IntroductionIn the framework of the EU-Erasmus+, the European Alliance for Sport and Mental Health (EASMH) project has been funded, aiming to promote the improvement of good clinical practice for ...sport-based psychosocial interventions throughout Europe. A specific training programme tailoring professional sport coaches has been developed in order to improve their skills in engaging and involving patients with severe mental disorders in sport-based rehabilitation activities.Objectivesto evaluate the perceived quality and utility of the EASMH training programme by sport coaches from different European countries (including Italy, UK, Romania, and Finland).MethodsAs part of the EASMH project, the University of Campania “L. Vanvitelli” has coordinated the development of training materials for professional sport coaches. The training programme has been tested in a pilot training programme. An ad-hoc questionnaire has been developed and administered at the end of the training, during a meeting held in Brussels in July 2022.ResultsThe EASMH training programme consists of six modules, dealing with the following topics: definition of mental health/mental disorders; classification systems; essential clinical features of severe mental disorders; personal and social burden associated with severe mental disorders; how to build a therapeutic relationship with a patient with severe mental disorders; verbal and non-verbal communication; evaluation of patient’s preference in selecting sport activities; definition of a personalized plan; motivational interview/problem-solving strategy. A total of eight professional coaches involved in different sport coming from Italy, Romania, United Kingdom and Finland participated in the entire training, consisting of six 4hr training modules. Seven out the eight coaches compiled the questionnaire. The overall feedback has been extremely positive. Overall, coaches have judged the modules as very clear, useful and of high standing. Each question has been rated with an average of 4.35 related to the overall content.ConclusionsThe present survey confirms that a short online training programme focused on professional sport coaches is well received by participants and can provide them with useful information on how to engage patients with severe mental disorders. The next step of the EASMH project foresees the implementation of several local pilot actions with the active involvement of patients with severe mental disorders.Disclosure of InterestNone Declared
Introduction
Among psychosocial interventions, recent studies have highlighted that sport-based interventions can positively impact on the long-term outcomes of patients with severe mental disorders, ...in terms of improving their quality of life and promoting social inclusion. Although sport-based interventions should be considered an effective strategy for promoting patients’ recovery, few data are available on their dissemination in the clinical routine care in Europe.
Objectives
to evaluate the availability of sport-based psychosocial interventions in European countries.
Methods
In the framework of the EU-Erasmus+, the European Alliance for Sport and Mental Health (EASMH) project has been funded. In order to evaluate the availability of sport-based interventions, an ad-hoc online survey, sent to national mental health centres, has been developed.
Results
103 responses were obtained (49 from Italy, 31 from UK, 17 from Finland and 12 from Romania). The respondents were mainly psychiatrists working in community mental health centers. Sport-based interventions were frequently provided by mental health services, in particular in Italy, UK and Finland. While in UK and Finland sport-based interventions are commonly offered to all patients, in the other countries these are provided only by patient’s request. The most frequent types of sport practised were: running, football, volleyball, tennis and table tennis and basketball. Almost all respondents reported to not use a dedicated monitoring tool for evaluating the efficacy of those interventions.
Conclusions
Sport-based interventions are not frequently provided in the routine clinical settings, although no monitoring tools are routinely adopted. The EASMHaims to fill this gap by disseminating good clinical practice related to sport-based interventions.
Disclosure
No significant relationships.
•Safety profile of alemtuzumab may differ in real-world populations compared to subject investigated in clinical trials.•The switch to alemtuzumab must take into account previous therapeutic ...regimens.•The implementation of a monitoring program is crucial to recognize and promptly manage adverse events.•The efficacy of alemtuzumab is maintained after other second line therapies.
Alemtuzumab, is a compound approved for highly active MS, and, in Europe, employed after the use of other disease-modifying treatments (DMTs) with an escalation approach or used as a first therapeutic option. The occurrence of secondary autoimmune adverse events and or infections can differ depending on the employed approach.
To evaluate the efficacy and safety of alemtuzumab in real-world MS population that encompassed patients previously treated with other DMTs.
35 patients, treated with alemtuzumab in a single MS Center, were followed for at least 36 months. The study investigated the prevalence of patients reaching the phase of the non-active disease (NEDA-3). All the adverse events were also reported, and correlations assessed.
At the 36-month follow-up, 66,7% of patients achieved the NEDA-3 status, 90,5% of the patients were relapse-free, 85,7% showed no signs of disability progression, nor signs of MRI activity. Adverse events were observed in 45,7% of the patients and ranked as severe in 23% of them. Cases of autoimmune hemolytic anemia (AIHA), pancytopenia, viral hepatitis E, and noninfectious meningo-encephalomyelitis were found and reported. For these complications, the post hoc analysis showed possible interactive factors and causality related to previous DMT treatments.
