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Papers by Vissia Viglietta

Research paper thumbnail of Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis

New England Journal of Medicine, 2012

Research paper thumbnail of F.23. A Panel of Immunologic Biomarkers Can Discriminate Between Patients with Multiple Sclerosis and Healthy Individuals

Clinical Immunology, 2008

Research paper thumbnail of Effects of BG-12 (dimethyl fumarate) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: findings from the CONFIRM study

Multiple Sclerosis Journal, 2014

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with s... more Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS.

Research paper thumbnail of Time course of clinical and neuroradiological effects of delayed-release dimethyl fumarate in multiple sclerosis

European journal of neurology : the official journal of the European Federation of Neurological Societies, 2015

Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF), demonstrated efficac... more Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF), demonstrated efficacy and safety in relapsing-remitting multiple sclerosis in the 2-year, randomized, placebo-controlled, phase 3 DEFINE and CONFIRM trials. A post hoc analysis of integrated data from DEFINE and CONFIRM was conducted to determine the temporal profile of the clinical and neuroradiological effects of DMF. Eligible patients were randomized to receive placebo, DMF 240 mg twice (BID) or three times (TID) daily or glatiramer acetate (GA; reference comparator; CONFIRM only) for up to 96 weeks. Patients in the GA group were excluded from this analysis. A total of 2301 patients were randomized and received treatment with placebo (n = 771) or DMF BID (n = 769) or TID (n = 761). DMF significantly reduced the annualized relapse rate beginning in weeks 0-12 (BID, P = 0.0159; TID, P = 0.0314); the proportion of patients relapsed beginning at week 10 (BID, P = 0.0427) and week 12 (TID, P = 0.0451); and th...

Research paper thumbnail of Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis

New England Journal of Medicine, 2012

Research paper thumbnail of F.23. A Panel of Immunologic Biomarkers Can Discriminate Between Patients with Multiple Sclerosis and Healthy Individuals

Clinical Immunology, 2008

Research paper thumbnail of Effects of BG-12 (dimethyl fumarate) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: findings from the CONFIRM study

Multiple Sclerosis Journal, 2014

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with s... more Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS.

Research paper thumbnail of Time course of clinical and neuroradiological effects of delayed-release dimethyl fumarate in multiple sclerosis

European journal of neurology : the official journal of the European Federation of Neurological Societies, 2015

Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF), demonstrated efficac... more Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF), demonstrated efficacy and safety in relapsing-remitting multiple sclerosis in the 2-year, randomized, placebo-controlled, phase 3 DEFINE and CONFIRM trials. A post hoc analysis of integrated data from DEFINE and CONFIRM was conducted to determine the temporal profile of the clinical and neuroradiological effects of DMF. Eligible patients were randomized to receive placebo, DMF 240 mg twice (BID) or three times (TID) daily or glatiramer acetate (GA; reference comparator; CONFIRM only) for up to 96 weeks. Patients in the GA group were excluded from this analysis. A total of 2301 patients were randomized and received treatment with placebo (n = 771) or DMF BID (n = 769) or TID (n = 761). DMF significantly reduced the annualized relapse rate beginning in weeks 0-12 (BID, P = 0.0159; TID, P = 0.0314); the proportion of patients relapsed beginning at week 10 (BID, P = 0.0427) and week 12 (TID, P = 0.0451); and th...

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