Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study

Planche, Vincent; Moisset, Xavier; Morello, Rémy; Dumont, Émilie; Gibelin, M.; Charré-Morin, Julie; Saubusse, Aurore; Mondou, Audrey; Reuter, Françoise; Defer, Gilles; Pelletier, Jean; Brochet, Bruno; Clavelou, Pierre

doi:10.1016/j.jns.2017.10.008

Cited by 17 publications

(13 citation statements)

References 28 publications

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“…The impact of fingolimod treatment on HRQoL in the real-world setting over the longterm is still poorly characterised and further studies in this field are needed to clarify the issue [9]. With respect to natalizumab, a large and significant increase of 11 points in Musi-QoL score after 3 years' treatment has been described in small French study of 48 patients [38], but we were not able to document such a change in the present much larger study.…”

Section: Discussioncontrasting

confidence: 66%

Long-Term Effectiveness, Safety and Tolerability of Fingolimod in Patients with Multiple Sclerosis in Real-World Treatment Settings in France: The VIRGILE Study

et al. 2022

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Introduction: It is important to confirm the effectiveness and tolerability of disease-modifying treatments for relapsing-remitting multiple sclerosis (RRMS) in real-world treatment settings. This prospective observational cohort study (VIRGILE) was performed at the request of the French health authorities. The primary objective was to evaluate the effectiveness of fingolimod 0.5 mg in reducing the annualised relapse rate (ARR) in patients with RRMS. Methods: Participating neurologists enrolled all adult patients with RRMS starting fingolimod treatment between 2014 and 2016, who were followed for 3 years. Follow-up consultations took place at the investigator's discretion. The primary outcome measure was the change in ARR at month 24 after fingolimod initiation. Relapses and adverse events were documented at each consultation; disability assessment (EDSS) and magnetic resonance imagery were performed at the investigator's discretion. Results: Of 1055 eligible patients, 633 patients were assessable at month 36; 405 (64.0%) wereThe members of The Virgile Study Group are listed in the Acknowledgements section.

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Section: Discussioncontrasting

confidence: 66%

Long-Term Effectiveness, Safety and Tolerability of Fingolimod in Patients with Multiple Sclerosis in Real-World Treatment Settings in France: The VIRGILE Study

et al. 2022

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“…While one cannot exclude the possibility that additional cumulative benefits or loss of benefits could be observed with a longer treatment duration, prior studies have demonstrated a quick onset of action for both natalizumab and ocrelizumab, as well as sustained effects of natalizumab on PROs starting at three months and continuing through three years of follow-up. 8,10,24,35,36 In addition, given that the average (SD) time of followup for both natalizumab and ocrelizumab was 6 (6) months, we do not anticipate that relapses or the use of extended interval dosing would have had a major impact on the study findings. This analysis has several strengths in design, notably, the use of standardized data from a real-world patient cohort, the ability to adjust for use of comedications acting as potential effect modifiers, and the incorporation of several sensitivity analyses aimed at understanding the clinical meaningfulness of the findings.…”

Section: Discussionmentioning

confidence: 99%

“…[1][2][3][4][5] Natalizumab, a monoclonal antibody against verylate-activation antigen 4, reduces central inflammatory activity in MS and can lead to improvements in HRQoL in both real-world and clinical-trial settings. [6][7][8][9][10] Many natalizumab-treated patients anecdotally report a "feel-good effect," which has not been well characterized clinically or physiologically. Patient interview-based studies suggest that the "feelgood effect" might reflect improved depression and fatigue and an overall perception of well-being and energy.…”

Section: Introductionmentioning

confidence: 99%

Impact of natalizumab on quality of life in a real-world cohort of patients with multiple sclerosis: Results from MS PATHS

