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
Journal of the Neurological Sciences. 2017-11-01; 382: 148-154
DOI: 10.1016/j.jns.2017.10.008
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Planche V(1), Moisset X(2), Morello R(3), Dumont E(4), Gibelin M(5), Charré-Morin J(6), Saubusse A(6), Mondou A(7), Reuter F(8), Defer G(7), Pelletier J(8), Brochet B(6), Clavelou P(2).
Author information:
(1)Service de Neurologie, CHU de Clermont-Ferrand, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France. Electronic address: .
(2)Service de Neurologie, CHU de Clermont-Ferrand, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France; Neuro-Dol, Inserm U1107, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France.
(3)Unité de Biostatistique et Recherche Clinique, CHU de Caen, Université de Normandie, F-14033 Caen, France.
(4)Service de Neurologie, CHU de Clermont-Ferrand, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France.
(5)Réseau NeuroSEP Auvergne, F-63110 Beaumont, France.
(6)Service de Neurologie, CHU de Bordeaux, Université de Bordeaux, F-33007 Bordeaux, France.
(7)Service de Neurologie, CHU de Caen, Université de Normandie, F-14033 Caen, France.
(8)APHM, Hôpital de la Timone, Pôle de Neurosciences Cliniques, Service de Neurologie, F-13000 Marseille, France.
BACKGROUND:
Health-related quality of life (HRQoL) is impaired in multiple sclerosis (MS) but can be improved by disease-modifying therapies such as natalizumab. However, the predictive factors and neuropsychiatric correlates of HRQoL improvement are unknown.
METHODS:
In this study, 48 patients with relapsing-remitting MS were included in a 3-year open-label, single group, multicenter, clinical trial (NCT01392872). HRQoL was measured by the disease-specific MusiQoL questionnaire, together with physical disability, cognition, fatigue, anxiety and depression scores at baseline, 6months, 12months, 18months and 36months after starting natalizumab therapy.
RESULTS:
Compared to baseline, global HRQoL, as measured with the index of the MusiQoL, was significantly increased 6months after the beginning of natalizumab therapy, with medium effect-size (58.6±16.2 vs 69.8±18.9, p<0.001, Cohen’s d=0.63). This improvement was maintained over time for up to 3years and mainly concerned activity of daily living, psychological well-being, symptoms and coping (p<0.001 for every dimensions). The variation of global HRQoL after 3years was negatively correlated with the variation of fatigue score (r=-0.44, p=0.015). Furthermore, a higher fatigue score at baseline was correlated with improvement in global HRQoL 3years afterwards (r=0.34, p=0.041), independently of age, educational level, disease duration and disability at baseline (β=2.45, p=0.020). Disability at baseline, cognitive impairment, anxiety and depression failed to predict or correlate with global HRQoL improvement in multivariate analyses.
CONCLUSION:
Natalizumab improved HRQoL quickly and sustainably in patients with relapsing-remitting MS. In terms of HRQoL, natalizumab seems to benefit mostly patients with more marked fatigue at baseline.