Vincent Planche1, Xavier Moisset2, Remy Morello3, Emilie Dumont4, Marion Gibelin5, Julie Charré-Morin6, Aurore Saubusse6, Audrey Mondou7, Françoise Reuter8, Gilles Defer7, Jean Pelletier8, Bruno Brochet6, Pierre Clavelou2. 1. Service de Neurologie, CHU de Clermont-Ferrand, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France. Electronic address: planche.vincent@gmail.com. 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.
Abstract
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.
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.
Authors: S Salhofer-Polanyi; F Friedrich; S Löffler; P S Rommer; A Gleiss; R Engelmaier; F Leutmezer; B Vyssoki Journal: BMC Psychiatry Date: 2018-05-23 Impact factor: 3.630
Authors: Carrie M Hersh; Bernd Kieseier; Carl de Moor; Deborah M Miller; Denise Campagnolo; James R Williams; Kathryn C Fitzgerald; Kuangnan Xiong; Marisa P McGinley; Megan Hyland; Richard A Rudick; Tjalf Ziemssen; Irene Koulinska Journal: Mult Scler J Exp Transl Clin Date: 2021-04-15
Authors: Iman Adibi; Mehdi Sanayei; Farinaz Tabibian; Neda Ramezani; Ahmad Pourmohammadi; Kiarash Azimzadeh Journal: J Res Med Sci Date: 2022-03-17 Impact factor: 1.852
Authors: Zina-Mary Manjaly; Neil A Harrison; Hugo D Critchley; Cao Tri Do; Gabor Stefanics; Nicole Wenderoth; Andreas Lutterotti; Alfred Müller; Klaas Enno Stephan Journal: J Neurol Neurosurg Psychiatry Date: 2019-01-25 Impact factor: 10.154