Hersh

Kieseier²,

Moor

et al. 2021

Multiple Sclerosis Journal - Experimental, Translational and Cl

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Background Optimizing multiple sclerosis treatment warrants understanding of changes in physical, mental, and social health. Objective To assess the impact of natalizumab on Quality of Life in Neurological Disorders (Neuro-QoL) scores. Methods Annualized change in T-scores and likelihood of ≥5-point improvement over baseline were calculated for each Neuro-QoL domain after natalizumab initiation. Comparisons with ocrelizumab-treated patients were conducted after propensity score weighting and adjustment for relevant co-medications, year, and drug-year interaction. Results Among 164 natalizumab patients analyzed, 8 of 12 Neuro-QoL domains improved significantly, with greater improvement in patients with abnormal baseline Neuro-QoL. In the subgroup comparison of natalizumab-treated ( n = 145) and ocrelizumab-treated ( n = 520) patients, significant improvement occurred in 9 of 12 and 4 of 12 domains, respectively. The difference between groups was statistically significant for positive affect and well-being ( p = 0.02), sleep ( p = 0.003), and satisfaction with social roles and activities (SRA) ( p = 0.03) in the overall population and for emotional and behavioral dyscontrol ( p = 0.01), participation in SRA ( p = 0.0001), and satisfaction with SRA ( p = 0.02) in patients with abnormal baseline Neuro-QoL. Conclusions Natalizumab can produce clinically meaningful improvements in mental and social health. Such improvements are unlikely to be primarily driven by expectation bias, as their magnitude exceeded improvements with another high-efficacy therapy, ocrelizumab.

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“…Besides, the statistically significant effect of temperament types on HRQoL was also independent of co-morbid mood disorders and immunomodulatory treatments, both factors known to influence HRQoL of MS patients [ 18 ]. Depression and fatigue were independently associated with reduced HRQoL in another study [ 20 ] and the benefit of immunomodulation on HRQoL was most prominent in MS patients suffering from marked fatigue [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

Health-related quality of life in multiple sclerosis: temperament outweighs EDSS

et al. 2018

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BackgroundThe influence of personality on health-related quality of life in patients with multiple sclerosis has been the focus of previous studies showing that introversion and neuroticism were related with reduced health related quality of life. However, no data exist on the impact of temperament on quality of life in this patient group.MethodsBetween April 2014 and March 2016 139 multiple sclerosis patients were recruited from a specialized outpatient clinic of the general hospital of Vienna. Health-related quality of life was measured by “The Multiple Sclerosis International Quality of Life Questionnaire (MusiQol)”, temperament by “Temperament Evaluation of Memphis, Pisa, Paris, and San Diego Questionnaire – Münster version” (briefTEMPS-M), and disability by the “Expanded disability status scale”. All patients underwent a diagnostic psychiatric semi-structured interview (MINI).ResultsKnown predictors (like disease duration, EDSS, psychiatric co-morbidities, immunomodulatory treatments) explain the proportion of variation in the outcome of MusiQol global index score in 30.9% in multi-variable linear regression analysis. It increased respectively to 40.3, 42.5, and 45.8% if adding the depressive, cyclothymic, or hyperthymic temperament to the list of variables. An increase of depressive and cyclothymic temperament scores significantly reduced global index score of MusiQol (p = 0.005, p = 0.002, respectively), while the hyperthymic temperament significantly raised it (p < 0.001).ConclusionIn MS patients, the depressive and cyclothymic temperament predict a lower and hyperthymic temperament an increased health-related quality of life, independent of current disability status, immunomodulatory treatments, and affective co-morbidities.Electronic supplementary materialThe online version of this article (10.1186/s12888-018-1719-6) contains supplementary material, which is available to authorized users.

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Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study

Cited by 17 publications

References 28 publications

Long-Term Effectiveness, Safety and Tolerability of Fingolimod in Patients with Multiple Sclerosis in Real-World Treatment Settings in France: The VIRGILE Study

Long-Term Effectiveness, Safety and Tolerability of Fingolimod in Patients with Multiple Sclerosis in Real-World Treatment Settings in France: The VIRGILE Study

Impact of natalizumab on quality of life in a real-world cohort of patients with multiple sclerosis: Results from MS PATHS

Health-related quality of life in multiple sclerosis: temperament outweighs EDSS

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