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Objective: To assess the feasibility of collaboration and retrospective data harmonization among three multiple sclerosis (MS) registries by investigating employment status. Methods: We used the Maelstrom guidelines to facilitate retrospective harmonization of data from three MS registries, including the NARCOMS (North American Research Committee on MS) Registry, German MS Register (GMSR), and United Kingdom MS (UK-MS) Register. A protocol was developed based on the guidelines, and summary-level data were used to combine results. Employment status and a limited set of factors associated with employment (age, sex, education, and disability level) were harmonized. A meta-analytic approach was used to pool estimates using a weighted average of logistic regression estimates and their variances in a random effects model. Results: Employment status, age, sex, education, and disability were mapped. The overall employment rate was 57% (11,143 employed out of 19,562 persons with MS) with the GMSR having the highest proportion of participants employed (66.2%), followed by the UK-MS (55.2%) and NARCOMS (43.0%) registries. As disability level increased, the odds of not being employed increased. Conclusion: Harmonization across registries was feasible. The Maelstrom guidelines provide a valuable roadmap for conducting high-quality harmonization projects. The pooling of data sources has the potential to be an important mechanism for conducting research in MS.

Background: The tailored immunomodulatory treatment strategy for secondary progressive multiple sclerosis (SPMS) depends on disease activity. Objective: To assess the real-world situation in monitoring disease activity in SPMS patients and to identify associations of resulting subgroups with demographics, symptomatology, and therapy Methods: This study included 4,263 SPMS patients from the German MS register (GMSR). For the classification into 'active' and 'inactive' according to relapse activity and MRI findings during the year prior to the latest clinical visit, we used the following definitions: active -gadolinium enhancing (Gd+)/new T2 lesions or ≥1 relapse, inactive -neither Gd+/new T2 lesions nor relapses. The active, inactive, and unclassifiable patients were compared in terms of clinical data, socio-demographics, symptomatology, healthcare, and DMT. Results: Classification was possible for 1,513 (35.5%) SPMS patients, with 467 classified as active and 1,046 as inactive. For the classification, MRI data was available for 33.2% of the 4,263 patients. Higher MRI frequencies were observed for younger patients (OR 1.22 [1.12,1.33] per 10 years) with short disease duration (OR 1.19 [1.09, 1.30] per 10 years) (p < 0.001). Conclusion: MRI coverage was low, especially in elderly SPMS patients. Roughly one third of the SPMS patients presented markers of disease activity in the last year. Overall, the clinical differences (concerning symptomatology and care) between patients with active and inactive SPMS were small.

Introductions: Therapy switches in patients with multiple sclerosis (MS) receiving treatment with fingolimod occur frequently in clinical practice but are not well represented in realworld 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)(2011)(2012)(2013)(2014)(2015)(2016)(2017)(2018)(2019). Results: Overall, 28.3% of PwMS were treatment-naı ¨ve before fingolimod initiation. Interferon beta (30.7%) was the most common prefingolimod treatment. Ocrelizumab (19.8%) was the most frequent subsequent treatment in the 944 patients on fingolimod who switched.

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This work is licensed under Creative Commons Attribution 4.0 License AJBSR.MS.ID.001276.

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.

Daclizumab was approved by the FDA and the EMA in 2016 for the treatment of relapsing forms of multiple sclerosis (MS). Cases of severe inflammatory brain disease with fatal outcome led to the withdrawal of approval in Europe and the US on March 2, 2018. Approximately 8,000 patients worldwide received daclizumab, but little is known about the further therapy management of these patients after the withdrawal of daclizumab. The aim of this study is to further analyze therapy management in MS patients after safety warnings and market withdrawal. Data from two registries in Germany, the German MS Registry (GMSR) and REGIMS, were used for this analysis. In total, 267 patients were included in this study. For almost 25% of patients (in the GMSR) daclizumab was the initial treatment. Most common pre-treatments were fingolimod, dimethyl fumarate, and natalizumab; various injectables summed up to 25.9%. The most common follow-up therapies were ocrelizumab and fingolimod. In most patients, follow-up therapies were administered shortly after discontinuation of daclizumab. The wash-out time for subsequent therapies varied between 1.2 and 4.0 months. Warnings and decisions by authorities led to a rapid decline and termination of therapies in both cohorts, indicating that such warnings have an immediate impact on the treatment landscape. Therapies that were started within a short time after the discontinuation of daclizumab were subsequently replaced by other therapies and may be considered as bridging therapies.