OBJECTIVES We present the first study to explore safety and efficacy of the human CD20 monoclonal antibody ofatumumab in relapsing-remitting multiple sclerosis (RRMS). METHODS In this randomized, double-blind, placebo-controlled study, patients received 2 ofatumumab infusions (100 mg, 300 mg, or 700 mg) or placebo 2 weeks apart. At week 24, patients received alternate treatment. Safety and ef...

Glatiramer acetate (GA) has been used as an immunomodulatory agent for the treatment of relapsing-remitting multiple sclerosis (MS) in the United States since 1996. It is currently one of two first-line agents for use in the treatment of relapsing-remitting MS. GA was the first agent to be used in the treatment of MS that was developed using the animal model of MS called experimental autoimmune...

BACKGROUND Natalizumab (Tysabri, Biogen Idec and Elan Pharmaceuticals) significantly reduces the relapse rate and disability progression, and improves health-related quality of life (HRQoL), in patients with relapsing-remitting multiple sclerosis. We investigated the impact of natalizumab on patient-reported outcomes (PROs) in a real-world setting. METHODS PRO data were collected from patient...

Although Vitamin D is best known as a modulator of calcium homeostasis, it also has immune modulating potential. A protective effect of Vitamin D on multiple sclerosis is supported by the reduced risk associated with sun exposure and use of Vitamin D supplements. Moreover, high circulating levels of Vitamin D have been associated with lower risk of multiple sclerosis. In this study, we measured...

BACKGROUND Autonomic nervous system dysfunction is commonly seen in multiple sclerosis patients and should be explored in the routine evaluation. Composite Autonomic Symptom Score questionnaire was validated as a self-assessment instrument of autonomic symptoms. OBJECTIVES Determine the frequency of autonomic symptoms in multiple sclerosis patients through a Portuguese version of Composite Au...

Background Study objectives were to evaluate the Multiple Sclerosis Impact Scale (MSIS-29) and explore an optimized scoring structure based on empirical post-hoc analyses of data from the Phase III ADVANCE clinical trial. Methods ADVANCE MSIS-29 data from six time-points were analyzed in a sample of patients with relapsing-remitting multiple sclerosis (RRMS). Rasch Measurement Theory (RMT) an...

BACKGROUND AND PURPOSE Recent studies have suggested that enhancing lesions on contrast-enhanced T1-weighted MR images are predictive of impending exacerbations in cases of relapsing-remitting multiple sclerosis. We examined whether enhancing lesions, new enhancing lesions, and new hypointense lesions ("black holes") could accurately predict exacerbations in a cohort of 50 patients with relapsi...

INTRODUCTION Generally, fingolimod administration is simply discontinued when fingolimod-associated macular edema (ME) appears, and the majority of cases are said to recover spontaneously. However, to the best of our knowledge, this is the 1st report regarding improvement of ME without discontinuation of fingolimod administration. CASE PRESENTATION The patient was a 66-year-old woman with rel...

We investigate the effect of the choice of parameterisation of meta-analytic models and related uncertainty on the validation of surrogate endpoints. Different meta-analytical approaches take into account different levels of uncertainty which may impact on the accuracy of the predictions of treatment effect on the target outcome from the treatment effect on a surrogate endpoint obtained from th...

BACKGROUND Adequate risk knowledge of patients is a prerequisite for shared decision making but few attempts have been made to develop assessment tools. Multiple Sclerosis (MS) is a chronic inflammatory disease of young adults with an increasing number of partially effective immunotherapies and therefore a paradigmatic disease to study patient involvement. OBJECTIVE/METHODS Based on an item b...