Andrzej Wajgt

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BACKGROUND Natalizumab is the first alpha4 integrin antagonist in a new class of selective adhesion-molecule inhibitors. We report the results of a two-year phase 3 trial of natalizumab in patients with relapsing multiple sclerosis. METHODS Of a total of 942 patients, 627 were randomly assigned to receive natalizumab (at a dose of 300 mg) and 315 to(More)
BACKGROUND In a 2-year, placebo-controlled trial (the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] study), involving 942 patients with relapsing multiple sclerosis (MS), natalizumab significantly reduced the relapse rate by 68% and progression of sustained disability by 42% vs placebo. We report the effect of(More)
OBJECTIVE To report the relationship between disease activity and health-related quality of life (HRQoL) in relapsing multiple sclerosis, and the impact of natalizumab. METHODS HRQoL data were available from 2,113 multiple sclerosis patients in natalizumab clinical studies. In the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis(More)
OBJECTIVE To determine the incidence and clinical effects of antibodies that develop during treatment with natalizumab. METHODS In two randomized, double-blind, placebo-controlled studies (natalizumab safety and efficacy in relapsing remitting multiple sclerosis [MS, AFFIRM] and safety and efficacy of natalizumab in combination with interferon beta-1a(More)
OBJECTIVE To examine the effects of natalizumab on low-contrast letter acuity as a prespecified tertiary endpoint in two randomized clinical trials and to evaluate the usefulness of low-contrast letter acuity testing as a candidate test of visual function in multiple sclerosis (MS). METHODS AFFIRM and SENTINEL were randomized, double-blind,(More)
OBJECTIVE To evaluate the effects of oral delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on MRI lesion activity and load, atrophy, and magnetization transfer ratio (MTR) measures from the Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis (CONFIRM) study. METHODS CONFIRM was a 2-year, placebo-controlled(More)
The AFFIRM and SENTINEL studies showed that natalizumab was effective both as monotherapy and in combination with interferon beta (IFNβ)-1a in patients with relapsing multiple sclerosis (MS). Further analyses of AFFIRM and SENTINEL data were conducted to determine the efficacy of natalizumab in prespecified patient subgroups according to baseline(More)
BACKGROUND Multiple sclerosis is presumably cell-mediated autoimmune disorder with immune abnormalities as presence of activated T-cells and increase interleukin 2 (IL-2) and soluble IL-2 receptor (sIL-2R) levels in central nervous system and peripheral blood of patients. The aim of immunosuppressive treatment is to diminish such activation. The aim of this(More)
Cerebrospinal fluid (CSF) from 40 multiple sclerosis (MS) patients was tested by solid-phase radioimmunoassay (RIA) for ability to bind 2 common structural components of myelin and oligodendroglia, i.e., to bind myelin basic protein (MBP) and myelin-associated glycoprotein (MAG). To prevent the effect of differences in CSF IgG concentration on binding(More)