In a real-world MS population like the one investigated in our study, alemtuzumab was found to be an effective treatment when employed as an escalation or rescue therapy. The compound exhibits a variable safety profile and frequent adverse events that are likely depending on previous treatments and their impact on the immune system.
To assess pregnancy and fetal outcomes after in utero exposure to interferon-β (IFNβ) in all pregnancies occurring in women with multiple sclerosis (MS) during the study period, with a specific focus ...on the risk of spontaneous abortion.
In this cohort study, data were gathered through a standardized, semi-structured interview. Patients who discontinued IFNβ less than 4 weeks from conception (exposed) were compared with those who had discontinued the drug at least 4 weeks from conception or who were never treated (not exposed). Possible confounders were handled through multivariate analyses adjusted for propensity score (PS).
We collected data on 396 pregnancies in 388 women, 88 classified as exposed (mean exposure 4.6 ± 5.8 weeks). IFNβ exposure was not associated with an increased risk of spontaneous abortion (PS-adjusted odds ratio OR 1.08, 95% confidence interval CI 0.4 to 2.9, p = 0.88), although it was associated with both lower baby weight (PS-adjusted β -113.8, p < 0.0001) and length (PS-adjusted β -1.102, p < 0.0001). Proportion of spontaneous abortion in exposed patients fell within the range expected for the Italian population in the same period. IFNβ exposure (PS-adjusted OR 2.11, 95% CI 1.18 to 3.78, p = 0.012) and cesarean delivery were the only predictors of preterm delivery. In the exposed group, we did not observe any significant fetal complications, malformations, or developmental abnormalities over a median follow-up of 2.1 years.
Our findings point to the relative safety of IFNβ exposure times of up to 4 weeks and can assist neurologists facing therapeutic decisions in women with MS with a pregnancy plan.
We evaluated efficacy of natalizumab in relapsing-remitting multiple sclerosis patients in a clinical practice setting. We report data on the first consecutive 343 patients receiving natalizumab in ...12 multiple sclerosis (MS) Italian centers enrolled between April 2007 and November 2010. The main efficacy endpoints were the proportion of patients free from relapses, disease progression, combined clinical activity, defined as presence of relapse or disease progression, from MRI activity, and from any disease activity defined as the absence of any single or combined activity. At the end of follow-up, the cumulative proportion of patients free from relapses was 68%; the proportion of patients free from Expanded Disability Status Scale (EDSS) progression was 93%; the proportion of patients free from combined clinical activity was 65%; the proportion of patients free from MRI activity was 77%; and the proportion of patients free from any disease activity was 53%. Natalizumab was effective in reducing clinical and neuroradiological disease activity. Its effectiveness in clinical practice is higher than that reported in pivotal trials and was maintained over time.
Nail loss might represent a new, reversible, adverse event associated with teriflunomide treatment. It shares close analogies with hair loss and thinning, known adverse events of teriflunomide. MS ...specialists should be aware of this possibility and evaluate treatment discontinuation.
•Nail loss following teriflunomide treatment.•The effect was reversible at drug discontinuation.•An expert dermatologist excluded other etiologies for the adverse event.•Nail loss might represent a new rare adverse event of teriflunomide.
To assess fetal risk after pregnancy exposure to natalizumab in women with multiple sclerosis (MS), with a specific focus on spontaneous abortion (SA) and congenital anomalies (CA).
Data of all ...pregnancies occurring between 2009 and 2015 in patients with MS treated with natalizumab and referring to 19 participating sites were collected and compared with those of pregnancies in untreated patients and patients treated with injectable immunomodulatory agents. Rates of SA and CA were also compared with those reported in the Italian population. Multivariable logistic and linear regression models were performed.
A total of 92 pregnancies were tracked in 83 women. In the multivariable analysis, natalizumab exposure was associated with SA (odds ratio OR 3.9, 95% confidence interval CI 1.9-8.5,
< 0.001). However, the rate of SA (17.4%) was within the estimates for the general population, as well as the rate of major CA (3.7%). Moreover, exposure to natalizumab and interferon-β (IFN-β) was associated with lower length and weight of the babies (
< 0.001).
Our results showed that natalizumab exposure to up 12 weeks of gestation is associated with an increased risk of SA, although within the limits expected in the general population, whereas the risk of CA needs further investigation. Taking into account the high risk of disease reactivation after natalizumab suspension, pregnancy could be planned continuing natalizumab while strictly monitoring conception.
This study provides Class III evidence that in women with MS, natalizumab exposure increases the risk of spontaneous abortion as compared to IFN-β-exposed or untreated patients (OR 3.9, 95% CI 1.9-8.5).
To assess the risk of disease reactivation during pregnancy after natalizumab suspension in women with multiple sclerosis (MS).
