Contributions
Abstract: EP1836
Type: ePoster
Abstract Category: Therapy - symptomatic - 34 Quality of life
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, no long-term follow-up post-marketing study about Natalizumab and HRQoL is available and the predictive factors of HRQoL improvement are unknown.
Methods: Forty-eight patients with relapsing-remitting MS were included in a 3-year open-label, single group, multicenter, clinical trial (NCT01392872). HRQoL was measured by the MusiQoL questionnaire, together with physical disability, cognition, fatigue, anxiety and depression scores at baseline, 6 months, 12 months, 18 months and 36 months after starting Natalizumab therapy.
Results: Compared to baseline, global HRQoL, as measured with the index of the MusiQoL, was significantly increased 6 months after the beginning of Natalizumab therapy (58.8±16.8 vs 68.7±18.9,
p< 0.001, Cohen's d=0.55) and this improvement was maintained over time for up to 3 years. The improvement of the global HRQoL after 18 months was correlated with an improvement of information processing speed performances (r=0.43, p=0.003 for SDMT) and with a decrease in depression and fatigue scores (respectively r=-0.37, p=0.013 and r=-0.52, p< 0.001). The variation of the global HRQoL after 3 years was negatively correlated with the variation of fatigue score (r=-0.44, p=0.015). Higher fatigue score at baseline was correlated with improvement in global HRQoL 3 years after (r=0.34, p=0.041). Higher depression score and higher physical disability at baseline were correlated with improvement in some dimensions of the MusiQoL and especially in the activities of daily living (respectively r=0.39, p=0.020 and r=0.39, p=0.018).
Conclusions: Natalizumab improved quickly and sustainably HRQoL in patients with relapsing-remitting MS. In terms of HRQoL, Natalizumab seems to benefit mainly patients with higher physical disability, fatigue and depressive symptoms at baseline.
Disclosure: The study was funded by Biogen Idec. The sponsor did not participate in any aspect of the design or performance of the study, including data collection, management, analysis, and interpretation or the preparation, review, and approval of the manuscript.
VP received travel expenses and/or consulting fees from the ARSEP Foundation, Biogen-Idec, Teva-Lundbeck and Merk-Serono.
XM received travel expenses from Biogen, Sanofi-Pasteur-MSD and Genzyme and received honoraria from Merk-Serono, Teva, Astellas and Institut UPSA de la douleur.
GD received personal compensation for serving on scientific advisory boards for Biogen Idec, Merck-Serono, Novartis, Sanofi Aventis, Genzyme and Teva; he has received funding for travel and/or speaker honoraria from Merck Serono, Biogen, Guerbet, Sanofi Aventis, Novartis, Genzyme and Teva; his institution received grants supporting research in his department from Merck Serono, Biogen, Sanofi Aventis and Novartis.
JP has received compensation for serving as advisory board and research support from Novartis, Bayer Schering, Merck Serono, Sanofi Aventis, Teva.
BB serves on scientific advisory boards for or has received honoraria or research support for its institution from Biogen-Idec, Merck-Serono, Novartis, Genzyme, Teva, Roche, Medday and Bayer.
PC received travel expenses and serves on scientific advisory boards for Teva-Pharma, Merck-Serono, Novartis, Biogen, Genzyme, Bayer, and Almirall.
Abstract: EP1836
Type: ePoster
Abstract Category: Therapy - symptomatic - 34 Quality of life
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, no long-term follow-up post-marketing study about Natalizumab and HRQoL is available and the predictive factors of HRQoL improvement are unknown.
Methods: Forty-eight patients with relapsing-remitting MS were included in a 3-year open-label, single group, multicenter, clinical trial (NCT01392872). HRQoL was measured by the MusiQoL questionnaire, together with physical disability, cognition, fatigue, anxiety and depression scores at baseline, 6 months, 12 months, 18 months and 36 months after starting Natalizumab therapy.
Results: Compared to baseline, global HRQoL, as measured with the index of the MusiQoL, was significantly increased 6 months after the beginning of Natalizumab therapy (58.8±16.8 vs 68.7±18.9,
p< 0.001, Cohen's d=0.55) and this improvement was maintained over time for up to 3 years. The improvement of the global HRQoL after 18 months was correlated with an improvement of information processing speed performances (r=0.43, p=0.003 for SDMT) and with a decrease in depression and fatigue scores (respectively r=-0.37, p=0.013 and r=-0.52, p< 0.001). The variation of the global HRQoL after 3 years was negatively correlated with the variation of fatigue score (r=-0.44, p=0.015). Higher fatigue score at baseline was correlated with improvement in global HRQoL 3 years after (r=0.34, p=0.041). Higher depression score and higher physical disability at baseline were correlated with improvement in some dimensions of the MusiQoL and especially in the activities of daily living (respectively r=0.39, p=0.020 and r=0.39, p=0.018).
Conclusions: Natalizumab improved quickly and sustainably HRQoL in patients with relapsing-remitting MS. In terms of HRQoL, Natalizumab seems to benefit mainly patients with higher physical disability, fatigue and depressive symptoms at baseline.
Disclosure: The study was funded by Biogen Idec. The sponsor did not participate in any aspect of the design or performance of the study, including data collection, management, analysis, and interpretation or the preparation, review, and approval of the manuscript.
VP received travel expenses and/or consulting fees from the ARSEP Foundation, Biogen-Idec, Teva-Lundbeck and Merk-Serono.
XM received travel expenses from Biogen, Sanofi-Pasteur-MSD and Genzyme and received honoraria from Merk-Serono, Teva, Astellas and Institut UPSA de la douleur.
GD received personal compensation for serving on scientific advisory boards for Biogen Idec, Merck-Serono, Novartis, Sanofi Aventis, Genzyme and Teva; he has received funding for travel and/or speaker honoraria from Merck Serono, Biogen, Guerbet, Sanofi Aventis, Novartis, Genzyme and Teva; his institution received grants supporting research in his department from Merck Serono, Biogen, Sanofi Aventis and Novartis.
JP has received compensation for serving as advisory board and research support from Novartis, Bayer Schering, Merck Serono, Sanofi Aventis, Teva.
BB serves on scientific advisory boards for or has received honoraria or research support for its institution from Biogen-Idec, Merck-Serono, Novartis, Genzyme, Teva, Roche, Medday and Bayer.
PC received travel expenses and serves on scientific advisory boards for Teva-Pharma, Merck-Serono, Novartis, Biogen, Genzyme, Bayer, and Almirall.