relationship, dressing, self-care, or bathing, as well as having a negative impact on work and leisure activities. Aims. This study examined the relationship (correlational or associations/predictive) between self-perceived quality of life and performance of manipulative dexterity. Also, this study sought to measure predictors of dexterity. Study Design. A cross-sectional study from two associations of MS within the Community of Madrid, Spain. Methods and Procedures. A final sample of 30 people with multiple sclerosis. The outcome measures used were the ABILHAND questionnaire, the Purdue Pegboard Test, the Nine Hole Peg Test, and the Box and Block Test. Results. No significant correlations were found between dexterity and self-perception tests; however, correlations were found between perceived dexterity and quality of life (p < 0.001). Scores for the ABILHAND questionnaire, which measures the perception of skills in daily living, predicted up to 60% of the variance in the dexterity tests. Conclusions. The results of this study suggest that interventions for improving the manipulative dexterity of people with multiple sclerosis should address the person's perception of improving their manipulative dexterity and the perceived of quality of life, as both factors may influence manipulative dexterity. [ABSTRACT FROM AUTHOR]

Objective: Pivotal trial have shown that patients with multiple sclerosis (MS) receiving ocrelizumab had better outcomes. However, data on ocrelizumab in clinical practice are limited. The aim of this study was to evaluate the preliminary safety profile and effectiveness of ocrelizumab treatment for multiple sclerosis (MS) in a real‐world clinical setting. Methods: We conducted a retrospective study including consecutive patients from nine public hospitals in south‐eastern Spain who received ocrelizumab after it was approved. Results: A total of 228 MS patients were included (144 with relapsing–remitting MS [RRMS], 25 secondary progressive MS [SPMS], and 59 primary progressive MS [PPMS]). Median follow‐up period was 12 months (range, 1‐32). No evidence of disease activity (NEDA) status at year 1 was achieved in 91.2% of the relapsing MS (RMS) population, while disability progression was detected in 37.5% of the PPMS patients (median follow‐up period, 19 months). The most common adverse events reported were infusion‐related reactions and infections, with the most common infections being urinary tract infections followed by upper respiratory infections and COVID‐19. Interpretation: The preliminary results in our real‐world setting show that ocrelizumab presented excellent results in suppressing disease activity with a favorable and consistent safety profile. [ABSTRACT FROM AUTHOR]

It has been suggested that some individuals may present genetic susceptibility to SARS‐CoV‐2 infection, with particular research interest in variants of the ACE2 and TMPRSS2 genes, involved in viral penetration into cells, in different populations and geographic regions, although insufficient information is currently available. This study addresses the apparently reasonable hypothesis that variants of these genes may modulate viral infectivity, making some individuals more vulnerable than others. Through whole‐exome sequencing, the frequency of exonic variants of the ACE2, TMPRSS2, and Furin genes was analyzed in relation to presence or absence of SARS‐CoV‐2 infection in a familial multiple sclerosis cohort including 120 individuals from Madrid. The ACE2 gene showed a low level of polymorphism, and none variant was significantly associated with SARS‐CoV‐2 infection. These variants have previously been detected in Italy. While TMPRSS2 is highly polymorphic, the variants found do not coincide with those described in other studies, with the exception of rs75603675, which may be associated with SARS‐CoV‐2 infection. The synonymous variants rs61735792 and rs61735794 showed a significant association with infection. Despite the limited number of patients with SARS‐CoV‐2 infection, some variants, especially in TMPRSS2, may be associated with COVID‐19. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to describe the tolerability, safety, and effectiveness of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting. Methods: In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. Patients involved in any ocrelizumab trial and those patients with a follow-up shorter than 6 months were excluded. Results: The cohort included 70 patients (42 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients' mean age was 47.1 years in the PPMS group and 39.2 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 13.6 months. The median number of treatment cycles was three. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 57% of the patients; by the first MRI control at 4–6 months, all patients except one were free of T1 Gd-enhancing lesions (69/70, 98.6% P < 0.001). The proportion of patients with NEDA was 94% in the group of RMS patients who were followed for at least 1 year. Ocrelizumab was generally well-tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious. Conclusions: Our real-world study supports the tolerability, safety, and effectiveness of ocrelizumab in clinical practice. [ABSTRACT FROM AUTHOR]

