Clinical activity after fingolimod cessation: Disease reactivation or rebound?

Background and purpose: There is debate as to whether the apparent rebound after fingolimod discontinuation is related to the discontinuation itself or whether it is due to the natural course of highly active multiple sclerosis (MS). Our aim was to survey the prevalence of severe reactivation and rebound after discontinuation of fingolimod in a cohort of Italian patients with MS. Methods: Patients with relapsing-remitting MS who were treated with fingolimod for at least 6 months and who stopped treatment for reasons that were unrelated to inefficacy were included in the analysis. Results: A total of 100 patients who had discontinued fingolimod were included in the study. Fourteen patients (14%) had a relapse within 3 months after fingolimod discontinuation, and an additional 12 (12%) had a relapse within 6 months. According to this study's criteria, 10 patients (10%) had a severe reactivation. Amongst these patients, five (5%) had a reactivation that was considered to be a rebound. Conclusions: The present study showed that more than 26% of patients are at risk of having a relapse within 6 months after fingolimod discontinuation. Nevertheless, the risk of severe reactivations and rebound is lower than has been previously described

DMTs and Covid-19 severity in MS: a pooled analysis from Italy and France

We evaluated the effect of DMTs on Covid-19 severity in patients with MS, with a pooled-analysis of two large cohorts from Italy and France. The association of baseline characteristics and DMTs with Covid-19 severity was assessed by multivariate ordinal-logistic models and pooled by a fixed-effect meta-analysis. 1066 patients with MS from Italy and 721 from France were included. In the multivariate model, anti-CD20 therapies were significantly associated (OR = 2.05, 95%CI = 1.39–3.02, p < 0.001) with Covid-19 severity, whereas interferon indicated a decreased risk (OR = 0.42, 95%CI = 0.18–0.99, p = 0.047). This pooled-analysis confirms an increased risk of severe Covid-19 in patients on anti-CD20 therapies and supports the protective role of interferon

Assessing treatment outcomes in multiple sclerosis trials and in the clinical setting

Increasing numbers of drugs are being developed for the treatment of multiple sclerosis (MS). Measurement of relevant outcomes is key for assessing the efficacy of new drugs in clinical trials and for monitoring responses to disease-modifying drugs in individual patients. Most outcomes used in trial and clinical settings reflect either clinical or neuroimaging aspects of MS (such as relapse and accrual of disability or the presence of visible inflammation and brain tissue loss, respectively). However, most measures employed in clinical trials to assess treatment effects are not used in routine practice. In clinical trials, the appropriate choice of outcome measures is crucial because the results determine whether a drug is considered effective and therefore worthy of further development; in the clinic, outcome measures can guide treatment decisions, such as choosing a first-line disease-modifying drug or escalating to second-line treatment. This Review discusses clinical, neuroimaging and composite outcome measures for MS, including patient-reported outcome measures, used in both trials and the clinical setting. Its aim is to help clinicians and researchers navigate through the multiple options encountered when choosing an outcome measure. Barriers and limitations that need to be overcome to translate trial outcome measures into the clinical setting are also discussed

The Effects of Music on the Intensity and Direction of Pre-Competitive Cognitive and Somatic State Anxiety and State Self-Confidence in Collegiate Athletes

Music has been classified as a healing agent (Steckler, 1998), facilitator of mood enhancement (Stratton & Zalanowski, 1997), and contributing factor to improved autonomic responses and performance during stressful tasks for some surgeons (Allen & Blascovich, 1994). Although the psychophysiological effects of music have become a domain of increased interest among sports researchers throughout the last decade (Karageorghis & Terry, 1997), little research was found investigating athletes\u27 intrepretive psychological perceptions of listening to music during the pre-game period. This investigation examined the effects of the individual participant\u27s favorite music on the perception of intensity and direction of pre-competitive cognitive and somatic state anxiety, and state self-confidence in collegiate athletes. Intercollegiate athletes (N = 59) from a university in the southeast participated and were randomly placed in either a music or non-music group. Ranging from 1 hour and 45 minutes to 30 minutes prior to actual competition, participants engaged in a 3-minute session featuring uninterrupted, personally chosen, music listening on portable compact disc players for the music group and their normal pre-game activity for the non-music group. At the conclusion of the 3-minute interval, all participants completed a modified Competitive State Anxiety Inventory-2 (Martens, Burton, Vealey, Bump, & Smith, 1990) with direction variables (Gordon, Burke, Joyner, & Hardy, 1998; Jones, Hanton, & Swain, 1994). Two days after competition, all participants completed a modified Sport Competition Anxiety Test (Martens, Vealey, & Burton, 1990) with direction variables (Gordon et al.; Jones, Hanton, & Swain). Although the six 3-way ANCOVA revealed no significant 2-way or 3-way interactions, there were significant music and gender main effects (g \u3c .0083) for state self-confidence intensity. The results suggest that an individual music session, featuring the participant\u27s favorite music, significantly enhanced feelings of state self-confidence in collegiate athletes