Background: Covid-19 pandemic impacted on management of people with Multiple Sclerosis (pwMS). Level of satisfaction of pwMS regarding the care received by the staff of Multiple Sclerosis Centers (MSCs) during the pandemic was not fully investigated. In a large patient-centered multicenter study, the therapeutic adherence and quality of care of MSCs was assessed.Methods: In April-May 2021, an online survey was widespread by 16 Italian MSCs. Frequencies, percentages and/ or means and standard deviations were calculated to describe the sample. ANOVAs were performed to evaluate the effect of sociodemographic and clinical variables on overall pwMS' rating of MSC assistance.Results: 1670 pwMS completed the survey (67.3% women). During the pandemic, 88% did not change their disease modifying therapy schedule, and 89.1% reached their MSCs with no or little difficulties. Even if only 1.3% of participants underwent a tele-health follow-up visit with their MSC staff, the 80.1% believed that telehealth services should be improved regardless of pandemic. 92% of participants were satisfied of how their MSC took charge of their needs; ANOVAs revealed an effect of disease duration on pwMS' level of satisfaction on MSCs management during the pandemic.Conclusions: The results revealed an efficient MSCs response to Covid-19 pandemic and provided the basis for the implementing of tele-health services that would further improve the taking charge of patients, particularly those with longer disease, higher disability, and/or living far from their MSC.

Multiple sclerosis (MS) can sometimes cause uncommon pseudotumoural lesions that produce atypical symptoms, such as motor epileptic seizures which are often pharmacoresistant. In these cases, accurate diagnosis is essential for correct therapy, even if unconventional. We present the case of a brain tumour in a 40-year-old relapsing-remitting MS patient who presented with pharmacoresistant seizures which eventually responded to nabiximols. After various therapeutic approaches, delta-9-tetrahydrocannabinol therapy was introduced with good results. Spasticity improved, pain decreased and we observed a reduction in the number of daily seizures. It is possible that delta-9-tetrahydrocannabinol can enhance the efficacy of anti-epilepsy therapy.LEARNING POINTS:The patient experienced fewer daily focal motor crises after the administration of nabiximols in the morning.The correct combination of symptomatic drugs can optimize a specific multiple sclerosis (MS) therapy even if the real cause of symptoms is a primary brain tumour and not MS.The addition of nabiximols to the therapeutic program allowed anti-epilepsy drug doses to be reduced and improved the patient's cognitive impairment.

April 28, 2017April 18, 2017Free AccessEfficacy of Natalizumab and Fingolimod in Relapsing Remitting Multiple Sclerosis in Real World Clinical Setting: a 2-year follow-up (P6.377)Rocco Totaro, Gianfranco Costantino, Maura Danni, Paolo Bellantonio, Caterina Di Carmine, Roberta Fantozzi, Raffaella Cerqua, … Show All … , Aurora Fuiani, Ciro Mundi, Carmine Marini, Diego Centonze, Leandro Provinciali, and Antonio Carolei Show FewerAuthors Info & AffiliationsApril 18, 2017 issue88 (16_supplement)https://doi.org/10.1212/WNL.88.16_supplement.P6.377 Letters to the Editor

Rituximab (RTX) efficacy in NMO is suggested by several case series. No consensus exists on optimal dosing strategies. At present the treatment schedules more frequently used are 375 mg/m2/week iv for 4 weeks (RTX-A) and 1000 mg iv twice, 2 weeks apart (RTX-B). Aim of this study is to confirm RTX efficacy and safety in the treatment of NMO and to evaluate whether a most favourable dosage regimen exists. Data on RTX-treated NMO patients were collected from 13 Italian Hospitals. 73 patients (64 F), were enlisted. RTX-A was administered in 42/73 patients, RTX-B in 31/73. Median follow-up was 27 months (range 7–106). Mean relapse rate in the previous year before RTX start was 2.2 ± 1.3 for RTX-A and 2.3 ± 1.2 for RTX-B. ARR in the first year of treatment was 0.8 ± 0.9 for RTX-A and 0.2 ± 0.4 for RTX-B, in the second year of treatment was 0.9 ± 1.5 for RTX-A and 0.4 ± 0.8 for RTX-B patients (p = 0.001 for the first year, ns (0.09) for the second year). RTX-B was more effective in delaying the occurrence of a relapse (HR 2.2 (95 % IC 1.08–4.53) p = 0.02). Adverse events were described in 19/73 patients (mainly urinary tract and respiratory infections, and infusion reactions). Two deaths were reported in severely disabled patients. Though with the limitations of an observational study, our data support RTX efficacy in NMO and suggest that high dose pulses might be more effective than a more fractioned dose.

