8 research outputs found

    Frequency and predictors of relapses following SARS-CoV-2 vaccination in patients with multiple sclerosis: interim results from a longitudinal observational study

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    Despite protection from severe COVID-19 courses through vaccinations, some people with multiple sclerosis (PwMS) are vaccination-hesitant due to fear of post-vaccination side effects/increased disease activity. The aim was to reveal the frequency and predictors of post-SARS-CoV-2-vaccination relapses in PwMS. This prospective, observational study was conducted as a longitudinal Germany-wide online survey (baseline survey and two follow-ups). Inclusion criteria were age ≥18 years, MS diagnosis, and ≥1 SARS-CoV-2 vaccination. Patient-reported data included socio-demographics, MS-related data, and post-vaccination phenomena. Annualized relapse rates (ARRs) of the study cohort and reference cohorts from the German MS Registry were compared pre- and post-vaccination. Post-vaccination relapses were reported by 9.3% PwMS (247/2661). The study cohort’s post-vaccination ARR was 0.189 (95% CI: 0.167–0.213). The ARR of a matched unvaccinated reference group from 2020 was 0.147 (0.129–0.167). Another reference cohort of vaccinated PwMS showed no indication of increased post-vaccination relapse activity (0.116; 0.088–0.151) compared to pre-vaccination (0.109; 0.084–0.138). Predictors of post-vaccination relapses (study cohort) were missing immunotherapy (OR = 2.09; 1.55–2.79; p < 0.001) and shorter time from the last pre-vaccination relapse to the first vaccination (OR = 0.87; 0.83–0.91; p < 0.001). Data on disease activity of the study cohort in the temporal context are expected for the third follow-up

    Therapy switches in fingolimod-treated patients with multiple sclerosis: long-term experience from the German MS Registry

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    INTRODUCTIONS: Therapy switches in patients with multiple sclerosis (MS) receiving treatment with fingolimod occur frequently in clinical practice but are not well represented in real-world data. The aim of this study was to identify and characterize treatment switches and reveal sociodemographic/clinical changes over time in fingolimod-treated people with MS (PwMS). METHODS: Data on 2536 fingolimod-treated PwMS extracted from the German MS Registry during different time periods were analyzed (2010-2019). RESULTS: Overall, 28.3% of PwMS were treatment-naïve before fingolimod initiation. Interferon beta (30.7%) was the most common pre-fingolimod treatment. Ocrelizumab (19.8%) was the most frequent subsequent treatment in the 944 patients on fingolimod who switched. Between 2010 and 2019, median disease duration at fingolimod initiation decreased from 8.5 to 7.1 years (p < 0.001), and patients taking fingolimod for ≥ 1 year after treatment initiation decreased from 89.6 to 80.5% (p < 0.001). Females (p < 0.001) and young patients (p = 0.003) showed a shorter time on fingolimod. The most frequent reason for switching was disease activity (relapse/MRI) despite treatment. The annualized relapse rate increased from 0.37 in patients on fingolimod to 0.47 after treatment cessation, decreasing to 0.19 after treatment with a subsequent disease-modifying drug (DMD) was initiated. CONCLUSION: Treatment switches from fingolimod to subsequent DMDs currently occur after shorter treatment durations than 10 years ago, possibly due to the growing treatment spectrum. Planning adequate washout periods is essential and should be done on an individualized basis

    Risk Assessment of Clinical Trials Protocols with the Risk Based Monitoring Tools

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    Central Statistical Monitoring approach and implementations on the German MS Registry

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    Ultra Broadband Curved Pyramidal Absorber Metamaterial in the UHF/SHF Region

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    International audienceA microwave ultra-broadband polarization independent metamaterial absorber in the UHF/SHF frequency bands is presented. As a first task, we enhanced the relative absorptive bandwidth of the conventional pyramidal absorber making the altitude curved. Such modification increased the Relative Absorptive Bandwidth (RAB) from 36% to 70.45% with an absorptive level greater than 90%. In addition, we focused on another task by which we aimed to have an ultra-broadband of absorption in UHF/SHF region. In this manner, we present the new metamaterial absorber prototype, with a total thickness of (12.7) cm, consisting of 35 curved resonant layers of different sizes. Numerical simulations show an enhanced design with an absorption band from 0.3 GHz to 30 GHz. Both prototypes are tested using the numerical simulator High Frequency Structure Simulator (HFSS)

    Treatment switches of disease-modifying therapies in people with multiple sclerosis: long-term experience from the German MS Registry

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    BACKGROUND: The spectrum of disease-modifying therapies (DMTs) for people with multiple sclerosis (PwMS) has expanded over years, but data on treatment strategies is largely lacking. DMT switches are common clinical practice. OBJECTIVE: To compare switchers and non-switchers, characterize the first DMT switch and identify reasons and predictors for switching the first DMT. METHODS: Data on 2722 PwMS from the German MS Registry were retrospectively analyzed regarding sociodemographic/clinical differences between 1361 switchers (PwMS discontinuing the first DMT) and non-switchers matched according to age, sex, and observation period. Frequencies of first and second DMTs were calculated and switch reasons identified. Predictors for DMT switches were revealed using univariable and multivariable regression models. RESULTS: Switchers and non-switchers differed significantly regarding time to first DMT, education, calendar period of the first DMT start (2014-2017 versus 2018-2021), first DMT class used [mild-to-moderate efficacy (MME) versus high-efficacy (HE) DMT], time on first DMT, and disease activity at first DMT start or cessation/last follow-up. The majority of PwMS started with MME DMTs (77.1%), with the most common being glatiramer acetate, dimethyl/diroximel fumarate, and beta-interferon variants. Switchers changed treatment more often to HE DMTs (39.6%), most commonly sphingosine-1-phosphate receptor modulators, anti-CD20 monoclonal antibodies, and natalizumab. Fewer PwMS switched to MME DMTs (35.9%), with the most common being dimethyl/diroximel fumarate, teriflunomide, or beta-interferon. Among 1045 PwMS with sufficient data (76.8% of 1361 switchers), the most frequent reasons for discontinuing the first DMT were disease activity despite DMT (63.1%), adverse events (17.1%), and patient request (8.3%). Predictors for the first DMT switch were MME DMT as initial treatment [odds ratio (OR) = 2.83 (1.76-4.61), p < 0.001; reference: HE DMT], first DMT initiation between 2014 and 2017 [OR = 11.55 (6.93-19.94), p < 0.001; reference: 2018-2021], and shorter time on first DMT [OR = 0.22 (0.18-0.27), p < 0.001]. CONCLUSION: The initial use of MME DMTs was among the strongest predictors of DMT discontinuation in a large German retrospective MS cohort, arguing for the need for prospective treatment strategy trials, not only but also on the initial broad use of HE DMTs in PwMS
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