Data of all pregnancies occurring between 2009 and 2015 in patients ...with MS treated with natalizumab and referring to 19 participating sites were collected and compared with those of pregnancies in untreated patients and patients treated with injectable immunomodulatory agents through a 2-factor repeated measures analysis. Predictors of disease activity were assessed through stepwise multivariable logistic regression models.
A total of 92 pregnancies were tracked in 83 women receiving natalizumab. Among these pregnancies, 74 in 70 women resulted in live births, with a postpartum follow-up of at least 1 year, and were compared with 350 previously published pregnancies. Relapse rate during and after pregnancy was higher in women treated with natalizumab (
< 0.001). In multivariable analysis, longer natalizumab washout period was the only predictor of relapse occurrence during pregnancy (
= 0.001). Relapses in the postpartum year were related to relapses during pregnancy (
= 0.019) and early reintroduction of disease-modifying drugs (DMD;
= 0.021). Disability progression occurred in 16.2% of patients and was reduced by early reintroduction of DMD (
= 0.024).
Taken as a whole, our findings indicate that the combination of avoiding natalizumab washout and the early resumption of DMD after delivery could be the best option in the perspective of maternal risk. This approach must take into account possible fetal risks that need to be discussed with the mother and require further investigation.
This study provides Class IV evidence that in women with MS, the risk of relapses during pregnancy is higher in those who had been using natalizumab as compared to those who had been using interferon-β or no treatment.
Multiple sclerosis (MS) is thought to be an autoimmune T-cell-mediated disease directed at myelin antigens of the central nervous system. Besides myelin proteins, lipid components of CNS are supposed ...to play a role as antigens for T cells in MS. CD1 is a family of MHC-like glycoproteins specialized in capturing and presenting a variety of microbial and self lipids and glycolipids to antigen-specific T cells. CD1-restricted T cells specific for gangliosides and sulfatide have been isolated from subjects with MS and in mice with experimental allergic encephalopathy. We genotyped exon 2 of CD1A and CD1E in 205 MS patients and 223 unrelated healthy controls and determined their association with the presence of anti-ganglioside and anti-sulfatide antibodies. CD1E 01-01 is associated with a reduced risk of MS (OR 0.54, p=0.001); CD1A 02-02 (OR 1.99, p=0.012) or CD1E 02-02 (OR 2.45, p=0.000) with an increased risk. The combination of the genotypes CD1A 02-02 and CD1E 02-02 is present in 90.7% of patients but in only 9.4% controls (OR 94.16, p= 0.000). CD1A and CD1E polymorphisms contribute to the polygenic susceptibility to MS. The functional effects of CD1 polymorphisms are unknown, however changes in CD1 alleles may affect numerous immunological functions.
After multiple sclerosis (MS) relapse while a patient is receiving an injectable disease-modifying drug, many physicians advocate therapy switch, but the relative effectiveness of different switch ...decisions is often uncertain.
To compare the effect of the oral immunomodulator fingolimod with that of all injectable immunomodulators (interferons or glatiramer acetate) on relapse rate, disability, and treatment persistence in patients with active MS.
Matched retrospective analysis of data collected prospectively from MSBase, an international, observational cohort study. The MSBase cohort represents a population of patients with MS monitored at large MS centers. The analyzed data were collected between July 1996 and April 2014. Participants included patients with relapsing-remitting MS who were switching therapy to fingolimod or injectable immunomodulators up to 12 months after on-treatment clinical disease activity (relapse or progression of disability), matched on demographic and clinical variables. Median follow-up duration was 13.1 months (range, 3-80). Indication and attrition bias were controlled with propensity score matching and pairwise censoring, respectively. Head-to-head analyses of relapse and disability outcomes used paired, weighted, negative binomial models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity analyses were conducted.
Patients had received fingolimod, interferon beta, or glatiramer acetate for a minimum of 3 months following a switch of immunomodulatory therapy.
Annualized relapse rate and proportion of relapse-free patients, as well as the proportion of patients without sustained disability progression.
Overall, 379 patients in the injectable group were matched to 148 patients in the fingolimod group. The fingolimod group had a lower mean annualized relapse rate (0.31 vs 0.42; 95% CI, 0.02-0.19; P=.009), lower hazard of first on-treatment relapse (hazard ratio HR, 0.74; 95% CI, 0.56-0.98; P=.04), lower hazard of disability progression (HR, 0.53; 95% CI, 0.31-0.91; P=.02), higher rate of disability regression (HR, 2.0; 95% CI, 1.2-3.3; P=.005), and lower hazard of treatment discontinuation (HR, 0.55; P=.04) compared with the injectable group.
Switching from injectable immunomodulators to fingolimod is associated with fewer relapses, more favorable disability outcomes, and greater treatment persistence compared with switching to another injectable preparation following on-treatment activity of MS.
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