Objective. The aim of this prospective observational multicenter postmarketing study was to evaluate fingolimod efficacy in a real world clinical setting. Methods. One hundred forty-two subjects with relapsing-remitting multiple sclerosis (RRMS) were enrolled in three multiple sclerosis centers throughout Central and Southern Italy between January 2011 and September 2013. After enrollment, regular visits and EDSS assessment were scheduled every 3 months, and MRI scan was obtained every 12 months. Patients were followed up from 1 to 33 months (mean 14.95 ± 9.15 months). The main efficacy endpoints included the proportion of patients free from clinical relapses, from disability progression, from magnetic resonance imaging activity, and from any disease activity. Results. Out of 142 patients enrolled in the study, 88.1% were free from clinical relapse and 69.0% were free from disability progression; 68.5% of patients remained free from new or newly enlarging T2 lesions and 81.7% of patients were free from gadolinium enhancing lesions. Overall the proportion of patients free from any disease activity was 41.9%. Conclusions. Our data in a real world cohort are consistent with previous findings that yield convincing evidence for the efficacy of fingolimod in patients with RRMS.

Objective:The aim of this study was to compare the efficacy of natalizumab and fingolimod in relapsing-remitting multiple sclerosis patients in real-world clinical setting. Methods:We enrolled 391 patients starting either natalizumab or fingolimod for relapsing-remitting multiple sclerosis, referred to four multiple sclerosis centers between March 2007 and July 2013.Cumulative proportion of patients free from any disease activity, as defined by freedom from relapse, Expanded Disability Status Scale (EDSS) progression, new or newly enlarging T2 lesions, and gadolinium enhancing lesions at magnetic resonance imaging (MRI) was assessed at 12-month follow-up.Results: Out of 391 patients, 197 were treated with natalizumab and 194 with fingolimod.The cumulative proportion of patients free from any disease activity was 72.0% in the natalizumab and 59.1% in the fingolimod group (P=0.014).This proportion was lower in fingolimod patients with prior natalizumab exposure compared to those without (51.7% vs. 61.8%;P=0.008).Moreover, the cumulative proportion of patients free from new MRI lesions was 87.5% in the natalizumab vs. 70.0% in the fingolimod group (P<0.001); the cumulative proportion of patients free from clinical relapse was 82.5% in the natalizumab vs. 81.3% in the fingolimod group (P=0.739);93.5% of patients on natalizumab were free from EDSS progression compared to 89.6% of patients on fingolimod (P=0.186). Conclusions:Results from 1-year follow-up of treatment suggest higher efficacy of natalizumab compared to fingolimod in terms of proportion of patients free from any disease activity.

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.