Background: Dimethyl fumarate (DMF) has demonstrated efficacy in phase III studies. However, real-world data are still limited. Objective: The objective of this study was to describe the profile of patients who receive DMF and to assess the effectiveness of DMF regarding relapses, disability progression, magnetic resonance imaging activity, and NEDA (No Evidence Disease Activity)-3 status in a Spanish population in a real-world setting. Methods: We conducted a multicenter prospective study of patients who started DMF between 2014 and 2019 in Spain. Three subgroups were considered: naïve, switch to DMF because of inefficacy, and switch to DMF because of adverse effects. The effects of DMF on clinical and radiological measures were evaluated. Results: Among 886 patients, 25.3% were naïve, 28.8% switched because of adverse effects, and 45.9% because of inefficacy. Median follow-up was 38.9 (interquartile range 22.6–41.8) months. Annualized relapse rates were 0.15, 0.10, and 0.10 at 12, 24, and 36 months respectively, and 77.7% of patients were relapse free at month 42. At 12, 24, and 42 months, 96.1%, 87.4%, and 79.7% of patients were progression free, respectively. The number of T1 gadolinium-enhancement (T1Gd+) lesions was 0.19, 0.14, and 0.18 at 12, 24, and 36 months. NEDA-3 status at month 42 was maintained by 49.8% of patients. Relapsing was associated with higher annualized relapse rates the year before (hazard ratio 1.34, p < 0.001) and to the inefficacy switch vs naïve group (hazard ratio 1.76, p = 0.003). A higher baseline Expanded Disability Status Scale score was associated with disability progression (hazard ratio 1.15, p = 0.003) and more T1Gd+ lesions (hazard ratio 1.07, p < 0.001) with radiological progression. A higher baseline Expanded Disability Status Scale score, a larger number of T1Gd+ lesions, and a switch because of inefficacy (vs adverse events) were all risk factors for losing NEDA-3 status. DMF was discontinued in 29.9% of patients, in 13.5% because of inefficacy. Conclusions: Our findings confirm the sustained effectiveness of DMF on the clinical and radiological activity of multiple sclerosis in a real-world setting, both in naïve patients and in those switching from other multiple sclerosis therapies. [ABSTRACT FROM AUTHOR]

Background: Disease-modifying therapies for multiple sclerosis have been developed tremendously over the last two decades. Objective: The aim of this study was to review the short-, medium-, and long-term safety of alemtuzumab in relapsing remitting multiple sclerosis (RRMS). Method: This retrospective observational study (2015–2019) included all patients with highly active or rapidly progressing and aggressive RRMS who were treated with alemtuzumab at the Cabueñes University Hospital. The short-, medium-, and long-term adverse effects were evaluated following the risk management program of the European Medicines Agency. Results: 39 patients were included, 23 of them received at least two cycles of treatment. Most patients showed at least one adverse event. The following adverse reactions were reported: infusional reactions (17), urinary tract infections (six), thrombopenia (five), and thyroid dysfunction (six). Conclusion: In clinical practice alemtuzumab showed an acceptable safety profile in selected patients even if all of them suffered at least one adverse effect. Thorough and prolonged follow-up is required to further confirm the safety of this drug. [ABSTRACT FROM AUTHOR]

