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Background: Persons with severe Multiple Sclerosis (PwsMS) face complex needs and daily limitations that make it challenging to receive optimal care. The implementation and coordination of health care, social services, and support in financial affairs can be particularly time consuming and burdensome for both PwsMS and caregivers. Care and case management (CCM) helps ensure optimal individual care as well as care at a higher-level. The goal of the current qualitative study was to determine the experiences of PwsMS, caregivers and health care specialists (HCSs) with the CCM. Methods: In the current qualitative sub study, as part of a larger trial, in-depth semi-structured interviews with PwsMS, caregivers and HCSs who had been in contact with the CCM were conducted between 02/2022 and 01/2023. Data was transcribed, pseudonymized, tested for saturation and analyzed using structuring content analysis according to Kuckartz. Sociodemographic and interview characteristics were analyzed descriptively. Results: Thirteen PwsMS, 12 caregivers and 10 HCSs completed interviews. Main categories of CCM functions were derived deductively: (1) gatekeeper function, (2) broker function, (3) advocacy function, (4) outlook on CCM in standard care. Subcategories were then derived inductively from the interview material. 852 segments were coded. Participants appreciated the CCM as a continuous and objective contact person, a person of trust (92 codes), a competent source of information and advice (on MS) (68 codes) and comprehensive cross-insurance support (128 codes), relieving and supporting PwsMS, their caregivers and HCSs (67 codes). Conclusions: Through the cross-sectoral continuous support in health-related, social, financial and everyday bureaucratic matters, the CCM provides comprehensive and overriding support and relief for PwsMS, caregivers and HCSs. This intervention bears the potential to be fine-tuned and applied to similar complex patient groups. Trial registration: The study was approved by the Ethics Committee of the University of Cologne (#20–1436), registered at the German Register for Clinical Studies (DRKS00022771) and in accordance with the Declaration of Helsinki. [ABSTRACT FROM AUTHOR]

Several studies reported post-SARS-CoV-2-vaccination (PV) symptoms. Even people with multiple sclerosis (PwMS) have concerns about disease activity following the SARS-CoV-2 vaccination. We aimed to determine the proportion of PwMS with PV relapses, the PV annualized relapse rate (ARR), the time from vaccination to subsequent relapses, and identify sociodemographic/clinical risk factors for PV relapses. PwMS were surveyed several times at baseline and four follow-ups as part of a longitudinal observational study regarding the safety and tolerability of the SARS-CoV-2 vaccination. The inclusion criteria for this analysis were age ≥18 years, ≥1 SARS-CoV-2 vaccination, and ≥1-year observation period since initial vaccination. Of 2466 PwMS, 13.8% reported PV relapses (mostly after second [N = 147] or booster vaccination [N = 145]) at a median of 8.0 (first/third quantile: 3.55/18.1) weeks PV, with the shortest period following initial vaccination (3.95 weeks). The ARR was 0.153 (95% confidence interval: 0.138–0.168), with a median observation period since initial vaccination of 1.2 years. Risk factors for PV relapses were younger age, female gender, moderate-severe disability levels, concurrent autoimmune diseases, relapsing-remitting MS courses, no DMT, and relapses within the year prior to the first vaccination. Patients' health conditions before/during initial vaccination may play a more important role in PV relapse occurrence than vaccination per se. [ABSTRACT FROM AUTHOR]

Background: Vaccines offer people with multiple sclerosis (PwMS) an effective protection against severe COVID-19 disease courses. However, representative real-world data on the tolerability of SARS-CoV-2 vaccines in PwMS are limited. We aimed at analysing vaccination reactions (VRs) and MS deterioration following SARS-CoV-2 vaccinations in German and United Kingdom (UK) PwMS, especially regarding gender-specific differences., Methods: The German Multiple Sclerosis Society and the UK MS Registry acquired health data via an online system following the first (X 1 ) and second SARS-CoV-2 vaccination (X 2 ), respectively: sociodemographic and clinical data, vaccines used, VRs, MS deterioration (worsened or new MS