OBJECTIVE To evaluate the efficacy of fingolimod treatment in a cohort of relapsing-remitting multiple sclerosis (MS) patients in a real clinical practice setting. BACKGROUND Fingolimod is the first oral drug approved for treatment of MS patients. In Italy, the use fingolimod in clinical practice is reserved to patients with inadequate response to other disease-modifying drugs or with rapidly evolving disease. There are no data on the impact of the drug in patients who satisfy eligibility criteria. DESIGN/METHODS We report data referring to the first 142 consecutive patients receiving fingolimod at 3 Italian MS centers. Patients have been chosen according to AIFA Eligibility Criteria. Main efficacy endpoints were the proportion of patients free from relapses, from MRI activity, from EDSS progression, from combined clinical activity, and from any disease activity. RESULTS Out of 142 patients included, 95 were women and 47 men. Mean age was 39.9±8.1 years. Twenty-eight patients (19.7%) were treated with natalizumab before starting fingolimod and were shifted to this treatment because of risk of progressive multifocal leukoencephalopaty. Eighty-one patients received fingolimod for at least 12 months and 45 patients for at least 24 months. Mean duration of treatment was 15.0±9.2 months. During the overall treatment period, 90.8% of patients were relapse-free, 82.8% were free form MRI activity, 87.1% were free from EDSS progression, 79.7% were free from combined clinical activity and 72.5% were free from any disease activity. Patients previously treated with natalizumab had a greater risk to have a relapse during the follow-up (P=0.02). Proportion of patients relapse-free was 82.1% in the group previously treated with natalizumab and 93.0% in the other. CONCLUSIONS In clinical practice, fingolimod is effective in reducing disease activity and progression of disability over the treatment period.

OBJECTIVE: To evaluate efficacy of fingolimod in a cohort of relapsing-remitting multiple sclerosis (MS) patients treated with fingolimod in a real clinical practice setting.

Recent findings support greater efficacy of early vs. delayed interferon beta (IFNβ) treatment in patients with a first clinical event suggestive of multiple sclerosis (MS). We aimed to evaluate the effectiveness of early IFNβ treatment in definite relapsing‐remitting MS (RRMS) and to assess the optimal time to initiate IFNβ treatment with regard to the greatest benefits on disability progression.

BACKGROUND:There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender in response to currently used disease modifying drugs in Multiple Sclerosis (MS). Observational studies may be especially valuable for answering effectiveness questions in subgroups not studied in RCTs. OBJECTIVE:To conduct a post-marketing analysis aimed to evaluate the gender effect on Interferon beta (IFNbeta) treatment response in a cohort of relapsing (RR) MS patients. METHODS:A cohort of 2570 IFNbeta-treated RRMS was prospectively followed for up to 7 years in 15 Italian MS Centers. Cox proportional hazards regression models were used to assess gender differences for risk of reaching 1st relapse and risk of progression by 1 point on Expanded Disability Status Scale (EDSS) score. Gender effects were also explored by a propensity score (PS) matching algorithm, and a tree-growing technique. RESULTS:The multivariate Cox Regression analyses showed that male patients had a significant (p=0.0097) lower risk for 1st relapse and a trend (p=0.0897) for a higher risk to reach 1 point EDSS progression than females. The PS matched multivariate Cox Regression confirmed these results. The RECPAM analysis showed that male sex conferred a significant reduction in the risk for 1st relapse (HR=0.86; 95% CI=0.76-0.98; p=0.0226) in the subgroup with a low pre-treatment number of bouts, and a significant increase in the risk for 1 point EDSS progression (HR=1.33; 95% CI: 1.00-1.76; p<0.05) in the subgroup with a delayed treatment, but a still young age at the start of treatment. CONCLUSION:The results of this exploratory analysis seem to suggest that male patients do not respond to IFNbeta treatment in the same way of females.

The randomized controlled trial (RCT) is considered to be the "gold standard" for providing evidence on drug efficacy. However, particularly for answering long-term questions in chronic diseases such as multiple sclerosis (MS), RCTs are often not feasible because of their size, duration, ethical constraints and costs. Data derived from observational studies complement information provided by RCTs. A major issue is that observational studies are more exposed and prone to biases, which can partly be addressed through rigorous study design or statistical analysis. Propensity score (PS) techniques are the most frequently used. PS is the probability that an individual would receive a certain treatment based on his/her pretreatment characteristics. This score is being widely used in many therapeutic areas and also in MS to adjust for the uncontrolled assignment of treatment in observational studies. However, since PS cannot adjust for unmeasured or unknown confounders, the conclusions from an observational study may not be considered as strong as those from RCTs.