The purpose of this research is to study the specific activity of our developed nasal dosage form with n-phenylacetyl-lprolylglycine ethyl ester. The experiments were performed on 260 white outbred rats weighing 190-220 g. Experimental allergic encephalomyelitis (EAE) was induced by a single subcutaneous inoculation of an encephalitogenic mixture (EHM) in Complete Freund's Adjuvant (CFA) based on 100 mg of homologous spinal cord homogenate; 0.2 ml of CFA (the content of killed mycobacteria 5 mg/ml) and 0.2 ml of physiological saline per animal. There were five groups of animals in the study: 1) intact; 2) control - untreated with EAE, received saline solution; 3) animals with EAE that received basic treatment - methylprednisolone (MP), 3.4 mg/kg, intraperitoneally slowly in saline no more than 1/10 of the CBV rat; 4) animals with EAE treated with MP + Noopept, at a dose of 10 mg/kg; 5) animals with EAE treated with MP + Citicoline (Ceraxon, Ferrer Internacional S.A., Spain) D003U1 series, 500 mg/kg, intragastrically. The integrative functions of rats’ brain with EAE were studied using the “Open Field” method with an arena of own production with dimensions 80x80x35 cm. The study of memory was carried out using the radial labyrinth LE760 (AgnTho's, Sweden). Capture and image recording was carried out using a color video camera SSC-DC378P (Sony, Japan). Video file analysis was performed using Smartv 3.0 software (Harvard Apparatus, USA). As a result of the studies on experimental model of multiple sclerosis with a nasal gel containing ethyl ester of n-phenylacetyl-l-prolylglycine revealed the presence of normotimic activity, antidepressant and anxiolytic effects, an increase in the total activity of the central nervous system. The results obtained indicate a high neuroprotective and nootropic activity of the Noopept intranasal gel. By the degree of influence on reducing the number of errors in working memory, the Noopept gel significantly exceeds monotherapy with methylprednisolone and combination therapy with methylprednisolone and citicoline. A further study of the effect of the developed nasal gel on the morphofunctional indices of sensorimotor cortical neurons under experimental multiple sclerosis, as well as on the content of HSP70 in the animal brain, is promising. [ABSTRACT FROM AUTHOR]

Objectives: To analyze the frequency and demographic characteristics of multiple sclerosis (MS) in the Council of Santiago de Compostela (SPAIN). Material and methods: The patients diagnosed with MS according to the McDonald 2010 diagnostic criteria were identified within the population of the District of Santiago de Compostela. Several sources were used (records and databases from Hospital, General Practitioners, Private Clinics, and the MS Patients Association). Demographic and clinical data were obtained from the electronic files. Results: The incidence of MS between 2010 and 2015 was 8/100 000/year (95% CI: 6‐10), and the prevalence on December 31, 2015, was 152/100 000 (95% CI: 127‐176). The age‐standardized prevalence (using the European Standard Population 2013) was 137 (95% CI: 114‐159) and the incidence of 7 (95% CI: 2‐12). The female:male ratio was 1.84, the mean age at the first symptom was 32.23 years, the diagnosis was delayed 3.12 years, and the mean EDSS was 2.82. 71.17% had relapsing‐remitting MS, 16.55% secondary progressive MS, 7.59% primary progressive MS, and 0.69% progressive relapsing MS. A disease‐modifying treatment was established in 62.76% of patients in a mean of 1.96 years after the diagnosis. Conclusions: The northwest of Spain is a high‐risk area for MS, with frequencies similar to other Atlantic regions and higher than the rest of the country. [ABSTRACT FROM AUTHOR]

Background: Dimethyl fumarate (DMF) tolerability and safety in multiple sclerosis (MS) has been analyzed in randomized clinical trials. Real-life studies are needed to assess possible harms of this therapy in a wider MS population. Objective: To evaluate DMF tolerability, safety and persistence in MS in a real-world setting. Methods: We conducted a multicenter prospective study of patients who started DMF, attended in 16 public hospitals of Spain. A specific database was elaborated to collect data on most frequent adverse events (AE). Regression models were used to analyze the effect of demographic and clinical characteristics on risk of AEs and DMF discontinuation. Results: We collected data of 886 patients (2681 patients/years-exposition) with median 39.5 (IQR 23, 51.5) months on DMF exposure; 25.3% were treatment naïve and 74.7% switched to DMF from other disease-modifying therapies. DMF was discontinued in 29.9% of patients, in 13.2% due to AEs and in 13.5% to inefficacy. AEs were experienced by 71.2%, being flushing the most frequent (44.1%), 5.4% developed grade III lymphopenia, without cases of grade IV. Females showed a higher risk of flushing and gastroenteric symptoms (OR 1.49, p = 0.011; OR 1.69, p = 0.001, respectively); lymphopenia was associated with older age (OR 1.04, p < 0.001), and a higher EDSS with lymphopenia (OR 1.10, p = 0.035) and DMF withdrawal (HR 1.43, p = 0.012). No safety problems were reported. Conclusions: Our findings confirm good tolerability and safety of DMF in real-world setting and suggest that women have an increased risk of AEs and higher baseline disability involves greater risk of drug discontinuation. [ABSTRACT FROM AUTHOR]

