Results 61 to 70 of about 11,898 (160)
Abstract Evaluation of the pharmacokinetics (PK) of new drugs in Japanese individuals is regularly requested by the Japanese regulatory agency prior to participation in global clinical trials or for bridging approaches for regulatory approval. However, the need for PK assessments in the Japanese population may be less compelling for monoclonal ...
Paridhi Gupta +2 more
wiley +1 more source
Abstract This first‐in‐human study evaluated the safety, pharmacokinetics (PK), food effect, and pharmacodynamics (PD) of AJM347, a novel orally active, selective α4β7 integrin antagonist, in healthy Caucasian and Japanese adult males. The study consisted of three parts.
Tetsuya Koyama, Tatsunori Seki
wiley +1 more source
In a 2‐year post‐marketing surveillance of Japanese patients with multiple sclerosis, dimethyl fumarate (DMF) showed manageable safety, with no new concerns identified; lymphocyte decreases were more frequent in older patients and those switching from fingolimod.
Ichiro Nakashima +10 more
wiley +1 more source
Natalizumab for the treatment of relapsing multiple sclerosis
Richard A Rudick1, Michael A Panzara21Cleveland Clinic Foundation, Cleveland, OH, USA; 2Biogen Idec, Inc., Cambridge, MA, USAAbstract: Natalizumab is an α4-integrin antagonist approved as monotherapy for patients with relapsing multiple ...
Richard A Rudick, Michael A Panzara
doaj
Background Fatigue is the most debilitating symptom in patients with multiple sclerosis (MS). Natalizumab and rituximab are the most used MS disease modifying therapies in Sweden, but comparative data on the effect on fatigue is sparse. Objective Primary
Johan Hellgren +3 more
doaj +1 more source
Progressive multifocal leukoencephalopathy (PML) induced by JC virus (JCV) is a risk for natalizumab-treated multiple sclerosis (MS) patients. Here we characterize the JCV-specific T cell responses in healthy donors and natalizumab-treated MS patients to
Molly R Perkins +19 more
doaj +1 more source
ABSTRACT The exclusion of pregnant individuals from clinical trials has resulted in a significant medical knowledge gap for this population. Leveraging real‐world data (RWD) provides a critical window into the prevalence and use of medications during pregnancy.
Jacqueline Williams +4 more
wiley +1 more source
Abstract Multiple sclerosis (MS) may impair ventricular‐vascular coupling (VVC), a measure of the interaction between the cardiac and vascular systems. We evaluated if VVC differed between individuals with and without MS with similar age‐predicted fitness.
Brooks A. Hibner +9 more
wiley +1 more source
Bruising following natalizumab infusion for relapsing-remitting multiple sclerosis: a case report
Introduction Natalizumab is a new treatment for relapsing-remitting multiple sclerosis. Because of limited experience of this treatment, medical professionals must be alert to possible side effects.
Gatzonis Stylianos, Siatouni Anna
doaj +1 more source
Introduction The TITAN study examined changes in productivity, ability to work, and quality of life (QoL) before and after treatment with the high-efficacy therapy natalizumab (TYSABRI®) in patients with multiple sclerosis (MS) in France.
Patrick Vermersch +9 more
doaj +1 more source

