Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS

Spelman, Tim; Kalinčík, Tomáš; Jokubaitis, Vilija; Zhang, Annie; Pellegrini, Fabio; Wiendl, Heinz; Belachew, Shibeshih; Hyde, Robert; Verheul, Freek; Havrdová, Eva; Horáková, Dana; Grammond, Pierre; Duquette, Pierre; Prat, Alexandre; Iuliano, Gerardo; Terzı, Murat; Izquierdo, Guillermo; Hupperts, Raymond; Boz, Cavit; Pucci, Eugenio; Giuliani, G.; Sola, Patrizia; Spitaleri, Daniele; Lechner‐Scott, Jeannette; Bergamaschi, Roberto; Grand’Maison, François; Granella, Franco; Kappos, Ludwig; Trojano, María; Butzkueven, Helmut

doi:10.1212/cpj.0000000000000227

Cited by 33 publications

(26 citation statements)

References 39 publications

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“…Our clinical validity and population impact results (Table 4, Figure 2), modeled for natalizumab with an adverse event frequency of 1.3% (maximal risk reported by the manufacturer, see Methods), show that at least a quarter of PML cases could be prevented. Natalizumab is a highly effective treatment for many MS patients and some would benefit from its use as a first line therapy, such as those with aggressive or early onset forms of the disease (21,(83)(84)(85). Furthermore, an MRI surveillance study suggests that therapy duration is potentially not a very effective risk stratification factor (8).…”

Section: Discussionmentioning

confidence: 99%

Germline Genetic Risk Variants for Progressive Multifocal Leukoencephalopathy

Eis

Bruno²,

Richmond³

et al. 2020

Front. Neurol.

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Section: Discussionmentioning

confidence: 99%

Germline Genetic Risk Variants for Progressive Multifocal Leukoencephalopathy

Eis

Bruno²,

Richmond³

et al. 2020

Front. Neurol.

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“…However, healthcare costs for DMT administration and management have never been tested in long-term real-life scenarios in relation to MS clinical outcomes. In previous observational studies trying to investigate the long-term efficacy of DMTs, Natalizumab determined more positive disease outcomes, compared with Interferon-beta or Glatiramer acetate, in a large propensity-matched cohort [28]. Similarly, the highest cumulative exposure (a parameter including both dosage and time) to Interferon beta-1a treatment had more beneficial effects on long-term outcomes, compared to the lowest, in patients with similar baseline clinical features [6].…”

Section: Discussionmentioning

confidence: 99%

Healthcare Costs for Treating Relapsing Multiple Sclerosis and the Risk of Progression: A Retrospective Italian Cohort Study from 2001 to 2015

et al. 2017

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BackgroundDisease modifying treatments (DMTs) are the main responsible for direct medical costs in multiple sclerosis (MS). The current investigation aims at evaluating possible associations between healthcare costs for treating relapsing remitting MS (RRMS) and disease evolution.MethodsThe present cohort study retrospectively included 544 newly diagnosed RRMS patients, prospectively followed up for 10.1±3.3 years. Costs for DMT administration and management were calculated for each year of observation. Following clinical endpoints were recorded: time to first relapse, 1-point EDSS progression, reaching of EDSS 4.0, reaching of EDSS 6.0, and conversion to secondary progressive MS (SP). Covariates for statistical analyses were age, gender, disease duration and EDSS at diagnosis.ResultsAt time varying Cox regression models, 10% increase in annual healthcare costs was associated with 1.1% reduction in 1-point EDSS progression (HR = 0.897; p = 0.018), with 0.7% reduction in reaching EDSS 6.0 (HR = 0.925; p = 0.030), and with 1.0% reduction in SP conversion (HR = 0.902; p = 0.006).ConclusionHigher healthcare costs for treating MS have been associated with a milder disease evolution after 10 years, with possible reduction of long-term non-medical direct and indirect costs.

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“…Propensity score analysis of a large cohort of patients with relapsing remitting multiple sclerosis found that natalizumab was superior to interferon beta and glatiramer acetate in terms of improved outcomes. 28…”

Section: Propensity Score Matchingmentioning

confidence: 99%

Observational studies and their utility for practice

Gilmartin‐Thomas¹,

Liew²,

Hopper³

2018

Aust Prescr

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Randomised controlled clinical trials are the best source of evidence for assessing the efficacy of drugs. Observational studies provide critical descriptive data and information on long-term efficacy and safety that clinical trials cannot provide, at generally much less expense. Observational studies include case reports and case series, ecological studies, cross-sectional studies, case-control studies and cohort studies. New and ongoing developments in data and analytical technology, such as data linkage and propensity score matching, offer a promising future for observational studies. However, no study design or statistical method can account for confounders and bias in the way that randomised controlled trials can. Clinical registries are gaining importance as a method to monitor and improve the quality of care in Australia. Although registries are a form of cohort study, clinical trials can be incorporated into them to exploit the routine follow-up of patients to capture relevant outcomes. Ecological studies Ecological studies are based on analysis of aggregated data at group levels (for example populations), and do not involve data on individuals. These data can be analysed descriptively, but not definitively for causation. Typical examples include studies that examine patterns of drug use over time. One example is the comparison of the use of non-steroidal anti-inflammatory drugs and COX-2 inhibitors in Australia and Canada. 11 Sometimes ecological studies describe associations between drugs and outcomes, such as changes in the rates of upper gastrointestinal haemorrhage after the introduction of COX-2 inhibitors. 12 However, because individual-level data are not presented, causality is at best only implied in ecological studies. The 'ecological fallacy' refers to the error of assuming that associations observed in ecological studies are causal when they are not. Cross-sectional studies Cross-sectional studies collect data at a single point in time for each single individual, but the actual data collection may take place over a period of time or on more than one occasion. There is no longitudinal follow-up of individuals. Cross-sectional studies represent the archetypal descriptive study. 1 Typically, they provide a profile of a population of interest, which may be broad, like the Australian Health Survey undertaken intermittently by the Australian Bureau of Statistics, 13 or focused on specific populations, such as older Australians. 14 Julia FM Gilmartin-Thomas NHMRC-ARC* Dementia research development fellow 1

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Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS

Cited by 33 publications

References 39 publications

Germline Genetic Risk Variants for Progressive Multifocal Leukoencephalopathy

Germline Genetic Risk Variants for Progressive Multifocal Leukoencephalopathy

Healthcare Costs for Treating Relapsing Multiple Sclerosis and the Risk of Progression: A Retrospective Italian Cohort Study from 2001 to 2015

Observational studies and their utility for practice

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