Background: The vsMS survey was conducted to better understand the negative effects of fatigue, cognitive impairment, emotional burden, and decreased physical functioning on the personal, professional, and social lives of individuals with multiple sclerosis (MS). Methods: The vsMS survey was an online survey conducted in Australia, Canada, France, Italy, Spain, the United Kingdom, and the United States that assessed the impact of MS on individuals' daily activities, emotional well-being, relationships, and employment. Results: The survey included 1075 participants with relapsing-remitting MS. Almost 42% of participants reported that their ability to perform and manage daily activities had worsened during the previous 2 years. More than 50% reported limitations in daily activities due to fatigue, physical weakness, problems with balance/coordination, heat/cold sensitivity, memory problems, numbness/tingling, trouble concentrating, impaired movement/muscle stiffness, and impaired sleeping. Participants also reported a negative effect on emotional and social factors, including self-esteem, general outlook, well-being, maintaining/ starting relationships, ability to progress in their career/keep their job, and ability to cope with life roles. Conclusions: These data highlight the importance of addressing the impact of MS and the social and emotional disease burdens on daily activities when planning the care of patients with MS. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost-effectiveness of Cladribine Tablets in the treatment of relapsing multiple sclerosis (RMS) with high disease activity compared with fingolimod, from the perspective of the National Health System (NHS) in Spain.Methods: A Markov model was developed. The annual transition probabilities, were adjusted to patients with RMS with high disease activity. The effect of the treatments compared on the Expanded Disability Status Scale (EDSS) was modeled by hazard ratios for the confirmed progression of disability. The annual relapse rate and the probability of suffering adverse reactions were obtained from a meta-analysis and the literature. The derived costs were calculated from Spanish unit costs. The utilities were obtained from the CLARITY clinical trial and the literature. Deterministic and probabilistic sensitivity analyzes were performed.Results: Cladribine tablets was the dominant treatment: lower costs (-86,536 €) and more effective (+1.11 quality-adjusted life years - QALYs) compared to fingolimod. The probability that Cladribine Tablets was cost-effective compared to fingolimod ranged between 94.6% and 96.1% for willingness to pay from € 20,000 to € 30,000 per QALY gained.Conclusions: Cladribine Tablets is a cost-effective treatment, compared to fingolimod, for the treatment of RMS with high disease activity.Expert Opinion: According to the present study, compared to fingolimod, treatment with Cladribine Tablets of relapsing multiple sclerosis with high disease activity is an option that could generate savings for the Spanish National Health System, with a considerable gain in QALYs. Cladribine Tablets is considered cost-effective and dominant (less costs and more effectiveness) than fingolimod treatment option in this population. [ABSTRACT FROM AUTHOR]

