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It has also shown to have a positive effect on quality of life and mental status: improving depressive symptoms and cognitive performances

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Academic year: 2021

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Title:

MANAGEMENT OF PATIENTS WITH MULTIPLE SCLEROSIS: THE NATALIZUMAB THERAPY

Summary:

Multiple sclerosis is an inflammatory disease of the central nervous system characterized by multifocal demyelinating lesions and inflammatory and degenerative damage. The clinical course is highly variable, with alternating remissions and relapses, and subsequent progressive course. Motor, sensory, cerebellar, mental and visual functions are the systems involved. In addition, about half of patients develop variable cognitive impairments: the casualness of times, the course of the disease, its severity and the site of injury outbreak contribute to the onset of significant variability of the patient’s mental state. Natalizumab is a monoclonal antibody indicated in relapsing remitting multiple sclerosis with high activity.

The aims of this study were to assess efficacy, tolerability and impact on the quality of life in a cohort of 23 patients and to analyze cognitive performances and mood disorder in a subgroup of 10 patients, after one year’s therapy. The drug has shown to significantly reduce the clinical relapse rate, the development of T2 and the gadolinium-enhancing lesions and it has also proved to have excellent tolerability and safety.

The cognitive assessment showed an improvement in test scores for frontal functions, attention, working memory and mood. In our analysis, Natalizumab was effective in reducing neurologic disability and disease activity. It has also shown to have a positive effect on quality of life and mental status: improving depressive symptoms and cognitive performances. The data obtained are consistent with those of pivotal studies and literature, but beed further confirmation.

Key words:

Multiple Sclerosis, Natalizumab, Cognitive Impairment

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Index

Summary pag 2

Multiple Sclerosis (MS)

Pathological description pag 3

Therapeutic description pag 11

Immunological mechanisms pag 16

MS and cognitive impairment pag 18

Neuroimaging in MS cognitive impairments pag 22

Neurobiological patterns of MS cognitive impairment pag 25 Natalizumab

Biochemical characteristics and action mechanism pag 28

Pre-clinical and clinical development: references to main studies pag 31

Immunogenicity, safety and tolerability pag 34

Progressive Multifocal Leucoencephalopathy pag 35

Indications and treatment procedures pag 37

Natalizumab and cognitive impairment pag 39

Study aims pag 41

Patients pag 41

Method pag 42

Clinical and neuroradiological assessment pag 42

Quality of life assessment pag 44

Fatigue Severity Scale pag 44

Beck Depression Inventory pag 45

Neuropsychological assessment pag 46

Statistical Analysis pag 52

Results pag 53

Clinical and neuroradiological assessment pag 53

Quality of life assessment pag 54

Neuropsychological assessment pag 55

Discussion and conclusions pag 57

Tables and graphics pag 66

Addenda pag 71

Bibliography pag 79

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