symptoms, Germany only) and relapses (Germany only). The frequencies of VRs and MS deterioration were analysed stratified by gender., Findings: Following X 1 (X 2 ), 2346 (1835) German PwMS and 3796 (683) UK PwMS participated in the study. The most frequent vaccination scheme was two-dose tozinameran for Germany (77·1%, 1424/1847) and two-dose AZD1222 for the UK (61·3%, 419/683). The most common VRs were fatigue, headache and pain (at the injection site) and occurred more often in women compared with men. German PwMS reported VRs more frequently after X 2 vs. X 1 (65·4% [1201/1835] vs. 61·2% [1435/2346]), while for UK patients it was the opposite (X 1 vs. X 2 : 48·7% [1849/3796] vs. 30·0% [205/683]). MS deterioration occurred in 19·0% (445/2346) of the German PwMS without resulting in gender-specific differences. Fatigue and gait impairment were the most frequent deteriorated MS symptoms., Interpretation: Female PwMS reported experiencing VRs more often than men. Longitudinal data are needed to enable valid statements regarding long-term MS deterioration and long-lasting VRs., Funding: German Multiple Sclerosis Society (DMSG Bundesverband e.V.), Biogen, Bristol Myers Squibb, Merck Serono, Mylan, Novartis, Roche and Sanofi., Competing Interests: Niklas Frahm is an employee of the MSFP. Moreover, he is an employee of Rostock's University Medical Center and received travel funds for research meetings from Novartis; none resulted in a conflict of interest. Firas Fneish, Melanie Peters, David Ellenberger and Sarah Schilling had no personal financial interests to disclose other than being employees of the German MS Registry; none resulted in a conflict of interest. Tina Parciak had no personal financial interests to disclose. Anna-Lena Röper is employee of the MSFP and Germany MS society, which is funded by many public and corporate sponsors. She received travel funds from Novartis. None resulted in a conflict of interest. Micha Löbermann received speaker honoraria from Sanofi, AbbVie and Pfizer, he served as investigator in vaccine studies sponsored by Janssen, GSK and Novartis; none resulted in a conflict of interest. Herbert Temmes has no personal pecuniary interests to disclose, other than being the Secretary General of the German MS Society, federal association, which receives funding from a range of public and corporate sponsors, recently including Bundesgesundheitsministerium (BMG), The German Innovation Fund (G-BA), The German MS Trust, Biogen, Bristol Myers Squibb, Merck Serono, Novartis, Roche, Sanofi, Viatris (former Mylan); none resulted in a conflict of interest. Judith Haas has no personal pecuniary interests to disclose, other than being the President of the German MS Society, federal association, which receives funding from a range of public and corporate sponsors, recently including BMG, G-BA, The German MS Trust, Biogen, Bristol Myers Squibb, Merck Serono, Novartis, Roche, Sanofi, Viatris (former Mylan); none resulted in a conflict of interest. Dieter Pöhlau received speaking fees, travel support and financial support for research projects from: Allmirall, Bayer, Biogen-Idec, Merck-Serono, Octapharm, Novartis, Roche, Sanofi-Aventis and Teva; none resulted in a conflict of interest. Jeff Rodgers has no personal pecuniary interests to disclose, other than being an employee of the UK MS Register which is funded by the MS Society, travel research and conference costs are also funded by them; none resulted in a conflict of interest. Uwe K. Zettl has received speaking fees, travel support and /or financial support for research activities from Alexion, Almirall, Bayer, Biogen, Bristol-Myers-Squibb, Janssen, Merck Serono, Novartis, Octapharm, Roche, Sanofi Genzyme, Teva as well as EU, BMBF, BMWi and DFG; none resulted in a conflict of interest. Alexander Stahmann has no personal financial interests to disclose, other than being the leader of the German MS Registry, which receives funding from a range of public and corporate sponsors, recently including G-BA, The German MS Trust, German MS Society, Biogen, Bristol Myers Squibb, Merck, Novartis, Roche and Sanofi; none resulted in a conflict of interest. Rod Middleton has no personal pecuniary interests to disclose, other than being the lead of the UK MS Register which is funded by the MS Society, travel research and conference costs are also funded by them; none resulted in a conflict of interest., (© 2022 MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH).)