Background. Manipulative dexterity impairments affect 76% of individuals with multiple sclerosis (MS). Patients with MS can experience reduced skill when performing both basic activities of daily living and instrumental activities of daily living. Many studies consider that physical rehabilitation leads to a decrease in the level of disability, especially at the mild and moderate stages of the disease. However, most studies fail to distinguish between the different MS subtypes. Purpose. Our aims were (1) to describe the manipulative skills of people according to the different subtypes of MS, (2) to analyze the correlation between dexterity and self-perception variables, and (3) to identify possible predictors of functionality. Study Design. A descriptive cross-sectional study. Methods. 30 individuals with MS. The measurement tools used were the ABILHAND, the Purdue Pegboard Test (PPT), the Nine-Hole Peg Test, and the Box and Block Test. Results. All subtypes of MS obtained lower scores for manipulative dexterity compared to normal skill levels, with individuals with primary progressive MS displaying the lowest values. However, the analysis of differences between the different subtypes did not reveal statistically significant intragroup differences. In addition, differences were found regarding the effect size of practically all the variables analyzed for both manipulative dexterity (PPT, NHPT, and BBT) and the self-perception of ADLs (ABILHAND), for which high values ( d r = 0.72) and very high values ( d r = 1.46) were obtained. Conclusions. Although no significant differences were found between the different types of MS, the assessment of manual dexterity and perceived efficacy of daily activities must be considered as prognostic factors in the progression of the disease. These findings may help support further research on targeted interventions to improve dexterity deficiencies, as well as promote an improved quality of therapeutic interventions. [ABSTRACT FROM AUTHOR]

Purpose: The objective of this study was to characterize the demographic and clinical profile of RRMS patients receiving fingolimod in Spain, and to evaluate drug effectiveness and safety in clinical practice. Methods: This observational, retrospective, multicentre, nationwide study was performed at 56 Spanish hospitals and involved 804 RRMS patients who received oral fingolimod (0.5 mg) since November 2011, with a minimum follow-up of 12 months. Results: The mean annualized relapse rate (ARR) in the year before fingolimod was 1.08 and the median EDSS was 3; patients were exposed to fingolimod for 2.2 years as average; regarding magnetic resonance imaging (MRI) activity, more than half of the patients had >20 lesions at baseline. Patients were previously treated with first-line injectable DMTs (60.3%), or natalizumab (31.3%), and 8.3% were naïve patients. Overall, the ARR significantly decreased to 0.28, 0.22 and 0.17 (74.1%, 79.7% and 83.5% of relative reduction, respectively) after 12, 24 and 36 months of treatment, P<0.001. The ARR of patients who switched from natalizumab to fingolimod was stable over the study. Most of the patients (88.7%) were free from confirmed disability and MRI activity (67.3%) after 24 months. The persistence after 12 months on fingolimod was 93.9%. Conclusions: The subgroups of patients analysed showed differential baseline demographic and clinical characteristics. The analysis of patients who received fingolimod in routine clinical practice confirmed adequate efficacy and safety, even for long-term treatment. The present data also confirmed the positive benefit/risk balance with fingolimod in real-world clinical practice setting. [ABSTRACT FROM AUTHOR]

Background: Multiple Sclerosis (MS) is a chronic inflammatory, demyelinating and neurodegenerative disease that in many cases produces disability, having a high impact in patients' lives, reducing significantly their quality of life. The aim of this study was to agree on a set of proposals to improve the current management of MS within the Spanish National Health System (SNHS) and apply the Social Return on Investment (SROI) method to measure the potential social impact these proposals would create.Methods: A Multidisciplinary Working Team of nine experts, with representation from the main stakeholders regarding MS, was set up to agree on a set of proposals to improve the management of MS. A forecast SROI analysis was carried out, with a one-year timeframe. Data sources included an expert consultation, a narrative literature review and a survey to 532 MS patients. We estimated the required investment of a hypothetical implementation, as well as the potential social value that it could create. We calculated outcomes in monetary units and we measured intangible outcomes through financial proxies.Results: The proposed ideal approach revealed that there are still unmet needs related to MS that can be addressed within the SNHS. Investment would amount to 148 million € and social return to 272 million €, so each euro invested could yield almost €2 of social return.Conclusions: This study could guide health interventions, resulting in money savings for the SNHS and increases in patients' quality of life. [ABSTRACT FROM AUTHOR]

