Impact of Natalizumab Treatment on Fatigue, Mood, and Aspects of Cognition in Relapsingâ€“Remitting Multiple Sclerosis

Kunkel, Annett; Fischer, Martin; Faiss, Judith; Dähne, D; Köhler, Wolfgang; Faiss, Jürgen

doi:10.3389/fneur.2015.00097

Cited by 34 publications

(24 citation statements)

References 52 publications

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“…In general, functional health status appeared higher, whereas depression and fatigue scores were lower compared to other cohorts of MS patients [ 15 , 19 – 25 ]. Cognitive function was comparable to prior studies (Table 4 ) [ 22 , 25 – 27 ].…”

Section: Resultssupporting

confidence: 85%

Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® autoinjector: a prospective observational cohort study

Kleiter

Lang²,

Jeske

et al. 2017

BMC Neurol

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BackgroundMaintaining patient adherence to disease modifying drugs in multiple sclerosis is a challenge, which can be improved by autoinjectors. The BETACONNECT® is a fully electronic autoinjector for the injection of interferon beta-1b (IFN beta-1b) automatically recording injections.MethodsThe BETAEVAL study was a prospective, observational, cohort study over 24 weeks among patients with relapsing remitting multiple sclerosis or clinically isolated syndrome treated with IFN beta-1b in Germany using the BETACONNECT®. The primary aim was to investigate treatment adherence, secondary aims included assessing satisfaction and functional health status. Adherence was evaluated from injection data recorded by the device. Patient-related data were obtained from clinical examinations and patient questionnaires.ResultsOf the 151 patients enrolled, 143 were available for analysis. Thirty-four patients discontinued the study prematurely. 107/143 (74.8%) patients still used the BETACONNECT® at the end of the study. Injection data from the device at any visit was available for 107 patients. Among those, the percentage of adherent patients injecting ≥80% of doses and still participating in the study was 57.9% at week 24. 29% of patients prematurely stopped the study, 13.1% injected <80%. Among patients with BETACONNECT® data at the respective visit, the proportion of adherent patients was high over the entire study period (week 4: 81.1% [N = 95], week 12: 86.7% [N = 83], week 24: 80.5% [N = 77]). Participants (N = 143) indicated high satisfaction with the BETACONNECT®. At week 24, 98.0% of patients who completed the corresponding questionnaire (strongly) agreed that it was user-friendly, 81.2% felt confident in using it compared to their previous way and 85.5% preferred it to their previous way of injection. Injection-related pain was rated as mild to moderate at all follow-up visits. Whereas 17.2% of patients with corresponding questionnaire indicated using analgesics prior to injection at week 4, only 9.1% did at week 24. Outcomes from questionnaires assessing functional health status, depression, fatigue and cognitive function were very similar throughout the study course.ConclusionsThe majority of patients continued using the BETACONNECT® for IFN beta-1b treatment during the 24-week study period. Adherence was high among participants still using the BETACONNECT® and patients were highly satisfied with the device. Ongoing studies will evaluate long-term adherence and treatment outcomes in patients using the BETACONNECT®.Trial registrationclinicaltrails.gov NCT02121444 (registered April 22, 2014).Electronic supplementary materialThe online version of this article (10.1186/s12883-017-0953-8) contains supplementary material, which is available to authorized users.

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Section: Resultssupporting

confidence: 85%

Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® autoinjector: a prospective observational cohort study

Kleiter

Lang²,

Jeske

et al. 2017

BMC Neurol

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“…Since these symptoms are absolutely rare in MS, their appearance in MS patients treated with NTZ should be considered as a red flag and should give rise to a suspicion of PML, thus prompting a rapid MR scan. Indeed, evidences are now available regarding the positive effects of NTZ on cognitive deterioration of MS patients over long follow ups, as well as on cognitive improvement of MS patients treated with NTZ over time [15][16][17][18][19][20][21]. Furthermore, a rebound of cognitive impairment has also been described following natalizumab discontinuation [22].…”

