Publications by authors named "Lixin Zhang-Auberson"
Article Synopsis
- The study focuses on older adults (60+) who have undergone hip fracture surgery, investigating the potential benefits of bimagrumab, a monoclonal antibody, in improving their recovery and muscle mass.
- Conducted across 50 research centers worldwide, the trial was double-blind and placebo-controlled, enrolling participants with specific criteria to ensure accurate results.
- The primary goal was to assess changes in lean body mass after 24 weeks, while secondary goals included evaluating gait speed and physical performance, alongside monitoring for safety and adverse effects.
Article Synopsis
- The study aimed to examine the long-term effects of bimagrumab over two years in patients with sporadic inclusion body myositis (sIBM), following an initial core study.
- Participants continued receiving bimagrumab or a placebo every four weeks, with the main outcomes being changes in the 6-minute walk distance and safety.
- Results showed that all treatment groups experienced a decline in mobility over time, with high rates of adverse events; however, bimagrumab did not result in significant clinical benefits, leading to the early termination of the extension study.
Background: Inclusion body myositis is an idiopathic inflammatory myopathy and the most common myopathy affecting people older than 50 years. To date, there are no effective drug treatments. We aimed to assess the safety, efficacy, and tolerability of bimagrumab-a fully human monoclonal antibody-in individuals with inclusion body myositis.
View Article and Find Full Text PDFBackground: The low level of disease activity and manageable safety profile seen with fingolimod versus placebo in a 6-month, phase 2, randomized controlled trial in Japanese patients with relapsing multiple sclerosis (MS; ClinicalTrials.gov Identifier NCT00537082) were maintained in the initial 6-month observational study extension. Here, we report long-term safety and efficacy results of the 3-year follow-up to the phase 2 study extension.
View Article and Find Full Text PDFFirst-dose effects of fingolimod: Pooled safety data from three phase 3 studies.
Mult Scler Relat Disord
September 2014
Fingolimod treatment initiation is associated with a transient slowing of heart rate and atrioventricular conduction. This report presents first-dose fingolimod effects (0.5mg or 1.
View Article and Find Full Text PDFBackground: Fingolimod 0.5mg once daily is the first approved oral therapy for relapsing multiple sclerosis (MS).
Objective: To report integrated long-term safety data from phase 2/3 fingolimod studies.
Background: Fingolimod is a once-daily, oral sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing multiple sclerosis.
Objective: This post-hoc analysis of phase 3 FREEDOMS data assessed whether the effects of fingolimod are consistent among subgroups of patients defined by prior treatment history.
Methods: Annualized relapse rate and safety profile of treatment with fingolimod 0.
Objective: To assess long-term safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS).
Methods: Patients completing FTY720 Research Evaluating Effects of Daily Oral Therapy in MS (FREEDOMS) were eligible for this dose-blinded, parallel-group extension study, continuing fingolimod 0.5 mg/day or 1.
Background: A 6-month phase 2 study of fingolimod demonstrated efficacy and safety in Japanese patients with relapsing-remitting multiple sclerosis (MS). Here we report a 6-month observational extension that evaluated efficacy and safety in patients who received fingolimod continuously for 12 months or who switched from placebo to fingolimod.
Methods: Of 147 patients who completed the 6-month core study, 143 entered the extension.
Background: Siponimod is an oral selective modulator of sphingosine 1-phosphate receptor types 1 and type 5, with an elimination half-life leading to washout in 7 days. We aimed to determine the dose-response relation of siponimod in terms of its effects on brain MRI lesion activity and characterise safety and tolerability in patients with relapsing-remitting multiple sclerosis.
Methods: In this double-blind, adaptive dose-ranging phase 2 study, we enrolled adults (aged 18-55 years) with relapsing-remitting multiple sclerosis at 73 medical centres in Europe and North America.
Objective: To assess the impact of fingolimod (FTY720) therapy on magnetic resonance imaging measures of inflammatory activity and tissue damage in patients participating in a 2-year, placebo-controlled, phase 3 study.
Design: Patients with active relapsing-remitting multiple sclerosis were randomized to receive fingolimod, 0.5 mg; fingolimod, 1.
Background: Fingolimod 0·5 mg once daily is approved for treatment of relapsing multiple sclerosis (MS). In the phase 3, 2-year FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy in MS) study, fingolimod significantly reduced annualised relapse rates (ARRs) and the risk of confirmed disability progression compared with placebo. We aimed to investigate whether the beneficial treatment effect reported for the overall population is consistent in subgroups of patients with different baseline characteristics.
View Article and Find Full Text PDFArticle Synopsis
- NVA237 (glycopyrronium bromide) is being developed as a once-daily inhalation treatment for chronic obstructive pulmonary disease (COPD), focusing on its pharmacokinetics in patients.
- A study involved COPD patients receiving either NVA237 or a placebo for 14 days, measuring plasma levels and urinary excretion to understand drug absorption and clearance.
- Results indicated that NVA237 reached maximum plasma concentration quickly, showed dose-proportional exposure, and had a mean elimination half-life of 13 to 22 hours, with consistent pharmacokinetics across different doses and limited accumulation over time.
Background: In a 12-month phase 3 study in patients with relapsing-remitting multiple sclerosis (RRMS), TRANSFORMS, fingolimod showed greater efficacy on relapse rates and MRI outcomes compared with interferon beta-1a. We had two aims in our extension: to compare year 2 with year 1 in the switched patients to assess the effect of a change from interferon beta-1a to fingolimod, and to compare over 24 months the treatment groups as originally randomised to assess the effect of delaying the start of treatment with fingolimod.
Methods: Patients randomly assigned to receive 0.
Background: Oral fingolimod, a sphingosine-1-phosphate-receptor modulator that prevents the egress of lymphocytes from lymph nodes, significantly improved relapse rates and end points measured on magnetic resonance imaging (MRI), as compared with either placebo or intramuscular interferon beta-1a, in phase 2 and 3 studies of multiple sclerosis.
Methods: In our 24-month, double-blind, randomized study, we enrolled patients who had relapsing-remitting multiple sclerosis, were 18 to 55 years of age, had a score of 0 to 5.5 on the Expanded Disability Status Scale (which ranges from 0 to 10, with higher scores indicating greater disability), and had had one or more relapses in the previous year or two or more in the previous 2 years.