Background. Low levels of 25-hydroxyvitamin D (25(OH)D) have been described as one of the possible environmental factors involved in multiple sclerosis (MS) etiopathogenesis. Objectives. To study epidemiology of MS and 25(OH)D serum levels of patients in Lanzarote (29°02′06″N), a region with high ultraviolet radiation values during the whole year which is located far apart from Iberian Peninsula (36°–43°N), but without genetic/ethnic differences with it. Methods. Incidence in Lanzarote was assessed according to McDonald 2005 criteria between January 2008 and December 2015 and prevalence date was 12/31/15. For 25(OH)D serum levels analyses, samples from 60 MS patients and 60 healthy donors (HD) were collected monthly in a one-year prospective study. Results. The prevalence of MS in Lanzarote was 50.0/100,000 and the incidence per year was 2.5/100,000. Median 25(OH)D levels values were 29.1 ng/ml for MS patients (maximum = 36.1 ng/ml, minimum = 22.5 ng/ml) and 27.1 ng/ml for HD (maximum = 34.8 ng/ml, minimum = 22.8 ng/ml). There were no significant differences between 25(OH)D serum levels between MS patients and HD. Conclusions. Lanzarote possesses lower prevalence and incidence values than peninsular Spain. Moreover, 25(OH)D serum levels do not differ between MS patients and HD. [ABSTRACT FROM AUTHOR]

Context: Physical exercise is regarded as a useful tool in the treatment of multiple sclerosis (MS). Generally, physical rehabilitation have been based on the prescription of aerobic exercises, while fewer programs have been aimed at developing muscular strength. Objective: To establish whether the physical fitness of MS sufferers can be improved by a training program for developing muscular strength. Design: Before and after study Setting: University multipurpose room Participants: 36 patients, all able to walk, belonging to the Leon Multiple Sclerosis Association. Interventions: The physical exercise programme consisted in resistance training sessions, based mainly on callisthenic, or bodyweight, exercises, during six weeks. [ABSTRACT FROM AUTHOR]

Multiple sclerosis (MS) is an autoimmune demyelinating disorder of the central nervous system that shares similar immunopathogenic mechanisms with chronic plaque psoriasis, such as the overexpression of the Th17 pathway. We report a 50-year-old male patient with MS and severe chronic plaque psoriasis who presented to Hospital Virgen de la Victoria, Málaga, Spain, in 2019. He was successfully treated with ixekizumab (anti-interleukin [IL]-17A and IL-17A/F monoclonal antibody). The treatment achieved complete skin clearance (i.e. a Psoriasis Area Severity Index 100 response) with no adverse event and no evidence of progression of the neurological disease either. [ABSTRACT FROM AUTHOR]

Objective: This study assesses the presence of sleep disturbances and their relationship with clinical and demographic variables in patients with MS, with a view to establishing correlations between the different variables and the frequency of sleep disturbances., Methods: The Pittsburgh Sleep Quality Index (PSQI) was used to detect sleep disorders. We contacted patients treated at the MS unit and distributed a questionnaire (PSQI) to 221 patients, receiving 142 usable questionnaires between 8 and 30 September 2019., Results: The prevalence of patients with sleep disturbances in our study was 74.7% (73.7% in women and 76.8% in men). Therefore, sleep disorders are pervasive in patients with MS, with 3 out of 4 patients experiencing them, a higher rate than that observed in the population without the disease. The frequency of sleep disorders gradually increased in line with age. In the 2 age groups analyzed, 44-54 years and 55-68 years, the proportion of moderate and severe sleep disorders was 42.8% and 53.9%, respectively. Moderate and severe sleep disturbances were observed in 27.5%, 44.7%, and 58.3% of patients with Expanded Disability Status Scale scores of 0-3, 3-6, and >6, respectively., Conclusion: Our results indicate that sleep disorders are more common in patients with MS than in other populations. Patients with secondary progressive forms of MS more frequently present sleep disturbances, while patients with primary progressive forms report them less frequently. Age and degree of disability were positively correlated with the prevalence and severity of sleep disorders in MS patients., (Copyright © 2021 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.)