Therapie der Multiplen Sklerose

Kip, Miriam; Wiendl, Heinz

doi:10.1007/978-3-662-49204-8_4

Cited by 3 publications

(4 citation statements)

References 58 publications

(63 reference statements)

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“…International guidelines recommend oral corticosteroid administration as the first treatment choice [ 9 ]. Currently, IV corticosteroid therapy for relapses is one of the main reasons for hospital admissions of people with MS (PwMS) in Germany [ 10 ], while only 36% of PwMS underwent outpatient relapse treatment between 2006 and 2011 [ 11 ]. The direct and indirect costs of an MS relapse in Germany amount to approx.…”

Section: Introductionmentioning

confidence: 99%

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Rahn

Wenzel

Icks

et al. 2021

Trials

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Introduction Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis. Methods The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle. Discussion We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients’ relapse management. Trial registration ClinicalTrials.govNCT04233970. Registered on 18 January 2020

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Section: Introductionmentioning

confidence: 99%

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Rahn

Wenzel

Icks

et al. 2021

Trials

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“…fingolimod, natalizumab, ocrelizumab, alemtuzumab, cladribine) in case of insufficient response. 4 – 6 The use of highly effective, disease-modifying therapies (DMT) in the early phase of MS is evolving, 7 – 10 as an early window of opportunity is assumed, when treatment is most effective and critical to maintain neurological function 11 and reduce disability progression. 8 – 10 In line with this, the early intervention with fingolimod, natalizumab and alemtuzumab in patients with RRMS was associated with a reduced risk of transition to SPMS.…”

Section: Introductionmentioning

confidence: 99%

Comparing the long-term clinical and economic impact of ofatumumab versus dimethyl fumarate and glatiramer acetate in patients with relapsing multiple sclerosis: A cost-consequence analysis from a societal perspective in Germany

Koeditz¹,

Frensch²,

Bierbaum

et al. 2022

Multiple Sclerosis Journal - Experimental, Translational and Cl

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Background Evidence suggests that early highly efficacious therapy in relapsing multiple sclerosis is superior to escalation strategies. Objective A cost-consequence analysis simulated different treatment scenarios with ofatumumab (OMB), dimethyl fumarate (DMF) and glatiramer acetate (GA): immediate OMB initiation as first treatment, early switch to OMB after 1 year on DMF/GA, late switch after 5 years or no switch. Methods An EDSS-based Markov model with a 10-year time horizon was applied. Cycle transitions included EDSS progression, improvement or stabilization, treatment discontinuation, relapse or death. Input data were extracted from OMB trials, a network meta-analysis, published literature, and publicly available sources. Results The late switch compared to the immediate OMB scenario resulted in a lower proportion of patients with EDSS 0–3 (Δ − 7.5% DMF; Δ − 10.3% GA), more relapses (Δ + 0.72 DMF; Δ + 1.23 GA) and lower employment rates (Δ − 4.0% DMF; Δ − 5.6% GA). The same applies to late versus early switches. No switch scenarios resulted in worse outcomes. Higher drug acquisition costs in the immediate OMB and early switch scenarios were almost compensated by lower costs for patient care and productivity loss. Conclusion Immediate OMB treatment and an early switch improves clinical and productivity outcomes while remaining almost cost neutral compared to late or no switches.

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“… 6 7 In Germany, early intravenous therapy with high-dose methylprednisolone is the standard treatment of acute relapses. 8 If symptoms persist after the initial treatment, escalation therapy may be considered. Corticosteroid doses can be increased in a second course, and either plasma exchange or immunoadsorption can be considered.…”

Section: Introductionmentioning

confidence: 99%

“…However, evidence concerning the benefit of all the mentioned treatment options is limited. 8 9 Corticosteroid therapy leads to an accelerated resolution of relapse symptoms in about 25% of treated patients within 5 weeks, while there is no evidence for long-term benefits. 10 11 This contrasts with the overall relapse treatment perception.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of an interactive web-based programme on relapse management for people with multiple sclerosis (POWER@MS2): study protocol for a process evaluation accompanying a randomised controlled trial

et al. 2021

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IntroductionProcess evaluations accompanying complex interventions examine the implementation process of the underlying intervention, identify mechanisms of impact and assess contextual factors. This paper presents the protocol for a process evaluation conducted alongside the randomised controlled trial POWER@MS2. The trial comprises the evaluation of a web-based complex intervention on relapse management in 188 people with multiple sclerosis conducted in 20 centres. The web-based intervention programme focuses on relapse treatment decision making and includes a decision aid, a nurse-led webinar and an online chat. With the process evaluation presented here, we aim to assess participants’ responses to and interactions with the intervention to understand how and why the intervention produces change.Methods and analysisA mixed methods design is used to explore the acceptance of the intervention as well as its use and impact on participants. Participants are people with multiple sclerosis, neurologists, nurses and stakeholders. Quantitative semistandardised evaluation forms will be collected throughout the study. Qualitative semistructured telephone interviews will be conducted at the end of the study with selected participants, especially people with multiple sclerosis and neurologists. Quantitative data will be collected and analysed descriptively. Based on the results, the qualitative interviews will be conducted and analysed thematically, and the results will be merged in a joint display table.Ethics and disseminationThe process evaluation has received ethical approval from the Ethical Committee of the University of Lübeck (reference 19–024). Findings will be disseminated in peer-reviewed journals, at conferences, meetings and on relevant patient websites.Trial registration numberNCT04233970.

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Therapie der Multiplen Sklerose

Cited by 3 publications

References 58 publications

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Comparing the long-term clinical and economic impact of ofatumumab versus dimethyl fumarate and glatiramer acetate in patients with relapsing multiple sclerosis: A cost-consequence analysis from a societal perspective in Germany

Evaluation of an interactive web-based programme on relapse management for people with multiple sclerosis (POWER@MS2): study protocol for a process evaluation accompanying a randomised controlled trial

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