Section: Discussionmentioning

confidence: 99%

The still under-investigated role of cognitive deficits in PML diagnosis

Scarpazza

Rossi

Moiola

et al. 2017

Mult Scler Demyelinating Disord

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Background: Despite cognitive deficits frequently represent the first clinical manifestations of Progressive Multifocal Leukoencephalopathy (PML) in Natalizumab-treated MS patients, the importance of cognitive deficits in PML diagnosis is still under-investigated. The aim of the current study is to investigate the cognitive deficits at PML diagnosis in a group of Italian patients with PML. Methods: Thirty-four PML patients were included in the study. The demographic and clinical data, the lesion load and localization, and the longitudinal clinical course was compared between patients with (n = 13) and without (n = 15) cognitive deficit upon PML suspicion (the remaining six patients were asymptomatic). Clinical presentation of cognitive symptoms was described in detail. Result: After symptoms detection, the time to diagnosis resulted to be shorter for patients presenting with cognitive than for patients with non cognitive onset (p = 0.03). Within patients with cognitive onset, six patients were presenting with language and/or reading difficulties (46.15%); five patients with memory difficulties (38.4%); three patients with apraxia (23.1%); two patients with disorientation (15.3%); two patients with neglect (15.3%); one patients with object agnosia (7.7%), one patient with perseveration (7.7%) and one patient with dementia (7.7%). Frontal lesions were less frequent (p = 0.03), whereas temporal lesions were slightly more frequent (p = 0.06) in patients with cognitive deficits. The longitudinal PML course seemed to be more severe in cognitive than in non cognitive patients (F = 2.73, p = 0.03), but differences disappeared (F = 1.24, p = 0.29) when balancing for the incidence of immune reconstitution syndrome and for other treatments for PML (steroids, plasma exchange (PLEX) and other therapies (Mefloquine, Mirtazapine, Maraviroc). Conclusion: Cognitive deficits at PML onset manifest with symptoms which are absolutely rare in MS. Their appearance in MS patients should strongly suggest PML. Clinicians should be sensitive to the importance of formal neuropsychological evaluation, with particular focus on executive function, which are not easily detected without a formal assessment.

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“…Natalizumab shows a neuroprotective role as it reduces the inflammatory processes in the brain, such as atrophy, being a key factor as well as improves cognitive functioning. MS immunomodulatory treatment mostly involves restraining of brain damage in the early phase of the disease [ 43 , 44 ]. Another common problem among MS patients is depression.…”

Section: The Influence Of Ms Treatment On Cognitionmentioning

confidence: 99%

Pharmacological and Non-pharmacological Therapies of Cognitive Impairment in Multiple Sclerosis

Miller¹,

Morel

Redlicka³

et al. 2018

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BackgroundCognitive impairment is one of the most important clinical features of neurodegenerative disorders including multiple sclerosis (MS). Conducted research shows that up to 65 percent of MS patients have cognitive deficits such as episodic memory, sustained attention, reduced verbal fluency; however, the cognitive MS domain is information processing speed. It is the first syndrome of cognitive dysfunction and the most widely affected in MS. Occasionally these impairments occur even before the appearance of physical symptoms.MethodsTherefore, this review focused on the current status of our knowledge about possible methods of treatment cognitive impairment in MS patients including novel strategies. Research and online content was performed using Medline and EMBASE databases.ResultsThe most recent research suggests that cognitive impairment is correlated with brain lesion volume and brain atrophy. The examination of the cognitive impairment is usually based on particular neuropsychological batteries. However, it can be not enough to make a precise diagnosis. This creates a demand to find markers that might be useful for identifying patients with risk of cognitive impairment at an early stage of the disease. Currently the most promising methods consist of neuroimaging indicators, such as diffusion tensor imaging, the magnetization transfer ratio, and N-acetyl aspartate levels. Diagnosis problems are strictly connected with treatment procedures. There are two main cognitive therapies: pharmacological (disease modifying drugs (DMD), symptomatic treatments) and non-pharmacological interventions that are focused on psychological and physical rehabilitation. Some trials have shown a positive association between physical activity and the cognitive function.ConclusionThis article is an overview of the current state of knowledge related to cognition impairment treatment in MS. Additionally, novel strategies for cognitive impairments such as cryostimulation and other complementary methods are presented.

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Impact of Natalizumab Treatment on Fatigue, Mood, and Aspects of Cognition in Relapsingâ€“Remitting Multiple Sclerosis

Cited by 34 publications

References 52 publications

Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® autoinjector: a prospective observational cohort study

Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® autoinjector: a prospective observational cohort study

The still under-investigated role of cognitive deficits in PML diagnosis

Pharmacological and Non-pharmacological Therapies of Cognitive Impairment in Multiple Sclerosis

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